Biotech/Pharma Docket

    By Suresh Pillai --

Stanford Graduate Student Adds Claims to Suit against Mentor and Professor over Patent Inventorship

Christopher Sclimenti, a former graduate student in the laboratory of Stanford University faculty member Michele Calos, has amended his suit against both Stanford and his former mentor, claiming that Dr. Calos plagiarized Dr. Sclimenti's Ph.D. dissertation and laboratory notebooks as part of providing support for patent applications based upon Dr. Sclimenti's work.  Dr. Sclimenti originally filed suit in September 2008, alleging breach of contract and correction of inventorship on U. S. Patent Nos. 6,808,925 and 7,141,426.  His amended complaint adds claims of intentional misrepresentation, copyright infringement, defamation, negligence, and unjust enrichment.

Dr. Sclimenti's claims stem from his allegations that, sometime in July 2002, Stanford University improperly removed Dr. Sclimenti as a named co-inventor on the '925 patent application.  According to Stanford, this happened around the time that it amended certain claims in order to satisfy patentability requirements.  However, Dr. Sclimenti's attorney contends that the removal occurred at or around the time that Stanford was in the midst of negotiating a licensing agreement for the applications with Poetic Genetics.  Poetic Genetics, in turn, was founded by Dr. Calos in 2002 as a vehicle for commercializing gene therapies based upon the patents' subject matter.  Dr. Sclimenti contends that he was wrongly removed as an inventor on the patents in order to deny him royalties from the licensing of the patents.

Both the '925 patent (issued in 2004) and the '426 patent (issued in 2006) name Dr. Calos as the sole inventor and Stanford University as the sole assignee.  The amended complaint also includes new allegations that Stanford and Dr. Calos have filed an additional family of patent applications naming Dr. Calos as sole inventor yet citing Dr. Sclimenti's research.  The amended complaint identifies numerous passages within the pending applications that appear to be derived from sections of Dr. Sclimenti's dissertation thesis.  [UPDATE: The amended complaint can be viewed here.]

Infosint Infringement Suit over Celexa® and Lexapro® Allowed to Move Forward

The U.S. District Court for the Southern District of New York has rejected a motion from Lundbeck A/S and its partner, Forest Laboratories, Inc., seeking to dismiss certain infringement claims filed by Infosint S/A alleging infringement of Infosint's patent, U.S. Patent No. 6,458,973.  The '973 patent covers a process for producing 5-carboxyphthalide, an intermediate chemical generated during the manufacture of citalopram, one of the active ingredients in both Celexa® and Lexapro®, two of defendants' antidepressant drugs.  In its complaint, Infosint alleged that Lundbeck and Forest Labs infringed upon the process claimed in the '973 patent.  Lundebeck and Forest Labs counterclaimed that Infosint infringed Lundbeck's patent, U.S. Patent No. 6,403,813, which discloses a process for creating the same intermediate compound as the '973 patent (see "Court Report," July 30, 2007).

In their latest attempt to secure a dismissal, Lundbeck and Forest Labs argued that the method employed by their chemical supplier in the manufacture of the compound did not meet a claim limitation of the '973 patent, namely, that the chemical mixture used in the process be heated to 120-140 degrees Celsius.  The District Court, however, refused to dismiss the infringement claims against Lundbeck and Forest Labs, holding that the only evidence in support of their assertion -- an unsigned photocopied letter dated from 2007 -- was inadmissible evidence of the temperature at which the defendants' supplier manufactured the compound.  The Court also found the testimony of an Infosint expert to be highly persuasive; the expert testified as to the unlikelihood of creating the compound at the lower temperature on an industrial scale.

Counterclaims Dismissed in Alzheimer's Institute/Mayo Patent Dispute

The U.S. District Court for the Middle District of Florida has dismissed two counterclaims filed by the Alzheimer's Institute of America Inc. (AIA) in its patent dispute with Mayo Clinic Jacksonville.  The original suit began in 2005 as part of an attempt by Mayo to compel arbitration to resolve a licensing dispute with AIA.  AIA granted Mayo a license to use the AIA's transgenic mice, and Mayo collaborated with its partner, Myriad Pharmaceuticals, to generate treatments through the use of the mice and related transgenic cell lines.  AIA objected to Mayo's use of the cell lines, claiming that under the terms of the licensing agreement, Mayo was only allowed to use the mice.  AIA then filed suit for patent infringement, and Mayo sued to compel arbitration of the dispute.  The separate suits were consolidated into a single suit in Florida, and AIA filed counterclaims alleging unjust enrichment, breach of contract, and equitable interest.

AIA argued that its counterclaims arose from the conduct of Mayo in negotiating the licensing agreement that was separate and distinct from their conduct in infringing the patents-in-suit, U.S. Patent Nos. 5,795,963 and 5,455,169.  The District Court, however, disagreed and concluded that AIA's counterclaims did not plead conduct that was separate and independent from AIA's claims under U.S. Patent Law.  Therefore, the Court held that the state law claims were preempted by federal patent law.  The Court dismissed the counterclaims with leave to refile by July 27.

BioMedica's Bid for Interlocutory Appeal to Federal Circuit Denied in TroVax® Suit

The U.S. District Court for the Northern District of California denied Oxford Biomedica Ltd.'s attempt to certify an order for an interlocutory appeal to the Court of Appeals for the Federal Circuit in BioMedica's patent dispute with Bavarian Nordic A/S over the cancer vaccine TroVax®.  Bavarian Nordic filed suit in 2008 (see "Court Report," July 6, 2008), claiming that BioMedica's TroVax® vaccine infringed upon Bavarian Nordic's patented method for delivering recombinant vaccines, covered by Bavarian Nordic's U.S. Patent Nos. 6,761,893, 6,913,752, 7,335,364, and 7,459,270.  BioMedica immediately claimed that Bavarian Nordic's suit was prematurely filed, as TroVax® was still in its development stage at the time of filing.  However, Bavarian Nordic countered that BioMedica's safe harbor argument failed because BioMedica, having entered into a contract with Sanofi-Aventis U.S. valued at $700 million, had already commercialized the TroVax® vaccine (see "Biotech/Pharma Docket," May 21, 2009).

In the latest ruling by the Court, it dismissed BioMedica's request to have the Federal Circuit address two questions that could resolve the suit.  The first question was whether the District Court had proper subject matter jurisdiction, where the suit involved a product currently in FDA clinical trials and a licensing agreement to jointly develop and co-fund the product with intent to commercialize.  The second question was whether such an agreement would be exempt from definitions of infringement.

Comments

[[correction]]

lexapro (escitalopram) and celexa (citalopram) are forest/lundbeck drugs, not infosint drugs.

[Suresh Pillai]

Dear [correction]:

Thank you for catching the error in the post. The post has been revised to reflect the correct identity of the drug manufacturers.

Suresh

[Keep It Real]

If what the complaint says is true, Stanford really effed this up.

[Josh K]

The increased focus of universities to develop and market IP has led to lawsuits like this and extended litigation. Companies have modified themselves to be more adaptive to this unique sector (see http://www.prweb.com/releases/2009/07/prweb2594164.htm). This may ultimately benefit the US consumer because as universities profit from their research they can invest more into it.