Greenblum & Bernstein, P.L.C.



Recent News in Intellectual Property


                                                                                                        February 2011   

In This Issue

·    Ninth Circuit Rules No Preemption After Supreme Court Agrees To Settle Federal Preemption Question In Generic Product Labeling - Products Liability Cases

·    Supreme Court Declines To Hear Appeal Regarding Trigger Based On Voluntary Delisting

·    Court Awards $16 Million In Damages For At-Risk Launch In Tarka® Infringement

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Ninth Circuit Rules No Preemption After Supreme Court Agrees To Settle Federal Preemption Question In Generic Product Labeling - Products Liability Cases

The U.S. Court of Appeals for the Ninth Circuit, in Gaeta v. Perrigo, recently held, agreeing with two other Circuits, that federal generic drug labeling requirements in the Hatch-Waxman Act do not preempt state products liability claims after the Supreme Court granted certiorari, in December 2010, to hear and settle whether generic manufacturers are preempted by federal law from unilaterally modifying the label of their products.  Generally speaking, the federal preemption doctrine holds that, where there is a conflict between federal law and state law, federal law should prevail.  The Supreme Court agreed to hear the cases despite acting Solicitor General Neal Katyal’s request to deny certiorari arguing, in an amicus brief, that the Circuits were correct in ruling that generic manufacturers can be found liable for not providing sufficient warnings of risks on labeling, even if such warnings are not found on the brand product’s labeling.

Three Circuits have now followed the Supreme Court’s ruling in Wyeth v. Levine, where the Supreme Court held that the federal regulatory scheme governing pharmaceuticals does not preempt state law failure to warn claims against brand manufacturers.  The Supreme Court held that a brand manufacturer, Wyeth, could be found liable for failing to modify their products’ labeling, even without FDA approval.  Now, the Fifth, Eighth and Ninth Circuits have all agreed, based upon the Supreme Court’s decision in Wyeth, that state law claims, including product liability claims, asserted against generic manufacturers are not preempted by federal law, including FDA regulations; the cases before the Supreme Court are Demahy v. Actavis, 593 F.3d 428 (5th Cir. 2010); Mensing v. Wyeth, 588 F.3d 603 (8th Cir. 2009); and Gaeta v. Perrigo, No. 09-15001 (9th Cir. 2011). 

The fundamental question posed to the Supreme Court by these three cases is whether the Hatch-Waxman regulatory scheme that applies specifically to generic drug approval and labeling, as opposed to the requirements for brand drugs, preempts the state law claims at-issue, such as failure to warn; given that the Hatch-Waxman Act requires a generic drug label be the same as that for the brand drug.  In Demahy, Mensing and Gaeta, the Fifth, Eighth and Ninth Circuits allowed state law failure to warn claims to proceed against generic manufacturers for failing to include additional safety information, than that contained in the brand products’ labels, in their warning labels.  Oral arguments have been scheduled for March 30, 2011.

Supreme Court Declines To Hear Appeal Regarding Trigger Based On Voluntary Delisting

The Supreme Court denied Apotex’s request for certiorari seeking review of the D.C. Circuit’s decision holding that “unilateral” action by the holder of the challenged Orange Book patent could not trigger the first-to-file ANDA applicant’s 180 day market exclusivity under 21 U.S.C. §355(j)(5)(D).  (See G&B August 2009, April 2010 and October 2010 Updates)

By way of background, Congress amended the Hatch-Waxman Act in 2003 to, among other things, list six circumstances in which a generic manufacturer could forfeit the 180 day market exclusivity.  The two forfeiture events at-issue in this case are: (i) failure to market after the brand-name manufacturer’s delisting of a patent from the Orange Book; and (ii) expiration of all patents listed by the brand manufacturer.

In this case, Merck listed three patents in the Orange Book for hypertension drugs Cozaar® and Hyzaar® containing the active ingredient losartan.  Apotex and other generic manufacturers filed ANDA’s directed to losartan, each of which included a Paragraph IV certification for U.S. Patent No. 5,608,074 (the ‘074 patent).  Merck elected not to sue the ANDA applicants and requested that FDA delist the ‘074 patent from the Orange Book. 

The FDA and the District Court both held that the Act permits the ANDA applicant to forfeit exclusivity if it fails to market a drug after the patent is delisted from the Orange Book.  The D.C. Circuit reversed, however, holding that the FDA’s ruling was contrary to the intent of the Act because Congress could not have intended to permit the brand manufacturer to unilaterally deprive a generic manufacturer of its 180 day first-to-file exclusivity by unilaterally deciding to delist a patent.  This D.C. Circuit’s decision will now stand.

Court Awards $16 Million In Damages For At-Risk Launch In Tarka® Infringement

The U.S. District Court for New Jersey has awarded Sanofi-Aventis SA, and its exclusive licensee, Abbott Laboratories, $16 Million in damages in connection with Glenmark Pharmaceuticals’ at-risk launch of its generic version of the hypertension drug, Tarka® (combination of ACE inhibitor trandolapril and verapamil hcl). 

Glenmark received FDA approval to market its generic Tarka® before trial commenced, but the District Court declined to issue an injunction blocking Glenmark from going to the market at-risk.  Then, at-trial, the jury found that Sanofi's U.S. Patent No. 5,721,244 (the '244 patent) which is directed to, among other things, compositions containing both active ingredients of Tarka®, valid and infringed by Glenmark's generic product.  In so doing, the jury rejected Glenmark’s argument that the '244 patent covered an invention protected by an expired Sanofi patent.  The jury awarded $15.2 million in lost profits and an additional $800,000 for higher prices that Abbott could have charged had Glenmark not infringed the ‘244 patent.   

The GREENBLUM & BERNSTEIN NEWSLETTER is issued by GREENBLUM & BERNSTEIN, P.L.C., an intellectual property firm, to provide timely news in the field of intellectual property.  The NEWSLETTER provides monthly updates on recent issues of general interest in this field.  The views and/or opinions expressed herein do not necessarily reflect those of GREENBLUM & BERNSTEIN, P.LC.  Information regarding the contents of the Newsletter can be obtained by contacting P. Branko Pejic at GREENBLUM & BERNSTEIN, P.L.C., 1950 Roland Clarke Place, Reston, VA 20191.  Copyright 2011 GREENBLUM & BERNSTEIN, P.L.C. [01114816.DOC