Prasugrel receives positive opinion from CHMP

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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....

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

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

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)

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

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

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

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

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

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

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

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

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)

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

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

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

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

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.

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

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

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

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