Earlier, Amgen tried to stop the importation of recombinant human erythropoietin and derivatives (EPO) by filing a complaint with the International Trade Commission that is was a violation of Section 337 of the Tariff Act of 1930. Amgen charged that the imported EPO and the process by which it is produced in Europe are covered by one or more claims of the following Amgen patents:  Pat. Nos. 5,411,868, 5,547,933, 5,618,698, 5,621,080, 5,756,349 and 5,955,422.

urinesampleIn related news, this new form of EPO, named MIRCERA, was just in the news after the International Olympic Committee (IOC) reported that three (3) athletes have returned positive tests for MIRCERA following re-analysis of samples taken by the IOC in Beijing.

Roche moved for summary judgment on the ground that the imported EPO is exempt from infringement by operation of 35 U.S.C. ‘271(e)(1), the “safe harbor” statute, because the imported EPO is used only for the statutorily exempt purpose of the development and submission of information under a federal law regulating the manufacture, sale, and use of drugs.

The Commission granted the motion for noninfringement, holding that all of Roche’s activities are within the safe harbor, including the foreign production of the imported product. Amgen appealed that the safe harbor statute does not apply to Tariff Act violations based on foreign practice of patented processes, and also on the ground that not all of the imported EPO was used for the statute’s exempt purposes.

The CAFC, however, affirmed the ruling that the safe harbor provided by ‘271(e)(1) applies in proceedings under the Tariff Act relating to process patents as well as product patents, for imported product that is used for exempt purposes.

After getting a petition for rehearing by the ITC and Roche, an en banc Federal Circuit authorized”the panel in the earlier Amgen v. ITC case to revise Part II of its opinion related to the jurisdictional question, vacate the previous judgment and opinion and remandedto the original panel for further review.  Amgen v. ITC and Roche (07-1014).

In part II, the court reversed the Commission’s ruling that Roche was entitled to summary determination, because there was a genuine dispute of material fact concerning whether all of Roche’s activities fell within this safe harbor.

Section 337 assigns the ITC the authority to investigate and block importation based on unfair competition derived from patent, trademark, and copyright infringement, not the Patent Act.  Section 337 prevents the importation, sale for importation, or the sale within the US after importation by the owner, importer, or consignee, of articles that–

(i) infringe a valid and enforceable United States patent or a valid and enforceable United States copyright under title 17, United States Code; or
(ii) are made, produced, processed, or mined under, or by means of, a process covered by the claims of a valid and enforceable United States patent. . . .

The issues on this appeal focused on the safe harbor statute for drug products, on application to the imported EPO:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . 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.  35 U.S.C. ‘271(e)(1)

The Commission held that the safe harbor statute applies to products produced offshore by a process patented in the United States. Amgen argued that this statute does not bar the exclusion of such importation, reasoning that the ‘271(e)(1) reference to importing “a patented invention” is necessarily limited to importation of product, for a process can’t be imported.

Amgen argued that the 1988 enactment of 35 U.S.C. ‘271(g) limits the safe harbor to process patents that would be enforced under ‘271(g):

A product which is made by a patented process will, for purposes of this title, not be considered to be so made after–(1) it is materially changed by subsequent processes; or (2) it becomes a trivial and nonessential component of another product.

In Kinik v. ITC, the court held that the Tariff Act remedy of exclusion based on practice of a patented process was unchanged, and that the exceptions set forth in ‘271(g)(1) and (2), did not apply in Section 337 cases. So, Amgen argued that Kinik confirmed that no change whatsoever was made in the Commission’s authority under the Tariff Act to exclude products made offshore by an infringing process, and that this was not changed by the enactment of either ‘271(g) or ‘271(e)(1).

The ITC didn’t buy it and ruled that the safe harbor statute insulates the Roche EPO from Section 337 exclusion not only as to infringement of Amgen’s product patents but also as to Amgen’s process patents.

The CAFC concluded that the Commission’s ruling aligned with Congressional intent that it would not be an act of infringement to import a product which is made by a process patented in the United States “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.”

Amgen argued that even on the Commission’s interpretation of the safe harbor statute, at least some of the imported Roche EPO is not exempt because its actual use was not “reasonably related to the development and submission of information under [the FDCA],” §271(e)(1).

The court felt likewise:

The Commission appears to have assumed that all otherwise infringing activities are exempt if conducted during the period before regulatory approval is granted. That assumption is incorrect, for the Court in Merck confirmed that “[e]ach of the accused activities must be evaluated separately to determine whether the exemption applies.” Id. at 200. The studies at issue in Merck were presented as scientific studies, and it is apparent that commercial and marketing studies are more clearly subject to separate evaluation for application of the exemption.

Applying the safe harbor exemption of 35 U.S.C. ‘271(e)(1), the imported EPO is not subject to exclusion based on infringement of either product or process patents, to the extent that the imported EPO is used to develop information that is reasonably related to the development and submission of information to the federal regulatory authority. The Commission’s holding to this effect is affirmed. However, Roche’s uses of imported EPO unrelated to obtaining FDA approval are not shielded by the exemption. We therefore reverse the Commission’s summary determination in favor of Roche and remand for further proceedings consistent with this opinion.

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    […] Patent Baristas placed an interesting blog post on Court Revises Opinion on Amgen Case with ITCHere’s a brief overviewEarlier, Amgen tried to stop the importation of recombinant human erythropoietin and derivatives (EPO) by filing a complaint with the International Trade Commission that is was a violation of Section 337 of the Tariff Act of 1930 . Amgen charged that the imported EPO and the process by which it is produced in Europe are covered by one or more claims of the following Amgen patents:  Pat. Nos. 5,411,868, 5,547,933, 5,618,698, 5,621,080, 5,756,349 and 5,955,422. In related news, this new for […]