Solicitor General Recommends Cert Denial In Hatch-Waxman Safe Harbor Patent Case

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Despite a “ misguided” decision by the U.S. Court of Appeals for the Federal Circuit, the U.S. Supreme Court should deny review of the scope of the Hatch-Waxman Act's safe harbor provision on patent infringement, according to a Dec. 13 government brief (GlaxoSmithKline v. Classen Immunotherapies Inc., U.S., No. 11-1078, gov't brief filed, 12/13/12).

The Office of the U.S. Solicitor General, responding to the high court's request for the government's views, said that the appeals court “cabin[ed] the adverse impact of that decision” through its later decision in Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 686 F.3d 1348, 103 USPQ2d 1800 (Fed. Cir. 2012) (151 PTD, 8/7/12).

Further, the actions of the alleged infringer in the instant case could be outside the safe harbor even under the Momenta standard, the government said, so the petition for writ of certiorari should be denied.

The Supreme Court is scheduled to discuss the petition in its Jan. 11 conference.

Question Presented

The question presented in the cert petition is: Is the U.S. Court of Appeals for the Federal Circuit's interpretation that the safe harbor from patent-infringement liability provision of 35 U.S.C. §271(e)(1) is limited to activities conducted to obtain pre-marketing approval of generic counterparts faithful to the statutory text and decisions of the U.S. Supreme Court?

The provision provides an exception to infringement “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.”

Second Time at High Court

In the instant case, Classen Immunotherapies Inc. is assignee of patents (6,638,739; 6,420,139; and 5,723,283) on methods for determining an optimum immunization schedule for certain diseases.

Classen initially sued a number of vaccine suppliers, including Biogen IDEC and GlaxoSmithKline, for patent infringement based on their participation in immunization studies occurring after marketing approval for the vaccines was obtained from the U.S. Food and Drug Administration.

The case has already been the subject of controversy for conflicting rulings on patent eligibility under 35 U.S.C. §101, the second ruling coming after remand from the Supreme Court. Classen Immunotherapies Inc. v. Biogen Idec, 659 F.3d 1057, 100 U.S.P.Q.2d 1492 (Fed. Cir. 2011). In the remanded August 2011 decision, the court held that the asserted claims of the '739 and '139 patents were statutory subject matter under Section 101.

Safe Harbor Controversy Begins

The decision also addressed Biogen and GSK's argument that their participation in the studies complied with the FDA reporting requirements and thus were noninfringing under the Section 271(e)(1) safe harbor. The 2-1 court ruled that the safe harbor applies only to pre-approval activities.

Judge Pauline Newman wrote that the companies “are not required by law or regulation to perform … post-approval vaccinations in order to generate data. … The fact that GSK or Biogen would have to report to the FDA any adverse reaction after administering a vaccine does not mean the administration itself is noninfringing.”

The majority and dissent differed in their interpretations of a Supreme Court precedent on the issue, Merck K.G.a.A. v. Integra Lifesciences I Ltd., 545 U.S. 193, 74 USPQ2d 1801 (U.S. 2005).

The Integra court held that “[t]here is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included.”

The Classen appeals court majority--Chief Judge Randall R. Rader joined the opinion--ruled that the “phase of research” limitation applied only to “the types of information that are relevant to an IND [investigational new drug application] or NDA [new drug application].”

In dissent, Judge Kimberly A. Moore said, “While it is true that the Supreme Court decided Integra in the context of pre-approval activities, the Court repeatedly underscored the breadth of the statute's text. Accordingly, I conclude that the safe harbor extends to all uses that are reasonably related to submitting any information under the [Federal Food, Drug, and Cosmetic Act], including information regarding post-approval uses.”

GSK filed a petition for certiorari on Feb. 28.

Momenta Comes Out the Other Way

The Momenta case involved post-approval activities as well, but this time Moore was in the majority, joined by Judge Timothy B. Dyk, with Rader in dissent.

The Momenta court acknowledged that some activities could be outside the scope of the safe harbor, but it was not because they were post-approval.

Rader provided a detailed review of the legislative history, since he had been an active participant as a member of the staff of Sen. Orrin G. Hatch's (R-Utah) at the time the Hatch-Waxman Act was being approved. Rader said that the safe harbor should only apply to very specific acts and applied only to experimentation performed for pre-marketing approval and not for commercial activities.

Government Says Momenta Cabined Error

The high court called for the views of the solicitor general June 25.

“The court of appeals erred in stating that Section 271(e)(1)'s safe harbor encompasses only activities undertaken to obtain the FDA's pre-marketing approval of generic products,” according to the brief filed by Solicitor General Donald B. Verrilli Jr. “Congress not only contemplated that drug manufacturers would conduct post-approval scientific studies and clinical trials, but specifically authorized the FDA to require such studies in a variety of circumstances.”

“Nevertheless, there is no longer any practical need for this court's intervention in light of the Federal Circuit's subsequent decision in Momenta,” Verrilli said.

The brief acknowledged Rader's recap of the legislative history, but characterized as “true but unsurprising” his statement that the record was “replete with statements that the legislation concerns premarketing approval of generic drugs.”

The Hatch-Waxman debate was certainly focused on pre-marketing activities so as to facilitate generic drugs' market entry, Verrilli said, but that does not mean the safe harbor was strictly confined to those activities. Quoting from another case on Section 271(e), Eli Lilly & Co. v. Medtronic Inc., 496 U.S. 661, 669 n. 2, 15 U.S.P.Q.2d 1121 (1990), he said, “[i]t is not the law that a statute can have no effects which are not explicitly mentioned in its legislative history.”

The brief then made some distinctions as to post-approval activity that would fall under the safe harbor. “[A] researcher's use of a patented invention in conducting an experiment reasonably related to the development and submission of information to the FDA is protected by Section 271(e)(1), even if that experiment also advances other commercial objectives, such as product development,” the government said.

But the alleged infringer could be simultaneously selling a drug commercially while participating in a controlled study, the brief noted, such that one activity would be infringing while the other would not.

But Alleged Infringers May Still Be Liable

The immunization studies in the instant case were conducted by the Centers for Disease Control and Prevention and the alleged infringers were invited to participate. However, the researchers were interested in receiving vaccination records and medical histories of children after the fact. That is, the companies had already delivered and health care professionals had already administered the vaccines.

The '283 patent claims that the Federal Court earlier held not to be patent eligible ended with a step of reviewing and comparing information on the effects of different immunization schedules. But the patent-eligible claims of the '739 and '139 patents, according to the solicitor general, could be infringed by the immunization of a patient.

Consequently, the government said, the companies' allegedly infringing acts were performed prior to their participation in the CDC study. Classen's allegation, according to the brief, “which asserts that petitioner infringed the patented methods in the routine conduct of its business, does not implicate Section 271(e)(1).”

The brief concluded, “This case therefore would not provide the court with the opportunity to interpret Section 271(e)(1) against the backdrop of a genuine claim of entitlement to the protection of the statutory safe harbor.”

Carter G. Phillips of Sidley Austin, Washington, D.C., represents GSK. Joseph J. Zito of Washington, D.C., represents Classen. Harry J. Roper of Jenner & Block, Chicago, filed an amicus brief on behalf of the Pharmaceutical Research and Manufacturers of America.

By Tony Dutra  

Text is available at

For more detail on the issue, see “Patent Infringement After FDA Approval: New Developments” and “Webinar Discusses Split in Federal Circuit: Hatch-Waxman Safe Harbor a 'Safe Ocean'?”

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