Spanish Court Supports Ranbaxy

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.

EPO Opined in favor of Atorvastatin Calcium Salt Patent

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.

Amgen v. Roche: U.S. Court Scheduled Discovery Phase

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.

Japan’s Supreme Court Delivers a Landmark Judgment

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 Signs Consent Judgment with Teva

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.

District Court Upheld Risperdal Patent

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.

WIPO Patent Report: India Ranked Twelfth in Patent Filing

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

Medtronic Loses Patent Challenge in CAFC

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.

Court Upholds Eisai Ulcer Drug

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.

Who Played Smart – DRL or Glaxo?

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?

Savient Sued Barr over Oxandrin Patents

New Jersey-based Savient Pharmaceuticals has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Barr Pharmaceuticals in response of abbreviated new drug application (ANDA) filed with the U.S. FDA seeking marketing approval for generic Oxandrin prior to expiration O.B. listed patents. Oxandrolone, active ingredient of Oxandrin tablet is an off-patent molecule disclosed in the U.S. Patent No. 3,128,283 and currently been used to promote weight gain following extensive surgery, chronic infection, or severe trauma. Orange Book currently lists five U.S. patents for Oxandrin tablet, which will run through patent protection till December 2017.

Indian Court All Set for Gleevec Case

On September 26, 2006 a Chennai High Court Judge has ruled that patent dispute over the anti-leukemia drug Gleevec should be heard by a two-judge panel, contending that the importance of the questions involved required a larger panel. The ruling came as setback to aid groups, which wanted the case to be dismissed by the judge. Novartis, which is challenging the Patent Office decision back in January 2006 to reject its patent application for Gleevec and seeking review by the Chennai High Court, has subsequently challenged the constitutional validity of section 3 (d) contending that section 3(d) of the Patents Act 1970 is not TRIPS compliant.

Beware! Patent Thieves

The U.S. District Court for the Southern District of New York in Manhattan has ruled in the favor of Yeda Research and Development Company concerning inventorship disputes of a U.S. Patent # 6,217,866 (the ‘866 patent) that ImClone licenses from Sanofi-Aventis. The court ruled that three scientists associated with Yeda are sole inventors of the patent, which covers the use of certain monoclonal antibodies in combination with anti-neoplastic agents for the treatment of cancer. U.S. District Judge Naomi Reice Buchwald directed the USPTO to replace seven names now on the controversial patent with those of Professor Michael Sela, Dr. Esther Aboud-Pirak and Dr. Esther Hurwitz. In his 140-page opinion, Judge Buchwald indicated it was not a close call because the events described by the researchers and their experts were “strongly corroborated” by documents, while the version presented by the defendants (ImClone/Aventis) was not. She also found that the plaintiffs’ (Yeda) witnesses were, “as a whole, far more credible than the defendant’s witnesses.” However, ImClone disagrees with the Court’s decision and intended to appeal against it. ImClone believes the former Aventis scientists originally named as inventors are the correct inventors of the patent. The ruling was the first judgment in lawsuits brought by Yeda in five countries against ImClone/Aventis. Other lawsuits are pending in England, Germany, France and Austria. Case: Yeda Research v. ImClone Systems et al. (03 CV 8484).

Toshiba, Micron Ended the Patent Brawl

Toshiba Corp. and Micron Technology Inc. have settled a number of pending patent infringement lawsuits related to computer memory chips. According to settlement agreement, Toshiba would purchase some Micron patents related to semiconductor technology and secure licenses for patents held by Micron unit Lexar Media Inc. for US $ 288 million. However, the amount is substantially less than the US $ 465 million in compensation awarded to Lexar by a California Court last year. The payment has been on hold after Toshiba managed to have the damages reconsidered and filed an appeal seeking to overturn the original guilty verdict.

Let’s Do It Together

Unimed Pharmaceuticals Inc., a subsidiary of Solvay Pharmaceuticals Inc. has settled its pending patent infringement litigation with Watson Pharmaceutical and Par Pharmaceutical Companies Inc. on a generic version of AndroGel, a replacement therapy in men with conditions associated with a deficiency or absence of endogenous testosterone. Under the separate settlements, generic AndroGel may be marketed in 2015, almost five years before the AndroGel patent expires in 2020. Under terms of settlement agreement, Solvay has granted Watson a non-exclusive license to the U.S. Patents covering AndroGel and Watson would not commence marketing its generic version until August 31, 2015 or the date on which another generic product enter the U.S. market, whichever occurs first. Watson, which earlier received final approval of its ANDA on January 27, 2006 and was awarded 180 days marketing exclusivity for its ANDA, has agreed to forfeit its 180-day marketing exclusivity. Additionally, Watson has agreed that Watson’s Specialty Products sales force will co-promote AndroGel to urologists in the U.S. Further, Par has acquired all rights to the ANDA for AndroGel from Paddock Laboratories, and subsequently entered into a separate agreement with Solvay under which Par’s branded sales force will co-promote AndroGel for six years.

Xbox runs into trouble

Paltalk Holdings Inc assignee of U.S. Patent # 5,822,523 and 6,226,686 (the PalTalk Patents) has filed a patent infringement lawsuit in the U.S. District Court for the Eastern District of Texas against Microsoft alleging that Microsoft Xbox and Xbox 360 through Xbox Live online gaming service infringes the PalTalk Patents under 35 U.S.C. § 271 (a) (direct infringement), § 271 (b) (induced infringement) and § 271 (b) (contributory infringement). PalTalk also contented that Microsoft’s infringing conduct is unlawful and willful under 35 U.S.C. § 285. PalTalk is also seeking damages including attorney fees and permanent injunction.

Same Old Story

The three-judge panel of the District Court of Hague has ruled that Ranbaxy’s proposed atorvastatin product infringed the broadest claims of Pfizer’s European Patent EP 247633 (the ‘633 patent) in the Netherlands and thereby preventing Ranbaxy from launching its generic version of Lipitor before Pfizer’s basic patent expires in November 2011. The Dutch Court also ruled Pfizer’s second patent EP 409281 (‘281 patent) covering calcium salt of atorvastatin invalid, yet again repeating the U.K. Court of Appeal judgment in June 2006 which invalidated species patent but found Ranbaxy’s proposed product infringing the broadest claims of genus patent. Same like in past cases, this ruling would have no practical commercial interest to Ranbaxy as the ‘633 patent will remain in effect beyond the expiration of the calcium salt of atorvastatin (the ‘281 patent).

Mylan Conquered Ditropan XL Patent Litigation

On September 06, 2006 the U.S. Court of Appeals for the Federal Circuit upheld the District Court decision that Mylan’s unique delivery system did not infringed the U.S. Patent No. 6,124,355 (the ‘355 patent) assigned to ALZA Corporation (now Johnson & Johnson subsidiary) and declared the ‘355 patent invalid on the grounds of anticipation and obviousness. This judgment would now trigger Mylan’s exclusive supply deal with Ortho-McNeil Pharmaceutical and ALZA Corporation, and allow Mylan to launch its generic Ditropan XL with 180-day marketing exclusivity for 5mg and 10mg strengths in the U.S. Ditropan XL market worth around US $ 440 million (2005). The CAFC also upheld a similar lower court decision for Impax Laboratories which holds 180-day marketing exclusivity for 15mg strength.

Cordis Corp. Penalized in the Patent Infringement Dispute

On September 05, 2006 U.S. Federal Judge Tim Leonard penalized Cordis Corp. (A division of Johnson & Johnson) in a patent infringement dispute concerning three U.S. patents issued to Dr. Jan K. Voda. The judge awarded $8.1 million in damages and prejudgment interest and $ 2.2 million in attorney fees to Dr. Voda. Earlier in October 2003, Dr. Voda brought patent infringement suit against Cordis in the U.S. District Court for the Western District of Oklahoma for infringement of three U.S. patents relating to guiding catheters for performing angioplasty on the left coronary artery. In response, Cordis denied that the sale of its catheters infringed Dr. Voda’s patents and counterclaimed for a declaratory judgment of patent invalidity and non-infringement. Later in May 2006, the jury found that Cordis Corp. willfully infringed Dr. Voda’s patents and rejected Cordis motion for declaratory judgment and also awarded Dr. Voda a 7.5 percent royalty.

Some Relief to Sanofi & Bristol

Judge Sidney H. Stein of the U.S. District Court for the Southern District of New York has issued an injunction to halt the sale of generic clopidogrel bisulphate tablets after two-day hearing giving much relief to Sanofi and Bristol which were desperately trying to win motion for injunction against Apotex generic Plavix. However, Apotex has said to appeal the decision and file an emergency motion with the Court of Appeals for the Federal Circuit to stay the injunction pending the appeal.