Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., 603 F.3d 1377, CPLRG 0065 (Fed. Cir. 2010) (NEWMAN, Rader & Linn) OrthoLupin05102010
MAJOR ISSUES: patent term extension for drugs, Hatch-Waxman Act; first commercial marketing of “drug product”; active ingredient of drug product; enantiomer distinct from racemate
COMMENTS. Two cases, this one and Photocure ASA v. Kappos, 603 F.3d 1372, CPLRG 0066 (Fed. Cir. 2010), decided the same day and written by the same author (Newman) for the same panel (Newman, Rader and Linn), address patent term extension for drugs. Both give an expansive interpretation to a key requirement for extension: that the requested extension be for the first commercial marketing of a “drug product,” that is, that the same “drug” not have been previously marketed.
In this case, a drug based on a left enantiomer of a compound was held to be a different drug product from a previously marketed drug based on a racemate of that compound. A racemate is a mixture of left and right enantiomers.
CROSS REFERENCES. On patent term extension for patents covering drugs and methods of using them, see Chisum Patent Law Digest 5143; Chisum on Patents 16.04.
1. ANTIMICROBIAL; LEVOFLOXACIN. A patent concerned “an antimicrobial compound having the common name levofloxacin.” U.S. Pat. No. 5,053,407 USPatNo5053407.
2. The Federal Circuit held that a Section 156 term extension was properly granted by the PTO, acting on advice from the FDA, for a patent claiming a levo-enantiomer of a compound. The FDA approved for marketing a drug based on the enantiomer. That approval was the statutorily-required “first permitted commercial marketing” of the drug, even though the FDA had previously approved a drug based on the compound’s racemate, that is, a mixture of levo- and dextro- enantiomers.
3. DIFFERENT DRUG PRODUCT; SEPARABLY PATENTABLE; FDA APPROVAL REQUIRED. An enantiomer was “a different drug product from the racemate.” The difference was supported by the separate patentability of the enantiomer, which displayed superior properties compared to the racemate. It was further supported by FDA policy, which was to require separate marketing approval.
4. “PRODUCT” IS ACTIVE INGREDIENT; GLAXO OPERATIONS (1990); EXTENSION FOR SEPARATELY PATENTABLE ESTER EVEN THOUGH SALTS OF SAME ACID HAD BEEN PREVIOUSLY APPROVED. In Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 399 (Fed. Cir. 1990), “the court held that `product’ as used in § 156(a) is the active ingredient present in the drug. See 894 F.2d at 393-95 (extending term of patent on a new separately patentable ester, although salts of the same acid had previously been approved).”
5. 2007 STATUTORY CHANGE ON DATA EXCLUSIVITY FOR NEW ENANTIOMER PRODUCTS. Arguing that the extension for an enantiomer of a previously approved racemate was improper, an accused infringer relied on a 2007 statutory change on data exclusivity. The argument lacked merit.
a. ELECTION TO HAVE ENANTIOMER TREATED AS SEPARATE FROM RACEMIC. The statute authorizes an applicant for a single enantiomer drug to elect to have the enantiomer not considered to be the same active ingredient as the previously approved racemic drug. 21 U.S.C. § 355(u)(1).
b. GENERAL CONGRESSIONAL UNDERSTANDING THAT ENANTIOMERS ARE THE SAME AS RACEMICS FOR ALL OTHER PURPOSES? The accused infringer argued that that the statute represented a Congressional understanding that enantiomers should be regarded as the same active ingredient “for all other purposes, including patent term extension.”
c. There was no support for the accused infringer’s argument in the statute’s legislative history or otherwise. Legislative silence cannot change long-standing FDA and PTO policy on patent term extension.