Wockhardt Certified Para IV for Comtan

Wockhardt has filed an Abbreviated New Drug Application (ANDA) No. 78-941 seeking the US FDA approval to market a generic version of entacapone before the expiration of the Orange Book listed Patent Nos. 5,446,194 (the ‘194 patent) titled ‘Pharmacologically active catechol derivatives’ and 5,135,950 (the ‘950 patent) titled ‘Stable polymorphic form of (E)-N, N-diethyl-2-cyano-3-(3, 4-dihydroxy-5-nitrophenyl) acrylamide and the process for its preparation.’ Entacapone is marketed in the US by Orion, through its partner Novartis under the brand name Comtan for treatment of Parkinson’s disease. In response to Wockhardt’s submission of the ANDA, Orion filed a civil action for patent infringement in the US District Court for the District of Delaware, alleging infringement of the ‘194 and ‘950 patents under 35 USC § 271 (e)(2)(A) and subsequently seeking declaratory judgment.

Sanofi Defending Patent Rights in China

Sanofi-Aventis, world’s third largest pharmaceutical company has cleared its intention to defend its patent rights in China by filed a patent infringement lawsuit in the Beijing High Court against Chinese anti-tumor drug manufacturer Jiangsu Hengrui Medicine Co Ltd. In its complaint, Sanofi has alleged that Jiangsu has infringed upon a patent for docetaxel, a cytotoxic injectable issued by the China’s State Intellectual Property Office on December 27, 2006 and is seeking RMB 45 million ($ 5.98 million) in patent fees, RMB 55 million ($ 7.31 million) in compensation for economic loss, and RMB 200,000 ($ 26,595) in sampling and notarization fees. Earlier in 2003, Aventis filed a lawsuit against Jiangsu for infringing a process patent for manufacturing of docetaxel, which Shanghai No. 2 Intermediate People’s Court later in September 2006 ruled in favor of Sanofi-Aventis, and ordered Jiangsu to pay a total of RMB 230,000 ($30,616) in compensation and legal cots. Jiangsu appealed to the Shanghai Higher People’s Court, which withdrew the previous judgment.

Anticancer drug Tarceva received Patent Term Extension

OSI Pharmaceuticals Inc. has received a patent term extension for the US Pat. 5,747,498 (the ‘498 patent) covering anticancer drug Tarceva, generically known as erlotinib indicated for second-line advanced Non-Small Cell Lung Cancer (NSCLC) and for combination therapy for first-line advanced pancreatic cancer. The term of the ‘498 patent is extended by 1,251 days under 35 USC § 156, extending expiration date from June 06, 2015 to November 08, 2018. OSI has already received Supplementary Protection Certificates (SPCs) for Tarceva extending exclusivity to March 2020 in 14 Contracting States including France, Germany, Italy, Switzerland and the United Kingdom.

With Opportunities Come Challenges!

My recent article for pharmabiz pull-out edition read here.

Sepracor Suing Sun Pharmaceutical Over Desloratidine Patent

Sepracor jointly with University of Massachusetts has filed a civil action for patent infringement against Sun Pharmaceutical Industries alleging infringement of Orange Book listed US Patent Nos. 7,211,582 (the ‘582 patent), 7,214,683 (the ‘683 patent) and 7,214,684 (the ‘684 patent) for Clarinex tablets, generically known as Desloratidine. The complaint is filed in the US District Court for the District of New Jersey in response to Sun’s filing of an Abbreviated New Drug Application (ANDA) No. 78-359 under Para IV certification with the US FDA seeking approval of commercially market a generic version of Clarinex tablets prior to the expiration of the ‘582, ‘683 and ‘683 patents. Sepracor alleged that Sun’s ANDA product constitutes infringement of one or more of the claims of the ‘582, ‘683 and ‘684 patents under 35 USC § 271 (e) (2) (A).

Lupin Knock-down Altace Patent

Indian-based pharmaceutical manufacturer Lupin Ltd. has finally tasted the success of the knocking down King’s US Pat. 5,061,722 (the ‘722 patent) covering blockbuster drug Altace, generically known as Ramipril. The US Court of Appeals for the Federal Circuit ruled in the favor of Lupin holding that the ‘722 patent is invalid. Earlier, the US District Court for the District of Columbia concluded at summary judgment that claims of the ‘722 patent are valid and infringed by Lupin’s Abbreviated New Drug Application No. under the doctrine of equivalence. Accordingly Lupin appealed to Court of Appeals. The Court of Appeals invalidated the ‘722 patent over obviousness holding that claims 1 and 2 of the ‘722 patent are invalid over the SCH 31925 mixture (referring to work conducted by Dr. Smith), the US Pat. 5,348,944, and the enalapril references in the prior art.

Wyeth v. Teva | Protonix ‘Generic’ Lawsuit

On September 06, 2007 judge Jose L. Linares of the US District Court rejected Wyeth’s request for an injunction order against the generic challenger Teva Pharmaceutical Industries Ltd. that would have barred Teva from selling its generic version until a patent dispute between the companies get resolved. Generically known as pantoprazole, Protonix is Wyeth’s leading pharmaceutical products worth US $ 1.8 billion in sales in 2006 for which Teva had already bagged first-to-file status, giving 180-days market exclusivity for the US market. Pantoprazole is broadly covered within the scope of the US 4,758,579 (the ‘579 patent) for which Teva has filed a Para IV certification challenging its validity and enforceability.

Indian Automobiles Players Tussle Over DTS-i Technology Patent

Digital Twin Spark Plug Ignition (DTS-i) Technology has made its way into first-major patent fight between two Indian automobiles (two-wheeler) major --- Bajaj Auto Ltd. and TVS Motors, with Bajaj alleging TVS of patent infringement over its DTS-i technology patent and threatening to initiate a legal action against TVS Motors if TVS schedule to launch its 125 CC Flame which uses a technology similar to Bajaj’s patented DTS-i technology. In its company statement, TVS contended that Flame is very different from any of the bikes that Bajaj makes and the patent does not hold for it. TVS’s Senior Vice President H.S. Goindy argued that “Bajaj has a patent for twin spark technology only for two valve engine. Flame for the first time in the country sports a three valve heart and is thus outside the purview of the patent.” He further added that “the technology is prepared by Austrian company AVL specifically for us and we are licensee to it.” Bajaj has to still wait for launch of Flame before zeroing down to file a lawsuit for patent infringement. On the other hand, TVS has filed a petition for revocation of Bajaj’s DTS-i technology patent contending that the patent is wrongly issued by the Indian Patent Office as it was already been patented in the US by Japanese Automobile major Honda Motor Co.

Indian Court Ruled Against Novartis

Madras High Court has ruled against Novartis appeal which challenged the constitutional validity of section 3(d) of the Patents Act 1970 which according to Novartis excludes ‘incremental innovation’ from patent protection and denies patents for modifications of known medicines. Ranjit Shahani, Managing Director Novartis India said that Novartis is likely not to appeal to the Supreme Court.

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.