Tuesday, August 07, 2012

CAFC interprets the the Hatch-Waxman safe harbor provision, 35 U.S.C. § 271(e)(1)

The Momenta v. Amphastarcase involved interpretation of the safe harbor provision of the Hatch-Waxman Act:

The parties thus present us with conflicting views about the scope of the safe harbor. If Amphastar is correct that its post-approval activities actually fall within the scope of 35 U.S.C. § 271(e)(1), Momenta is unlikely to succeed on its claim of infringement and the preliminary injunction is likely inappropriate. Genentech, 108 F.3d at 1364. In order to determine whether the preliminary injunction was appropriate in this case, we must first ascertain the scope of the Hatch-Waxman safe harbor provision, 35 U.S.C. § 271(e)(1).

Of analysis:

This analysis is not groundbreaking: the Supreme Court came to essentially the same conclusion in 1990. In Eli Lilly & Co. v. Medtronic, Inc., the Court explained that “the phrase ‘a Federal law which regulates the manufacture, use, or sale of drugs’ more naturally sum- mons up the image of an entire statutory scheme of regulation,” and not just a particular provision of the law. 496 U.S. 661, 666 (1990) (emphasis added). Although the legislative history of the safe harbor only mentioned drugs, id. at 669 n.2, the Court nevertheless concluded that the safe harbor also extended to medical devices, which were also part of “a Federal law which regulates the manufacture, use or sale of drugs,” namely the Fed- eral Food, Drug, and Cosmetic Act, id. at 674.

Yes, Merck v. Integra was cited:

The Court later reaffirmed this expansive view, ex- plaining: “we think it apparent from the statutory text that § 271(e)(1)’s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA [(Food, Drug, and Cosmetic Act)].” Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005) (citing Eli Lilly, 496 U.S. at 665-69). Merck KGaA expressly rejected the notion that the safe harbor only applies to information developed during a clinical trial. 545 U.S. at 202 n.6. Instead, “the statutory text makes clear that it provides a wide berth for the use of patented drugs in activities related to the federal regula- tory process.” Id. at 202 (emphasis added). In light of the unqualified exemption for uses reasonably related to the development and submission of information, “[t]here is simply no room in the statute for excluding certain infor- mation from the exemption on the basis of the phase of research in which it is developed or the particular submis- sion in which it could be included.” Id. (emphasis added). The use of the word “under” in the statute is expansive. Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. __, 132 S. Ct. 1670, 1683-84 (2012). “Under a federal law” extends beyond just the “most barebones information” required by the FDA, and instead encompasses all “mate- rials the FDA demands in the regulatory process.” Id.

The bottom line

Under the correct interpretation of 35 U.S.C. §271(e)(1), Momenta’s admission that Amphastar’s testing is carried out to “satisfy the FDA’s requirements,” Appellee’s Brief at 40-41, makes it unlikely that Momenta will succeed on the merits of its infringement claim.

CJ Rader dissented. Within the dissent:

The public readily applauds the role of patents in the development and delivery to the marketplace of life- saving drugs or modern technology products like smart- phones. At the same time, many incremental advances contribute to these monumental advances or, as in this case, enhance their delivery to the public. These incre- mental inventions also represent difficult and expensive advances in technology. For example, in this case, Am- phastar had a strong incentive to invent this patented manufacturing method. As the first-filer, it would have obtained 180 days of market exclusivity as the only seller of the generic drug — a right worth $260 million per quarter. Nevertheless, Amphastar could not make that invention. Instead, the patentee Momenta made the investment, did the research, and engineered the new method disclosed in the '886 patent.

The Chief Judge states [the majority] "ignores the binding precedent of Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011). Sadly this result will render worthless manufac- turing test method patents. Accordingly, I must respectfully dissent."


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