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.