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.

Indian Patent Filings Expected to Increase by 23%

Indian Patent Office is expecting to receive somewhat 30,000 patent applications in 2006-2007, around 23% more as compared to the last year which account 24,500 patent applications. The largest applications are expected at the Delhi Patent Office, and overall most of the applications continue to be from foreign companies, tentatively around 80% of total filing (read more). According to Mr. Amitava Chakraborty, Assistant Controller of Patents & Designs, in terms of number of filings the Delhi Office is likely to rank first with 12,000 applications, followed by 7,000 applications from Chennai, 6,000 from Kolkata, and the rest from Mumbai. However, the largest number of patent filings has been in the chemicals and pharmaceuticals segment, which account 50% of total applications filed, followed by IT and electronics with around 20% (read more).

Torrent Pharmaceuticals received a U.S. Patent for novel heterocyclic compounds

Ahmedabad-based Torrent Pharmaceuticals Ltd. has recently received a U.S. Patent No. 7,138,416 (the ‘416 patent) directed to a novel heterocyclic compounds of general formula I and its pharmaceutically acceptable salts useful for (i) normalizing elevated blood glucose levels in diabetics, (ii) treating disorders related to glucose intolerance and (iii) scavenging free radicals from body cells. The ‘416 patent explicitly discloses list of 115 representative compounds covered within the structural scope of general formula I. According to the ‘416 patent disclosure, compounds of general formula I exhibit in vitro dipeptidyl peptidase-IV (DPP-IV) inhibitory activity.

Mylan Continue Firing Legal Canons!

Mylan and Pfizer are in middle of a patent war regarding blockbuster drug – Norvasc, generically known as amlodipine besylate which worth around US $ 2.2 billion sales last year. Pressure will definitely be on Pfizer which will rigorously be defending its patent exclusivity on Norvasc valid till September 2007 (including pediatric exclusivity), as losing the trial could lead Mylan to penetrate amlodipine generic market sooner than expected. A bench trial which began yesterday before Judge Terrence McVerry is expected to last about a week. Mylan, which in October 2005 received FDA final approval for three dosage strengths of generic Norvasc, has admitted to infringing on Pfizer’s patent, but claims the patent is invalid and unenforceable. Till date, Mylan has not started marketing its generic version as it could face heavy damages if it started selling its product and then lost the patent trial to Pfizer. At yesterday trail, Dr. James I. Wells, a co-inventor of Norvasc, admitted that the patent application submitted for Norvasc contained an incorrect formula in reply to questions made by Mylan attorney (read more). For Mylan, wining the trial means getting a 180-day marketing exclusivity for generic version of Norvasc. Considering that Pfizer has already defended two similar patent infringement cases regarding Norvasc this year against Apotex (in January) and Synthon Laboratories (in August), Mylan must go on to continue firing legal canons!

Jharkhand Government Seeks Patent Power

Jharakhand, one of the largest silk producing states in India, is likely to seek patent protection for the variety of organic silk to give a boost to the state economy. The Sericulture and Handicraft Department has approached the Central Silk Board (CSB) to work towards getting the organic silk patented.

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AIPS to Launch New Session for Diploma in Patent Management from January 07

1-yr. Part-time Post Graduate Diploma in Patent Management Commencement: January 20, 2007 Timing: 3 p.m. – 7 p.m. on Saturdays, and 9 a.m. – 1 p.m. on Sundays Mumbai-based Patent training institute --- Academy of Intellectual Property Studies will be inaugurating its new batch for One-year Part-time Post Graduate Diploma in Patent Management from January 20, 2007. The diploma is an in-depth programme providing a specialization in Patents. Both the theory and practice elements are addressed, and areas such as Patent Fundamentals, the Indian Patent Act, International Treaties relating to Patents, Prior Art Search, Specification Drafting, Opposition procedures, PCT filing, Pharma patenting, Polymorphism, Patent litigation, Patent Strategy and Management, etc are some of the topics covered. For complete details regarding course contents, faculty, methodology etc. visit www.aips.ac.in or email AIPS at info@aips.ac.in or call +91 22 6522 1067/2650 9035.

Upcoming Events

Intellectual Property Profile in Business Composition December 18, 2006 Mumbai The Institute of Intellectual Property Research and Practice will be organizing one-day symposium at Le Royal Meridian, Mumbai on Intellectual Property Profile in Business Composition to cover various practical aspects of Intellectual Property in corporate working. The symposium would deal with case studies to provide the direction to formulate the right strategies for creation, promotion, protection and commercialization of Patents, Trademarks, Trade Secrets and other Intellectual Properties. The one-day symposium will also be organized at Chennai (December 16, 2006) and New Delhi (December 20, 2006). For further information Visit @ http://www.iiprp.com/seminar_dec_2006.htm or contact at iiprp@sify.com.

Teva Settled Patent Dispute with Pfizer

Pfizer and Teva Pharmaceutical Industries has settled patent litigation over Teva’s sale of generic versions of Pfizer’s Zithromax (generically known as Azithromycin) antibiotic and Idamycin (generically known as Idarubicin) cancer medication. Under the terms of agreement, Teva will pay Pfizer up to $70 million and agrees not to contest the validity of the patents at issue. However, Teva will continue to market its generic versions of the drugs. The settlement deal also includes an option in 2007 for Teva to sell its own generic version of another cancer drug, Ellence generically known as epirubicin hydrochloride, prior to the August 2007 patent expiry. Earlier in on February 09, 2006 Pfizer petitioned the U.S. FDA to recall generic versions of Zithromax sold by Teva and Sandoz on the ground that the generic products inaccurately equated their active ingredients with the active ingredient of Zithromax. The petition is still pending with the U.S. FDA. Pfizer also has patent litigation pending against Sandoz over Zithromax.

Riluzole Patent Litigation Still Open for Impax Laboratories

The Court of Appeals for the Federal Circuit (CAFC) has vacated the district court’s ruling that claims 1-5 of Aventis’s U.S. Patent # 5,527,814 (the ‘814 patent) are not invalid by reason of anticipation and remanded the case to the district court for further proceedings consistent with the CAFC opinion, keeping Impax laboratories, which earlier challenged the validity and enforceability of the ‘814 patent, still in the race to crack Riluzole generic market. Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc., 05-1313 CAFC 2006

Mr. USFDA: It’s Time to Revise Homework!

Remember the Generic 23/6 Battle with Teva and Ranbaxy fighting to obtain 180-day marketing exclusivity under Hatch-Waxman provision for their respective strengths of generic Simvastatin tablets after USFDA refused their citizen petitions to re-list Merck’s two de-listed patents and not to approve subsequent ANDAs till the period of 180-day exclusivity period get expired. On April 30, 2006 Judge Richard W. Roberts of the U.S. District Court for the District of Columbia supported Ranbaxy and Ivax motion for summary judgment seeking to vacate the FDA decision, and asked FDA for review its decision. However, FDA appealed and filed a motion with US Court of Appeals for the District Court of Columbia Court seeking expedited review concerning Ivax and Ranbaxy’s 180-day exclusivity issue but did not request a stay. Meanwhile, after receiving final marketing approval from the FDA, Ranbaxy and Teva became the sole generic players to enter US Simvastatin market following Simvastatin patent expiry on June 23, 2006. On November 14, 2006 Court of Appeals affirmed the district court decision finding that the FDA wrongly delisted two Merck patents on Zocor. The Court of Appeals upheld the district court’s finding that FDA’s interpretation of the statue was contrary to the clear intent of Congress. The Court of Appeals in its opinion analyzed that “whether the FDA may delist a patent upon the request of the NDA holder after a generic manufacture has filed an ANDA containing a Paragraph IV certification so that the effect of delisting is to deprive the applicant of a period of marketing exclusivity.” Relying on two-step analysis in Chevron, U.S.A. Inc. v. NRDC, 467 U.S. 837 (1984), the Court of Appeals knock-down FDA’s policy, concluding that “not only does the statute not require litigation to preserve a generic applicant’s eligibility for exclusivity … such a requirement is inconsistent with the structure of the statute because, if the patent is delisted before a pending ANDA is approved, then the generic manufacturer may not initiate a period of marketing exclusivity.” Further added that “the FDA’s policy allows an NDA holder, by delisting its patent, to deprive the generic applicant of a period of marketing exclusivity. By thus reducing the certainty of receiving a period of marketing exclusivity, the FDA's delisting policy diminishes the incentive for a manufacturer of generic drugs to challenge a patent listed in the Orange Book in the hope of bringing to market a generic competitor for an approved drug without waiting for the patent to expire. The FDA may not, however, change the incentive structure adopted by the Congress.” The Court of Appeals concluded that “the FDA improperly denied Ranbaxy and Teva a period of marketing exclusivity by delisting Merck’s patents” and that “the FDA’s policy conditioning a generic applicant’s period of marketing exclusivity upon the generic applicant being sued for patent infringement by the NDA holder is inconsistent with the text and structure of the Act”. This means now Ranbaxy and Teva will continue to be sole generic players till end of December 2006 before other generic players make way to generic Simvastatin market and as far as FDA is concerned – It’s time for Mr. FDA to revise their homework! Ranbaxy Laboratories Ltd. et al v. Michael O. Leavitt, No. 05cv01838

Novo Nordisk sues USPTO

Novo Nordisk, after facing novelty rejection twice for its patent application relating to AERx inhaled insulin delivery system, has sued Jon Dudas, the head of the US Patent & Trademark Office. Novo claims the USPTO authority has misinterpreted data, evidence and legislation and as a result of which Novo chooses to go to the court for presenting its evidence.

Patent Circle Recommends – TTABlog and Daily Dose of IP

Recently I encountered a US trademark law blog – TTABlog - authored by John L. Welch focusing on the procedure and jurisprudence of the USPTO’s Trademark Trial and Appeal Board. Mr. John is attorney at Lowrie, Lando & Anastasi, LLP. Patent Circle recommends TTABlog if you are interested or active in Trademark Law. Daily Dose of IP is yet another worth reading Intellectual Property Law blog authored by Mark Reichel, a patent attorney with the Intellectual Property Group at IceMiller LLP. Daily Dose of IP focuses mostly on patents and also contains links to important case laws.

Upcoming Events

EU-India Training on IP Management Practices November 18, 2006, Mumbai CII in collaboration with the EU-India Trade and Investment Development Programme (TIDP) is organizing a corporate training programme on Intellectual Property Rights at Hotel Hyatt Regency, Mumbai. The EU-India TIDP training programme will focus on the fact that the companies need to dedicate resources and time for Creation, Protection and Management of Intellectual Property in order to achieve and sustain competitiveness at the market place. The EU-India Training on IP Management Practices will also be organized at Ahmedabad (November 20, 2006), New Delhi (November 22, 2006), Chennai (November 24, 2006), Bangalore (November 25, 2006), Hyderabad (November 27, 2006) and Kolkata (November 29, 2006). For further information contact Shilpi Jha @ shilpi.jha@ciionline.org. IPR Summit January 2007, Mumbai CII will be organizing an IPR Summit in January 2007 at Mumbai. For further information contact Shilpi Jha @ shilpi.jha@ciionline.org.

Mayne Pharma Loses Patent Litigation to AstraZeneca

Australian-based Mayne Pharma has lost a patent infringement lawsuit in the U.S. Court of Appeals for the Federal Circuit for an anesthetic drug Propofol, which upholds a U.S. District Court for the Southern District of New York decision finding that Mayne’s injectable formulation of propofol infringed patents held by AstraZeneca. Earlier on June 28, 2002 ESI filed an abbreviated new drug application (ANDA) along with Para IV certification, seeking marketing approval for generic propofol formulation. In respone, AstraZeneca filed a patent infringement lawsuit against ESI on October 04, 2002 alleging that ESI proposed generic propofol infringes AstraZeneca’s U.S. Patent Nos. 5,714,520 (the ‘520 patent), 5,731,355 (the ‘355 patent) and 5,731,356 (the ‘356 patent). Thereafter, Mayne, an indirect assignee of ESI, sent AstraZeneca a notice letter dated July 15, 2003 informing its intent to commercially manufacture, use or sell its generic propofol formulation in 50ml and 100ml vials. AstraZeneca reacted by filing a second lawsuit, and both actions were consolidated. On December 28, 2004 the District Court issued a Markman ruling, construing three contested terms including “edetate” which timely appealed by Mayne. After eleven day of bench trial, the District Court entered judgment in the favor of AstraZeneca concluding that the filing of Mayne’s ANDA infringed asserted claims of the patents in suit.

Cobalt follows DRL and Spectrum

After DRL and Spectrum, Cobalt also reached a patent lawsuit settlement with GSK regarding infringement of O.B. listed patents for Sumatriptan Succinate tablets. According to Cobalt it may distribute a generic version in the U.S. by the first quarter of 2009 following the settlement which remains subject to government review. Read also: What Glaxo Want? After DRL, its Spectrum to Settle Imitrex Patent Dispute with Glaxo

After DRL, its Spectrum to Settle Imitrex Patent Dispute with Glaxo

Spectrum Pharmaceutical has settled Imitrex patent litigation with GlaxoSmithKline relating to Sumatriptan injection. However, the terms of settlement are subject to government review which provides Spectrum to distribute authorized generic versions of Sumatriptan injection products in the U.S. With this, GSK continue to keep playing smarter!

Andrx Sued for Infringement of Adderall XR Patents

Shire Laboratories has filed patent infringement lawsuits in the U.S. District Court for the District of New Jersey and the Southern District of Florida against Andrx Pharmaceuticals (recently acquired by Watson Laboratories) for Infringement of the U.S. Patent Nos. 6,322,819 (the ‘819 patent) and 6,605,300 (the ‘300 patent). The lawsuits are result of Para IV certification by Andrx filed with USFDA seeking market approval for its abbreviated new drug application for generic versions of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg Adderall XR before the expiration of the ‘819 and ‘300 patents in 2018.

India & Malaysia to Start IPR Institute

Under a bilateral agreement, India and Malaysia has agreed to establish an India-Asean Institute for Intellectual Property Rights to build human resource capacities and training to serve the region. The institute will be located in Malaysia and would also help protect IPR interests of both regions. [Read More]

Generics Ready to Hit U.S. Zofran Market!

Glaxo’s critical U.S. Patent # 4,753,789 (the ‘789 patent) will be expiring on December 24, 2006 (including additional six months pediatric exclusivity), exposing U.S. Zofran market worth USD 900 million (sales in 2005) to generic drug manufactures. U.S. Patent # 4,695,578 (the ‘578 patent) covering Ondansetron hydrochloride, the active ingredient of Zofran, expired on July 25, 2005 but the ‘789 patent covering the approved indication is due to expire in next month. Interestingly, on November 07, 2006 Apotex sued U.S. regulators to block any rival from getting exclusive rights to sell generic versions of Zofran. Read More. Earlier in August 2001, Glaxo filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Reddy-Cheminor and Dr. Reddy’s Laboratories (DRL) alleging patent infringement of the Glaxo’s three patents including the ‘578 patent and two method of use patents, the later of which expires in December 2006. The lawsuit was result of DRL Para IV certification for Zofran tablets. In July 2003, Glaxo filed another patent infringement lawsuit against DRL in the same district court for infringement of the Glaxo’s patents related to Zofran orally disintegrating tablets followed by another lawsuit in October 2003 by Glaxo against West-ward Pharmaceuticals in the same district court for infringement of the Glaxo’s patents related to Zofran injections. Both the DRL disintegrating tablet case and West-ward case later consolidated with the earlier DRL case for Zofran tablets. However, prior to trial both DRL and West-ward withdrew their challenge to the ‘578 patent. The trial for infringement and validity of the Glaxo’s method of use and process patents got completed in June 2004 and closing arguments were heard in May 2005. Till date no decision has been announced. In March 2002, the Glaxo filed a similar action against Teva in the U.S. District Court for the District Court of Delaware alleging infringement of the two method of use patents for Zofran tablets. Teva certified invalidity or non-infringement of the two method of use patents. On August 20, 2004 the trial judge Gregory M. Sleet ruled in the favor of Glaxo, upholding the validity of method of use patents and infringed by Teva proposed ANDA product which was subsequently appealed by Teva to the Court of Appeals for the Federal Circuit (CAFC). However, Glaxo and Teva later reached a settlement agreement, the terms of which are kept confidential. In January 2003, Glaxo filed an infringement suit against Kali (now Par Pharmaceutical Company) in the U.S. District Court for the District of New Jersey involving orally disintegrating Zofran tablets. The trial judge denied Kali’s summary judgment motion and granted the Glaxo’s summary judgment motions in June 2005 and July 2005, affirming the validity of the Glaxo’s method of use patents and holding that Kali’s proposed generic product would infringe those patents. Following the district court decision, Kali filed a notice of appeal with the CAFC. Till date, no hearing date for that appeal has been announced. In June 2003, Glaxo filed an infringement action in the US District Court for the District of New Jersey against the Faulding Pharmaceutical Company (now Mayne Pharma) alleging infringement of the two method of use patents for ondansetron. Faulding case has been stayed pending decisions in the Reddy/West Ward case. Till date --- Teva, Hospira and Baxter received tentative approval for Ondansetron injection whereas Barr, Teva and Par received tentative approval for Ondansetron orally disintegrating tablets. Glenmark, Sun, Mylan, Kali, Teva and Taro received tentative approval for Ondansetron tablets. However, Kali received the FDA final approval for Zofran orally disintegrating tablets but later FDA rescinded its approval following the district court judgment that Kali’s ANDA infringes Glaxo’s unexpired patents.

Cephalon received U.S. Patent for Armodafinil Polymorphic Form

U.S. Patent & Trademark Office has issued U.S. Patent # 7,132,570 (the ‘570 patent) against the patent application number 10/539,918 filed by Cephalon France for polymorphic form of laevorotatory enantiomer of modafinil or armodafinil, the active ingredient in NUVIGIL tablets which is pending for approval with the US Food and Drug Administration. The ‘570 patent will run out its patent term on December 18, 2023. NUVIGIL is improved version of Cephalon’s blockbuster drug PROVIGIL.

Palomar & Cynosure Entered into Cross Licensing Agreement

Palomar Medical Technologies Inc. and Cynosure has entered into patent cross-licensing agreement for hair removal technology covered by specified U.S. and foreign patents. Cynosure will make a one-time payment to Palomar of USD 10 million for royalties related to prior sales of hair-removal systems including Cynosure’s Apogee family of products and the PhotoLight, Acclaim 7000 and PhotoSilk Plus systems. According to the agreement, Palomar granted a non-exclusive, royalty bearing license to Cynosure to U.S. Patent Nos. 5,735,844 (the ‘844 patent) and 5,595,568 (the ‘568 patent) and foreign counterparts. Further, under the terms of agreement, Cynosure also agreed to pay a royalty to Palomar on Cynosure’s future sales of certain hair removal products until all of the specified patents expire or all of the claims under the specified patents are no longer valid.

District Court Sets a Hearing Date in Diomed Patent Litigation

Diomed Holdings, Inc has announced that U.S. District Court for the District of Massachusetts has set a hearing date on December 08, 2006 to establish a trial date for infringement of the U.S. Patent # 6,398,777 (the EVLT patent). Diomed filed a patent infringement lawsuit in January 2004 against AngioDynamics and Vascular Solutions, Inc. seeking injunctive relief and damages for infringement of the EVLT patent covers the EndoVenous Laser Treatment (EVLT) of varicose veins. Diomed, Inc. v. AngioDynamics, Inc. et al. Earlier, this year U.S. District Judge Nathaniel M. Gorton ruled in the favor of Diomed contending that the EVLT patent is both valid and enforceable and rejecting defenses by AngioDynamics and Vascular Solutions that the EVLT patent is invalid and unenforceable. The court further denied separate motions by each of the parties for summary judgment on the issue of infringement by the defendants, in effect ruling that Diomed is entitled to proceed to trial on its claims for an injunction and damages against the defendants.

Terbinafine: The Next Blockbuster to Go Off-patent

Terbinafine hydrochloride, the active ingredient of Novartis blockbuster antifungal drug Lamisil, will be running out patent protection on December 30, 2006 making USD 538 million (Source: Novartis Annual Report, 2005) US market vulnerable to generic players. Indian leading pharmaceutical company – Ranbaxy has already received tentative approval from the U.S. FDA to manufacture and market Terbinfaine hydrochloride tablets, 250mg. Apart from Ranbaxy, Mylan also received tentative approval for terbinafine hydrochloride tablets whereas Taro received tentative approval for Terbinafine hydrochloride cream, 1%. Earlier in 2004, Novartis successfully defended Para IV challenge against Indian generic company Dr. Reddy’s Laboratories (DRL) which withdrew its Para IV challenge after evaluating the critical time period required to obtain favorable Federal Circuit decision and subsequently amended its ANDA from Para IV certification to Para III certification. The infringement suit was filed in the U.S. District Court for the Southern District of New York by Novartis in response of DRL Para IV certification on the U.S. Patent # 4,755,534 (the ‘534 patent).

Fulvestrant Expiring in December 2007, not October 2006

Fulvestrant, an antiestrogen drug used in the treatment of certain types of breast cancer in postmenopausal women marketed by AstraZeneca under the brand name Faslodex, is disclosed in U.S. Patent # 4,659,516 (the ‘516 patent) which was expected to run-out patent protection on October 01, 2006 (including 2 years patent term extension. But according to the current information available at Orange Book, Fulvestrant will be going off-patent on December 11, 2007. However, it is not sure why Fulvestrant patent expiry got revised from October 2006 to December 2007 but FDA docket refers to a document where AstraZeneca attorney has requested USFDA for reconsideration and revision of the Regulatory Review Determination under § 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)). Drugs expired in October 2006 Nedocromil Sodium expired on October 02, 2006 Zolpidem Tartrate expired on October 21, 2006

What Glaxo Want?

India’s leading Para IV challenger – Dr. Reddy’s Laboratories (DRL) has finally zeroed down to settle its pending Para IV patent litigation with GlaxoSmithKline (GSK) over the blockbuster anti-migraine drug, Imitrex, generically known as Sumatriptan Succinate which worth around US $ 890 million in sales in the U.S. market. GSK, under the terms of agreement, has agreed to grant an authorized generic (AG) status to DRL for its Imitrex tablets in the U.S. market which would eventually allow DRL to launch its authorized generic in the last quarter of 2008 ahead of the expiration of the pediatric exclusivity on the U.S. Patent # 5,037,845. After Merck’s blockbuster drugs, Zocor & Proscar, Imitrex is third in a row to fall in DRL expanding authorized generic portfolio. As far as DRL is concerned, it is undoubtly a win situation, both on strategic and financial frontier. This settlement strategically gives DRL an advantage over other generic manufactures and financially reduces DRL legal burden of fighting expensive patent litigations. But what made GSK to go about it?

Sumatriptan Succinate and Orange Book Status

Sumatriptan succinate is broadly covered by the U.S. Patent No. 4,816,470 (the genus patent) within the Markush Structural Formula and in particular claimed by the U.S. Patent No. 5,037,845 (the species patent). The genus patent was subject to 35 U.S.C. § 156 and received an extension of the patent term for the period of 275 days, extending the original expiration date from March 28, 2006 to December 28, 2006. Both genus and species patents also received additional six months pediatric exclusivity, extending patent validity period till June 28, 2007 (genus patent) and February 06, 2009 (species patent). In addition to genus and species patents, Orange Book also lists three more U.S. patents for pharmaceutical compositions and method of treating migraine running out patent protection from September 2012 to July 26, 2016 (including six months pediatric exclusivity). These patents are as follows.

U.S. Patent # 5,863,559 (the ‘559) directed to a pharmaceutical composition for oral administration comprising a compressed film-coated tablet comprising a tablet core containing 25 to 200mg of 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamide succinate (1:1) salt as active ingredient, and a pharmaceutically acceptable carrier or excipient and a film coating on said tablet core wherein the film coating is applied to the tablet core in an amount of from 2 to 5% w/w of the tablet.

U.S. Patent # 6,020,001 (the ‘001 patent) directed to a pharmaceutical composition for oral administration comprising a film-coated tablet containing 3-[1-(dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulphonamide succinate (1:1) salt as active ingredient, and a pharmaceutically acceptable carrier or excipient.

U.S. Patent # 6,368,627 (the ‘627 patent) directed to a method of treating or prophylactically treating a human suffering from migraine which comprises oral administration of a pharmaceutical composition comprising a film-coated solid dosage form of 3-[2-dimethylamino)ethyl]-N-methyl-1H-indole-5-methanesulfonamide or a pharmaceutically acceptable salt or solvate therefore as active ingredient.

DRL Eyes Sumatriptan!

In December 2003, DRL filed an abbreviated new drug application (ANDA) with USFDA seeking marketing approval for its generic version of Imitrex tablet, along with Para IV certification on four of the five O.B. listed patents for Imitrex tablets. After receiving notification for DRL, GSK subsequently sued DRL and filed patent infringement lawsuit in the U.S. District Court for the Southern District of New York alleging patent infringement of the species patent. Later six other generic companies also filed ANDAs for imitrex but of those only Cobalt Pharmaceuticals certified Para IV certification for the species patent, challenging its validity. GSK filed infringement suit against Cobalt in the U.S. District Court for the Southern District of New York. In February 2005, GSK also filed a patent infringement suit against Spectrum Pharmaceutical in the U.S. District Court for the District of Delaware, alleging infringement of the species patent. However, Spectrum filed ANDA for marketing approval for sumatriptan injection.

GSK Unexpected Move

In the meantime, GSK made a surprising and unexpected move by filing Disclaimer and Dedication with USPTO for the ‘559, ‘001 and ‘627 patents under 35 U.S.C. § 253 and thereby dedicating to the public the entire term of the said patents. The dedication was filed on August 16, 2004 and subsequently notified in Official Gazette on November 02, 2004.

It is expressly provided under 37 CFR § 1.321(a) that “a patentee owning the whole or any sectional interest in a patent may disclaim any complete claim or claims in a patent. In like manner any patentee may disclaim or dedicate to the public the entire term, or any terminal part of the term, of the patent granted. Such disclaimer is binding upon the grantee and its successors or assigns.” This is furthermore a right that is guaranteed by U.S. patent statute as provided under 35 U.S.C. § 253 that “a patentee, whether of the whole or any sectional interest therein, may, on payment of the fee required by law, make disclaimer of any complete claim, stating therein the extent of his interest in such patent. Such disclaimer shall be in writing, and recorded in the Patent and Trademark Office; and it shall thereafter be considered as part of the original patent to the extent of the interest possessed by the disclaimant and by those claiming under him. In like manner any patentee or applicant may disclaim or dedicate to the public the entire term, or any terminal part of the term, of the patent granted or to be granted.”

GSK also asked USFDA to delist the ‘559 and ‘627 patents from the Orange Book but USFDA refrained from delisting the said patents in the light of petitions filed by Ranbaxy and Ivax against the delisting of Orange Book listed patents for Simvastatin. Moreover, referring USPTO ‘Patent Maintenance Fees’ section, the ‘627 patent has already expired on April 10, 2006 due to non-payment of maintenance fees.

Glaxo Playing Smart

Considering that GSK already dedicated the ‘559, ‘001 and ‘627 patents to the public under 35 U.S.C. § 253 and likely to run-out patent protection for its species patent in February 06, 2009 it seems to be that GSK has moved much smarter than DRL. By allowing DRL to launch Imitrex authorized generic in the last quarter of 2008, GSK has well avoided DRL attack on the validity of the species patent.

Forgent Settles JPEG Patent Battle

Forgent Networks has announced to reach a settlement agreement regarding its pending patent infringement lawsuits with all of the parties including Microsoft for infringing Forgent’s JPEG patent --- U.S. Patent # 4,698,672 (the ‘672 patent). Forget sued companies throughout the tech industry but face hard resistance for Microsoft which retaliated and tried to invalidate Forgent’s patent on the image-compression technology. On June 28, 2006 the Court issued its claims construction ruling, which favored the majority of the defendants’ claim construction. Specifically, the Court ruled the claims to be limited to video and as a result of the unfavorable claims construction ruling, Forgent pursued settlement negotiations with the defendants. On October 25, 2006 Forgent signed a Patent License and Settlement Agreement with the defendants. Under this agreement, Forgent granted the defendants a license and the defendants agreed to pay Forgent US $ 8 million.

Apotex Asks Federal Circuit to Lift Ban

Apotex Inc. has asked a federal appeals court to lift a ban on sales of generic versions of the blood-thinning drug Plavix in the US. Apotex attorney told the U.S. Court of Appeals for the Federal Circuit that a ban imposed by a judge should be overturned because the patent is invalid and because Sanofi-Aventis and Bristol-Myers could be reimbursed anyway if they win at trial in January, 2007. Apotex further added that the key ingredient in Plavix, clopidogrel bisulphate, is covered by a patent that has already expired and the 2011 patent is invalid because it’s an obvious variation on the earlier patent. In response, Sanofi attorney argued that Apotex was “making an after-the-fact, hindsight argument.” He argued that after years of testing various chemical compounds, Sanofi researchers produced “dramatically different” results that expected. He further added why his clients would “spend seven years and millions of dollars” if clopidogrel bisulfate is “obvious.”

Spanish Court Supports Ranbaxy

A Spanish Court has favored Ranbaxy’s action for invalidation of Pfizer’s Spanish patent covering calcium salt of atorvastatin and eventually invalidate Spanish Patent ES 2,167,306 for lack of novelty. Earlier, the Mercantile Court of Barcelona had sought an advisory opinion on Spanish patent covering atorvastatin calcium from the European Patent Office, wherein EPO found them to be valid. The court delivered its decision after considering the views of Spanish Patent Office and technical expert reports.

EPO Opined in favor of Atorvastatin Calcium Salt Patent

In response to a request from a Spanish Court which is hearing an infringement suit filed by Ranbaxy against Pfizer, the European Patent Office (EPO) has rejected Ranbaxy’s argument contending that a patent covering atorvastatin calcium is invalid for ‘lack of novelty’ and ‘lack of inventive step’ and has upheld the validity of calcium salt patent. The EPO’s statement will be considered among comments from several experts before a court decision is made. The EPO opinion follows a decision earlier this week by a U.S. Court of Appeals for Federal Circuit not to review a previous ruling that granted a split decision on two Lipitor patents, supporting Pfizer’s basic patent and invalidating calcium salt patent.

Amgen v. Roche: U.S. Court Scheduled Discovery Phase

Patent infringement suit filed by Amgen has advanced to Discovery phase following the order from the U.S. District Court in Boston which denied Roche’s motion to dismiss Amgen’s patent lawsuit against it. The Court has not made any determination as to Amgen’s claim that C.E.R.A. infringes its patents, and Roche remains confident that it does not infringe any of Amgen’s patents. The Court has set a Nov. 6 deadline for Roche to answer Amgen’s compliant. However, the Court order does not impact Roche’s efforts to seek regulatory approval from the U.S. FDA or other health authorities for its investigational Continuous Erythropoietin Receptor Activator (C.E.R.A.) for the treatment of renal anemia including chronic kidney disease patient on dialysis and not on dialysis. Earlier in November 2005, Amgen Inc., the world’s largest biotechnology company, sued Roche Holding AF, alleging the Roche’s experimental anemia drug C.E.R.A. infringes Amgen’s patents. The lawsuit reveals that C.E.R.A. contains erythropoietin (or EPO), a human protein that forms the basis of Amgen’s anemia drug – Epogen. Amgen complaint seeks an order to prevent Roche from making or selling C.E.R.A. in the U.S. Currently, C.E.R.A. is in the final stage of human tests needed for regulatory approval. C.E.R.A. is so called “pegylated” drug, designed to be longer-acting by attaching a polyethylene glycol molecule. The lawsuit alleges that Riche infringes six U.S. patents on products and pharmaceutical compositions, and processes for making EPO. Amgen seeks a declaration by the Court that Roche’s importation, use, sale or offers to sell a pegylated version of recombinant human erythropoietin infringe Amgen’s patents.

Japan’s Supreme Court Delivers a Landmark Judgment

Japan’s Supreme Court backed a January 2004 high court decision, and asked Hitachi to pay 163 million yen (U.S. $ 1.4 million) to a former employee, Seiji Yonezawa, who invented technology for reading compact discs and digital video discs while working for the Hitachi. However, Hitachi has found the Supreme Court ruling “Regrettable” and likely to hinder the research development and business efforts of Japanese companies. According to Yonezawa’s lawyer, Yonezawa received only 118,000 yen for one of three patents he filed between 1973 and 1977, providing technology to read CDs and DVDs. In the 2004 High Court case, Yonezawa, who retired from Hitachi in 1996, demanded 250 million yen in royalties. Hitachi argued it had already paid him for the patents.

Purdue Signs Consent Judgment with Teva

Purdue Pharma and Teva Pharmaceutical signed a consent judgment in the U.S. District Court for the Southern District of New York, with Teva admitting that Purdue’s OxyContin patents are valid, enforceable and infringed by Teva’s extended-release oxycodone products, and thereby ending a patent infringement dispute. Earlier on August 29, 2006 Purdue and Teva announced their agreement to terminate the litigation subject to certain contingencies, including review by the United States antitrust agencies and the United States District Court for the Southern District of New York. The agreement permits Teva to continue sales of generic version of OxyContin at least through March 31, 2007.

District Court Upheld Risperdal Patent

Judge John C. Linfland of the U.S. District Court for the District of New Jersey has upheld the validity and enforceability of Janssen key U.S. Patent # 4,804,663 (the ‘663 patent) for Risperdal, generically known as Risperidone, used to treat schizophrenia, bipolar mania, and irritability in autistic children. The Injunction prohibits Mylan Pharmaceuticals Inc. and Dr. Reddy’s Laboratories Ltd. from selling their proposed generic risperidone products in the U.S. until the Janssen patent on Risperdal expires next year. The judge also directs the Food and Drug Administration to change the effective date of Mylan’s tentative approval to market its generic risperidone tablets to no earlier than the December 29, 2007 when the ‘663 patent expires. The lawsuit was result of Janssen patent infringement complaint in 2003, contending that Mylan and DRL proposed generic products infringed the ‘663 patent – a charge that Mylan and DRL did not dispute at trial. Two additional suits against DRL for its orally disintegrating risperidone tablet, filed in February 2005 and November 2005, were consolidated in this trial. Risperdal generated sales of about US $ 3 billion in 2005.

WIPO Patent Report: India Ranked Twelfth in Patent Filing

According to WIPO Patent Report: Statistics on Worldwide Patent Activity (2006 Edition), India ranked 12th in the world for the number of patent applications filed in 2004. Japan (ranked 1st) and the US (ranked 2nd) saw the highest number of patent applications filed, followed by Europe, the Republic of Korea and China, all of which account for 75% of all patent applications filed in 2004. The number of patent applications filed worldwide has increased from 884,400 in 1985 to 1,599,000 in 2004. Interestingly, Indian Patent Office also witness phenomenon growth in the number of patent applications filed by residents, increased by +365% between 1995 to 2004, while patent applications filing by non-residents increased by +105%. Compared to India, China Intellectual Property Office patent applications filing increased by +557% between 1995 to 2004 by residents and +644% by non-residents signifying a considerable edge over India’s patenting scenario, particularly when it comes to patent applications filed by non—residents. That means inventors and MNCs from other countries are considering China as a huge potential market and industrially-innovative economy than India. Apart from filing large number of patent applications in India, Indians also filed 2,400 patent applications in other countries lagging behind Chinese and Koreans which filed 3,100 and 30,900 patent applications in other countries. Considering patents signifies country’s innovative capacity, India ranked very low rate of resident patent filings per million populations, standing 7 patent filings per million inhabitants. China and Korean witness 51 and 2,189 patent filings per million inhabitants. Applications filed with Indian Patent Office in 2004: 18,145 Patents issued by Indian Patent Office in 2004: 2,317 Patent Filings Per $ Million R&D Expenditures (India) in 2004: 0.22 Total Number of Patents in Force Worldwide in 2004: 5.4 million

Medtronic Loses Patent Challenge in CAFC

The U.S. Court of Appeals for the Federal Circuit has affirmed an earlier District Court ruling which rejected a patent dispute by Medtronic Inc., challenging the validity of a heart-rhythm device patent license to Guidant Corp. The Federal Appeals Court backed the District Court’s decision to uphold cardiac resynchronization patent for which Guidant had exclusive rights under an agreement with Mirowski Family Ventures LLC. Earlier in 2003, Medtronic filed a declaratory judgment action in the U.S. District Court for the District of Delaware against Guidant Corp., Eli Lilly, and Mirowski Family Ventures LLC (collectively “the Guidant”) to avoid paying royalties to Guidant for use of the technology covered by the U.S. Reissue Patent # 38,119 (the ‘119 patent). In the action, Medtronic alleged that claims 15-26 of the ‘119 patent, a reissue of U.S. Patent # 4,928,688 (the ‘688 patent), are invalid by reason of violation of the rule against recapturing surrendered subject-matter. The ‘119 patent claims a method and a pacemaker apparatus for conditionally or unconditionally pacing the two ventricles of the heart to cause simultaneous ventricular contradictions. The District Court held a three-day bench trial and in its decision after trial, ruled that the ‘119 patent did not improperly recapture the subject matter that was surrendered during prosecution, which Medtronic appealed.

Court Upholds Eisai Ulcer Drug

U.S. District Court for the Southern District of New York in summary motion judgment has ruled in the favor of Eisai Co. over blockbuster ulcer drug, Aciphex, generically known as Rabeprazole sodium, ruling basic compound patent issued as the U.S. Patent # 5,045,552 (the ‘552 patent) to be valid, and thereby reducing the risk of generic penetration in the U.S. Aciphex market which worth around US $ 1.2 billion. The ‘552 patent will be running out patent protection in May 2013. However, the court reserved its ruling on the enforceability arguments until after trial. In addition, the court will continue to hear arguments from the generic makers, who say there were flaws in Eisai’s patent procedure. Earlier in November 2003, Eisai filed patent infringement lawsuits in the U.S. District Court against Teva Pharmaceutical and Dr. Reddy’s Laboratories, in response of their abbreviated new drug applications filed with USFDA, seeking marketing approval for their generic Aciphex. Later in January 2004, Eisai filed another patent infringement lawsuit against Mylan in response of abbreviated new drug application filed by Mylan with USFDA.

Who Played Smart – DRL or Glaxo?

India’s leading Para IV challenger – Dr. Reddy’s Laboratories (DRL) has finally zeroed down to settle its pending Para IV patent litigation with GlaxoSmithKline (GSK) over the blockbuster anti-migraine drug, Imitrex, generically known as Sumatriptan Succinate which worth around US $ 890 million in sales in the U.S. market. GSK, under the terms of agreement, has agreed to grant an authorized generic (AG) status to DRL for its Imitrex tablets in the U.S. market which would eventually allow DRL to launch its authorized generic in the last quarter of 2008. After Merck’s blockbuster drugs, Zocor & Proscar, Imitrex is third in a row to fall in DRL expanding authorized generic portfolio. As far as DRL is concerned, it is undoubtly a win situation, both on strategic and financial frontier. This settlement strategically gives DRL an advantage over other generic manufactures and financially reduces DRL legal burden of fighting expensive patent litigations. But what made GSK to go about it?

Savient Sued Barr over Oxandrin Patents

New Jersey-based Savient Pharmaceuticals has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Barr Pharmaceuticals in response of abbreviated new drug application (ANDA) filed with the U.S. FDA seeking marketing approval for generic Oxandrin prior to expiration O.B. listed patents. Oxandrolone, active ingredient of Oxandrin tablet is an off-patent molecule disclosed in the U.S. Patent No. 3,128,283 and currently been used to promote weight gain following extensive surgery, chronic infection, or severe trauma. Orange Book currently lists five U.S. patents for Oxandrin tablet, which will run through patent protection till December 2017.

Indian Court All Set for Gleevec Case

On September 26, 2006 a Chennai High Court Judge has ruled that patent dispute over the anti-leukemia drug Gleevec should be heard by a two-judge panel, contending that the importance of the questions involved required a larger panel. The ruling came as setback to aid groups, which wanted the case to be dismissed by the judge. Novartis, which is challenging the Patent Office decision back in January 2006 to reject its patent application for Gleevec and seeking review by the Chennai High Court, has subsequently challenged the constitutional validity of section 3 (d) contending that section 3(d) of the Patents Act 1970 is not TRIPS compliant.

Beware! Patent Thieves

The U.S. District Court for the Southern District of New York in Manhattan has ruled in the favor of Yeda Research and Development Company concerning inventorship disputes of a U.S. Patent # 6,217,866 (the ‘866 patent) that ImClone licenses from Sanofi-Aventis. The court ruled that three scientists associated with Yeda are sole inventors of the patent, which covers the use of certain monoclonal antibodies in combination with anti-neoplastic agents for the treatment of cancer. U.S. District Judge Naomi Reice Buchwald directed the USPTO to replace seven names now on the controversial patent with those of Professor Michael Sela, Dr. Esther Aboud-Pirak and Dr. Esther Hurwitz. In his 140-page opinion, Judge Buchwald indicated it was not a close call because the events described by the researchers and their experts were “strongly corroborated” by documents, while the version presented by the defendants (ImClone/Aventis) was not. She also found that the plaintiffs’ (Yeda) witnesses were, “as a whole, far more credible than the defendant’s witnesses.” However, ImClone disagrees with the Court’s decision and intended to appeal against it. ImClone believes the former Aventis scientists originally named as inventors are the correct inventors of the patent. The ruling was the first judgment in lawsuits brought by Yeda in five countries against ImClone/Aventis. Other lawsuits are pending in England, Germany, France and Austria. Case: Yeda Research v. ImClone Systems et al. (03 CV 8484).

Toshiba, Micron Ended the Patent Brawl

Toshiba Corp. and Micron Technology Inc. have settled a number of pending patent infringement lawsuits related to computer memory chips. According to settlement agreement, Toshiba would purchase some Micron patents related to semiconductor technology and secure licenses for patents held by Micron unit Lexar Media Inc. for US $ 288 million. However, the amount is substantially less than the US $ 465 million in compensation awarded to Lexar by a California Court last year. The payment has been on hold after Toshiba managed to have the damages reconsidered and filed an appeal seeking to overturn the original guilty verdict.

Let’s Do It Together

Unimed Pharmaceuticals Inc., a subsidiary of Solvay Pharmaceuticals Inc. has settled its pending patent infringement litigation with Watson Pharmaceutical and Par Pharmaceutical Companies Inc. on a generic version of AndroGel, a replacement therapy in men with conditions associated with a deficiency or absence of endogenous testosterone. Under the separate settlements, generic AndroGel may be marketed in 2015, almost five years before the AndroGel patent expires in 2020. Under terms of settlement agreement, Solvay has granted Watson a non-exclusive license to the U.S. Patents covering AndroGel and Watson would not commence marketing its generic version until August 31, 2015 or the date on which another generic product enter the U.S. market, whichever occurs first. Watson, which earlier received final approval of its ANDA on January 27, 2006 and was awarded 180 days marketing exclusivity for its ANDA, has agreed to forfeit its 180-day marketing exclusivity. Additionally, Watson has agreed that Watson’s Specialty Products sales force will co-promote AndroGel to urologists in the U.S. Further, Par has acquired all rights to the ANDA for AndroGel from Paddock Laboratories, and subsequently entered into a separate agreement with Solvay under which Par’s branded sales force will co-promote AndroGel for six years.

Xbox runs into trouble

Paltalk Holdings Inc assignee of U.S. Patent # 5,822,523 and 6,226,686 (the PalTalk Patents) has filed a patent infringement lawsuit in the U.S. District Court for the Eastern District of Texas against Microsoft alleging that Microsoft Xbox and Xbox 360 through Xbox Live online gaming service infringes the PalTalk Patents under 35 U.S.C. § 271 (a) (direct infringement), § 271 (b) (induced infringement) and § 271 (b) (contributory infringement). PalTalk also contented that Microsoft’s infringing conduct is unlawful and willful under 35 U.S.C. § 285. PalTalk is also seeking damages including attorney fees and permanent injunction.

Same Old Story

The three-judge panel of the District Court of Hague has ruled that Ranbaxy’s proposed atorvastatin product infringed the broadest claims of Pfizer’s European Patent EP 247633 (the ‘633 patent) in the Netherlands and thereby preventing Ranbaxy from launching its generic version of Lipitor before Pfizer’s basic patent expires in November 2011. The Dutch Court also ruled Pfizer’s second patent EP 409281 (‘281 patent) covering calcium salt of atorvastatin invalid, yet again repeating the U.K. Court of Appeal judgment in June 2006 which invalidated species patent but found Ranbaxy’s proposed product infringing the broadest claims of genus patent. Same like in past cases, this ruling would have no practical commercial interest to Ranbaxy as the ‘633 patent will remain in effect beyond the expiration of the calcium salt of atorvastatin (the ‘281 patent).

Mylan Conquered Ditropan XL Patent Litigation

On September 06, 2006 the U.S. Court of Appeals for the Federal Circuit upheld the District Court decision that Mylan’s unique delivery system did not infringed the U.S. Patent No. 6,124,355 (the ‘355 patent) assigned to ALZA Corporation (now Johnson & Johnson subsidiary) and declared the ‘355 patent invalid on the grounds of anticipation and obviousness. This judgment would now trigger Mylan’s exclusive supply deal with Ortho-McNeil Pharmaceutical and ALZA Corporation, and allow Mylan to launch its generic Ditropan XL with 180-day marketing exclusivity for 5mg and 10mg strengths in the U.S. Ditropan XL market worth around US $ 440 million (2005). The CAFC also upheld a similar lower court decision for Impax Laboratories which holds 180-day marketing exclusivity for 15mg strength.

Cordis Corp. Penalized in the Patent Infringement Dispute

On September 05, 2006 U.S. Federal Judge Tim Leonard penalized Cordis Corp. (A division of Johnson & Johnson) in a patent infringement dispute concerning three U.S. patents issued to Dr. Jan K. Voda. The judge awarded $8.1 million in damages and prejudgment interest and $ 2.2 million in attorney fees to Dr. Voda. Earlier in October 2003, Dr. Voda brought patent infringement suit against Cordis in the U.S. District Court for the Western District of Oklahoma for infringement of three U.S. patents relating to guiding catheters for performing angioplasty on the left coronary artery. In response, Cordis denied that the sale of its catheters infringed Dr. Voda’s patents and counterclaimed for a declaratory judgment of patent invalidity and non-infringement. Later in May 2006, the jury found that Cordis Corp. willfully infringed Dr. Voda’s patents and rejected Cordis motion for declaratory judgment and also awarded Dr. Voda a 7.5 percent royalty.

Some Relief to Sanofi & Bristol

Judge Sidney H. Stein of the U.S. District Court for the Southern District of New York has issued an injunction to halt the sale of generic clopidogrel bisulphate tablets after two-day hearing giving much relief to Sanofi and Bristol which were desperately trying to win motion for injunction against Apotex generic Plavix. However, Apotex has said to appeal the decision and file an emergency motion with the Court of Appeals for the Federal Circuit to stay the injunction pending the appeal.

Ranbaxy: Where there is a will…

Norwegian Court has ruled in the favor of Ranbaxy in a patent infringement lawsuit against Pfizer, contending that Ranbaxy’s proposed generic product would not infringe two of Pfizer’s Norwegian patents --- # 177,566 and # 180,199 --- covering a particular intermediate compound. However, this judgment does not have any immediate practical effect to Ranbaxy but will allow Ranbaxy to launch generic version of Lipitor by February 2009 rather than 2010. Pfizer has already planned to make an appeal against the decision. Pfizer has shown confidence in its Norwegian Patent # 177,706 expiring in February 2009 which was earlier upheld by Norwegian Court as valid and infringed by Ranbaxy’s proposed product. However, Ranbaxy has already made an appeal against the decision to the Norwegian Court of Appeals which is scheduled to be heard next March.

Teva Too Zeroed Down to Patent Settlement

Following Endo and Purdue settlement move, Teva too settled its pending patent litigation with Purdue over the Oxycodon extended-release tablets, marketed as OxyContin. Under the deal, Teva has agreed to stop selling its generic OxyContin at an undisclosed future date. And in exchange, Purdue has agreed not to pursue damages against Teva for past infringement of Purdue’s patents. This lawsuit was pending in the U.S. District Court for the Southern District of New York.

Endo, Purdue Zeroed Down to Patent Settlement

Endo Pharmaceuticals has settled long-running patent infringement litigation with Purdue Frederick over three U.S. Patents, namely, 5,656,295 (the ‘295 patent); 5,508,042 (the ‘042 patent); and 5,266,331 (the ‘331 patent) listed with O.B. for oxycodone extended-release tablets, marketed as OxyContin. Under the settlement deal, Endo will continue to market its generic product until December 31, 2006 and will be released from all liability for infringement in connection with Endo’s prior and future sales of generic oxycodone extended-release tablets. However, the deal is subject to approval by the U.S. Federal Trade Commission and the Antitrust Division of the Department of Justice. Endo launched its generic oxycodone extended-release tablets on June 07, 2005 after the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the Southern District of New York ruling that Purdue’s patents were unenforceable due to inequitable conduct before the USPTO and sent the case back to the District Court for further considerations. Following CAFC ruling, Purdue filed a petition for rehearing which was granted on February 01, 2006 withdrawing its earlier decision. In its revised decision, the CAFC vacated the inequitable conduct judgment and sent the case back to the District Court for further proceedings in accordance with its revised opinion. The CAFC also affirmed the District Court ruling that Endo proposed product would infringe Purdue’s patents. After almost 6 years of legal tussle, Endo and Purdue finally zeroed down to patent settlement leaving behind the trace of unsettled patent dispute, particularly the critical balance of materiality and intent in determining inequitable conduct.

Believe in Innovation!

Singapore-based company Creative not only made news recently by settling patent dispute with Apple for U.S. $ 100 million but also made a substantially bold move by suing one of leading IT giant company – Apple for infringing its U.S. Patents, particularly U.S. Patent No. 6,928,433 famously known as “Zen” patent, involving the software menus used to find and play back music on portable music players. Steve Jobs, CEO Apple is his statement admitted that “Creative is very fortunate to have been granted this early patent.” Even though Apple iPod covers major percent of U.S. market, Creative dared to sued Apple to enforce its patents and keeping its believe in Innovation!

Do You Know!

The first U.S. patent was issued to Samuel Hopkins for a process for making potash and pearl ash, types of potassium compounds used to make soap and fertilizer. The patent was issued on July 31, 1790 and signed by President George Washington and Secretary of State Thomas Jefferson. Surprisingly, even though, this was the first patent issued, it wasn’t U.S. Patent # 1. Why? Prior to Patent Act of July 04, 1836, U.S. patents were issued by name and date rather than number. The U.S. Patent Office had already issued nearly 10,000 patents, when a fire destroyed many of the original records in December 1836. Using private files, the U.S. Patent Office restored 2,845 patents records, and issued a number beginning with an “X” and called the “X-Patents.” Thus the first patent ever issued was actually designated Patent X1. U.S. Patent 1, the first patent issued under new numbering system, was issued to Senator John Ruggle for a cog mechanism for locomotive wheels which was, in fact, reinvention of the wheel. Ruggle designed a new train wheel that yielded more traction and prevented sliding.

Who Invented and Who Cashed Telephone?

For 113 years, Alexandra Graham Bell was considered to be inventor of Telephone and famously referred as Father of modern mass communication but in June 2002 U.S. Congress officially passed an unprecedented resolution crediting Antonio Meucci as the rightful inventor of telephone. Why such a blunder happened in the history of telecommunication? The Answer is Patent. Yes, it was the issuance of U.S. Patent 174,465 which changed the fortune of Bell and deprived Meucci from crediting his invention in his name. Following the U.S. resolution, one of the Italian newspaper la Repubblica wrote down that justice had finally been served – 113 years after Meucci’s death. The newspaper also referred to Bell as an imposter, profiteer and a “cunning Scotsman” who usurped Meucci’s spot in history, while Meucci died poor and unrecognized. Meucci, who first demonstrated his invention in 1860, also filed a patent application for telephone but couldn’t afford the US $ 250 needed for a definitive patent for his “talking telegraph” so in 1871 filed a one-year renewable notice of an impending patent. Three years later he could not even afford the US $ 10 to renew it. However, he sent a model and technical details to the Western Union telegraph company but could not succeed to attract company’s executives. Moreover, when he asked for his materials to be returned, in 1874, he was told they had been lost. Two years later Bell, who shared a laboratory with Meucci, filed a U.S. patent for a telephone against which U.S. Patent was issued on March 07, 1876, and went on to became a celebrity and made lucrative deal with Western Union. On June 11, 2002 the U.S. Congress in its resolution recognized that in the past number of years, historical records and scholarly research have concluded that Meucci was the original inventor of the telephone, long before Bell. The resolution also recognized that Meucci filed a caveat on his early telephone on Dec. 28, 1871, which gave notice of an impending patent. But the Italian inventor couldn't afford the $10 to renew the caveat in 1876. If he had, Alexander Graham Bell would not have been granted his patent two years later. This is how a single patent changed the fortune of Alexandra Graham Bell, and documented his name in the history as the inventor of telephone which, unfortunately, he wasn’t.