By Jason Rantanen
During the summer, the Federal Circuit is a relatively quiet place. The judges often take their non-sitting months during this time, and the pace of opinions tends to drop. Thus, for the next few weeks, I'll mostly be posting summaries of cases that issued this past spring and early summer. The two cases discussed below deal with a relatively minor — but still important — issue in the pharmaceutical and medical device context: patent term extensions based on extensive regulatory review periods.
Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc. (Fed. Cir. May 10, 2010)
Photocure ASA v. Kappos (Fed. Cir. May 10, 2010)
35 U.S.C. §156 allows a patentee to obtains a term extension if the patent covers a product that has been subject to a regulatory review period before it can be marketed or used. Pharmaceuticals and medical devices are subject to such a review period, and new drug products in particular often involve a lengthy application and testing process. The initial determination as to whether a patent term extension should be granted is made by the USPTO, in consultation with the FDA. That decision is subject to review or challenge in district court proceedings.
One of the key issues in determining whether a patent term extension is warranted for a drug is whether it is the first time regulatory approval has been granted for this particular drug product, a determination that turns on whether or not the "active ingredient" had previously been approved by the FDA. Ortho-McNeil and Photocure, both authored by Judge Newman and issued on the same day, provide an interesting contrast on this issue.
Ortho-McNeil v. Lupin
In Ortho-McNeil, the extension issue arose in the context of an injunction entered against Lupin Pharmaceuticals prohibiting it from making, using, selling, etc. a drug product covered by U.S. Patent No. 5,053,407 (the '407 patent) during the extension period. In that case, the district court affirmed the PTO's determination that an enantiomer was a different drug product then its racemate. In doing so, the district court noted that the PTO's determination should be afforded great deference.
Note: Enantiomers are molecules that are mirror images of one another. Due to their different orientation, they have different properties. A racemate is a composition consisting of equal parts of the two enantiomers. The '407 patent covered a substantially purified form of one of the two enantiomers (levofloxacin) in the racemate ofloxacin. There was no dispute that levofloxacin was separately patentable from ofloxacin.
On appeal, the Federal Circuit agreed with the district court, concluding that there was no basis for challenging the established FDA and PTO practices of treating enantiomers as different drug products and rejecting Lupin's legislative intent argument.
Photocure v. Kapos
Photocure involved a contrary determination by the PTO: that the drug product at issue was not a different "active ingredient," and thus the patentee was not entitled to an extension. In Photocure, the product at issue ("MAL") was a methyl ester of a compound ("ALA") that had previously been approved for the same therapeutic use. While the FDA treated MAL as a new drug, requiring a full approval process, the PTO rejected the extension based on its conclusion that § 156(f)(2) does not mean the product approved by the FDA, but rather the "active moiety," which it concluded was the same in both MAL and ALA.
Both the district court and Federal Circuit disagreed. In rejecting the PTO's interpretation of 156(f)(2), the Federal Circuit reasoned that § 156 focuses on the product that is subject to approval by the FDA, not the underlying pharmacological mechanism. Furthermore, Skidmore and Chevron deference standards did not apply because the statute was not unambiguous and the PTO's interpretation was neither persuasive nor consistent.
Note: although not the primary focus of the opinon, the panel also concluded that the PTO was wrong even under its "active moiety" interpretation as the biological properties of ALA and MAL are indisputably different.
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In addition to the issues discussed above, the scope of the injunction in Ortho-McNeil is worth noting. Although the extension authorized by 35 U.S.C. § 156 covers the "selling" or "using" of the product covered by the patent, the district court enjoined Lupin from engaging in any of the traditional forms of direct infringement, including "making" or "importing." Despite the literal language of §156, the Federal Circuit affirmed the scope of this injunction because there are no non-pharmaceutical "uses" of the drug product, a point that Lupin apparently conceded. Although as a practical matter this distinction may be of little value, as pharmaceutical companies often have production facilities located outside the United States, it is something to consider when seeking or opposing litigation under § 156.