Biotech/Pharma Docket

    By Suresh Pillai --

The Medicines Company Files New Lawsuits in Angiomax® Patent Dispute

Following up on lawsuits filed in October against defendant Teva Pharmaceuticals, The Medicines Company has now filed new lawsuits alleging infringement of U.S. Patent No. 7,598,343, which covers The Medicines Company's blood thinning drug, Angiomax®.  In its original suit, The Medicines Company alleged that Teva's proposed generic version of the drug, as described in Teva's ANDA filing seeking permission to market and manufacture said generic, would infringe The Medicines Company's U.S. Patent No. 7,582,727, which also covers Angiomax® (see "Court Report," October 11, 2009).  In the most recent lawsuits, The Medicines Company alleges that Teva sent letters indicating that Teva had amended its ANDAs to include Paragraph IV certifications that the '343 patent was not valid, currently infringed, or would be infringed in the future by Teva's proposed generic.  However, Teva failed to offer The Medicines Company confidential access to the filed ANDAs.

The Medicines Company is seeking a declaratory judgment that the '343 patent is valid and enforceable as well as injunctive relief that would prevent Teva from marketing and manufacturing its generic until after the expiration of the '343 patent.

As Abbott Appeals, Centocor Seeks Continuing Damages in Humira® Dispute

On the heels of Abbott Laboratories' appeal of a record $1.85 billion judgment in favor of Centocor Ortho Biotech, Centocor has filed a new suit seeking continuing damages against Abbott for its manufacture of the arthritis drug Humira®.  In its most recent suit, Centocor seeks both actual and enhanced damages, alleging that Abbott continues to willfully infringe Centocor's patents during the appeals process.

An Eastern District of Texas jury prevously found Abbott liable for willfull infringement of four claims of U.S. Patent No. 7,070,775 and awarded Centocor $1.17 billion in lost profits and $504 million as reasonable royalties (see "Biotech/Pharma Docket," June 30, 2009).  Abbott immediately moved for the District Court to find the '775 unenforceable on grounds of inequitable conduct, prosecution laches, and indefiniteness of the disputed claims, but the District Court denied this motion in November.  In December, the District Court entered final judgment in the case and added $176 million in interest to the original judgment.  Abbott then filed its appeal with the Court of Appeals for the Federal Circuit.

Teva, Others Found to Have Infringed Strattera® Patent

The U.S. District Court for the District of New Jersey has determined that generic drug manufacturers Teva Pharmaceuticals, Actavis Elizabeth, Mylan Pharmaceuticals, Sandoz, Sun Pharmaceuticals Industries, Apotex, and Aurobindo Pharma induced infringement of Eli Lilly's patent covering Strattera®, Lilly's attention deficit/hyperactivity disorder treatment (see "Lilly Strattera Litigation Down to 7 Defendants").  Although the patent-in-suit, U.S. Patent No. 5,658,590, covers a method of treatment, the District Court found that if the generic companies were to market their versions of Lilly's drug, the labeling on these generic versions would induce others to infringe, as the infringing use is the only method for using Strattera® that has been approved by the FDA.  Although the defendants argued that:  1) there was an absence of intent to infringe due to FDA labeling requirements, and 2) that doctors could prescribe the drug for non-infringing uses, the District Court disagreed, finding that the labeling requirements provided objective evidence that would be sufficient to establish the defendants' intent to infringe.

The District Court also ruled in favor of Lilly with respect to its summary judgment motion on validity and refused to rule on several summary judgment motions filed by the defendants.

Comments

[Dan Feigelson]

Interesting arguments by the defendants in the Strattera litigation, but they must have known that the arguments were hopeless. At least the case will serve as a useful example for clients for whom method of use claims are the only option, and who have (or will have) the only FDA-approved use. Thanks for pointing out this decision.