Webinar Discusses Split in Federal Circuit: Hatch-Waxman Safe Harbor a ‘Safe Ocean'?

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Either the Supreme Court or the U.S. Court of Appeals for the Federal Circuit is likely to decide soon if the Hatch-Waxman Act's “safe harbor” is more like a “safe ocean,” according to attorneys from Weil, Gotshal & Manges speaking in a Nov. 13 webinar hosted by Bloomberg BNA.

A resolution is required to deal with “two Federal Circuit cases clearly in conflict,” according to Nicolas G. Barzoukas of the firm's Houston office.

His colleague, Elizabeth Stotland Weiswasser, New York, provided a detailed background of the legislative history that drove the addition of 35 U.S.C. § 271(e)(1) to the 1984 Hatch-Waxman legislation, as well as the Supreme Court precedents since then that were given different interpretations by two Federal Circuit panels, both including Chief Judge Randall R. Rader and Judge Kimberly A. Moore on opposite sides.

Weiswasser identified two separate issues that must be resolved:

• After a firm has received the approval for a generic drug from the Food and Drug Administration, what other activities, if any, does the safe harbor protect?

• Even prior to FDA approval, what activities, if any, are protected that are not directly related to getting that approval?


Statutory Context for Safe Harbor.

The safe harbor provision, Section 271(e)(1) of the Patent Act, Weiswasser said, “provides that certain activities, otherwise covered by a patent, are not infringing to the extent they 'reasonably relate' to obtaining regulatory approval to market pharmaceutical and biologic products as well as medical devices.”

She said that Congress was reacting to a “dual distortion” in patent term that was evident after the Federal Circuit's 1984 decision in Roche Products Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858, 221 USPQ 937 (Fed. Cir. 1984).

One distortion was the loss of patent term after a brand name manufacturer was granted a patent on a drug but before the FDA approved the drug for marketing, she said. The second was the “de facto extension of the patent term,” because the generic maker was not allowed to begin the process for approving a generic version of the drug until after the patent had expired, as the Roche court held. Congress was intending to reconcile these distortions with the safe harbor, Weiswasser concluded.

Two Supreme Court Cases on Point.

The Supreme Court first dealt with an issue related to the safe harbor provision in Eli Lilly & Co. v. Medtronic Inc., 496 U.S. 661, 15 USPQ2d 1121 (1990). Justice Antonin Scalia's opinion sought to “balance the patent term restoration with the safe harbor protection,” according to Weiswasser. However, the case was really about the scope of the provision, as the court determined that the safe harbor extended to medical devices and not just drugs.

The second case, Merck KGaA v. Integra Lifesciences Ltd., 545 U.S. 193, 74 USPQ2d 1801 (2005) (113 PTD, 6/14/05), addressed the very different question of what kinds of activities should be considered “reasonably related” to regulatory approval, she said.

Also written by Scalia, the high court's opinon reversed the Federal Circuit decision limiting Section 271(e)(1)'s safe harbor protection to pre-clinical research that was ultimately included in a submission to the FDA.

The court held that the generic maker, in conducting the research, need only have a “reasonable basis for believing that the experiments will produce the types of information that are relevant,” but its test is “mushy and ambiguous,” Weiswasser said.

Nevertheless, both cases “still involved activities that were occurring before the approval process,” she added.

Federal Circuit's Split.

Barzoukas next described the results of the two Federal Circuit cases dealing with post-approval activities in the last 14 months.

Judge Pauline Newman sided with Rader, he noted, in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011), with Moore in dissent.

The Classen majority held that information reported to the FDA long after marketing approval did not fall under the safe harbor, he explained, while Moore's dissent argued that the plain language of Section 271(e)(1) includes no “pre-approval” limitation.

More recently, on Aug. 3, Judge Timothy B. Dyk joined Moore--with Rader now in dissent--in Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 686 F.3d 1348, 103 USPQ2d 1800 (Fed. Cir. 2012) (151 PTD, 8/7/12). Again, Barzoukas said, while Moore acknowledged that some activities of the generic maker could be outside the scope of the safe harbor, it was not because they were post-approval.

“Rader wrote a vigorous dissent,” Barzoukas said. “He expressed the view that a free pass at infringement should be given only at the express direction of a statute.”

Barzoukas characterized the dissent as “an exhaustive discussion of the legislative history,” with Rader being an active participant in that history because he was working on Sen. Orrin Hatch's (R-Utah) staff at the time. Rader said that the safe harbor should only apply to the very specific acts that were at issue in Roche, that it applied only to experimentation performed for premarketing approval and not for commercial activities.

The cases are in different procedural stances, Weiswasser and Barzoukas noted:

• Co-defendant GlaxoSmithKline filed a petition for writ of certiorari in Classen, and the Supreme Court asked for the views of the solicitor general in June. GlaxoSmithKline v. Classen Immunotherapies Inc., No. 11-1078 (U.S., gov't brief invited June 25, 2012) (122 PTD, 6/26/12). Barzoukas paraphrased the question presented: “You can't say that after you got approval, you're through with the FDA. There's a continual give-and-take” that should fall under the safe harbor.

• Momenta Pharmaceuticals Inc. filed a petition for rehearing en banc in its case at the Federal Circuit. No. 2012-1062 (Fed. Cir., rehearing requested Sept. 4, 2012). “It's fully briefed and pending,” Barzoukas said, calling it “a good candidate” for en banc review. There is no deadline for the solicitor general to weigh in on the Classen case, he noted, as well, indicating that the appeals court is not likely to wait for the Supreme Court to make its cert decision in that case.

Impact on Biosimilars.

Finally, Weiswasser and Barzoukas extended the likely impact of these cases to biosimilars, generic versions of biological products.

The Biologics Price Competition and Innovation Act of 2009, which was included in the Affordable Care Act of 2010, created a relationship between brand name and generic versions of biosimilars similar to the pharmaceuticals addressed by Hatch-Waxman, the attorneys said.

“Patents on biologics should be subject to patent term extension and thus also the safe harbor,” Barzoukas said. “Given the complexity of biologics and testing in their manufacture, the resolution of Classen and Momenta may have far reaching effects.”

He made predictions depending on the result in Momenta. “If Momenta is upheld, innovators' patents reflecting manufacturing and testing methods in characterizing the molecules produced may be easily circumvented,” Barzoukas said. “But if Momenta is rejected, additional paths for the protection of establishing biosimilarity will likely become available.”

By Tony Dutra  

Webinar materials at /patent-acts-safe-w17179870398/