IPR Biotechnology
June 2008
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Legal Scene
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Previous Issues


LEGAL SCENE
Appeal Against Court Ruling

Pfizer Inc has declared that it would appeal against a Canadian Federal Court ruling in favour of genetic manufacturer Apotex in its challenge to a Pfizer patent covering Lipitor.

The Canadian Federal Court had denied Pfizer's request to prevent Apotex from launching a generic version of Lipitor prior to the expiration of Pfizer's enantiomer (calcium salt) patent in July 2010.

The Court's decision has no immediate commercial impact because Lipitor is protected by other patents in Canada, which are also the subject of legal challenges.

The ruling by the Federal Court has also no impact on Lipitor patent litigation in other countries.

(Pfizer Inc, May 15, 2008)
Baxter Wins Case

Baxter International Inc. has won a long running battle in a patent infringement case, against Fresenius Medical Care involving Fresenius Number One-selling hemodialysis machine in the USA.

The US District Court for the Northern District of California, issued opinions permanently enjoining Fresenius from manufacturing its flagship product, affirming that it infringes on Baxter's technology and awarding damages to Baxter.

The Court order requires that Fresenius stop making, using or selling the 2008K hemodialysis machine effective January1, 2009. A royalty of 10% was also imposed on the sale price of each infringing machine sold from now till January 1, 2009, and a further 7% royalty was imposed on all disposable products used with the infringing 2008K hemodialysis machines.The 2008K is, according to Fresenius, its "cornerstone product" and is the best selling hemodialysis machine in the marketplace with over 90 percent market share .

In granting the injunction, the Court observed that much of the hardship that Fresenius would face from the injunction, was of its own doing because it did not take any steps to design around the patents in suit.

In February 2007, the Court had upheld the validity of Baxter's patents that had been challenged by Fresenius in a 2003 lawsuit ruling that Fresenius failed to introduce substantial evidence of invalidity.

(Medical Patent News, Apr 7, 2008)
Cellectis Sues Precision BioSciences

Cellectis SA, a world leader in rational genome engineering, has announced that it had filed a patent infringement lawsuit against Precision BioSciences in the Eastern District Court of North Carolina,USA, seeking a declaration that by making and selling certain meganucleases, Precision Biosciences was infringing two Cellectis patents relating to its proprietary meganucleases recombination systems.

The Precision BioSciences' meganucleases at issue are intended to target site specific DNA breaks and effect a genome modification in a given transgenic organism, such as a plant.

The law suit seeks both monetary damages for infringement as well as a permanent injunction preventing Precision Biosciences from any further making, using, or selling, of such meganucleases.

Since its creation in January 2000, and throughout its development, Cellectis has made special efforts to protect new discoveries made by its research team as well as those of its partner, the world renowned Pasteur Institute.Cellectis currently owns the exclusive rights to over 35 issued patents and has 113 pending patent applications . Most of these patents are based on Cellectis' fully integrated genome engineering system referred to as its Meganuclease Recombination Systems (MRSs).These systems offer natural , precise, efficient and flexible genome surgery with several applications among others in the therapeutic area and in the plant science field.

Cellectis SA is a world leader in genome engieering and genome surgery. The company is focused on developing and producing custom made meganucleases for in vivo DNA surgery and also provides new tools for rational reverse genetics, and targeted recombination. Its products induce unique site-directed double strand DNA breaks in living cells and can be used in a wide variety of biotechnological and therapeutic operations.

(Cellectis SA May 15, 2008)
Patent Office Rules Struck

A US Federal District Court sided with GlaxoSmithKline PLC and struck down new patent rules which, according to the British drug maker, were a threat to innovation. The Court held that in making the regulations the US Patent Office had overstepped its authority, as the rules made substantial changes to the patent application process which was outside the jurisdiction of the Patent Office.

Glaxo had sued in October 2007 to block the implementation of the US Patent and Trademark Office rules charging that they would jeopardise about 100 of the company's patent applications. The rules issued in August 2007 were intended to streamline the application process by limiting how many times patent applicants could tweak existing applications and how many claims they could make about an invention.

Glaxo argued that such limitations would harm pharmaceutical companies that frequently change the scope of their applications as research and testing uncover additional appplications to a drug. A spokesperson for Glaxo said that the judgment was in support of innovation across all industries. and it reaffirmed that all who wanted to protect their inventions in the USA would be allowed to seek protection on the full scope of their discoveries.

However, a spokesperson for the Patent Office said that the agency was disappointed with the decision and was considering the next steps.

The Biotechnology Industry Organisation which filed papers in suport of Glaxo said that the rules would have inhibited the ability of bitechnology innovators to obtain adequate patent protection and would have made it harder for them to get financing or new products.

(GlaxoSmithKline, Apr 1, 2008)
Ranbaxy Settles Dispute with GSK

India based Pharmaceutical MNC Ranbaxy Laboratories Ltd has announced that it has settled all matters relating to possible patent litigation with GlaxoSmithKline(GSK) relating to Sumatriptan Succinate tablets, the generic version of GSK's Imitrex tablets.

The terms of the settlement provide that Ranbaxy may distribute a generic version of Sumatriptan Succinate tablets in the 25mg, 50mg, and 100mg, strengths in the USA with an expected launch date in December 2008. Additional terms of the agreement were not disclosed.

The annual market sales of Sumatriptan Succinate tablets were $985 million.

(Ranbaxy Labs, Jan 29, 2008)
VNUS Gets Notice of Allowability

VNUS Medical Technologies has announced that it has received notice of allowability by the US Patent and Trademark Office for a patent application, that is a continuation of one of the three patents in the VNUS patent infringement lawsuit against suppliers of endovenous laser products.

The newly allowed VNUS patent application was filed as a continuation of VNUS's earlier US patent. The continuation patent uses the same patent specification as the earlier one.

VNUS has sued several endovenous laser manufacturers for infringement of its patents and that law suit is to begin trial later this year.

The newly allowed VNUS patent application contains claims that recite methods of applying energy from an elongate member leading to occlusion of a vein, where the elongate member may be a fibre optic and the energy may be light energy. Significantly before deciding to allow the VNUS patent, the Patent Office reviewed references that include those cited by the defendant endovenous laser companies during the patent litigation in their attempt to invalidate the earlier patent.

(vnus.com, Apr 18, 2008)