IPBLOGGER

Break till June 2010

2010-04-29T10:20:00.000+05:30

Dear Friends,

Offlate i had been out of blogging circuit and would not be able to blog till June 2010. I sincerely apologize to my friends for not being active for so long. I'll again come back in June 2010 with the updates.

Best regards,
IPBlogger.

Glenmark's Oxycodone HCl NDA for capsules and liquid solution under FDA review

2010-04-02T12:04:00.000+05:30

The USFDA has completed the filing review for NDA's for oxycodone hydrochloride capsules, and liquid solution of Glenmark Generics Inc., USA. The NDA was submitted by GGI's partner Lehigh Valley Technologies (LVT). The US FDA in a letter to the company indicated that it has begun reviewing the application for oxycodone hydrochloride. Total sales for oxycodone hydrochloride capsules and liquid solution in the twelve month period ending December 2009 were USD 16 million as reported by IMS Health. Pursuant to the Prescription Drug User Fee Act (PDUFA) guidelines, once an NDA is accepted for filing, it is expected that the FDA will complete its review and provide an action letter with respect to the NDA within 10 months following submission of the NDA.

Synthon sued for generic tadalafil and believes to be "FTF" for 180 days exclusivity

2010-04-02T11:55:00.000+05:30

Synthon has been sued by Eli Lilly and Icos Corporation in connection with the filing of Synthon's ANDA for Tadalafil 20 mg. Synthon's Tadalafil 20 mg Tablets product is a generic and bioequivalent version of Lilly's and United Therapeutics’ Adcirca® tablets which is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. Synthon believes that it is the ’Single First Filer’ of an ANDA with a Paragraph IV certification for the Adcirca® (Tadalafil) tablets, 20 mg. As a result, Synthon expects to be eligible for 180 days of Hatch-Waxman exclusivity upon the first commercial marketing of their generic drug product.

Teva Settles Generic Eloxatin Litigation

2010-04-02T11:36:00.000+05:30

Patent infringement litigation pertaining to Teva's generic version of sanofi-aventis and Debiopharm's Eloxatin (oxaliplatin injection) has been dismissed by the United States District Court for the District of New Jersey pursuant to a settlement between the parties. The settlement, which provides for a full release of Teva, includes an injunction prohibiting Teva from selling its oxaliplatin injection product and a license to reenter the market at a later point in time. Teva anticipates continued sales of its oxaliplatin injection at least through June 30, 2010, and will resume shipping additional units August 9, 2012, subject to acceleration under certain contingencies.

Dear Friends

2010-04-02T11:23:00.000+05:30

Dear Friends and fellow members,

After a long break of almost a month, i've come back. Sorry for the inconvenience. IPBlogger shall provide you updates time to time.

Best regards,
IPBlogger.

Ranbaxy's generic tamsulosin is delayed

2010-03-06T16:10:00.000+05:30

Ranbaxy Laboratories’ stab at potential sales of millions of dollars has come to naught after it failed to secure the FDA’s permission to market the generic version of tamsulosin (Flomax) in the

. Ranbaxy, the Indian unit of Japanese drugmaker Daiichi Sankyo, was to launch the generic version of the Japan-based Astellas’ Flomax on March 2, 2010 in the

, eight weeks before the drug’s patent expires in the

following an out-of-court settlement in 2007. Flomax, used to treat prostrate enlargement and marketed by German drugmaker Boehringer Ingelheim, recorded sales of around $2 billion in the

last year.

The USFDA refusal to give permission is another blow for the Gurgaon-based drugmaker, whose 30 drugs were banned by the FDA in September 2008. The FDA also halted fresh approval for two of its Indian plants for violating US manufacturing rules. Early last year, the FDA also delayed the launch of its generic version of GlaxoSmithKline’s Imitrex. The spokesman did not set a new launch date. Even if Ranbaxy is able to launch the product, its upside will be severely limited as it enjoyed only an eight-week marketing exclusivity window.

Moreover, US-based Impax Laboratories, another generic drug maker, was able to launch its product on Tuesday. Impax had also arrived at an out-of-court settlement with Astellas over the drug. An Impax release quoting a Wolters Kluwer Health figure said Flomax saw sales of around $1.9 billion for the 12 months ended August 31, 2009, in the

. A back-of-the-envelope calculation suggests that Ranbaxy could have earned up to $100 million during the eight-week exclusivity period. Ranbaxy would have been one of only three companies selling the drug besides Impax and Boehringer Ingelheim during that period. Once the patent of an original drug expires, several drugmakers launch their low-cost versions and there is significant price erosion, sometimes up to 95%. But during the period of marketing exclusivity, there are few players and price erosion is considerably less.

AstraZeneca sues Lupin on Nexium IV generic

2010-03-06T16:00:00.000+05:30

AstraZeneca sued

India

’s Sun Pharmaceuticals Industries Ltd. to prevent it from selling a generic form of the ulcer medicine Nexium IV in the

U.S.

before 2014. Sun is seeking U.S. Food and Drug Administration approval to sell Nexium in a form that is delivered through intravenous injections. AstraZeneca claims the generic copy would infringe two patents that expire in May 2014 and November 2014. Nexium IV, first approved by regulators in 2005, is similar to the “purple pill” that is most commonly sold as a capsule. Nexium in all forms generated $2.84 billion in

U.S.

sales last year for the London-based company, AstraZeneca said Jan. 28. Global Nexium sales were $4.96 billion, making it AstraZeneca’s biggest seller. Nexium IV is a small part of sales and is typically given while people are in the hospital through an intravenous drip, said Blair Hains, a spokesman for the company. He said the company doesn’t break out sales of Nexium IV. AstraZeneca settled patent claims against Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd., with both agreeing not to sell the Nexium pill until 2014. Similar suits are still pending against Lupin Ltd. and Dr. Reddy’s Laboratories Ltd., AstraZeneca said.

Teva Pharmaceutical Settles Lawsuit With Novartis

2010-02-17T10:48:00.000+05:30

Teva Pharmaceuticals USA, Inc., has signed an agreement with Novartis to settle patent litigation involving Teva’s U.S. generic version of Novartis’ Famvir(R) (famciclovir) 125 mg, 250 mg and 500 mg tablets including all claims for patent infringement and damages. Teva launched its generic famciclovir tablets in the U.S. in September 2007. The present agreement releases Teva for all past and future activities in connection with the U.S. marketing and sale of Teva’s generic famciclovir tablets. Under the terms of the agreement, Teva will make a one-time payment to Novartis in addition to an ongoing royalty on U.S. sales of the generic product.

Philippine Court denies Pfizer petition to block generic Variant

2010-02-16T15:20:00.000+05:30

A LOCAL court has denied Pfizer Inc.'s bid to stop the sale of a generic version of anti-hypertensive drug Variant manufactured by Philippine drug-maker United Laboratories Inc. (Unilab). In a statement, Pfizer said it would ask the court to reconsider its ruling on the generic version of Atorvastatin Calcium. Pfizer and co-plaintiff Warner Lambert Co. LLC had filed a patent infringement case against Unilab in October last year. Pfizer said it owns the Philippine patent of Atorvastatin Calcium, adding this patent would expire in 2012. The drug is sold by the company under the brand name Lipitor. Unilab and its sister company Therapharma Inc. also in October last year had released Avamax, a generic version of Atorvastatin. Unilab had also filed an invalidation case against Pfizer's Atorvastatin patent before the Intellectual Property Office of the Philippines in July last year, but this case is still pending.

Teva sends ANDA certificate notification to Gilead Sciences for Viread

2010-02-03T16:10:00.000+05:30

Gilead Sciences announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an ANDA to the USFDA requesting permission to manufacture and market a generic version of Viread^® (tenofovir disoproxil fumarate). In the notice letter, Teva alleges that three patents associated with tenofovir disoproxil – US Patent Numbers 5,922,695; 5,977,089; and 6,043,230; and one patent associated with tenofovir disoproxil fumarate – US Patent Number 5,935,946 – owned by Gilead Sciences are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA submission.

Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Teva. Such a lawsuit would restrict the FDA from approving Teva's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Viread is currently protected by four patents, which are listed in the FDA's Approved Drug Products List, and all four patents would need to be invalidated or expired before a generic version of Viread could be marketed. The USPTO confirmed the patentability of these four Viread patents in 2008.

Gilead currently has a lawsuit pending against Teva in response to Teva's attempts to seek approval for generic versions of Truvada^® (emtricitabine and tenofovir disoproxil fumarate) and Atripla^® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on allegations that two emtricitabine patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of its generic product.

Taro receives FDA Approval for Keppra® (Levetiracetam tablets)

2010-02-03T15:46:00.000+05:30

Taro Pharmaceutical Industries Ltd. has received approval from the USFDA for its ANDA for Levetiracetam Tablets, 250 mg, 500 mg, 750 mg and 1000 mg. Taro's levetiracetam tablets is a prescription product used in the treatment of epilepsy, and is bioequivalent to UCB's Keppra® Tablets. According to industry sources, levetiracetam tablets had U.S. sales of over $700 million in 2009.

Impax confirms Patent Challenge against Colesevelam HCl tablets, 625 mg

2010-01-20T14:51:00.000+05:30

Impax has initiated a challenge against patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) tablets, 625 mg by filing an ANDA containing a para IV certification for a generic version of WELCHOL® with the USFDA. Following receipt of the notice from the FDA that Impax's ANDA had been accepted for filing, Impax notified the NDA holder and patent owners of its paragraph IV certification. On January 14, 2010, Daiichi Sankyo, Inc. and Genzyme Corporation filed suit for patent infringement against Impax in the United States District Court for the District of Delaware. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Based on the filing date of the ANDA, the Company believes that it is the first to file an ANDA with a paragraph IV certification and expects to be entitled to 180 days of market exclusivity. Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax's generic division, will commercialize the products.

WELCHOL® is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin), reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy, and improve glycemic control in adults with type 2 diabetes mellitus. According to Wolters Kluwer Health, U.S. sales of WELCHOL® were approximately $308 million for the twelve-month period ending November 2009.

Endo receives para IV certification notice from Watson for lidocaine topical patch

2010-01-20T14:45:00.000+05:30

Endo Pharmaceuticals and its partners, Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. have received a Paragraph IV Certification Notice from Watson Laboratories. Watson has filed an ANDA for a generic version of LIDODERM® (lidocaine topical patch 5%). The certification refers to U.S. Patent No. 5,827,529, which covers the formulation of LIDODERM, a topical patch to relieve the pain of postherpetic neuralgia launched in 1999 wherein the patent shall expire in 2015. The company is currently reviewing the details of this notice from Watson. Endo intends to vigorously defend LIDODERM's intellectual property rights and pursue all available legal and regulatory pathways in defense of LIDODERM.

Watson files ANDA for generic LoSeasonique® [(levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg)]

2010-01-12T16:06:00.000+05:30

Watson has filed an ANDA with the USFDA seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of US Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd.

On November 23, 2009, pursuant to the Hatch-Waxman Act, Watson notified Duramed that its ANDA requesting approval from the FDA for a generic version of LoSeasonique® contained a paragraph IV certification asserting that the LoSeasonique® patent is invalid, unenforceable and/or not infringed. Teva Women's Health, Inc. filed suit against Watson on January 6, 2010 in the U.S. District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,615,545. Based on available information, Watson believes it may be entitled to 180 days of generic market exclusivity or shared exclusivity should its product receive approval.

Pros and Cons of US Reissue patent and reexamination system

2010-01-09T14:34:00.000+05:30

The reissue and reexamination procedures of the U.S. Patent and Trademark Office (USPTO) are valuable tools for businesses that want to strengthen their patent portfolio or weaken that of their competitors. Reissue allows patent owners to correct errors in U.S. patents. Reexamination allows anyone to test the validity of a U.S. patent. Neither procedure affects the original patent until either a reissue patent is granted or a reexamination certificate is issued.

Benefits of Reissue

1. Reissue allows a patentee to correct a wide variety of errors in a patent wherein the error may include inadvertently obtaining a patent that does not cover all of the disclosed inventions the patentee intended to protect.

2. By Reissue patent a patentee can help to correct errors wherein the patentee inadvertently covers too much subject matter, such as an invention already known in the prior art which if not corrected would render the patent invalid.

3. In reissue, patentability issues may be submitted based on any type of prior arts (patents, printed publications, and prior knowledge, use, or sale of the claimed invention). Reissue applications are handled by examiners in the same patent-examining group that issued the original patent; thus, they are likely to have technical expertise relevant to the claimed invention.

4. In reissue, a patent owner can request automatic extensions of time for a fee, file additional continuation applications, and request continued examination (RCE) of a patent, each providing the patentee additional time and opportunity to address any problems in the patent.

5. Besides the abovesaid points, reissue can correct typographical errors in a patent's specification and drawings, incorrect listings of inventors, or inadvertent procedural errors made by the patentee during the patent-application process.

Limitations of Reissue

To be eligible for reissue, the patent owner must acknowledge and identify an error in the patent. But there are limits to the types of errors correctable through reissue.

1. A patentee gets a limited period (two years post issue of the patent) to correct the errors.

2. Second, even if a patentee requests a broadening reissue within the two-year time limit, the patentee may not broaden the original patent to recapture disclaimed subject matter.

3. Third, if a patentee made misrepresentations or intentionally failed to submit relevant prior art to the USPTO during the patent-application process, the patentee may not use reissue to correct such inequitable conduct.

4. Only a patent owner can request a reissue of the patent, but once the reissue process has begun, a third party may file a protest arguing why a patent claim is not patentable. Other than the protest, a third party cannot participate in the reissue process.

Benefits of Reexamination

In the US, businesses can challenge a patent's validity through a lawsuit before a federal court or through reexamination at the USPTO. There are, however, a number of advantages to reexamination.

1. First, reexaminations are much cheaper than patent lawsuits, which can cost millions of dollars. One of the main reasons for the high litigation costs is the extensive discovery permitted in U.S. federal courts. Reexaminations, on the other hand, are more focused, discovery more limited or nonexistent.

2. Second, in federal court, an issued patent is automatically presumed valid. Judges and juries in federal court can declare the patent invalid only if there is "clear and convincing" evidence. But in reexaminations, there is no such presumption; thus, it can be easier to invalidate a patent at the USPTO.

3. Third, most reexaminations can be requested anonymously. If a requester fears the patent owner is targeting the requester for a patent-infringement suit, then he can file a reexamination request anonymously through a third party, such as a patent attorney. In contrast, lawsuits in federal court require identification of the real party in interest.

4. Fourth, reexamination can be requested during litigation. Judges will often stay a patent litigation pending the outcome of a reexamination. The stay benefits a defendant because it gives the defendant time to prepare the case and search for additional prior art to use in an invalidity defense. The likelihood that a judge will grant a stay depends greatly on each judge's preference. Judges in the district courts of California regularly grant stays pending the outcome of a reexamination, whereas judges in the Eastern District of Texas rarely grant stays.

5. Fifth, even if a patent is not completely invalidated during reexamination, the USPTO will often reduce the scope of patent claims. Thus, a device or process that might have infringed a patent before reexamination might not infringe the same patent after reexamination.

Limitations of Reexamination

Reexamination poses some risks. Before the USPTO grants a reexamination request, it reviews the request and the prior art submitted with the request to determine whether the request raises a substantial new question of patentability. If the USPTO denies the request, it has, in effect, determined that the prior art submitted with the request would not invalidate the patent. The USPTO, however, rarely denies a reexamination request—only about eight percent of the time. Alternatively, the USPTO may grant the reexamination request but confirm the validity of the patent during reexamination. In both cases, the reexamination strengthens the patent, making it harder to assert invalidity later on. Thus, reexamination can backfire on a requester who intended to invalidate the patent but must instead deal with a stronger patent that survives reexamination. This is why patent owners often file reexamination requests for their own patents after learning of prior art that may affect validity. Indeed, approximately 40% of ex parte reexaminations—one type of reexamination at the USPTO—are filed by patent owners. Only patentability issues based on prior patents or printed publications may be submitted for reexamination. The central reexamination unit at the USPTO handles reexaminations. It deals with a broad variety of technologies, so examiners working on a reexamination may not always have the technical expertise most relevant to the claimed invention. Lastly, like reissue, reexamination cannot be used to correct inequitable conduct.

It can take from less than a year to several years for the USPTO to complete a reexamination, which can cause much uncertainty for companies waiting to make business decisions based on the outcome. The USPTO is charged to handle all reexaminations with special dispatch, especially for patents already in litigation. But if the reexamination unit is busy or if the patent under reexamination is in a popular technology area, the reexamination process can often be slow. Further, if the patent owner disagrees with the outcome of the reexamination, he can appeal to the USPTO's Board of Patent Appeals and Interferences, then later to the U.S. Court of Appeals for the Federal Circuit, each of which may take several years to resolve.

Medicines Company files additional Patent Infringement Lawsuits

2010-01-08T15:29:00.002+05:30

The Medicines Company has filed lawsuits against Teva Parenteral Medicines, Inc., Pliva Hrvatska d.o.o. and related entities in the United States District Court for the District of Delaware alleging patent infringement based on ANDA seeking USFDA approval to market and sell generic versions of The Medicines Company's Angiomax(R) product prior to expiration of U.S. Patent No. 7,598,343 ("the '343 patent"). Each lawsuit alleges infringement of the '343 patent which was issued on October 6, 2009. As per an earlier announcement, The Medicines Company has patent infringement lawsuits pending against the same parties in the United States District Court for the District of Delaware for infringement of its U.S. Patent No. 7,502,727.

Strides Arcolab to market 40 off-patent sterile injectable & oral products in US

2010-01-08T15:19:00.002+05:30

Strides Arcolab has collaborated with Pfizer to commercialize 40 off-patent sterile injectable and oral products in the US through the latter’s established products business unit. The finished dosage form products will be licensed and supplied by Strides and Onco Laboratories Limited and Onco Therapies Limited, two joint ventures between Strides and Aspen, South Africa, in which each has a 50 per cent ownership interest.

Pfizer’s established products business unit launched its US Injectables team less than 10 months ago and is already marketing products in the US. Through this new collaboration with Strides, Pfizer is gearing up to become one of the top players in the injectables market, according to the company note. Both Strides and Pfizer view the collaboration as highly complementary. Many of these drugs are oncology therapeutics for healthcare providers and patients in the US. By integrating Pfizer’s solid commercial infrastructure with Strides’ high-quality manufacturing capabilities, the first of the products commercialized under this collaboration is expected to be launched in the second half of 2010.

Strides has 14 manufacturing facilities across 6 countries, including its joint venture with Aspen in India and has a marketing presence in more than 60 countries in developed and emerging markets. Its production and research wings has a total personnel strength 2000 across all countries of which 350 accounts for its scientific team.

Tentative approval of Lamivudine, Nevirapine, and Zidovudine FDC Tablets

2010-01-08T15:06:00.003+05:30

USFDA has granted tentative approval for a FDC product containing lamivudine, nevirapine, and zidovudine, 150mg/200mg/300mg, indicated for use alone as a complete regimen, or in combination with other antiretrovirals, for the treatment of HIV-1 infection. This new FDC is manufactured by Strides Arcolab Limited, India. Each constituent ingredient of this generic tablet is currently approved to treat HIV-1 in combination with other antiretroviral agents. The safety and effectiveness of the combination of lamivudine/nevirapine/zidovudine in lowering viral load and increasing CD4+ cells has been demonstrated in previous studies of the individual ingredients used together.

FDA's tentative approval means that although a product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the US, existing patents and/or proprietary issues currently prevent marketing of the product in the United States. Tentative approval, however, does qualify the product for consideration for purchase under the President's Emergency Plan for AIDS Relief, or PEPFAR. As with all generic applications, FDA conducts an on-site inspection of the manufacturing facilities and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application. These products were reviewed for PEPFAR under the FDA guidance titled Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV. A list of all FDA approvals and tentative approvals for PEPFAR can be found here

Watson filed ANDA for generic armodafinil

2010-01-08T14:59:00.003+05:30

Watson's subsidiary, Watson Laboratories, Inc. has filed an ANDA with the USFDA seeking approval to market its 50 mg, 100 mg, 150mg, 200 mg, and 250mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France. Watson's 50 mg, 100 mg, 150mg, 200 mg and 250mg armodafinil tablet products are generic versions of Cephalon, Inc.'s Nuvigil(R), which is indicated for the improvement of wakefulness in adults who experience excessive sleepiness (ES) associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), or narcolepsy.

Cephalon, Inc. and Cephalon France filed suit against Watson on January 5, 2010 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,132,570. Cephalon's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Watson claims to be a "first applicant" to file an ANDA for the 100 mg and 200 mg strengths of a generic version of Nuvigil(R) and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for those strengths.

Teva entered into agreement with AstraZeneca regarding Prilosec® (omeprazole) and Nexium® (esomeprazole) generics

2010-01-08T14:38:00.004+05:30

Teva Pharmaceuticals has entered into two definitive agreements with AstraZeneca to settle patent litigation regarding Teva's US generic versions of AstraZeneca's Prilosec® (omeprazole) and Nexium® (esomeprazole), including all claims for patent infringement and damages. Under the terms of the omeprazole agreement, Teva will obtain a release for all past sales of its generic omeprazole and will continue to market its product in the US and will make a one-time payment to AstraZeneca. As part of the esomeprazole agreement, AstraZeneca has granted Teva a license, subject to regulatory approval, to enter the US market with its generic esomeprazole delayed-release capsules on May 27, 2014, or earlier in certain circumstances. Additional details were not disclosed. Merck Sharp & Dohme Corp, through KBI Inc. and KBI-E, and under the terms of Merck's restructured partnership with AstraZeneca, announced in 1998, also entered into the settlement agreements.

TA-CD (Cocaine conjugate vaccine)

2010-01-08T13:18:00.003+05:30

Cocaine’s primary sites of action in the brain include monoamine neurotransmitter transporters for dopamine (DAT), serotonin (SERT) and norepinephrine (NET). DAT, SERT and NET regulate the amount of dopamine, serotonin and norepinephrine available for signal transduction by removing excess monoamine from the synapse back to the presynaptic neuron. Cocaine is able to bind to these transporters and causes a blockade in neurotransmitter reuptake by the presynaptic neuron, thus prolonging neurotransmitter availability in the synaptic cleft. This leads to excessive activation of the postsynaptic neuron, as a consequence of increased binding of the neurotransmitters to their respective receptors, which is manifested as cocaine-induced reward/reinforcement.

The current lack of approved pharmacotherapies in Europe and the US for the treatment of cocaine addiction has prompted the search for novel therapeutic modalities to supplement psychotherapy, a common treatment choice for cocaine dependence which, however, has not been proven to be substantially beneficial for a large number of patients. Effective treatments for addictions must possess the ability to initiate abstinence and prevent subsequent relapse. Celtic Pharma has taken a step forward in this regards and one its conjugate vaccine termed TA-CD is under clinical evaluation. The vaccine, which was generated by covalently attaching succinylnorcocaine to recombinant cholera toxin-B protein adsorbed onto aluminum hydrochloride adjuvant, represents a relapse-prevention therapeutic approach by stimulating the production of cocaine-specific antibodies that bind to cocaine and prevent it from crossing the blood-brain barrier. Blocking cocaine entry into the brain reduces its euphoric and reinforcing effects. The details can be read

here

EU probes Lundbeck for generic citalopram delay

2010-01-08T12:43:00.003+05:30

EU regulators suspect Danish Company Lundbeck may have delayed the launch of a cheaper, generic version of its antidepressant drug (citalopram) in Europe. The European Commission said it had opened a formal antitrust investigation to check whether H. Lundbeck A/S made deals with other pharmaceutical companies to delay them selling citalopram after Lundbeck's exclusive right to the drug it developed ran out in 2003. Citalopram is one of the most widely used drugs to treat depression and anxiety and is sold under the name Celexa in the U.S. and Canada and Cipramil in most of Europe. It acts by altering serotonin levels which can raise a person's mood. Lundbeck has expressed cooperation with the EU regulators and was "confident that the group has complied with all relevant national and EU competition legislation." The company recently patented escitalopram, which is chemically similar to citalopram. Three generics companies tried to challenge that patent in the British courts, claiming it was not significantly different to the original drug. In 2008, Lundbeck won on appeal, protecting its patent.

Investigations are in the pipeline to be carried out by EU regulators who would monitor the allegations on Lundeback as a matter of priority. The EU says generic drugs are on average 40 percent cheaper than their branded rivals two years after they launch. It warned that it knew of at least 200 settlement agreements - some including payments to delay drug launches - between generic and brand-name drug makers that could restrict the rollout of generic versions.

Abbott and Fournier agree to pay $22.5 million for blocking generic fenofibrate

2010-01-08T12:37:00.003+05:30

Makers of the popular cholesterol-lowering drug TriCor have agreed to pay $22.5 million to resolve allegations that they illegally kept generic versions off the market. As a result of these practices, consumers and state governments paid higher prices for the cholesterol drug.

Under the agreement, Abbott and Fournier will pay $22.5 million to the states. North Carolina's share of nearly $800,000 will go to the state's Medicaid program, a joint federal-state program that provides health insurance for the poor. TriCor is a brand-name prescription drug that uses the active ingredient fenofibrate to regulate trigyliceride and cholesterol levels.

Cooper and the other attorneys general allege that since 1998, Abbott and Fournier have successfully monopolized sales of fenofibrate drugs by blocking generics from the market. The companies crafted elaborate schemes like filing multiple patents with the Federal Drug Administration and then filing patent infringement lawsuits to delay generic versions of TriCor. The attorneys general also contend that Abbott and Fournier thwarted competition by making various clinically insignificant changes to the dosage and form of TriCor and manipulating the drug codes used to create generic substitutions. Under the settlement, Abbot and Fournier have agreed not to delete the drug codes for the latest version of TriCor in the event a generic manufacturer seeks FDA approval of a generic version of the drug.

USPTO has launched Interactive Patent Pendency Model (PPM)

2009-12-29T14:13:00.002+05:30

The USPTO on December 19 announced the launch of an interactive patent pendency model (PPM) that enables users to see how overall application pendency is affected by the number of examiner hires per year; the amount of overtime worked, and patent filing levels. In one example, the model shows that an additional 1,000 examiners hired in the period during 2010-2012 could reduce the backlog from 719,000 to just over 470,000 by the end of 2012. Alternatively, if no new examiners were hired and no overtime was allowed, the current backlog could increase to 1,651,000, and the first action pendency would increase from 25 months to 67 months. The PPM was established to further the USPTO's efforts to increase transparency and to reduce patent pendency. The PPM webpage can be found in the Patent statistics area of the USPTO Web site.

Arbitration result between Asahi Kasei and CoTherix, Inc. of the US

2009-12-29T14:11:00.001+05:30

A final ruling has been issued in arbitration proceedings between Asahi Kasei Pharma and CoTherix regarding a license agreement for CoTherix to develop fasudil, a rho-kinase inhibitor discovered and owned by Asahi Kasei Pharma. In June 2006 the two parties concluded a license agreement whereby Asahi Kasei Pharma granted CoTherix rights for the development and commercialization of fasudil. In January 2007 CoTherix discontinued the development of fasudil, and in October 2007 Asahi Kasei Pharma initiated arbitration proceedings with the International Chamber of Commerce in California seeking compensation for breach of the terms of the license agreement. In its final ruling, the arbitration panel has ordered CoTherix to pay Asahi Kasei Pharma approximately US$91 million. Asahi Kasei Pharma is now examining the details of this ruling and the effect the ruling will have on its financial results. The financial effect of the ruling will be disclosed upon final confirmation.

Amgen and Roche end EPO patent infringement dispute

2009-12-24T13:07:00.000+05:30

Roche has admitted the infringement and validity of Amgen's EPO Patents. Court has entered Permanent Injunction and Roche would launch its pegylated-erythropoietin (peg-EPO) product in the US market in mid-2014. The final judgement and injunction was entered by US District Court in Boston against Roche prohibiting Roche from infringing Amgen's patents on recombinant erythropoietin (EPO), thus bringing the five-year patent infringement dispute to an end. Roche conceded with the decision that the five Amgen EPO patents involved in the lawsuit are valid, enforceable and infringed by Roche's pegylated-erythropoietin (peg-EPO) product MIRCERA. The settlement terms do not include any financial payments between the parties.

NicOx submits naproxcinod MAA to the EMEA

2009-12-24T12:57:00.003+05:30

NicOx S.A. has submitted a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) through the centralized procedure, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). This follows the submission of a NDA to the USFDA in September that has recently been accepted for filing. Naproxcinod is NicOx's lead investigational compound and the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators). The MAA file is supported by data from a large program of 34 clinical trials that involved more than 4,000 subjects treated with naproxcinod.

NicOx's lead investigational compound is naproxcinod, an NCE and a first-in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory drug candidate for the relief of the signs and symptoms of osteoarthritis. NicOx submitted a NDA for naproxcinod to the USFDA in September 2009 and a MAA to the EMEA in December 2009, following the successful completion of three pivotal phase 3 studies. The NDA for naproxcinod was accepted for filing by the FDA in November 2009 and the FDA has set a target date of July 24 2010, for the completion of its review. The FDA and the EMEA will evaluate the data submitted. NicOx does not wish to make any claims in regard to naproxcinod’s safety or efficacy prior to its potential approvals.

Mylan sued for its generic version of Vytorin by Schering and MSP Singapore

2009-12-24T12:24:00.004+05:30

Mylan has been sued by Schering and MSP Singapore Company in the US District Court for the District of New Jersey alleging patent infringement for filing an ANDA with the USFDA for Ezetimibe and Simvastatin tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg. This product is the generic version of Vytorin tablets. Mylan says that it is the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for the product and expects to qualify for 180 days of sole marketing exclusivity once final US FDA approval is obtained. Vytorin Tablets had approximately US$ 1.6 billion in sales for the same strengths for the 12 months ending September 30, according to IMS Health.

Mylan receives tentative approval for Efavirenz tablets

2009-12-24T12:19:00.002+05:30

Mylan has received tentative approval from the USFDA for its NDA for Efavirenz Tablets, 50 mg, 100 mg and 200 mg. The approval was secured by the company's subsidiary Matrix Laboratories Limited under the President's Emergency Plan for AIDS Relief (PEPFAR). These innovative paediatric dosages in tablet form were developed by Matrix for use in treating paediatric HIV/AIDS, the company said. Efavirenz is a non-nucleoside reverse transcriptase inhibitor (nNRTI) that has been found to be effective in many combination regimens for the treatment of HIV infection, both in treatment-naive and in treatment-experienced individuals.

Lupin settles Alzheimer drug litigation with Forest Laboratories

2009-12-22T16:46:00.002+05:30

Pharma major, Lupin announced today that it has settled all ongoing Hatch Waxman litigation relating to memantine tablets, Lupin's generic version of Forest Laboratories, Alzheimer disease treatment "Namenda" tablets. As per the terms of the settlement, Lupin will be licensed under the relevant patents and would be free to commercially launch its generic product in Jan 2015 or earlier in certain circumstances. Lupin had earlier filed a Paragraph IV certification to US Patent No 5,061,703, contesting that the patent was invalid or had not been infringed, resulting in the subsequent litigation with Forest.

AstraZeneca Loses Appeal against Dr. Reddy's for generic Prilosec

2009-12-22T14:03:00.004+05:30

The U.S. Court of Appeals for the Federal Circuit has rejected AstraZeneca AB’s appeal of a lower court decision that Dr. Reddy's Laboratories Ltd.’s generic version of popular over-the-counter antacid Prilosec did not infringe (omeprazole delayed-release) capsules OTC did not infringe two US patents, Nos 5,900,424 and 5,690,960. Judge Colleen McMahon of the U.S. District Court for the Southern District of New York dismissed the suit in March, finding thatDr. Reddy’s drug used a different form of omeprazole magnesium (with less than 1 percent crystallinity), the primary ingredient in Prilosec, than that covered in the AstraZeneca patents.

Astra argued that Dr. Reddy’s had infringed its patents based on the doctrine of equivalents, but Judge McMahon deflated that line of reasoning, as well. “Because AstraZeneca argued to the USPTO that its patented product could be distinguished from other products because it was more than 70 percent crystalline, it cannot now argue that a product less than 70 percent crystalline infringes under the doctrine of equivalents,” she said.

IPblogger to provide time to time update on new molecules

2009-12-21T15:59:00.004+05:30

IPblogger shall timely provide information on new molecules with updates. Its a small initiative and IPblogger shall need your support in this small effort.

This month, the information is regarding Nalfurafine hydrochloride. Pruritus is a common symptom seen in up to 90% of uremic patients, especially those with chronic renal failure requiring hemodialysis. The cause and mechanism of induction of pruritus are not known. Research and studies have revealed that an imbalance in the endogenous opioid system may be responsible for pruritus, with particular involvement of the kappa opioid system. The existing kappa opioid receptor agonists lack morphine-like adverse effects and are associated with dysphoria and psychotomimetic alterations. Thus, research efforts continue to focus on new kappa opioid agonists with novel structures to circumvent unwanted adverse effects.

Nalfurafine hydrochloride is a novel kappa opioid receptor agonist that is highly selective for the kappa opioid receptor in vitro and displays potent antipruritic activity in vivo. A single dose of an oral formulation was shown to alleviate itch in hemodialysis patients suffering from severe pruritus. The kappa-opioid agonist nalfurafine hydrochloride (Remitch^®) was approved and launched for the first time in spring 2009 in Japan, where it is indicated for the improvement of pruritus in hemodialysis patients who have not responded to conventional treatment. Nalfurafine was codeveloped by Toray, Japan Tobacco and Torii Pharmaceuticals; it is manufactured and marketed by Toray. It has orphan drug status in Japan for the approved indication.

Trial date set for CUBICIN® (daptomycin for injection) patent litigation

2009-12-21T15:51:00.003+05:30

A trial date has been set for patent litigation in the U.S. District Court for the District of Delaware against Teva alleging infringement of Cubist's US Patent Nos. 6,468,967 and 6,852,689 (expiry September 24, 2019) and US Patent No. RE39,071 (expiry June 15, 2016). The Court has set a date for trial beginning on April 25, 2011. The court also scheduled a claim construction hearing (a.k.a. Markman hearing) for June 2, 2010. The court indicated that summary judgment motions will not be permitted in this lawsuit. Cubist filed the lawsuit in response to an ANDA filed by TPM seeking USFDA approval to market a generic version of daptomycin prior to the expiration of Cubist's patent rights. Daptomycin is marketed in the US and internationally under the brand name CUBICIN® (daptomycin for injection) as therapy for serious skin and bloodstream infections caused by certain Gram-positive bacteria.

Teva Launches Co-Beneldopa (Levodopa/Benserazide)

2009-12-21T15:45:00.001+05:30

Teva UK Limited has launched the first generic co-beneldopa capsules in a variety of strengths. Co-beneldopa is a dopaminergic drug indicated for treatment of symptoms of Parkinson's disease. It is a generic version of Madopar(R) (co- beneldopa) made by Roche. It is available immediately in the award-winning Teva 360 livery, which is designed to aid patient safety.

Ranbaxy to launch olmesartan medoxomil in Kenya, Mozambique, Nigeria, Tanzania, Uganda and Zambia

2009-12-21T15:43:00.002+05:30

Ranbaxy Labs is set to launch olmesartan medoxomil, an anti-hypertensive, under the brand name Olvance in six African countries viz., Kenya, Mozambique, Nigeria, Tanzania, Uganda and Zambia. The product is originally discovered by Daiichi. This is the first time in Africa that Daiichi and Ranbaxy are leveraging mutual synergies. Olmesartan medoxomil is a member of the Angiotensin receptor blocker (ARB) class of antihypertensive medications that help lower blood pressure by blocking the angiotensin II receptor on the blood vessels and antagonizing the release of hormone which causes salt retention and increased blood volume. Olmesartan medoxomil is available in more than 50 countries worldwide. Ranbaxy launched olmesartan medoxomil as Olvance in India in April 2009, followed by the August launch of Ol-Vamlo, a fixed-dose combination of olmesartan medoxomil with amlodipine besylate.

USFDA grants approval to Mylan's generic version of Keppra 1000mg

2009-12-16T16:56:00.000+05:30

Mylan has received final approval from the USFDA for its ANDA for Levetiracetam Tablets, 1000 mg. Levetiracetam Tablets are the generic version of UCB Pharma's antiepileptic Keppra®. This additional strength of Levetiracetam Tablets complements Mylan's already approved and marketed strengths of 250 mg, 500 mg and 750 mg. Levetiracetam Tablets, 1000 mg had U.S. sales of approximately $136 million for the 12 months ending Sept. 30 and is shipping immediately.

Bayer withdraws MAA for Recothrom (thrombin alfa)

2009-12-16T16:24:00.003+05:30

Bayer Schering Pharma has notified the EMEA of its decision to withdraw its application for a centralised marketing authorisation for the medicine Recothrom (thrombin alfa) 1,000 IU/ml. Recothrom was still under the review process by the CHMP at the time of withdrawl. In its official letter, the company stated that the withdrawal of the application was based on the concerns raised by the Committee regarding the choice of study population for the label in general surgery as well as the choice of comparator relative to the CHMP fibrin sealant guideline.

Free access Weblink to chemical molecules and associated patents

2009-12-16T15:54:00.004+05:30

Ipblogger has come across a weblink under the link name http://www.chemspider.com/. The said weblink is a free access service providing a structure centric community for chemists. Providing access to millions of chemical structures and integration to a multitude of other online services, ChemSpider is the richest single source of structure-based chemistry information.

A simple or an advanced search for a particular molecule can provide the searcher a good deal of information pertaining to different chemical properties as well as patent information from the USPTO, EPO as well as PCT website. The search takes few seconds to complete. Interested scientist/chemist can further create an account and can also upload information. Although this is a free to access website but ipblogger would like to recommend the same to each and every scientist/chemist to try this website once.

Note: Ipblogger would like to specially acknowledge Mr. Ratish Acharya who provided the information about this website.

Cephalon files an infringement suit on Teva for NUVIGIL® (armodafinil) Tablets

2009-12-03T09:56:00.001+05:30

Cephalon, Inc. it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV]. Cephalon has a three-year period of marketing exclusivity for NUVIGIL that extends until June 15, 2010. In addition, including the six-month pediatric extension, the '516 Patent, the '346 Patent, and the '570 Patent expire on April 6, 2015, May 29, 2024, and June 18, 2024, respectively.

Teva did not challenge Orange Book-listed U.S. Patent No. 4,927,855 (the "'855 Patent"), which provides additional protection until October 22, 2010, the expiration date of the '855 Patent. The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Teva seeking FDA approval for a generic equivalent of armodafinil to be sold in the United States. Teva alleges that the above NUVIGIL patents are invalid, unenforceable and/or will not be infringed by Teva's manufacture, use or sale of the product described in its ANDA.

Abbott files infringement suit for paricalcitol against Teva

2009-12-01T17:15:00.001+05:30

Abbott Laboratories et al. (Plaintiffs) have filed an infringement suit against Teva Parenteral Medicines Inc. et al (Defendants) for infringement of U.S. Patent Nos. 5,246,925 (“the ’925 patent”); 5,587,497 (“the ’497 patent”); and 6,136,799 (“the ’799 patent”). This action arises out of Teva’s filing of an Abbreviated New Drug Application (“ANDA”) seeking approval to sell a generic copy of Abbott’s highly successful Zemplar® injectable products prior to the expiration of patents owned by and exclusively licensed to Plaintiffs. The case was filed on November 19, 2009 in the District Court of Delaware. The details of the complaint are available here

Multaq(R) [Dronedarone] approved in the European Union

2009-12-01T16:12:00.002+05:30

European Commission has granted marketing authorization for Sanofi's Multaq(R) (dronedarone - 400mg Tablets) in all 27 European member states. This approval follows the European Commission positive opinion issued on September 25, 2009 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine agency (EMEA). Multaq(R) is indicated in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. Multaq(R) discovered and developed by sanofi-aventis is the first anti-arrhythmic drug approved in the European Union that has shown a clinical benefit to reduce cardiovascular hospitalizations or death from any cause in patients with AF/AFL as described in the ATHENA trial.

Sun Pharma recieves FDA approval for Nicardipine injection

2009-12-01T16:09:00.002+05:30

Sun Pharma and its subsidiary has been granted approval for its application for Nicardipine Hydrochloride Injections by the USFDA. These Nicardipine Hydrochloride Injections are available as 25 mg/10ml single use ampuls containing 2.5 mg/ml of the drug, and have annual sales of approximately USD 170 million in the US. These injections are used for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.

Merck Wins Summary Judgment involving Fosamax (alendronate sodium)

2009-11-28T14:35:00.001+05:30

The U.S. District Court Judge John F. Keenan granted summary judgment in Merck's favor in Flemings v. Merck.Flemings is the second of three cases involving FOSAMAX (alendronate sodium) designated by the federal MDL court as a bellwether trial case. In granting summary judgment in Flemings and dismissing all of the plaintiff's claims, Judge Keenan ruled that the physician relied upon by Ms. Flemings (Dr. Rose) was unqualified to render an opinion and that Ms. Flemings failed to present sufficient evidence to support her contention that FOSAMAX caused her to sustain osteonecrosis of the jaw (ONJ).

USFDA grants tentative approval to Sun Pharma's generic version of Gleevec® tablets

2009-11-28T14:16:00.002+05:30

The USFDA has granted tentative approval Sun Pharma's ANDA for generic Gleevec®, imatinib mesylate tablets. These imatinib mesylate tablets, therapeutically equivalent to Gleevec® tablets from Novartis, have two strengths viz. 100 mg and 400 mg and have annual sales of approximately USD 950 million in the US.Imatinib mesylate is used for patients with chronic myeloid leukemia. Gleevec® is a registered trademark of Novartis.

IP Blogger is back

2009-11-25T10:24:00.002+05:30

Dear Friends,

It's been a long break from mu usual routine of blogging. IP has developed so much in the recent times that even a small contribution would be like a pebble in the ocean.

But still, i will try my level best to keep upbreast with the knowledge.

Regards,

IP Blogger

Warner files lawsuit for Infringement of Doryx (US 6,958,161) Patent

2009-01-18T12:47:00.003+05:30

Warner and one of its subsidiaries and "Mayne", a subsidiary of Hospira Inc. have filed a lawsuit against Sandoz Inc. in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the "'161 Patent") which covers DORYX, a tetracycline-class oral antibiotic.

Warner markets and sells DORYX DR tablets in 150, 100 and 75 mg strengths under a license agreement with Mayne. Warner Chilcott previously announced the filing of similar lawsuits against each of Mutual Pharmaceutical Company, Inc., Mylan Pharmaceuticals Inc. and Impax Laboratories, Inc. on December 23, 2008. The lawsuit is in response to the submission of an ANDA) to the USFDA by Sandoz requesting approval to manufacture and sell generic versions of DORYX 100 and 75 mg DR tablets prior to the expiration in 2022 of the '161 Patent. Warner Chilcott and Mayne intend to vigorously defend the '161 Patent and pursue their legal rights.

patentmarvel-a boon for downloading US patents/publications

2009-01-18T12:31:00.003+05:30

IPblogger has come across a very useful site for patent downlaoding. The site patentMarvel.com is the place for intellectual property tools designed to make life easier. The patentMarvel's PDFinducer tool allows you to easily view and download US patents and published patent applications as PDF's. Simply input the US patent number or US publication number and let patentMarvel do the rest. If you would like to create multiple PDF's at one time just separate the numbers with semicolons.

Lupin receives USFDA approval for Levetiracetam tablets

2009-01-18T12:27:00.002+05:30

Lupin Pharmaceuticals, Inc. (LPI) has received final approval for the Company's ANDA for Levetiracetam Tablets 250mg, 500mg, 750mg and 1000mg from the USFDA. Commercial shipments of the product have commenced. Lupin's Levetiracetam tablets are the AB-rated generic equivalent of UCB Pharmaceuticals' Keppra(R) tablets, indicated as adjunctive therapy in the treatment of certain types of seizures associated with epilepsy.

Cypress receives FDA approval of Levetiracetam oral solution

2009-01-18T12:18:00.003+05:30

Cypress has been granted final approval by USFDA for it's ANDA for Levetiracetam Oral Solution, 100 mg/mL. Levetiracetam Oral Solution, 100 mg/mL is the AB-rated bioequivalent generic to UCB Pharma's Keppra® Oral Solution, 100 mg/mL.

Prasugrel receives positive opinion from CHMP

2008-12-22T21:11:00.001+05:30

Daiichi Sankyo and Eli Lilly and Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of prasugrel for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).

The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. The commission usually makes a decision about whether to approve a new drug candidate within two to three months of CHMP issuing its recommendation. Upon approval, this new oral antiplatelet agent is expected to be marketed throughout the European Union under the proposed brand name Efient.

Freepatents online creates another landmark by introducing citepatents

2008-12-22T21:03:00.004+05:30

FreePatentsOnline.com (FPO), one of the widely used free online search engines for patents has launched an informational site, http://www.citepatents.com/, particularly to help bloggers, journalists and others to easily reference to patent information, and to provide a free patent search box for adding to websites with a single mouse click.

One has to log in by creating a free account first. Another useful free patent search site launched by the FPO is SumoBrain with a powerful new feature of bulk PDF downloading from a database of tens of millions of records including US patents and published applications, European patents and published applications, and WO publications at a single go. SumoBrain also features basic and advanced search capabilities including field search, word stemming, proximity search and search term weighting. SumoBrain saves lot of time and capital investment. Ipblogger would suggest its esteemed readers to login to this website and benefit from its advantages.

RANBAXY reconstitutes Board of Directors

2008-12-22T20:58:00.002+05:30

Ranbaxy and Daiichi Sankyo Company Limited have announced the reconstitution of Ranbaxy’s Board of Directors. The composition of the new Board reflects the new ownership structure at Ranbaxy following Daiichi Sankyo’s strategic investment completed in November 2008. Daiichi Sankyo now holds 63.92% of the equity share capital of Ranbaxy.

The detailed news can be viewed by our privileged readers from linking into this site

Pfizer sues Apotex for infringement of '995 patent

2008-12-22T20:52:00.003+05:30

Innovator Pfizer sued Canadian pharma giant Apotex (as per complaint filed on December, 17, 2008 in federal court in Wilmington, Delaware) for filing ANDA with Para IV certification to United States Food and Drug Administration (USFDA) to import and sell 10, 20, 40 and 80 mg/tablet dosage strengths of the Atorvastatin Hemicalcium, in violation of a enantiomer patent listed in Orange Book.

For a detailed action filed by Pfizer, click here

NovaDel Pharma receives FDA Approval of Zolpimist

2008-12-22T20:38:00.002+05:30

NovaDel Pharma's Zolpimist (zolpidem tartrate) 5 mg and 10 mg Oral Spray has been approved by the USFDA for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpimist is NovaDel's second product approved by the FDA that uses NovaDel's proprietary NovaMist oral spray technology. Zolpimist contains zolpidem tartrate, the same active ingredient as Ambien®, the world's leading sedative hypnotic for the treatment of insomnia.

Aurobindo receives USFDA tentative nod for Abacavir Sulfate/Lamivudine tablets FDC

2008-12-22T20:33:00.001+05:30

Hyderabad based Aurobindo Pharma Limited has received tentative US FDA approval to manufacture and market fixed dosed combination Abacavir Sulfate/Lamivudine tablets 60/30mg for the treatment of HIV infections.

The company had earlier received tentative approvals to co-packaged Lamivudine/Zidovudine tablets + Abacavir Sulfate tables 150/300mg + 300mg and Abacavir Sulfate/Lamivudine tablets 600/300 mg. This is Aurobindo 87th ANDA approval from US FDA, a company release said.

Santarus, Cosmo sign pact for US rights to Budesonide & Rifamycin

2008-12-22T20:25:00.002+05:30

Santarus, Inc has entered into a strategic collaboration with Cosmo Technologies Limited (Cosmo), which grants Santarus exclusive rights to develop and commercialize Budesonide MMX and Rifamycin SV MMX for the US market.

Terms of the agreements include an upfront payment to Cosmo of cash and Santarus common stock, shared development costs, clinical/regulatory and commercial milestones and a royalty on net sales.

Budesonide MMX is an oral corticosteroid currently being investigated in two multi-centre phase-III clinical trials involving more than 800 patients in North America and Europe for the induction of remission of mild-to-moderate ulcerative colitis. Budesonide MMX is designed to retain the effectiveness of classical corticosteroids, but with reduced side effects due to its targeted controlled release in the colon with minimal systemic absorption. Rifamycin SV MMX is a broad spectrum, semi-synthetic antibiotic that also has targeted release characteristics when taken orally. The application of MMX technology to Rifamycin SV allows the antibiotic to be delivered directly to the colon, with the goal of minimizing unwanted effects on the bacterial flora in the small intestine. Cosmo has completed a phase-II clinical programme in traveler's diarrhoea. These two compounds are formulated using Cosmo's patented MMX Multi Matrix System technology.

MMX is a proprietary technology platform designed to produce a controlled release, homogeneous local application of the active pharmaceutical ingredient (API) throughout the colon, thereby limiting systemic absorption and offering an opportunity for reduced side effects. The MMX technology is covered by two issued US patents that expire in mid-2020, and additional patent applications are pending at the USPTO.

Centocor receives Complete Response Letter for Ustekinumab BLA from USFDA

2008-12-22T20:18:00.002+05:30

The USFDA has issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab. The application, filed by Centocor in late 2007, seeks approval to market ustekinumab as a subcutaneous biologic therapy for the treatment of adult patients with chronic moderate to severe plaque psoriasis.

The Complete Response letter requests additional information, including a proposal by Centocor for a Risk Evaluation and Mitigation Strategy (REMS). FDA requires REMS to ensure that benefits of an investigational or marketed treatment outweigh the risks. The ustekinumab REMS must contain a Medication Guide and communication plan. It does not require restricted distribution. The FDA has not requested any new non-clinical or clinical studies evaluating the efficacy or safety of ustekinumab prior to approval.

Unique website for claim mapping

2008-12-18T21:17:00.002+05:30

Ipblogger has come across a very useful website (Patent Matrix) link which aids in instantly providing claims mappings for all patents in an IP Portfolio. The said site requires one time free online registration.

The power of Patent Matrix Diagrams lie in their ability to Reduce Costs, Optimize IP Communication, and Identify Competitive Advantages through a competitive landscape analysis.Matrix saves money on legal costs. The speed and ease of Patent Matrix Diagrams allow organizations to focus their time and resources on competitive endeavors rather than legal issues.

Patent Matrix effectively and lucidly communicates IP Portfolio by focusing on the heart of each Patent -- the Claims. This ensures a total and uniform understanding of the Patent Scope. Identify CompetitionPatent Matrix empowers an organization to analyze competitive IP and identify a breadth of competitive advantages ranging from infringement issues to licensing capabilities. Ipblogger has checked and found it to be a useful handytool in order to cut expenses.

Recent updates for US patent law 2007-2008

2008-12-18T21:05:00.004+05:30

IP blogger has come across Recent updates regarding US patent law for the year 2007-2008. The said article is contributed by one of our co-authors Mr. Deeptymaya Sahu. Ipblogger would suggest to read the article. The said article can be downloaded from the link here

Watson Receives FDA Approval for Generic Razadyne ER Capsules

2008-12-18T20:50:00.001+05:30

Watson has received approval from the USFDA on its ANDA for galantamine hydrobromide ER capsules, eq. to 8 mg, 16 mg and 24 mg (galantamine base). Galantamine hydrobromide extended-release capsules are the generic equivalent to Ortho McNeil Janssen's Razadyne(R) ER, galantamine HBr extended-release capsules, which are indicated for the treatment of Alzheimer's disease.

Watson intends to launch the product immediately. Razadyne(R) ER had annual sales of approximately $112 million for the twelve months ending September 2008, according to IMS sales data.

BioDelivery Sciences seeks USFDA nod for Onsolis, resubmits NDA

2008-12-18T20:35:00.002+05:30

BioDelivery Sciences has resubmitted its NDA for the its lead product Onsolis to the FDA. The company continues to anticipate that the resubmission, which includes a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis, will be approved in the first half of 2009. Onsolis (formerly known as BEMA Fentanyl), the company's lead product in development, is a potential treatment for "breakthrough" pain in opioid tolerant patients with cancer.

In North America and Europe, the commercial rights to Onsolis are licensed to Meda AB. In August 2008, BDSI received a complete response letter from the FDA regarding the NDA for Onsolis. The FDA requested conversion of the submitted risk minimization action plan (RiskMAP) to a REMS and informed BioDelivery Sciences that all other aspects of the NDA review were complete.

USFDA grants tentative approval to MDRNA's generic calcitonin-salmon nasal spray

2008-12-18T20:27:00.003+05:30

The USFDA has granted tentative approval to MDRNA's ANDA for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex's 180-day exclusivity period, or June 2009.

MDRNA's generic calcitonin-salmon nasal spray is the generic equivalent of Miacalcin marketed by Novartis Pharmaceuticals Corporation. US sales of Miacalcin were approximately $147 million in 2007. On December 23, 2003, FDA accepted for filing MDRNA's 505(j) paragraph 4 ANDA for the product. In October 2004, MDRNA and Par Pharmaceutical Companies, Inc. entered into an exclusive license and supply agreement for US distribution and marketing of the product. Under terms of the agreement, MDRNA is responsible for obtaining regulatory approval and manufacturing, and will receive product transfer payments for manufactured product and profit sharing following commercialization.

Website for locating patent attorney's in USA

2008-12-18T10:05:00.002+05:30

Dear fellow readers,

Ipblogger has come across a very useful website where you can find a list of patent attorneys and the respective firms in USA working in the filed of IP. The said link can be accessed here

Lupin settles desloratadine lawsuit with Schering-Plough

2008-12-17T21:26:00.001+05:30

Lupin Ltd has announced that the company has settled all ongoing Hatch-Waxman litigation relating to desloratadine tablets, the generic version of Schering-Plough's 'Clarinex' tablets. As per the terms of the settlement, Lupin will be licensed under the relevant desloratadine patents, and free to commercially launch its generic desloratadine product, on July 1, 2012, or earlier in certain circumstances.

Lupin had earlier filed a Paragraph IV certification to, among others, US Patent Nos. 6,100,274, 7,214,683 and 7,214,684, contesting that these patents were either invalid or had not been infringed upon - resulting in the subsequent litigation by Schering Corp. and Sepracor. Schering-Plough's Clarinex tablets had US sales of $329 million for the year 2007-MAT June 2008, according to IMS Health.

New toolbar useful for IP updates

2008-12-09T21:13:00.002+05:30

IPblogger has come across a tool bar which is very useful to keep update on the patent and IP information. It provides the links to IP News Feed, IP Events and IP Links such as Patent and IP Search tools, Patent classification search, Patent search supporting tools, IP Forums, groups, communities, jobs, list and also National Patent, Trademark and design databases.

The said toolbar is very easy to install and is for free. This toolbar would prove to be an important tool for all IP professionals. The toolbar can be downloaded from the site

Orion files patent infringement suit against Wockhardt for Stalevo

2008-12-09T20:58:00.004+05:30

Orion has filed a patent infringement lawsuit in the US to enforce U.S. Patent Nos. 5,135,950; 5,446,194; and 6,500,867 against Wockhardt USA, Inc. and Wockhardt Limited. Wockhardt seek to market a generic version of Orion Corporation's proprietary drug, Stalevo® (specifically 12.5/200/50 mg strength of carbidopa/entacapone/levodopa) in the United States.

Stalevo is an enhanced levodopa treatment originated by Orion Corporation and marketed in the US by its exclusive licensee, Novartis, for the treatment of Parkinson's disease. In November 2008, Orion was notified that Wockhardt submitted an ANDA with the USFDA that included a Paragraph IV challenge to several of Orion Corporation's patents. By suing to enforce its patents within 45 days from receipt of the Paragraph IV certification notice, Orion is entitled to an automatic stay prohibiting the FDA from approving the applicants ANDA for 30 months, or until an earlier court decision adverse to Orion Corporation's patents in the infringement lawsuit. Orion and Novartis will vigorously defend the intellectual property rights covering Stalevo.

Warner paragraph IV certification for DORYX

2008-12-09T20:26:00.000+05:30

Warner Chilcott's subsidiaries and Hospira have received Paragraph IV Certification Notices from Mutual Pharmaceutical Company, Inc. and Mylan Pharmaceuticals Inc. ("Mylan") advising that each such company has filed an ANDA for generic versions of DORYX 100 and 75 mg delayed-release tablets. DORYX is a tetracycline-class oral antibiotic protected by Mayne's Patent No. 6,958,161 (the "161 Patent") which expires in 2022. The '161 Patent has been listed in the FDA's Orange Book pursuant to the transition provisions of the QI Program Supplemental Funding Act of 2008 enacted October 8, 2008.

Tesetaxel receives FDA Designation as an Orphan Drug

2008-12-08T21:29:00.001+05:30

Genta Incorporated has received notice from the USFDA that tesetaxel, the Company's oral taxane in clinical development, has been granted designation as an "Orphan Drug" for treatment of patients with advanced melanoma. Orphan drug status provides for a period of marketing exclusivity, certain tax benefits, and an exemption from certain fees upon submission of a New Drug Application.

FDA Review of Byetta (exenatide) Injection Monotherapy Submission

2008-12-08T21:20:00.002+05:30

USFDA is continuing with its review of the regulatory application for use of Amylin's and Eli Lilly's BYETTA(R) (exenatide) injection as a stand-alone therapy (monotherapy) in people with type 2 diabetes who are not achieving acceptable blood sugar control. It is likely that this review will not be complete by the end of 2008, and may extend into 2009. The regulatory application for use of BYETTA as monotherapy was submitted in the first quarter of 2008. The FDA is also reviewing several other BYETTA prescribing information updates submitted by the companies, including revision of safety language and conversion of physician labeling to the new standard format.

FDA Approves GSK's BOOSTRIX for Adults

2008-12-08T21:11:00.002+05:30

GSK has received USFDA approval for BOOSTRIX® [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap)] for use in adults 19-64 years of age. BOOSTRIX offers protection against tetanus, diphtheria and pertussis (whooping cough) to individuals 10-64 years of age -- the broadest age range for any Tdap vaccine. BOOSTRIX was previously approved as a booster vaccine for preteens and teens.

Madras High Court orders to reexamine Valganciclovir patent in India

2008-12-07T15:32:00.003+05:30

On 2nd December, 2008, the Madras High Court set aside the grant of a patent to Roche, in relation to its drug Valganciclovir because in the Court's opinion the Chennai Patent Office's decision to not grant a hearing to the petitioners/pre-grant opponents, who in this case were The Indian Network for people living with HIV/AIDS and the Tamil Nadu Networking People with HIV/AIDS, was in violation of Section 25 of the Patent Act. The Court also ordered the re-hearing of the pre-grant opposition by the end of January, 2009. The judgment can be accessed over here at the website of the Lawyer's Collective which was involved in the litigation.

Valganciclovir is a vital drug for patients suffering from HIV/AIDS. The original patent application was filed in India in 1995 and the application bears the number No.959/MAS/1995. The Patent Office granted it a patent bearing number Patent No.207232 in April, 2007.

Ipblogger wishes to acknowledge the efforts of Mr. Prashant Reddy of SpicyIP who has published comments on Valcyte. Ipblogger suggests to read from this site

Setrue Patent search-A free patent search tool

2008-12-07T15:09:00.003+05:30

A new “free” patent search tool called the Setrue Semantic Patent Search Engine has been explored by the Ipblogger. The Setrue website states that the search tool includes features such as: semantic natural language query capabilities; query auto-complete suggestions; detailed USPTO class directory structure enabling a one click segmentation of search results to a specific USPTO patent class; clustering of search results by USPTO classes; clustering of search results by years; clustering of search results by assignees; similar patents segmentation; dynamic weighting of search terms; and much more.

Ipblogger would like to mention that the Setrue semantic patent search engine is a free patent search engine for non-commercial usage only. If you are a law firm, a private patent attorney, a patent search agency, a litigation attorney, or a corporation, or if you are planning to use Setrue semantic patent search engine commercially, the website asks that the Setrue sales team be contacted first to purchase a commercial license. The basic Setrue search tool is available here, with advanced search capabilities available here.

CAFC oral arguments in USPTO vs. GSK and TAFAS

2008-12-07T15:03:00.003+05:30

The CAFC in relation to the ruling in Tafas v. Dudas had heard the oral arguments. It was regarding SmithKline Beecham Corp. v. Dudas, which permanently enjoined the USPTO’s claims and continuations rules. In permanently enjoining the claims and continuations rules, Judge Cacheris held that the USPTO’s rulemaking authority under 35 U.S.C. § 2(b)(2) does not extend to substantive rules, and that the claims and continuations rules are substantive in nature. The oral arguments can be heard from this link

USPTO new appeal procedures still active....

2008-12-07T14:48:00.002+05:30

On June 10, 2008, the USPTO published new Rules of Practice Before the Board of Patent Appeals and Interferences in Ex Parte Appeals. The rules can be seen here The new rules apply to all appeals in which an appeal brief is filed on or after December 10, 2008.

The Board of Patent Appeals and Interferences’ two main responsibilities include: (1) the review of ex parte appeals from adverse decisions of examiners in those situations where a written appeal is taken by a dissatisfied patent applicant and (2) the review of interferences to decide who is the first inventor whenever an applicant claims the same patentable invention which is already claimed by another applicant or patentee.

For further details please click here

Indian Patent granted for Lilly's tadalafil

2008-12-07T14:37:00.003+05:30

IPO(Chennai) has recently issued an Indian patent IN224314 herein referred to as ‘314 patent to Lilly Icos LLC for Tadalafil particulate form and method of preparation thereof. The said patent is issued against the national phase application (PCT) # IN/PCT/2002/143/CHE claiming priority from US provisional application # 60/147,048 dated August 03, 1999 which later issued as US 6,821,975 and currently listed with the US FDA Orange Book.

Tadalafil is marketed as Cialis by Eli Lilly whic was granted EMR in India against the application # 85/DEL/1995 (the 1995 application) which later got stayed by the Calcutta High Court after a petition made by Mumbai-based Ajanta Pharma. The 1995 application covered claims for Tadalafil per se and process of preparation thereof. A pre-grant opposition was filed by Ajanta Pharma at the Indian Patent Office (Delhi) last year on March 22 wherein the IPO rejected the product claims for Tadalafil per se but allowed process claims. The product claims were found obvious over the US 3,917,599 (the ‘599 patent) issued to CDRI. The ‘599 patent exemplified 2-substituted-1, 2, 3, 4, 6, 7, 12, 12a-octahydropyrazino [2’, 1’:6, 1] pyrido [3, 4-b] indoles which is the base structure of Tadalafil but never suggested to be useful for treatment of erectile dysfunction. Pre grant opposition filed for tadalafil can be found here

Govt may not amend Drugs & Cosmetics (Amendment) Bill, 2005

2008-12-07T14:19:00.002+05:30

The industry associations' concerted efforts to rectify the Drugs and Cosmetics (Amendment) Bill, 2005 by incorporating certain provisions to safeguard the genuine manufacturers may not succeed as the Bill, which was passed by Parliament, has already been sent for the President consent. Once the Bill gets the President's seal of consent, the only formality left is to notify the Bill to decide the date of its validity.According to sources, senior health ministry officials have expressed their helplessness in the matter as the Bill has already gone out of the ministry's jurisdiction. The only department which can interfere at this late stage is the PMO (Prime Minister's Office) and the probability of PMO interference in this matter is remote, sources said.
For more details, refer here http://www.pharmabiz.com/article/detnews.asp?articleid=47289

Lipitor better than Simvastatin in reducing cardiovascular risk (a study)

2008-12-07T14:10:00.001+05:30

Pfizer announced the results of an observational study that showed patients taking Lipitor (atorvastatin calcium) had a significant 13 per cent reduction in the relative risk of experiencing a cardiovascular event compared with patients taking simvastatin (Zocor) therapy. The patients in this study did not have evident cardiovascular disease and were newly initiated on either treatment. This study was performed in conjunction with HealthCore, WellPoint's health outcomes research subsidiary. Results of this study, from one of the largest US managed care claims databases with more than 219,000 adult patients, were published in the December issue of Mayo Clinic Proceedings. For more details referhttp://www.pharmabiz.com/article/detnews.asp?articleid=47292

Aurobindo receives tentative approval for Perindopril erbumine and Ecitalopram Oxalate

2008-12-07T14:04:00.003+05:30

Aurobindo's perindopril erbumine tablets 2mg, 4mg, 8mg and escitalopram oxalate oral solution 5mg (base)/ 5ml have been given tentative approvals by USFDA. Perindopril erbumine tablets are generic of Solvay Pharmaceuticals Aceon tablets and Escitalopram oxalate oral solution are the generic of Forest Laboratories' Lexapro oral solution. Aurobindo now has 85 approved ANDAs from the US FDA (61 final approvals, 24 tentative approvals).

Solvay completes pre-registration of 400 substances as per EU regulation

2008-12-07T14:01:00.000+05:30

Solvay, in accordance with the European REACH Regulation on Chemicals (Registration, Evaluation, Authorization and Restriction of Chemicals), has successfully completed the pre-registration at the European Chemicals Agency (ECHA). The Solvay group has successfully pre-registered 666 dossiers representing a total of 400 substances. By doing so, Solvay has given notice that it will register the substances before the end of the transitional period, which expires in 2010, 2013 or 2018 depending on the nature of the substances and the quantities involved.

Perrigo can commrecially launch desloratadine after settlement of patent litigation

2008-12-07T13:52:00.004+05:30

All Hatch-Waxman litigations relating to Perrigo's Desloratadine tablets (5 mg) has been settled with Perrigo taking a license under all relevant patents. Perrigo had been sued for patent infringement of US Patent Nos. 6100274, 7214683 and 7214684 based upon its filing of an ANDA containing a Paragraph IV certification. As per the settlement, Perrigo can commercially launch its generic Desloratadine product on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or OTC product depending on its status at the time of launch. The Perrigo product is awaiting FDA approval. Perrigo's generic seeks an AB-rating as equivalent to Schering-Plough's Clarinex(R) tablets (5 mg) indicated for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria. Sales for the brand were approximately $300 million, according to Wolters Kluwer data for the twelve months ending October 2008.

Oscient and Ethypharm receive paragraph IV notification from Lupin for Generic fenofibrate

2008-12-03T21:31:00.004+05:30

Oscient Pharmaceuticals Corporation and its licensor, Ethypharm SA, have received notice of a Paragraph IV certification on behalf of Lupin Limited, advising of the submission of an ANDA with the USFDA for ANTARA® (fenofibrate) capsules, 130 and 43 mg doses. The notice alleges that U.S. Patent No. 7,101,574, owned by Ethypharm, exclusively licensed to Oscient and listed in the FDA Orange Book for ANTARA, is invalid and/or will not be infringed by Lupin's manufacture, use or sale of the product for which the ANDA was submitted. U.S. Patent No. 7,101,574 is set to expire in 2020. Oscient and Ethypharm have 45 days to commence a patent infringement lawsuit against Lupin that would automatically stay, or bar, the FDA from approving Lupin's ANDA for up to 30 months or until a district court decision in its favor, whichever may occur earlier. Oscient and Ethypharm are currently in the process of evaluating the notice from Lupin and intend to pursue all available legal and regulatory options in defense of ANTARA, including enforcement of their intellectual property rights.

IPblogger will provide update on the developments time to time....

Wyeth Submits EMEA Application for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Young Children

2008-12-03T21:21:00.002+05:30

Wyeth Pharmaceuticals has submitted a marketing authorization application (MAA) to the EMEA for approval to market its investigational 13-valent pneumococcal conjugate vaccine (PCV13) for infants and young children. Wyeth is seeking an indication for the prevention of pneumococcal disease (PD) caused by the 13 serotypes included in the investigational vaccine in infants and children from two months to five years of age. The review of the MAA will be coordinated by the EMEA for all 27 countries in the European Union, as well as Norway, Iceland and Liechtenstein. PCV13 includes the 13 most prevalent pneumococcal serotypes associated with serious PD. Seven of these (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevenar* (Pneumococcal saccharide conjugated vaccine, adsorbed) - - the current global standard in PD prevention in infants and young children. The six additional serotypes (1, 3, 5, 6A, 7F and 19A) are associated with the greatest burden of remaining invasive disease.

The PCV13 submission to EU regulators includes data from 12 Phase 3 studies, involving more than 7,000 infants and young children. Data from these studies have demonstrated that, for the pneumococcal serotypes common to both vaccines, the immunogenicity of PCV13 is comparable to that of Prevenar using a pre-determined set of immunological criteria. In addition, PCV13 elicits antibacterial functional antibodies to the six additional serotypes. These observations indicate that PCV13 may be as effective as Prevenar in helping to prevent invasive pneumococcal disease (IPD) due to the seven shared serotypes in the vaccines and may also be effective in helping to prevent IPD due to the six additional serotypes. The results also showed that the safety and tolerability of PCV13 and Prevenar are comparable, and that PCV13 can be administered with other commonly used pediatric vaccines.

Earlier this year, the USFDA granted Fast Track designation to PCV13 for infants and toddlers. Fast Track designation is designed to facilitate review of products for serious or life- threatening conditions for which there is an unmet medical need. The Company expects to complete its U.S. filing for pediatric use of the vaccine in the first quarter of 2009, while initiating other pediatric filings in the near term. PCV13 is also being studied in global Phase 3 clinical trials in adults, with regulatory filings expected in 2010.

Competition in Pharmaceutical Sector-European Commission preliminary report

2008-12-02T21:04:00.003+05:30

Last Friday, the European Commission published a 426-page preliminary report (http://ec.europa.eu/comm/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf) regarding its competition inquiry into the European pharmaceutical sector. The Commission commenced the sector inquiry last January to examine why fewer new medicines were being brought to market in Europe and why generic entry seemed to be delayed in some cases (the report notes that while 40 new medicines were introduced annually between 1995 and 1999, only 27 were introduced annually between 2000 and 2007). The Commission has created dedicated webpage (http://ec.europa.eu/comm/competition/sectors/pharmaceuticals/inquiry/index.html) providing additional information regarding the sector inquiry into pharmaceuticals competition.

The Commission has offered its initial finding that "there is evidence that originator companies have engaged in practices with the objective of delaying or blocking market entry of competing medicines" and that as a result, "competition in this industry does not work as well as it should." The Commission reached this conclusion by examining a sample of 219 medicines facing a loss of exclusivity between 2000 and 2007, determining that but for delaying and blocking strategies employed by originator companies (i.e., innovator or brand companies that develop and sell new medicines), European consumers would have saved an additional € 3 billion ($3.79 billion) over this period.

The Commission concluded that the originators' strategies resulted in a delay of generic market entry of between four and seven months. In conducting the sector inquiry, the Commission sent out requests for information to 43 originator companies and 27 generic companies, engaged in a dialogue with industry associations at the European level, and consulted with representatives of consumer and patients associations, insurance companies, doctors, pharmacies, wholesalers, hospitals, parallel traders, patent offices, and competition authorities. Interestingly, the report states that the two biggest stakeholders -- the originator and generic companies -- were in agreement regarding the need to create a single Community Patent and a unified and specialized patent judiciary in Europe. Stakeholders and members of the public have until January 31, 2009 to submit comments concerning the Commission's preliminary findings, with the Commission expected to issue a final report sometime in the spring of 2009.

Mylan and Novartis undergo settlement for Mylan's Femara generic

2008-12-02T20:56:00.003+05:30

Mylan Inc and its subsidiary, Mylan Pharmaceuticals Inc., have entered into a settlement agreement with Novartis Pharmaceuticals Corp., Novartis Corp. and Novartis International AG related to Letrozole Tablets, the generic version of Novartis' Femara(R). Under the agreement Under the agreement, Mylan is provided a patent license that will enable the company to market Letrozole Tablets, 2.5 mg, prior to the expiration of U.S. Patent No. 4,978,672. The terms for the settlement remain confidential, and the agreement is subject to review by the US Department of Justice and the Federal Trade Commission. Mylan was the first company to file a substantially complete ANDA containing a Paragraph IV certification for the product.

sNDA for Cymbalta withdrawn by Eli Lilly

2008-12-02T20:50:00.003+05:30

Eli Lilly has withdrawn its supplemental New Drug Application (sNDA) from the USFDA for Cymbalta (duloxetine HCl) for the management of chronic pain. Lilly thinks of resubmitting the application in the first half of 2009 following the addition of data from a recently completed positive study in chronic osteoarthritis pain of the knee. Withdrawl of the application will affect duloxetine's FDA-approved indications for major depressive disorder, generalized anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia.

The Touchstone Effect: The Impact of Pre-grant Opposition on Patents (Another book by Feroz Ali Khader)

2008-12-02T20:19:00.005+05:30

Feroz Ali Khader, the author of "The Law of Patents-With A Special Focus On Pharmaceuticals In India" has published his latest book The Touchstone Effect – The Impact of Pre-grant Opposition on Patents and published by LexisNexis http://http//lexisnexis.in/Product-detail.aspx?cname=Intellectual%20Property&Pid=262, with the publishers charging only one rupee as delivery charges. The author has an online blog–www.touchstoneeffect.blogspot.com for interactive discussion pertaining to this book. The author has meticulously worked upon this book and has provided links to the complete text of all the pre-grant decisions of the Patent Office.

Ipblogger salutes the author. The book would be very beneficial to the IPR community who has strong interest in Patent systems in India. Mr. Feroz Ali Khader is a practicing advocate at the Madras High Court and has give orations in patent law in India and also conducted workshops and lectures on patent law. He was involved in Novartis litigation at the Madras HC. The book serves to ascertain the effect of pre-grant oppositions on the quality of Indian patents and by extensions the quality of innovation in India.

The book consists of number of case studies, with the one being the controversial TVS-Bajaj dispute which cost TVS Rs. 120 crores in losses.The focus of the book however remains on the legalities of the pre-grant opposition mechanism. The interesting feature of this book is that it tries to overcome the nuances and hurdles during the pre-grant opposition.

Ipblogger would solely recommend this book to all those IP professionals be it lawyers, policy-makers, students, academics, in-house counsels and management level executives who have interest in pre-grant opposition. Mr. Feroz has explained the criticalities in a very simplified manner so that a common person can understand the opposition perspective. Ipblogger feels that the abovesaid book would surely be an instrumental path to understand the complex IP system of India.

Gardasil successfully launched by MSD in India

2008-12-02T10:14:00.001+05:30

Gardasil, a quadrivalent human papilloma virus (HPV) type 6, 11, 16 and 18 vaccine has been successfully launched by MSD in India. It is the country's first vaccine to help prevent cervical cancer caused by the HPV types. The vaccine also helps prevent diseases abnormal and precancerous cervical lesions, vaginal lesions, vulvar lesions, and genital warts caused by the virus. It is also the only USFDA approved vaccine to help prevent cervical cancer and other diseases caused by HPV types. Gardasil is recommended to be given to females aged between nine to 26 years.

Bioavail's ANDA for Quetiapine fumarate ER tablets accepted by USFDA

2008-12-02T10:11:00.001+05:30

The USFDA has accepted the Bioavail’s ANDA for a generic formulation of 200mg, 300mg and 400mg strengths of quetiapine fumarate ER tablets (sold under the brand name Seroquel XR by AstraZeneca Pharmaceuticals LP). This is Biovail's third successful ANDA filing in 2008. Seroquel XR is an atypical antipsychotic agent indicated for the treatment of schizophrenia and bipolar disorder. The product is available in 150mg, 200mg, 300mg and 400mg strengths. According to IMS Health, Seroquel XR generated U.S. revenues of approximately $166 million in the twelve-month period ended September 30, 2008.

Cephalon Inc., Eyrand Inc. and Anesta AG sue Mylan over Cyclobenzaprine HCl ER ANDA

2008-12-02T09:53:00.002+05:30

Cephalon Inc., Eurand Inc. and Anesta AG collectively have sued Mylan and its subsidiary Mylan Pharmaceuticals Inc. by filing a lawsuit in the U.S. District Court for the District of Delaware in connection with the filing of an ANDA for Cyclobenzaprine Hydrochloride (HCl) Extended-release (ER) Capsules, 15 mg and 30 mg, the generic version of AMRIX(R) Capsules. The patent considered under infringement is US Patent No. 7,387,793. Mylan believes it is the first company to file ANDA containing a Paragraph IV certification for the product and expects to be awarded 180 days of sole marketing exclusivity once final approval is obtained. The ANDA was filed with the USFDA. Cyclobenzaprine HCl ER Capsules, a muscle relaxant introduced to the market in October 2007, had approximately $53 million in sales for the twelve months ending Sept. 30 and approximately $19 million for the quarter ending Sept. 30, according to IMS Health.

Website for searching US patent attorneys

2008-12-02T09:33:00.003+05:30

Ipblogger had come across a site www.patentbuddy.com which is dedicated for searching out good US attorneys. The site mentions as of today 39,259 attorneys/agents and 13,081 organizations. The site covers all USPTO-registered patent attorneys and agents, not just members. This site is also an interactive place where one can social networks or groups of myriad interests. One advantage of this site is the feasibility monitoring the career moves of other attorneys and agents, going thorugh their career history and a listing of their current and past colleagues.

Generic Wellbutrin XL 150mg receives approvalin the U.S.

2008-12-02T09:25:00.002+05:30

Actavis has received approval from the USFDA to market Bupropion Hydrochloride ER tablets (XL) 150mg. The product distribution has started. Bupropion ER tablets (XL), available in 150 & 300mg strength, are the generic equivalent of Wellbutrin XL(R) for the treatment of major depressive disorder. Annual U.S. sales of brand and generic Wellbutrin XL(R) were US$1,481 million for the 12 months ending September 2008 according to IMS Health data.

EPO rejects WARF stem cell application again

2008-12-01T10:01:00.003+05:30

European regulators have ruled against permitting a patent on developing human embryonic stem cells (hESCs). This would lead to a significant impact on companies which are working in the area of concern.

The Board of appeals at the EPO has upheld a decision made in June to reject a patent application regarding the use of stem cells filed by the Wisconsin Alumni Research Foundation in 1995. The office confirmed that “European patent law prohibits the patenting of human stem cell cultures whose preparation necessarily involves the destruction of human embryos”. The EPC already has a laid ban in place on the patenting of inventions whose commercial exploitation would be contrary to public order or morality, and specifically prohibits patents on uses of human embryos “for industrial or commercial purposes”.

The EPO found that the stem sells in the WARF application which was developed by scientist James Thomas cannot be produced without the use and destruction of human embryos. Contrary to that the Board also made a comment that “the decision does not mean that stem cells themselves are not patentable”, thus creating ambuguities in the minds of companies in Pharma domain.

Similar WARF patent applications have been challenged in the US. However WARF noted that the decision does not affect its patents in the USA, which were upheld in March by that country’s Patent and Trademark Office.

One day Symposium on Leveraging IP for business growth

2008-12-01T09:48:00.002+05:30

IIPRD, NOIDA is organising a one day symposium on Leveraging IP for business growth with focus on IP portfolio development, comercialisation, protection, due-diligence, Valuation, Licensing, Theft of IPR, IP litigation strategy & IP Risk Management. The datails of the symposium can be obtained from the website www.iiprd.com or contact Mr. Tarun Khanna, Executive Director, IIPRD. email: tarun@iiprd.com, phones (M): 09810617992, 0210-2342010/3104849, Fax: 0120-2342011

Leveraging IP for business growth

2008-12-01T09:34:00.004+05:30

An International Intellectual Property Rights Conference (Indo-US Knowledge Enterprise) is scheduled to be held on 8-10 January 2009 at Taj Bengal, Calcutta. The objective of the conference is to bring the technology near to business with due blending of Intellectual Property (IP) laws and various tools of IP Management.

The theme of the seminar aims at Empowering Business through Knowledge Management in the field of IPR.

IP personnal interested may contact Dr. Partha Sarathi Pal, Ms. Puja Bhupal; email: conference@iprconference.com. Further details are available from website www.iprconference.com