Biotech/Pharma Docket

    By Suresh Pillai --

Mylan and Matrix Fail in Bid to Dismiss Sustiva® Case

The U.S. District Court for the District of Delaware has ruled that Bristol-Myers Squibb may proceed with its patent infringement suit against defendants Mylan Pharmaceuticals and Matrix Laboratories over Bristol-Myers' patent covering the HIV treatment Sustiva®, U.S. Patent No. 6,673,372.  Bristol-Myers originally filed suit in August 2009 after the defendants both filed Abbreviated New Drug Applications (ANDAs) with the FDA in which they sought permission to manufacture and market generic versions of Sustiva® (see "Court Report," September 7, 2009).  Following the ANDA filings, the defendants informed Bristol-Myers of the filings by letter and included a Paragraph IV certification.

In the most recent action, the defendants argued that because the '372 patent was not listed in the FDA's Orange Book, the defendants had not included a Paragraph IV certification in their ANDA filings.  Therefore, the defendants argued, the case should be dismissed because the District Court lacked the requisite subject matter jurisdiction over the case.  Bristol-Myers, however, countered with the argument that because listing the '372 patent in the Orange Book was not a prerequisite for it to assert infringement, the ANDA filings themselves provided a cause of action within the necessary subject matter jurisdiction of the District Court.  The District Court agreed with Bristol-Myers and refused to dismiss the case.

Court Dismisses Protein Sciences from Circovirus Vaccine Suit

The U.S. District Court for the District of Connecticut has dismissed patentee Protein Sciences as a party in the licensing dispute between Boehringer Ingelheim and Merial over U.S. Patent No. 6,224,882, which is directed to a vaccine for porcine circovirus.  The original dispute centered on a pair of licensing agreements entered into by Protein Sciences and Boehringer, which permitted Boehringer to use the '882 patent.  These agreements were entered into prior to Protein Sciences assignation of the patent to Merial in 2008.  Though the subsequent assignation contained no reference to the earlier licensing agreement, Protein Sciences has maintained the existence of an oral agreement with Merial that permitted Protein Sciences to fulfill its obligations to Boehringer.

Merial originally filed suit in December 2008, alleging that Boehringer's CircoFLEX® products infringed their rights in the '882 patent.  Boehringer answered by filing a declaratory judgment suit against both Merial and Protein Sciences to establish Boehringer's rights under its licensing agreement with Protein Sciences (see "Court Report," February 8, 2009).  Although Boehringer argued that the assignment was void due to a lack of Boehringer's consent to the transfer, the District Court found that Boehringer's consent was not required.  The Court, however, also found that Merial, as a successor-in-interest to the '882 patent, was bound by the terms of the earlier Protein Sciences-Boehringer agreement.  In addition, the District Court ruled that as the earlier licensing agreement included a forum selection clause, the case must remain in Connecticut.  The Court also agreed to grant Merial's motion to dismiss Boehringer's declaratory judgment claim of invalidity of the '882 patent; however, Boehringer can refile on this matter.

Second Settlement Announced in Stinski Patent Dispute

The University of Iowa has announced a $9.5 million settlement with Abbott Laboratories in its patent infringement suit over Abbott's alleged infringement of U.S. Patent Nos. 5,168,062 and 5,385,839.  The patents, which are collectively known as "the Stinski patents" after inventor Mark Stinski, cover a cytomegalovirus promoter used in the design and manufacture of a number of marketed vaccines and therapeutics.  The settlement brings to an end the dispute, originally filed in June 2009 in the U.S. District Court for the District of Iowa (see "Court Report," June 28, 2009).

The settlement marks the second multimillion dollar settlement related to allegations of infringement over the Stinski patents.  In August 2009, the University of Iowa announced a separate $19 million settlement with Amgen (see "Biotech/Pharma Docket," August 18, 2009).

Additional Disclaimer:  MBHB represents Bristol-Myers Squibb in the case discussed above.  To the extent that the above summary contains any opinions, the opinions are not those of Bristol-Myers Squibb or MBHB.

Comments

[Sean]

"To the extent that the above summary contains any opinions, the opinions are not those of Bristol-Myers Squibb or MBHB."

OK, but could you provide a link to the judge's opinions when possible?

Thanks!