By Suresh Pillai --
Teva Files Counterclaims in Gilead Suit
In answer to a complaint filed in the U.S. District
Court for the Southern District of New York by Gilead Sciences Inc. over alleged patent
infringement, Teva Pharmaceuticals
has filed an amended answer and counterclaim alleging that the
patents-in-suit are invalid. The
patents-in-suit, U.S. Patent Nos. 6,642,245
and 6,703,396,
cover formulations of the HIV drugs Atripla®
and Truvada®. The subject matter of the patents-in-suit was developed by three
researchers, who then assigned their rights to Emory University, who in turn licensed the patents
to Gilead Sciences. Gilead filed
suit in 2008 following Teva's filing of an Abbreviated New Drug Application
seeking approval to import a generic version of a drug that Gilead claims is
identical in formulation to Truvada® (see "Court Report," December
21, 2008). Teva is seeking a declaratory judgment
that its generic product would not infringe the patents-in-suit.
Shire Announces Settlement with Sandoz over
Adderall®
Shire Pharmaceuticals Group has
announced a settlement in its patent dispute with Sandoz
over Sandoz's proposed generic version of the Shire product Adderall®. Shire originally filed suit in 2007 in
the U. S. District Court for the District of Colorado on the heels of Sandoz's
filing of an Abbreviated New Drug Application with the FDA seeking permission
to market and manufacture a generic version of Adderall® (see "Court
Report," February 18, 2007). In its suit, Shire claimed that Sandoz's
proposed generic would infringe U.S. Patent Nos. 6,322,819 and
6,605,300. During the course of the litigation,
the central issue concerned whether the coating, which would control the release
of medication for Sandoz's proposed drug, fell within the claims of the
patents-in-suit.
Under the terms of the settlement, Shire has
granted Sandoz a license to market a generic version of Adderall® XR in the
United States conditioned upon Sandoz receiving FDA approval. In turn, Shire would receive a royalty
from sales of the generic.
Court Finds Valcyte® Patent Valid and Not
Infringed
The U.S. District Court for the District of New
Jersey has ruled that, though Roche Palo Alto's patent
covering its anti-viral drug Valcyte® is valid, Ranbaxy Laboratories' generic version did
not infringe Roche's patent rights. Roche originally filed its complaint, accusing Ranbaxy of patent
infringement of Roche's U.S. Patent No. 6,083,953,
in April 2006. The complaint was
filed soon after Ranbaxy had notified Roche of Ranbaxy's submission of an Abbreviated New Drug Application seeking approval to market and manufacture a
generic version of Valcyte®. In
this communication, Ranbaxy stated that the generic version would not infringe Roche's patent because the form of the active ingredient, valganciclovir,
was amorphous rather than crystalline in nature.
In its complaint, Roche attempted to counter
Ranbaxy's argument by stating that, because the amorphous form of the active
ingredient would revert to the crystalline form spontaneously, Ranbaxy's
proposed generic would infringe the '953 patent. The District Court disagreed with Roche's arguments, finding instead
that Roche could not prove that Ranbaxy's generic contained crystalline forms
of the active ingredient. The Court also concluded, however, that the '953 patent was valid and that Ranbaxy
had failed to establish otherwise.
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