Center for Advanced Study & Research on Innovation Policy


CASRIP Newsletter - Winter/Spring 2008, Volume 15, Issue 1

Safe Harbor Statute Expanded and Limited: Amgen, Inc., v. Int'l Trade Commission

By Kevin Raudebaugh[1]


The Federal Circuit Court of Appeals both broadened and narrowed the scope of the “safe harbor” statute, 35 U.S.C. § 271 (e)(1), in the recent decision Amgen, Inc., v Int'l Trade Commission[2] . Congress enacted the safe harbor statute to remove patent-based barriers to proceeding with federal regulatory approval of medical products. The Federal Circuit stated that in order to further this purpose, the statute provides safe harbor to both product and process patents[3] . But the court also stated that safe harbor only applies to activities “reasonably related to the development and submission of information to the federal regulatory authority.” [4] This changes a previous interpretation of Section 271 (e)(1) by the International Trade Commission (ITC), which extended its protection even to commercial activities prior to regulatory approval. The court also clarified the jurisdiction of the ITC to hear claims related to activities conducted under the safe harbor statute.[5]


Amgen manufactures recombinant human erythropoietin (EPO) for use in the drugs Aranesp(r) and Epogen(r), and they hold several U.S. patents related to EPO and its manufacture. Hoffmann-LaRoche (Roche) has been making EPO in Europe and using it in a rival drug, Micera(r), for which it is currently seeking FDA approval. Roche has been importing EPO to support its regulatory activities, and then continued to import EPO even after its Biologic License Application (BLA) was completed.

Amgen filed a Section 337 action with the ITC against Roche, claiming that Section 271 (e)(1) provides safe harbor only to product patents and not to products made by infringing process patents, and that it does not shield Roche's post-BLA activities. Roche then moved for summary determination of noninfringement on the ground that the EPO is exempted from such claims. The ITC granted the summary determination, ruling that safe harbor applies to both product and process patents, that Roche's post-BLA activities are shielded, and then determined that it had no jurisdiction to investigate and remedy infringement in this case because Roche had not yet made any sales or contracts to sell EPO in the U.S.


A. Safe Harbor of Process Patents

The Federal Circuit relied on two previous Supreme Court decisions to determine whether Section 271 (e)(1) applies to process as well as product patents, Merck[6] and Eli Lilly[7] . In Merck, the Court emphasized that safe harbor applies to all uses of products that are related to the development and submission of any information under the FDCA,[8] and in Eli Lilly the Court extended the protection to medical devices even though the statute only specifically mentions drugs and veterinary products[9] . The Federal Circuit interpreted these cases as stressing “the congressional purpose of removing patent-based barriers to proceeding with federal regulatory approval of medical products.”[10] The Court reasoned that excluding process patents from safe harbor would frustrate that purpose, so its protections should extend to cover them.[11]

B. Activities Covered by Safe Harbor

Section 271 (e)(1) limits its exemptions to purposes which 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 products.” In Merck, the Supreme Court interpreted this as activities that “contribute, relatively directly, to the generation of the kinds of information that are likely to be relevant to the processes by which the FDA would decide whether to approve the product in question.”[12] Despite this language, the ITC had shielded Roche's post-BLA activities, which Amgen alleged included “infringement analysis experiments, market-seeding trials, and litigation-related activity,”[13] apparently “assum[ing] that all otherwise infringing activities are exempt if conducted during the period before regulatory approval is granted.”[14] The Federal Circuit rejected this reasoning, and remanded the case to the ITC to consider the exempt status of each purpose for which Amgen raised a reasonable question.[15]

C. ITC Jurisdiction

The Federal Circuit had ample precedent to rely upon to determine that the ITC has jurisdiction to hear claims against infringing acts while a product is still protected by Section 271 (e)(1). Although the ITC refused to assert jurisdiction on the basis that there had not yet been a sale or contract to sell the product in question, it has previously stated that “[i]t is well established that the Commission's jurisdiction under 337 is broad, and that Section 337... authorizes the Commission to ‘prevent unfair acts in their incipiency.’”[16] The Federal Circuit itself had previously reached the conclusion that Section 337 review is appropriate while a product is sheltered because relief is directed to the time after approval.[17] This decision satisfies the purpose of the statute while safeguarding the rights of patentees that would be infringed when the safe harbor has ended.[18]

D. Dissent- Process Claims Should Not be Covered

In his dissent, Judge Linn agreed with Judge Newman's majority opinion on all issues except for the extension of safe harbor to items that may infringe on process patents.[19] He reached this conclusion based on the fact that while Section 271 (e)(1) declares that certain activities are not acts of infringement, the plain language of 19 U.S.C.S. § 1337(a)(1)(B)(ii) does not require an act of infringement for the Commission to issue an exclusion order when the product under consideration was made using a process that is covered by a U.S. patent.[20]


While the issues of jurisdiction and restricting safe harbor to activities related to regulatory submission are well supported by precedent, the court reached a novel conclusion in its interpretation of the relationship between Sections 271 and 337. In Kinik, which was also authored by Judge Newman, the court held that “the defenses established in § 271(g) are not available in § 1337(a)(1)(B)(ii) actions.”[21] This left the impression that where the language differed between the statutes they would be considered separately. The same option was available to interpret the statutes separately in this case and rule that the ITC could exclude goods that were produced through violation of a process patent, but instead the Federal Circuit chose to harmonize the statutes in favor of the Supreme Court's broad interpretation of Section 271(e)(1) in the Merck and in Eli Lilly cases.

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  • [1] Kevin Raudebaugh is a J.D. student at the University of Washington School of Law focusing on intellectual property.
  • [2] Amgen, Inc., v. Int'l Trade Commission, 2008 U.S. App. LEXIS 5751(No. 2007-1014, March 19, 2008).
  • [3] Id. at *13.
  • [4] Id. at *24.
  • [5] Id.
  • [6] Merck KgaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 125 S. Ct. 2372, 162 L. Ed. 2d 160 (2005).
  • [7] Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 110 S. Ct. 2683, 110 L. Ed. 2d 605 (1990).
  • [8] Merck, 545 U.S. 193 at 202.
  • [9] Eli Lilly, 496 U.S. 661 at 665.
  • [10] Amgen, 2008 U.S. App. LEXIS 5751 at *13.
  • [11] Id.
  • [12] Merck, 545 U.S. 193 at 208.
  • [13] Amgen, 2008 U.S. App. LEXIS 5751 at *14.
  • [14] Id. at *15.
  • [15] Id. at *17.
  • [16] 1986 ITC LEXIS 91 at *4 (quoting In re Certain Apparatus for the Continuous Production of Copper Rod, 214 USPQ 892, 895 (Int'l Tr. Comm'n 1980).
  • [17] See Glaxo Inc. v. Novopharm Ltd., 110 F.3d 1562 (Fed. Cir. 1997), See also Glaxo Group, Ltd. v. Ranbaxy Pharmaceuticals, Inc., 262 F.3d 1333 (Fed. Cir. 2001).
  • [18] Amgen, 2008 U.S. App. LEXIS 5751 at *23.
  • [19] Id. at *25.
  • [20] Id.
  • [21] Kinik Co. v. ITC, 362 F.3d 1359, 1363 (Fed. Cir. 2004).

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