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.”