Happy New Year!

Patent Circle wishes all its readers and subscribers a very happy, prosperous and fulfilled new year! Let’s Rock 2007!!! Seema Singh & Varun Chhonkar

CAFC Rules Zyperxa Patent Valid, Blocks US Generics Penetration!

The U.S. Court of Appeals for the Federal Circuit (CAFC) has upheld the district court decision which earlier in April 2005 found the Eli Lilly’s U.S. Patent # 5,229,382 (the ‘382) to be valid and infringed, after been challenged by generic manufactures under the Hatch-Waxman Law. The ruling would excludes the possibility of generic Zyprexa till April 2011 following the expiry of the ‘382 patent. The CAFC rejected the appeal brought by generics defendants --- Zenith Goldline Pharmaceuticals, Inc. (now known as IVAX Pharmaceuticals, Inc.), Dr. Reddy’s Laboratories Ltd., and Teva Pharmaceuticals Inc. --- after it found no reversible error in the ruling made by the District Court Judge Richard Young. In line to make an early penetration in the US generic Zyprexa market, the generic defendants challenged the validity of the ‘382 patent, claiming that olanzapine was similar to previously disclosed compounds exemplified in the U.S. Patents # 4,115,574 (the ‘574 patent) assigned to Lilly and was in public use before Lilly received the ‘382 patent.

Barr Files ANDA for Generic Thaomid, Celgene Seeking to File Patent Lawsuit!

Celgene Corp. is seeking to file a patent infringement lawsuit against Barr Pharmaceuticals after been notified by the US FDA that Barr has filed an abbreviated new drug application (ANDA) under Para IV certification with an intention to market generic version of Thamoid tablets before expiry of O.B. listed patents. The lawsuit will entitle Celgene a 30-month injunction stay against marketing generic version of Thamoid, generically known as thalidomide.

USPTO to Train Indian Patent Examiners, Also to Develop Manual on Patent Practice

Recently India and the US signed a Memorandum of Understanding (MOU) on intellectual property issues to work together in promoting innovation, creativity and technological advancement. The MOU signed by Jon Dudas, Under Secretary of Commerce for Intellectual Property, and Ajay Dua, secretary of the Indian Ministry of Commerce and Industry, is a first between the United States and India on intellectual property issues. According to Under Secretary Dudas, “it will open the door for an unprecedented level of cooperation and sharing of best practices.” Under the terms of MOU, the USPTO and the Indian Ministry of Commerce and Industry Office of the Controller General will cooperate on capacity building, human resource development and public awareness of intellectual property. The USPTO will also help train Indian patent and trademark examiners, develop education material for the examiners and produce a manual on patent practice for use by Indian examiners and the public.

India BigPatents - An initiative for building Indian Patent Search Database!

Recently Professor Bhaven Sampat of the International Center for Health Outcomes and innovation Research (InCHOIR) and the Department of Health Policy and Management at Columbia University referred me about his initiative to provide a complete, searchable (and free!) database, India BigPatents of post TRIPS Indian patent applications and issued patents. The database is created by Professor together with Patrick Crosby of XB Labs LLC and bigpatents.com. According to BigPatents official website, the bulk of the data was parsed from the Indian patent journals, beginning with those published in January, 2005, using proprietary algorithms developed by XB Labs. Data not parsable via programming were hand coded by Digital Divide Data, a non-profit social enterprise offering data entry services. BigPatents is currently working on several enhancements including – Links from Indian applications to corresponding international applications (which I think is quite useful in tracking corresponding foreign applications, particularly when Indian patents/patent applications are difficult to trace/digitalize without the help of Indian Patent Office.) Links from the Indian application data on India BigPatents to relevant page (pages) in the Indian Patent Office Journal (however I feel there seems to be no need of doing this but may be useful to check authenticity of information) Weekly links to new applications and patents by firm name, and a weekly email newsletter summarizing the same (I think it is quite handy particularly for Indian pharma companies) User guides on “How to Search for Indian Applications and Patents” and “How to find Indian Applications for Drugs on the FDA’s Orange Book” (I hope Indian pharmaceutical companies would be happy to have such feature) Patent Circle greatly appreciates the initiative by Professor Bhaven Sampat and Patrick Crosby, especially when Indian Government miserably fails to come with any viable solution. Keep up rolling!

GlaxoSmithKline Withdraws Patent Application for Asthma

GSK has withdrawn its patent application for asthma drug covering combination of fluticasone and salmeterol following pre-grant opposition by Cipla. This is the second time that GSK has withdrawn its patent application. In March, it was forced to withdraw its patent application on fixed dose combination of zidovudine and lamivudine. Dr. Gopakumar G. Nair, IPR consultant representing Cipla said that “the application was withdrawn by Glaxo, based on the evidence which was overwhelming.” Dr. Nair is pharmaceutical patent expert and CEO of Mumbai-based Patent Consultancy firm Gopakumar Nair Associates and explicitly dealing with pre-grant, post-grant and other patent related matters.

Sutura files Patent Infringing Lawsuit against Abbott

California-based medical device company, Sutura, Inc. has filed a patent infringement lawsuit in the US District Court for the Eastern District of Texas against Abbott Laboratories Inc. alleging infringement of Sutura’s patents for vascular and cardiovascular suturing. Sutura is seeking unspecified damages and a court ordered injunction against barring Abbott from selling any device that infringes its product.

Sandoz to Continue Selling Generic Clarithromycin Extended Release tablet

U.S. District Court Judge David H. Coar has denied Abbott’s request for a temporary restraining order to block generic sales of Biaxin XL by Sandoz, the Novartis generic arm. Sandoz began selling generic Biaxin XL on December 04. Abbott claims that the Sandoz version infringes three patents, including one for an extended release version of the compound clarithromycin.

Pfizer prevails in Lipitor patent dispute, this time Australia!

Australian Federal Court has upheld Pfizer’s Australian Patent AU 601,981 (the ‘981 patent) covering atorvastatin, the active ingredient in Lipitor, blocking Ranbaxy from launching its generic version before May 2012. However, Justice Neil Young in his judgment also revoked Australian Patent AU 628,198 (the ‘198 patent) covering calcium salt of atorvastatin. Pfizer in its statement said it would appeal the decision to revoke the ‘198 patent.

Reliant Sues Par Pharma, defends Para IV against Rythmol SR

Reliant Pharmaceuticals Inc. has filed a patent infringement suit in the U.S. District Court for the District of Delaware against Par Pharmaceutical Inc. alleging infringement of Orange Book listed U.S. Patent # 5,681,588 for antiarrhythmic drug Rythmol SR, generically propafenone hydrochloride extended release capsule. The lawsuit is result of Par’s notification that it has filed a Para IV certification in connection with its abbreviated new drug application (ANDA) to the US FDA seeking marketing approval for generic Rythmol SR before expiry of O.B. listed patent.

EPO revokes Nexium Patent, AstraZeneca to lose potential market

EPO has revoked AstraZeneca’s European Patent EP0652872 covering esomeprazole magnesium, the active ingredient Nexium, a move which may potentially cost AstraZeneca more than US $ 1bn in annual sales in EU. According to spokeswoman for AstraZeneca, the EPO decision is not open to appeal. The ruling came out to be significant victory for German drug make Ratiopharm which challenged the validity of Astra’s patent. Ratiopharm first challenged the “novelty and inventiveness” of the Astra’s patent in 2001 which got rejected by the EPO in 2003 and subsequently appealed by Ratiopharm.

KRKA Wins Appeal, Court Lifts Ban on Generic Clopidogrel in Serbia

The Higher Commercial Court in Belgrade, Serbia has allowed KRKA’s appeal against the recent decision of the Commercial Court in Novi Sad, Serbia that granted the motion by Sanofi-Aventis for temporary injunction against the sales of generic Zyllt (clopidogrel hydrogen sulphate salt). Earlier on October 27, 2006 KRKA received adverse decision from Commercial Court which allowed Sanofi’s motion for temporary injunction due to alleged patent infringement protecting the clopidogrel and prohibiting import and sales activities in Serbia. However, KRKA subsequently appealed the decision for temporary injunction claiming that legal conditions for temporary injunction are still not fulfilled.

Latest U.S. Patents Issued to Indian Entities (issued on December 12, 2006)

U.S. 7,148,364 titled Process for the preparation of 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofura- n carbonitrile assigned to Sun Pharmaceutical Industries. U.S. 7,148,358 titled Process for the preparation of S (-) amlodipine-L (+)-hemi taratarte assigned to CSIR. U.S. 7,148,355 titled Process for preparation of repaglinide assigned to Ranbaxy Laboratories Limited. U.S. 7,148,354 titled Process for preparation of donepezil assigned to Dr. Reddy’s Laboratories Limited. U.S. 7,147,866 titled UV-absorbing lipid vesicles assigned to Galaxy Surfactants Limited.

Novo to continue Patent suit, Pfizer wins first round!

Novo Nordisk will continue fighting patent suit against Pfizer over the inhaler insulin product Exubera following adverse decision of a U.S. district judge to dismiss a preliminary motion against Pfizer. Judge Leonard Sand in his judgment denied to immediately block sales of Pfizer’s Exubera product, saying the public’s need for a ‘new and less invasive treatment for diabetes’ outweighed Novo Nordisk’s claims that Pfizer is infringing on its patents. In his 13-page ruling, Sand said determination of the validity and infringement of these patents “will be well served through closer inspection at trial.”

EPO to decide validity of AstraZeneca’s European Patent for Nexium

December 19, 2006 is going to be critical for AstraZeneca as European Patent Office will be hearing an appeal over a European Patent EP0652872 (the ‘872 patent) covering esomeprazole, the active ingredient of blockbuster drug Nexium. Losing the appeal would allow generic players to enter European Nexium market four years early than the expected expire until 2014. Even though AstraZeneca loses appeal, data exclusivity will continue to protect the Nexium from generic competition until at least 2010. At appeal EPO will be deciding that whether the ‘872 patent on Nexium is valid as esomeprazole is enantiomeric form of previous AstraZeneca blockbuster Prilosec, generically known as omeprazole. AstraZeneca expressing its confidence in patent contended that it was not obvious that isolating the isomer would have produced an improved drug. Earlier in November 2003, EPO ruled that the ‘872 patent is valid after been opposed by German drug manufacture Ratiopharm. However, the ruling was later appealed by Ratiopharm. In US, AstraZeneca is already defending Para IV challenges against Ranbaxy (November 2005 in U.S. District Court for the District of New Jersey) and Ivax (March 2006 in the U.S. District Court for the District of New Jersey).

Canadian Federal Court backs Pfizer, blocks Generic Lipitor

Canadian Federal Court has ruled in the favor of Pfizer, backing Pfizer move to block Novopharm from launching a generic version of Lipitor until its Canadian Patent # 2,021,546 (the ‘546 patent) expires in July 2010. The ruling is subject to appeal. Novopharma is Canadian Unit of Teva Pharmaceutical Industries Ltd.

Genentech, Tercica Awarded Damages in Patent Suit

The U.S. District Court Jury has awarded Genentech and Tercica US $ 7.5 million in damages, a 15% royalty on Iplex sales less than US $ 100 million, and 20% on sales above US $ 100 million. After an 11-day jury trial and 7 days of deliberations, the jury found that though Insmed infringed two patents, only one was willful. The court also upheld the validity of Genentech’s third patent under litigation. However, Tercica being a lead plaintiff in the litigation is expecting to recover a substantial portion of the damages. Tercica exclusively licensed disputed patents from Genentech in April 2002 for use in its manufacture and sale of, among other things, Increlex. Earlier in December 2004, Tercica and Genentech filed the patent infringement lawsuit seeking a declaratory judgment against Insmed and two of its subsidiaries, Insmed Therapeutic Proteins and Celtrix Pharmaceuticals, in the U.S. District Court for Northern District of California. Both Tercica and Genentech alleged infringement of the U.S. Patent Nos. 5,187,151 (the ‘151 patent); 5,258,287 (the ‘287 patent) and 6,331,414 (the ‘414 patent). The jury found that Insmed infringed the ‘287 patent; willfully infringed the ‘151 patent; and upheld the validity of the ‘414 patent. However, prior to trial the court has ruled that Insmed’s process for making the IGF-1 in Iplex literally infringes three claims of the ‘414 patent.

Sun Pharma Files Para IV Challenge for Anti-cancer Gemzar

Eli Lilly early this month has sued Mumbai-based Sun Pharmaceutical Industries in a move to negate Para IV challenge against Lilly’s blockbuster anti-cancer drug Gemzar, generically known as Gemcitabine hydrochloride worth around US $ 586 million US sales in 2005 (source Eli Lilly Annual Report 2005). Sun, which recently filed an abbreviated new drug application with the US FDA under Para IV certification, claims Orange Book listed patents --- U.S. Patent # 4,808,614 (the ‘614 patent) expiring on November 15, 2010 and U.S. Patent # 5,464,826 (the ‘826 patent) expiring on May 07, 2013 --- to be invalid and non-infringed. Early in January 2006, Sicor Pharmaceuticals, Inc. (a subsidiary of Teva) submitted an abbreviated new drug application with the US FDA seeking marketing approval for generic version of Gemzar, claiming both Orange Book patents to be invalid and non-infringed. Subsequently in February 2006, Lilly filed a patent infringement lawsuit against Sicor in the U.S. District Court for the Southern District of Indiana. (Eli Lilly & Co. v. Sicor Pharmaceuticals, Inc. et al insdce 1:2006cv00238 2/15/2006).

Savient Sues Sandoz and Upsher-Smith for Patent-Infringement

Savient Pharmaceuticals Inc. has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Sandoz Pharmaceuticals and Upsher-Smith Laboratories alleging infringement of five methods of using Oxandrin, generically known as Oxandrolone. Savient has also filed a motion seeking a temporary restraining order and preliminary injunction to restrain Sandoz and Upsher-Smith from marketing and selling their generic formulations of Oxandrin. The lawsuit was result of decision by the Food and Drug Administration denying two Citizens Petitions filed in 2004 and 2005 attempting to stop the approval of a generic version of Oxandrin made by Sandoz and Upsher-Smith. Savient also added it is examining the impact of the FDA decisions and its agreement with Watson on its pending patent-infringement lawsuit against Barr Laboratories, which also seeks to market a generic version of Oxandrin. Savient further added that it signed a supply and distribution deal with Watson granting it exclusive U.S. distribution rights to the authorized generic version of Oxandrin tablets.

US Stand: India Needs to Update its Patent & Copyright Law

US Under-Secretary of Commerce for International Trade, Mr. Franklin L. Lavin has raised concerns for India to update its patent and copyright laws with modern regulatory framework to attract more foreign capital. Leading the largest-ever business delegation from the US, Lavin told during a CII meeting on India-US trade that “Patent and copyright laws in India are old and backdated and they nowhere match the world standards.” He further added that “Both the countries need to sit and work out a proper regulatory framework by identifying the weak areas.” The delegation includes some big names like Exxon, GE, Motorola, AT&T, Avaya, IBM, Lockheed Martin, Northrop Grumman, Boeing, Datacorp, Bank of America and many other small and medium firms.

Thailand Dilutes Merck’s Patent Monopoly

Government of Thailand has diluted Merck’s patent monopoly for antiretroviral drug --- Efavirenz, by triggering the provision for compulsory licensing which will allow Thailand to import generic efavirenz from India and also local production of the generic efavirenz. Compulsory license will be valid for five-years. However, Merck has shown disappointment over the issue.