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Supreme Court Invites Solicitor General’s View on “Safe Harbor” of the Hatch-Waxman Act

On June 25, 2012, the United States Supreme Court invited the Solicitor General to file a brief expressing the views of the United States in GlaxoSmithKline v. Classen Immunotherapies Inc., U.S., No. 11-1078.  The scope of the “safe harbor” provision of the Hatch-Waxman Act, 35 U.S.C. § 271(e)(1), will be determined by the Supreme Court’s decision in the case.  

Under § 271(e)(1), otherwise infringing acts are exempt from liability if they are “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 or veterinary biological products” (emphasis added).  

The question presented by GSK in its petition for certiorari is whether the United States Court of Appeals for the Federal Circuit’s interpretation of the safe harbor provision, limiting it to pre-market approval activities for generic drugs, is faithful to the statutory text and prior Supreme Court decisions interpreting the provision. Resolution of this question could impact drug and biologic product development, for both originators and generic/follow-on product manufacturers. 


Classen Immunotherapies is the assignee of three U.S. patents pertaining to methods for evaluating the safety of vaccine administration schedules.  Classen sued GlaxoSmithKline, Merck, Biogen IDEC, and several other companies for alleged infringement of those patents.  The complaint alleged that GSK and Biogen IDEC infringed the Classen patents when they “participated in, facilitated and/or otherwise conducted a study believed to have begun in the late 1990’s and continuing through 2001, to evaluate suggested associations between [certain] childhood vaccinations … and [the] risk of developing type 1 diabetes,” after those vaccines received FDA market approval.  Classen Immunotherapies, Inc. v. Biogen IDEC, 381 F. Supp. 2d 452, 455 (D.Md. 2005). 

The district court initially granted GSK’s and Biogen’s motions to dismiss the complaint for failure to state a claim on which relief may be granted, finding that the alleged acts of infringement fell within the § 271(e)(1) safe harbor.  GSK and Biogen asserted that their actions were reasonably related to the submission of information to the FDA, because they were required by FDA regulations relating to post-approval market surveillance. Classen argued that the safe harbor only applied to pre-approval activities for drugs.[1]The district court agreed with GSK and Biogen, relying on the Supreme Court’s broad interpretation of the safe harbor provision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005), which held that Section 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 [Federal Food, Drug, and Cosmetic Act].”  Id.; Classen, 381 F. Supp. 2d at 456. 

The district court later granted co-defendant Merck’s motion for summary judgment of unpatentability, holding that the patents-in-suit attempted to patent an unpatentable natural phenomenon.  Classen Immunotherapies, Inc. v. Biogen IDEC, 2006 WL 6161856 (D.Md. Aug. 16, 2006). 

Classen appealed to the Federal Circuitwhich, in a two sentence opinion, “held that the Classen methods are not associated with a machine and do not transform matter, and affirmed the district court’s holding of ineligibility under §101 on that ground.”  Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1062-63 (Fed. Cir. 2011).  The Federal Circuit applied the machine-or-transformation test then applied by the Federal Circuit, and affirmed the district court’s grant of summary judgment that the asserted patent claims did not claim subject matter eligible for patenting  under 35 U.S.C. § 101, because they were “neither ‘tied to a particular machine or apparatus’ nor do they ‘transform[ ] a particular article into a different state or thing.’”  See Classen Immunotherapies, Inc. v. Biogen IDEC, 304 Fed. Appx. 866 (Fed. Cir. 2008), citing In re Bilski, 545 F.3d 943, 954 (Fed. Cir. 2008) (en banc).  

Classen petitioned the Supreme Court for a writ of certiorari, raising the question whether the machine-or-transformation test should apply to medical diagnostic methods.  In the interim, the Supreme Court decided Bilski v. Kappos, 130 S.Ct. 3218, 3227 (2010), and held that the machine-or-transformation test was “not the sole test for deciding whether an invention is a patent-eligible ‘process.’”  The Supreme Court granted Classen’s petition, vacated the Federal Circuit’s determination of unpatentability, and remanded the case to the Federal Circuit for further consideration in light of the Supreme Court’s intervening decision in Bilski.  

The Federal Circuit’s Safe Harbor Ruling on Remand

On remand, the Federal Circuit held two of the three Classen patents were eligible under 35 U.S.C. § 101, even in view of the Supreme Court’s decision in Bilski.  The Federal Circuit also addressed the district court’s prior determination dismissing Classen’s complaint against GSK and Biogen based on the safe harbor provision of Section 271(e)(1).  The appellate court determined that Section 271(e)(1) is not applicable to GSK’s and Biogen’s post-approval activities, and vacated the district court’s judgment.  Classen, 659 F.3d at 1059-60. 

In reversing the district court’s decision, Judge Newman, writing for the majority, relied on the Supreme Court’s decision in Merck v. Integra.  According to Judge Newman, Merck limited the application of § 271(e)(1) to preclinical activities relevant to submission of an IND or NDA.  Further, because the accused GSK and Biogen activities occurred after FDA approval of the vaccines, they were not related to pre-marketing development activities for an IND or NDA and were “not a ‘phase of research’ possibly leading to marketing approval.”  The majority opinion found that the “statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.”  Classen, 659 F.3d at 1070.[2]

Judge Moore dissented, disagreeing with the majority’s interpretation of Merck.  Judge Moore noted that “[w]hile it is true that the Supreme Court decided [the case] in the context of pre-approval activities, the Court repeatedly underscored the breadth of the statute’s text.”  In Merck, she said, the Supreme Court emphasized that “[t]here is simply no room in the statute for excluding certain information fromthe exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included.”  Merck, 545 U.S. at 202.[3]  Rejecting the majority’s “phase of research” approach, and agreeing with the district court’s “plain language construction of the statute,” Judge Moore concluded that the § 271(e)(1) safe harbor extends to all uses that are reasonably related to submitting any information to the FDA, including post-approval uses.  Classen, 659 F.3d at 1083.  She continued: 

… None of the legislative history cited by the majority, nor the cases it references, speak to the question at issue here—whether the statute as enacted also covers post-approval activities. The question is not whether Congress intended to protect pre-approval activity—but whether the enacted legislation covers more than just preapproval activity. The language Congress chose to enact and that was signed into law by the President is plain on its face. There is no “pre-approval” limitation. The statute includes within the safe harbor activity “solely for uses reasonably related to the development and submission of information under a Federal law.” 35 U.S.C. § 271(e)(1). This statute could have been written to indicate solely for uses seeking federal approval or solely for pre-approval uses. It was not. The plain language of this statutory text is broader. Any activity solely for uses reasonably related to the development and submission of information under a Federal law is included in § 271(e)(1). 

Id. at 1083-84. 

Judge Moore concluded that the safe harbor only applied to certain of GSK’s and Biogen’s infringing activities.  Specifically, Judge Moore found that “the alleged participation by GSK and Biogen in studies evaluating risks associated with different vaccination schedules is reasonably related to their requirement to review and report adverse information to the FDA.  See, e.g., 21 C.F.R. § 601.70 (requiring annual progress reports of post-approval studies); 21 C.F.R. § 600.80 (requiring the reporting of post-approval adverse reactions).”  Id. at 1084.  Nevertheless, Judge Moore found that some of the actions by GSK and Biogen would not be protected by the § 271(e)(1) safe harbor: 

… Although GSK and Biogen might be required to report adverse events that occur as a result of their vaccines, they are not required by law or regulation to perform such post-approval vaccinations in order to generate data. Accordingly, I conclude that these activities are not reasonably related to the development and submission of data to the FDA and therefore do not fall within § 271(e)(1)’s safe harbor exception. 

The general administration of drugs or vaccines is not reasonably related to post-approval reporting requirements. For example, while the FDA requires the reporting of post-approval adverse reactions, this does not mean that all commercial uses of the vaccine are “solely for uses reasonably related to the development and submission of information under a Federal law.” 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. 


Following the Federal Circuit’s second opinion in Classen, a petition for certiorari to the Supreme Court was filed by GSK.  As noted above, although the Federal Circuit’s decisions in Classen also considered the eligibility of the Classen patents under 35 U.S.C. § 101, the only question raised in GSK’s petition for certiorari is “whether the Federal Circuit’s interpretation of § 271(e)(1), which arbitrarily restricts the safe harbor to preapproval activities, is faithful to statutory text that contains no such limitation, and decisions of this Court rejecting similar efforts to impose extra-textual limitations on the statute.”  Petition for a Writ of Certiorariat i,GlaxoSmithKline v. Classen Immunotherapies Inc., No. 11-1078 (U.S. Feb. 28, 2012). 

GSK’s petition notes that “Drug development is not a binary process in which all that matters is a one-time decision whether to grant a product marketing authorization.”  Quite the contrary, the petition continues, “it is an iterative process both for manufacturers (who seek to develop additional or improved uses for already-approved products) and for regulators (who review information about safety and efficacy on an ongoing basis, and whose tolerance for risk and assessment of benefit may change over time as new therapeutic options become available).”  The “preapproval line” drawn by the majority decision in Classen, the petition continues, 

… therefore creates considerable uncertainty about whether a variety of such socially important activities will fall within the statutory safe harbor. … [W]hen innovators work to improve a drug or its administration, they do not know in advance whether or in what form the information they “develop” will be “submitted” to FDA. There is no principled basis to distinguish these studies based upon the phase of research underway at the time an initial approval is obtained, and nothing in § 271(e)(1) requires this result. 23-24. 

As noted above, on June 25, 2012, prior to ruling whether the petition for certiorari should or should not be granted, the Supreme Court requested a brief expressing the views of the United States.  That brief will be filed this summer.  The Supreme Court will not act on the petition until next fall. 

The Myriad Case

In the last several months, the Supreme Court also issued its decision in Mayo Collaborative Services, et al. v. Prometheus Laboratories, Inc., 566 U.S. ____ (2012), holding certain patent claims invalid under 35 U.S.C. § 101 because they “effectively claim the underlying laws of  nature themselves.”  Shortly thereafter, the Supreme Court granted a petition for certiorari in Association for Molecular Pathology, et al., v. United States Patent and Trademark Office (Myriad), vacating the opinion of the Federal Circuit and remanding the case for consideration in light of the Supreme Court’s decision in PrometheusSee Myriad, 702 F. Supp. 2d 181 (S.D.N.Y. 2010), rev’d 653 F.3d 1329 (Fed. Cir. 2011), cert. granted, vacated and remanded, 2012 WL 1500104 (Apr. 30, 2012). 

Briefs in the Myriad case have now been filed in the Federal Circuit.  Among other things, several briefs, including an amicus curiae brief filed by the United States Department of Justice, argue that the patents at issue in Myriad would allow Myriad to inhibit or stop research.  See, e.g., Supplemental Brief for Appellees at 10-11, Association for Molecular Pathology, et al., v. United States Patent and Trademark Office, No. 2010-1406 (Fed. Cir. June 15, 2012) (“The Myriad and similar patents … impeded innovation in several ways…more significant perhaps is the impediment to follow-up research…[and] even for basic research…”; a study found that gene patents had “delayed or limited their research;” another researcher found that patenting genes had “persistent negative effects on subsequent scientific research.”). 

These arguments appear to come directly in conflict with statements by the majority in the Federal Circuit’s most recent opinion in Classen, that patents promote research and invention.  Classen, 659 F.3d at 1072-73.  

The Myriad case will be argued on July 20, 2012.  To some extent, at least, the decision in Myriad will address questions that may ultimately be considered by the Supreme Court in Classen


The Supreme Court’s decision to hear the Classen case, or to decline to do so, may well depend on several events, including the filing of the Government’s brief in Classen in response to the Court’s recent Order, and the outcome of the Federal Circuit’s reconsideration of its decision in Myriad, after its remand in light of Prometheus.  Both Classen and Myriad may ultimately be decided by the Supreme Court, and each may offer the Supreme Court an opportunity to determine the scope of the safe harbor provided by 35 U.S.C. § 271(e)(1).  In particular, the Classen case will determine whether that safe harbor will be construed to apply to research conducted by pharmaceutical companies following approval by the FDA of a drug or biologic product.  Any decision will have a profound impact on the development of drugs and biologic products, whether by companies involved in discovery of new drug and biologic products or by those involved in development of generic or biosimilar versions of previously marketed products. 

[1]“Specifically, the Food and Drug Administration (“FDA”) collects vaccine data from vaccine manufacturers after their vaccines have been approved. See, e.g., 21 C.F.R. § 601.70 (2005) (requiring annual progress reports of postmarketing studies); 21 C.F.R. § 600.80 (requiring reports of postmarketing adverse reactions to vaccinations). As the Defendants’ alleged acts of infringement involve examining risks associated with various vaccination schedules, GSK and Biogen assert that their actions are reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs. Classen argues that the § 271(e)(1) exemption applies only to drugs which have not yet been approved by the FDA, not to post approval activities associated with a drug that is already on the market.”  Classen, 381 F. Supp. 2d at 455-56.

[2]Judge Newman relied on the statute’s legislative history: 

The House Report explains that the Act “provides that it is not an act of patent infringement for a generic drug maker to import or to test a patented drug in preparation for seeking FDA approval if marketing of the drug would occur after expiration of the patent.” H.R. Rep. No. 98–857, pt. 1, at 15, 1984 U.S.C.C.A.N. 2647, 2648 (1984). The Report is replete with statements that the legislation concerns premarketing approval of generic drugs. The Report emphasizes that “The information which can be developed under this provision is the type which is required to obtain approval of the drug.” Id. at 45, 1984 U.S.C.C.A.N. at 2678. 

This purpose was emphasized throughout the legislative process: “The purpose of sections 271(e)(1) and (2) is to establish that experimentation with a patented drug product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a patent infringement.” Id. Again in Part 2 of H.R. Rep. No. 98-857, at 8, 1984 U.S.C.C.A.N. 2686, 2692 (1984), the Report is explicit that “the only activity which will be permitted by the bill is a limited amount of testing so that generic manufacturers can establish the bioequivalency of a generic substitute.” The Report states that “the generic manufacturer is not permitted to market the patented drug during the life of the patent; all that the generic can do is test the drug for purposes of submitting data to the FDA for approval.” Id. at 30, 1984 U.S.C.C.A.N. at2714.…

Classen, 659 F.3d at 1071.  

[3]In Merck the Supreme Court stated, inter alia, that “Congress did not limit § 271(e)(1)’s safe harbor to the development of information for inclusion in a submission to the FDA; nor did it create an exemption applicable only to the research relevant to filing an ANDA for approval of a generic drug.  Rather, it exempted from infringement all uses of patented compounds ‘‘reasonably related’’ to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs.”  Merck v. Integra, 545 U.S. at 206-07. 

© 2022 ArentFox Schiff LLPNational Law Review, Volume II, Number 188

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