Sepracor files patent infringement complaint against Glenmark

Sepracor jointly with University of Massachusetts has moved a civil action for patent infringement against Indian generic drug manufacturer Glenmark Pharmaceuticals alleging infringement of the US Patent Nos. 7,214,683 (the ‘683 patent) and 7,214,684 (the ‘684 patent) covering anti-allergic drug Clarinex, generically known as Desloratidine. The complaint filed in the US District Court for the District of New Jersey, is in response to Glenmark submission of an Abbreviated New Drug Application (ANDA) No. 78-362 with the US Food and Drug Administration seeking approval to commercially market the generic (bioequivalent) version of Clarinex before the expiration of the ‘683 and ‘684 patents. The ‘683 patent covers oral pharmaceutical composition of Desloratidine whereas the ‘684 patent relates to method of treating allergic rhinitis.

Patent Dust: Bakelite - Belgian Genius!

Disruptive Patent: US 942,699 Method of making insoluble products of phenol and formaldehyde Leo H. Baekeland On July 13, 1907 Belgian genius chemist Leo H. Baekeland filed a patent application for a method of making insoluble condensation products of phenols and formaldehyde by the reaction a phenolic body with formaldehyde, and with combine action of heat and pressure against which US Patent No. 942,699 (the ‘699 patent) was issued on December 07, 1909. This ‘699 patent uncovered the first synthetic plastic known as Bakelite which completely revolutionized the manufacturing of everything from buttons to car parts. Baekeland used money from the sale of his first invention – Velox, a photographic printing paper, to Eastman Kodak to start his own laboratory where he developed phenolic resin or Bakelite, a non-flammable plastic that was less expensive and more versatile than other plastics of the day. Later, Baekeland founded the General Bakelite Corp. now merged with Union Carbide and Carbon Corporation. Bakelite was used to make electrical and automobile insulators, and was also used in such diverse products as kitchenware, jewelery, pipe stems, and children’s toys. In 1993 Bakelite was designated as ACS National Historical Chemical Landmark in recognition of its significance as the world’s first synthetic plastic.

Patent Dust!

I am starting a new section labeled ‘Patent Dust’ to uncover and remove dust from known and unknown facts related to patents, patent system, outstanding inventions and inventors etc. which are either forgotten with time or lost in the past. Label will further cover some of the ‘Disruptive Patents’ which entirely changed the facet of customary technology to revolutionized the development of new technology domains, in parallel transforming the human society with its sheer distinction and source of future innovation. My first post comes for Belgian genius – Leo H. Baekeland!

Valacyclovir Patent Litigation: Ranbaxy Settles with GSK

Ranbaxy, India’s largest generic drug manufacturer has announced to reached an agreement with GlaxoSmithKline to dismiss Valacyclovir US patent litigation over US Patent No. 4,957,924 (the ‘924 patent) covering Valacyclovir hydrochloride, the active ingredient of million-dollar anti-viral drug Valtrex with an annual market sales of US $ 1.3 billion. As per the agreement, Ranbaxy will enter the US Valtrex generic market in late 2009 and will enjoy 180-days market exclusivity. Ranbaxy also obtained license to other two Orange Book listed Patent Nos. 5,879,706 and 6,107,302. Earlier in May 2003, GSK filed a patent infringement lawsuit in the US District Court for the District of New Jersey against Ranbaxy alleging that Ranbaxy’s Abbreviated New Drug Application (ANDA) would infringe the ‘924 patent expiring in June 2009. In February 2007, Ranbaxy received the US FDA final approval to market and manufacture generic Valacyclovir tablets.

AstraZeneca Loses Toprol-XL in Court of Appeals

AstraZeneca AB et al. v. KV Pharmaceuticals, LLC et al. US Court of Appeals for the Federal Circuit (CAFC) has affirmed the US District Court’s invalidity ruling on double patenting over the US Patent No. 5,081,154 (the ‘154 patent) which simply reads “Metoprolol Succinate.” Earlier, Astra appealed the grant of summary judgment of invalidity of the ‘154 patent based on double patenting. Citing In re Emert, the Appeal Court agreed with the district court that claim 1 of the ‘154 patent is invalid for obviousness-type double patenting.

Indian Patent System Takes A Step Forward

Union Commerce and Industry Minister Kamal Nath on past Friday launched the e-filing facility for filing patent and trademark applications at a function organized by the Department of Industrial Policy and Promotion (DIPP). Mr. Kamal Nath said with the launch of e-filing facilities, applicants would now be able to file their patent and trademark applications from anywhere in the world at any time at their convenience through internet. Payments for e-filings could be made through the payment gateway of authorized bankers. India has now joined elite group of countries such as the US, China, Japan, South Korea, and the Europe which provides e-filing of patent and trademark applications. Mr. Kamal Nath also said the next step would to make Indian Patent Office an International Search Authority (ISA) and an International Preliminary Examination Authority (ISEA) under the Patent Cooperation treaty (PCT). Government Press Release.

Novartis Corp. et al v. Dr. Reddy’s Labs Inc. et al.

Novartis has filed a civil action in the US District Court for the District of New Jersey for the infringement of the US Patent No. 6,162,802 (the ‘802 patent) against Hyderabad-based Dr. Reddy’s Laboratories which earlier filed an Abbreviated New Drug Application (ANDA) No. 77-183 with the US Food and Drug Administration, seeking approval to market amlodipine besylate and benazepril hydrochloride capsules. In its complaint, Novartis alleged that submission of Dr. Reddy’s ANDA would constitute an act of infringement of the ‘802 patent pursuant to 35 USC § 271 (e) (2) which includes Paragraph IV certification as to the ‘802 patent, seeking approval prior to the expiration of the ‘802 patent. The ‘802 patent is related to synergetic combination therapy using benazapril and amlodipine for the treatment of cardiovascular disorders for which Novartis holds an New Drug Application (NDA) under the brand name Lotrel.

India: Glivec Update

In latest update, the Intellectual Property Appellate Board (IPAB) has reserved its judgment on Novartis’s appeal challenging the appointment of former Controller General of Patents S. Chandrasekhar as a technical member of IPAB. IPAB is currently hearing Novartis appeal against the decision of Indian Patent Office not to issue a patent against its patent application for beta-crystalline form of Imatinib Mesylate. Earlier, Novartis has objected the composition of the IPAB on the grounds that Chandrasekhar was Controller General of Patents when the application for beta-crystalline Imatinib Mesylate was rejected. Novartis counsels argued that IPAB could have one or more technical member in addition to Chandrasekhar or the tribunal could ask the government to appoint another person. However, the Additional Solicitor General V. T. Gopalan defended the appointment of Chandrasekhar and contended that Novartis should have made its objection when the case was shifted to the appellate board by the Madras High Court. He further added, since Novartis had failed to raise the issue before the Madras High Court, it was not right to raise the issue now. He argued that once a statutory order is passed, the tribunal should hear the case and cannot ask the government to appoint another person.

Daiichi Sues Mylan for Patent Infringement

Daiichi Sankyo Company Ltd. et al. v. Mylan Pharmaceuticals Inc. et al. 2:07-cv-03039 filed June 22, 2007 in the District Court of New Jersey Daiichi Sankyo has filed a civil action for patent infringement in the US District Court for the District of New Jersey against Mylan Pharmaceuticals Inc. alleging infringement of the US 5,616,599 (the ‘599 patent) covering chemical compound Olmesartan Medoxomil, one of the active ingredients of Sankyo’s antihypertension drug Benicar HCT tablets. The complaint is in response to Mylan’s submission of an Abbreviated New Drug Application (ANDA) No. 78-827 to the US FDA under Para IV certification seeking approval to market and sell generic Olmesartan Medoxomil and Hydrochlorothiazide tablets before the expiration of the ‘599 patent. In its complaint, Sankyo alleged that Mylan ANDA product would infringe one or more claims of the ‘599 patent under 35 USC § 271 (e)(2).

Pioglitazone Survived Post-KSR Obviousness Standard

Takeda Chem. et al. v. Alphapharm et al. (Fed. Cir. 2007) Ever since the US Supreme Court laid down its KSR ‘common sense’ syndrome, the US pharma industry is being constantly surrounded by the speculations quantifying the impact of the KSR obviousness standards over the ongoing and future patent litigations. However, in one of the major development, the US Court of Appeals for the Federal Circuit (CAFC) has put an end to some of the speculations after it knocks down Alphapharm et al. assertion over the Supreme Court’s decision in KSR v. Teleflex and Federal Circuit’s decision in Pfizer v. Apotex (Norvasc) in challenging obviousness of the US Patent No. 4,687,777 (the ‘777 patent) which covers chemical compound pioglitazone hydrochloride. This case is of great importance to pharma industry as the CAFC meritoriously negate the application of KSR and Norvasc obviousness test to evaluate the obviousness of chemical (species) compound. Last year on February 21, Judge Denis Cote ruled in the favor of Takeda after generic drug manufacturers Alphapharm and Mylan failed to establish obviousness and inequitable conduct against the ‘777 patent. During the district court trial, Alphapharm identified two key prior art literatures – US Patent No. 4,287,200 (the ‘200 patent) and a publication by Dr. Sohda to challenge the obviousness of the ‘777 patent. However, the district court later found that Alphapharm’s arguments failed to show any persuasive evidence, much less by clear and convincing evidence, that one with ordinary skill in the art have had any reasonable expectation or motivation based on the prior art for synthesizing pioglitazone. Moreover, Alphapharm appealed the district court judgment. In its appeal, Alphapharm argued that the ‘777 patent would have been obvious under 35 USC § 103 at the time invention was made. Alphapharm made three distinctive arguments to support its contention for obviousness – First, that the district court misapplied the law, particularly the law governing obviousness in the context of structurally similar chemical compounds. Second, that the district court erred in determining the scope and content of the prior art. Lastly, that the district court erred in numerous legal and factual determinations and certain evidentiary rulings made during course of the trial. The CAFC addressed above arguments by applying time-tested Graham Factors along with the obviousness standards laid down by KSR and Norvasc decisions. To be continued…

Sun Eyes Generic Optivar!

Indian generic drug maker, Sun Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) No. 78-738 to the US Food and Drug Authority (FDA) seeking approval for marketing and selling generic ophthalmic solution product containing 0.05% azelastine hydrochloride in an aqueous solution for use in treatment of seasonal allergic rhinitis. Sun’s proposed ANDA is bioequivalent product to MedPointe’s anti-allergic drug Optivar. On June 22, 2007 MedPointe files a civil motion for the infringement of the US Patent No. 5,164,194 (the ‘194 patent) in the US District Court for the District of Delaware against Sun Pharmaceuticals alleging that Sun’s proposed ANDA would constitute an infringement of the ‘194 patent under 35 USC § 271(e)(2) if approved prior to the expiration date of the ‘194 patent.

Sankyo Commences Litigation Over Infringement of Benicar HCT Patent

Daiichi Sankyo has commenced litigation on June 22, 2007 against Mylan in the US District Court for the District of New Jersey for infringement of Orange Book listed patent covering olmesartan medoxomil, one of the active ingredients in Sankyo’s antihypertensive drug, Benicar HCT. The lawsuit is pursuant to 35 USC § 271(e) following Mylan submission of Abbreviated New Drug Application (ANDA) with the US FDA seeking marketing approval for generic Benicar HCT prior to expiration of Orange Book listed patent.

Febit Files Infringement Complaint Against Codon

German biotech company Febit Biotech has filed a infringement complaint in the US District Court for the District of Delaware against Codon Devices alleging infringement of the US Patent # 6,586,211 (the ‘211 patent) pursuant to 35 USC § 271(a) and (g). In complaint, Febit alleged that Codon manufactures and uses a gene synthesis platform called the BioFAB platform which infringes literally or under doctrine of equivalents, one or more claims of the ‘211 patent. Febit is seeking compensatory damages under 35 USC § 284 and treble damages for willing infringement.

Dabur Joins Eloxatin Patent Dispute

Delhi-based Dabur Pharma Limited and its subsidiary Dabur Oncology Plc are new to join Eloxatin patent infringement dispute following Sanofi’s complaint in the US District Court for the District of New Jersey alleging infringement of US Patent Nos. 5,338,874 (the ‘874 patent) and 5,716,988 (the ‘988 patent). In separate complaint, Sanofi also extended allegation of patent infringement against Teva Pharmaceutical Industries over the same patents. The complaint is result of Dabur submission of Abbreviated New Drug Application (ANDA) No. 78-811 with the US FDA for the generic approval of Oxaliplatin solution before the expiration of Orange Book listed patents. Earlier, Sanofi filed a patent infringement complaint against Sandoz over the same US patents.

Novartis Object Over Appellate Board Formation

Pharmaceutical major Novartis which dared to challenge the Indian patent system is fighting tooth and nail against the decision of Chennai Patent Office to reject its patent application for beta-crystalline form of Imatinib Mesylate, has now raised an objection against the formation of two-member bench of the Intellectual Property Appellate Board (IPAB), in particularly objecting the presence of S. Chandrashekran as a technical member pursuant to section 116(2) of the Patents Act 1970. Novartis alleged it was under the tenure of S. Chandrashekran as a Controller General of Patents the application for beta-crystalline form of Imatinib Mesylate was rejected, and also that he was acting as a party in the recent court case reviewing the decision of the Indian Patent Office to reject application for beta-crystalline Imatinib Mesylate. However, Chandrasekran denied any conflict of interest stating that the application was rejected at the Chennai Patent Office by the Assistant Controller of Patents & Designs.

Sanofi-Sandoz Fights Over Eloxatin Patent

Sanofi-Aventis, the world’s third largest pharmaceutical company jointly with Debiopharm has filed a patent infringement complaint in the US District Court for the District of New Jersey to keep generic drug maker Sandoz off from the US Eloxatin market till the expiration of Eloxatin Orange Book listed US Patent Nos. 5,338,874 (the ‘874 patent) and 5,716,988 (the ‘988 patent). In its complaint dated June 14, 2007, Sanofi alleged that Sandoz’s Abbreviated New Drug Application (ANDA) No. 78-817 will infringe one or more claims of the ‘874 and ‘988 patents and will constitute an act of an infringement pursuant to 35 USC § 271(e) (2). The The patents-in-suit are two of the four Orange Book listed patents for Eloxatin Injectable Solution exclusively licensed to Sanofi-Aventis from Debiopharm. The other two Orange Book listed patents are US 5,290,961 (the ‘961 patent) and US 5,420,319 (the ‘319 patent).The ‘961 patent particularly covers Oxaliplatin (the active ingredient of Eloxatin) as cis-oxalate (trans-1, 1, 2-cyclohexanediamino) platinum (II). The ‘874 patent in particularly claims optically pure cis-oxalate (trans-1, 1, 2-cyclohexanediamino) platinum (II) whereas the ‘319 patent exemplifies optically pure cis-oxalate (trans-1, 1, 2-cyclohexanediamino) platinum (II) having optical purity of 99.94% or more and a melting point between 198.3 degree centigrade and 199.7 degree centigrade. The ‘988 patent covers pharmaceutically stable parenteral solution of oxaliplatin.

Canadian Court Upheld Levofloxacin Patent

Canadian Federal Appeal Court has affirmed the decision of the Canadian Federal Court which upheld the validity of the Daiichi Sankyo’s Canadian Patent No. 1,304,080 (the ‘080 patent) for antibacterial agent, Levofloxacin and also found the ‘080 patent infringed by generic Levofloxacin tablets manufactured by generic drug maker Novopharm Limited. This decision will enjoin Novopharm from selling, offering for sale a generic version of Levofloxacin tablets in the Canadian market until the expiration of the ‘080 patent will expires on June 23, 2009.

Tata Tea Boils Over Unilever

World’s second largest tea maker – Tata Tea has filed a petition for patent revocation in the Mumbai High Court against an Indian patent issued to Unilever for the process of making instant tea from cold water. The appeal has now referred to the Intellectual Property Appellate Tribunal by the Mumbai High Court. In its petition, Tata Tea alleged that the process of making tea has been known to Indian for centuries and is not an invention and cannot be patented in India. The process is already been patented in Europe and the US and later issued by Indian Patent Office in 1997. According to Hindustan Unilever, an Indian Subsidiary of Unilever the invention relates to a method of treating cold water with soluble solids derived from tea leaves.

Sandoz to Step in as Authorized Generic

Novartis is likely to launch an authorized generic for Lotrel through its generic division Sandoz after the US District Court for the District of New Jersey vacated a restraining order against Teva Pharmaceuticals to halt shipments of generic versions of the drug in the US, which means now Teva can resume shipments of generic Lotrel. The New Jersey court also denied a Novartis motion for a preliminary injunction in an ongoing patent dispute. However, Novartis will continue pursuing its defense of patent rights as Lotrel has a US patent valid until 2017. Lotrel is combination of ACE inhibitor benazepril with calcium channel blocker amlodipine besylate, and had sales of US $ 1.35 billion in 2006.

Updates: Indian Patents

New Drug Compounds Sun Pharmaceuticals secured an Indian Patent No. 204126 (the ‘126 patent) titled 4-(Diarylmethyl)-1-piperazinyl derivatives against its application number 302/MUM/2002 (Equivalent US Publication No. 20050107393). World’s leading pharma major Pfizer obtained an Indian Patent No. 204132 (the ‘132 patent) titled CCR5 Modulator Compounds against its application number 885/MUM/1999 (Equivalent US Patent Nos. 6,586,430 and 7,041,667) and an Indian Patent No. 204344 titled 1-Thifluoromethyl-4-Hydroxy-7-Piperidinylaminomethylchroman derivatives against its application number 456/MUM/2000 (Equivalent US Patent No. 6,239,147). Janssen Pharmaceutica N.V. received an Indian Patent No. 204144 (the ‘144 patent) titled Benzimidazoles and imidazopyridines having Inhibitory Antiviral Activity against its application number IN/PCT/2001/01539/MUM. Glaxo secured an Indian Patent No. 204151 (the ‘151 patent) titled Substituted oxazoles and thiazoles derivatives as HPPAR ALPHA Activators against its application number IN/PCT/2002/00583/MUM. World’s third largest company AstraZeneca obtained an Indian Patent No. 204158 (the ‘158 patent) titled Imidazo Pyridine Derivatives which inhibit Gastric Acid Secretion against its application number IN/PCT/2000/00496/MUM (Equivalent US Patent Nos. 6,313,136 and 6,313,137). New Form Pfizer secured an Indian Patent No. 204325 (the ‘325 patent) titled An Eletriptan Hydrobromide Monohydrate and a process for the preparation of the same against its application number 841/MUM/1999. Pfizer obtained an Indian Patent No. 204343 (the ‘343 patent) titled Polymorph of (2R, 3S, 4R, 5R, 8R,10R, 11R, 12S, 13S,14R)- 13- [[2,6-dideoxy-3-cmethyl-3-0-methyl-4-(-[(propylamino)methyl]-a-l- ribohexopryanosyl]- 2-ethyl-3,4,10- trihydroxy-3,5,8,10,12,14-examethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)- b-d-xylohexopyranosyl] oxa]-1-oxa-6-azacycopentadecan-15-one diphosphate