Teva Pharmaceutical Settles Lawsuit With Novartis

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

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

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)

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

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

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)]

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

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

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

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.