Saturday, April 19, 2014

Loss for Teva in Copaxone patent war

On Good Friday, April 18, 2014, Chief Justice Roberts, denied Teva a request for a stay in the Copaxone case, noting that he was not convinced Teva had shown the "likelihood of irreparable harm" if the application was denied, because if Teva wins the Supreme Court case it can seek damages from the generic companies for past infringement on its patents.

In this case, Teva, a known generic manufacturer, is in the role of proprietary drug maker, fighting the generic arm of a proprietary company [Novartis AG's Sandoz Inc ]. Major role reversals! [Copaxone is the world’s best-selling multiple sclerosis drug; from a compositional point of view, Copaxone is a polymer of the amino acids glutamate, alanine, lysine, and tyrosine mixed in defined molar ratios but in no set order or structure. See footnote 606 of 60 Food Drug L.J. 143 (2005) ]

And Teva, well-known for attacking deficiencies in the patents of proprietaries, is in the position of defending against attacks for indefiniteness associated with definitions of molecular weight.

IPBiz covered the earlier CAFC case in the post Teva prevails in Copaxone case, but was the case correctly decided? Yes, Teva won on some of the claims, but sadly lost on the more important ones. Of those, IPBiz noted

As to the group I claims, Teva had a problem because of arguments made in file histories. For one application, Teva argued molecular weight was Mp (peak average) but for another Mw (weight average). As the CAFC observed, Teva's two definitions cannot be reconciled. There was also an inconsistency within a figure as between the graph itself and the legend for the figure.

[The CAFC stated the peak average molecular weight Mp is the molecular weight of the most abundant molecule in the sample, so that it is not an "average" molecular weight." The CAFC also noted that Mn is the total mass of all molecules divided by the number of molecules, but did not give a definition for Mw. For completeness, Mw is the sum of the (square of molecular weight X number with that molecular weight) divided by sum of (molecular weight X number with that molecular weight).)

Link for Roberts decision Supreme Court denies Teva stay in Copaxone patent fight

Also, note Sam Hananel wrote in the Boston Globe:

The rival companies had argued that granting a stay would effectively extend Teva’s monopoly for years to come. That’s because Teva is trying to switch existing Copaxone patients to a new formulation of the drug that has patent protection until 2030.

Teva released the following text:

in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808 (the “’808 patent”), [Roberts] denied the Company’s application to stay the Federal Circuit's decision due to the potential for the Company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE® (glatiramer acetate injection) 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for COPAXONE®.

Teva previously prevailed in the District Court, which upheld the validity of nine COPAXONE® patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE® patents that expire in May 2014, while invalidating the ‘808 patent that is the subject of Teva’s now-granted certiorari petition.

Any purported generic version of COPAXONE® would be required to obtain the approval of the Food and Drug Administration prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of COPAXONE® would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS patients.

The Company is confident COPAXONE® will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.


Teva recruited a predecessor of Sanofi-Aventis to help sell its multiple sclerosis drug Copaxone. Sanofi-Aventis, Annual Report (Form 20-F), at 61 (Mar. 7, 2008); Teva Pharmaceutical Industries Ltd., Annual Report (Form 20-F), at 20 (Mar. 31, 2001).


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