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.
Saturday, October 28, 2006
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.
Friday, October 27, 2006
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.
Tuesday, October 17, 2006
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 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.
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.
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
Saturday, October 14, 2006
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.
Friday, October 13, 2006
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.
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?