Sepracor filed patent infringement complaint against Dr. Reddy’s

Sepracor jointly with University of Massachusetts has filed a complaint for patent infringement in the US District Court for the District of New Jersey to safeguard its patent rights over Clarinex, generically extended release tablet containing desloratadine and pseudoephedrine sulfate against the generic manufacturer Dr. Reddy’s Laboratories (DRL) prior to the expiration of the Orange Book listed Patent Nos. 7,214,683 (the ‘683 patent) and 7,214,684 (the ‘684 patent). Earlier, DRL made an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration seeking approval to market generic extended release tablet containing desloratadine and pseudoephedrine along with the Para IV certification, alleging both ‘683 and ‘684 patents invalid. In its complaint, Sepracor alleged submission of DRL ANDA would constitutes infringement of the ‘683 and ‘684 patents under 35 USC 271 (e) (2) (A).

Reliance serious on Innovation

October 12, 2007

In a shareholders meeting recently Reliance Industries Chairman, Mr. Mukesh Ambani proposed five shifts in the strategy of Reliance Industries in future, surprisingly one of the major one is, shift in innovation. Traditionally, Reliance has grown on the strength of licensing technologies. This strategy has limitations in its play in the context of technology-driven opportunities and global competitors harboring India aspirations, he said. Reliance therefore has an imperative to invest in innovation. RIL will be building a Reliance Centre for Technology at Navi Mumbai and will also creating an Innovation Council at Pune.This Council will have several Nobel Prize winners and global thought leaders, quoted the Chairman.

So now India's biggest Petrochemical company becomes serious for owning IP in the line of Exxon Mobil and Shell.

Cheers

Patent Agent Qualifying Examination Schedule in November 2007

The second sitting for 2007 Qualifying Examination for Patent Agent is schedule on November 26 and 27, 2007 as published on the official website of the Indian Patent Office. Read more.

Angola Became Contracting State to PCT

Angola became the 138th contracting state of the Patent Cooperation Treaty (PCT), will enter into force on December 27, 2007. Angola deposited its instrument of accession at WIPO on September 27, 2007 and will be designated AO as country code. Angola will be bound by Chapter II of the Treaty, will automatically be elected in any demand for international preliminary examination filed in respect of an international application filed on or after December 27, 2007.

Lupin Further Assigned Patent Rights Over Antihypertensive Drug

Earlier this year, Pune-based Lupin Ltd. assigned its patent right (process patents) over antihypertensive drug perindopril to French company Laboratories Servier for 20 million euros, now further to the development Lupin has assigned additional patent rights for additional 20 million euros. Perindopril patent assignment is one of the significant commercial transactions made by an Indian company from its intellectual property portfolio.

Sanofi | Torrent – Uroxatral Para IV Certification

Sanofi has filed a civil action for patent infringement in the US District Court for the Western District of Michigan in a move to prevent generic entry of Uroxatral tablet, generically alfuzosin hydrochloride by Indian drug manufacturer Torrent Pharma Inc. prior to the expiration of the Orange Book listed US Patent Nos. 4,661,491 (the ‘491 patent) and 6,149,940 (the ‘940 patent). Alfuzosin is an alpha-adrenergic blocker approved by the United States Food & Drug Administration for the treatment of Benign Prostatic Hyperplasia (BPH) and covered within the scope of the ‘491 patent till early 2011. Earlier Torrent filed an Abbreviated New Drug Application (ANDA) No. 79-054 with the FDA seeking approval to market generic alfuzosin hydrochloride extended release tablet in 10mg strength, alleging both the ‘491 and ‘940 patents are invalid and not infringed by the manufacture, use or sale of the proposed generic version of Sanofi’ Uroxatral tablet. In its complaint, Sanofi alleged that the submission of Torrent ANDA would constitutes infringement of the ‘491 and ‘940 patents under 35 USC § 271 (e) (2) (A). According to Sanofi Business Report 2006 Uroxatral is worth 353 million euros in worldwide sales.

HLR Files Infringement Suit against Indian Generics Over Boniva Patent

Hoffmann-La-Roche has filed patent infringement lawsuits in the US District Court for the District of New Jersey to safeguard its patent rights over Boniva, generically ibandronate sodium against Indian generic drug manufacturers, Dr. Reddy’s Laboratories Ltd. and Orchid Chemicals and Pharmaceuticals Ltd., both filed Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration seeking regulatory approval to market generic ibandronate before expiration of two Orange Book US Patent Nos. 7,192,938 (the ‘938 patent), expiring May 06, 2023, and 6,294,196 (the ‘196 patent), expiring October 07, 2019. However, Dr. Reddy’s has made Paragraph IV certification against the ‘196 patent, not the ‘938 patent. HLR also filed infringement complaints against Cobalt alleging infringement of four Orange Book US Patent Nos. ‘938 patent, ‘196 patent, 6,143,326 (the ‘326 patent), and 4,927,814 (the ‘814 patent).

Eli Lilly Filed Patent Lawsuit against Sun Pharmaceutical

Eli Lilly & Co. has filed a patent infringement lawsuit in the US District Court for the Eastern District of Michigan to safeguard its patent rights over Strattera, generically atomoxetine hydrochloride against the generic drug manufacturer Sun Pharmaceutical Industries, which filed an Abbreviated New Drug Application (ANDA) with the United States Food & Drug Administration seeking regulatory approval to market generic atomoxetine before the expiration of the Orange Book listed US 5,658,590 (the ‘590 patent). The ‘590 patent expires on November 26, 2016, and particularly covers a method of treating attention-deficit/hyperactivity disorder by administrating an effective amount of tomoxetine. Earlier, on August 09, 2007 and August 27, 2007 Eli Lilly filed patent infringement lawsuits for same drug in the US District Court for the District of New Jersey against Actavis Elizabeth LLC and Sandoz Inc.

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!