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. |