Photocure ASA v. Kappos, 603 F.3d 1372, 2010 U.S. App. LEXIS 9465 (Fed. Cir. 2010) (NEWMAN, Rader & Linn)Photocure05102010
MAJOR ISSUES: patent term extension for drugs, Hatch-Waxman Act; first commercial marketing of “drug product”; active ingredient of drug product; methyl ester of compound in previous drug
COMMENTS. Two cases, this one and Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., 603 F.3d 1377, CPLRG 0065(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 methyl ester of a compound was held to be a different drug product from a previously marketed drug based on the compound.
CROSS REFERENCES: On patent term extension, see Chisum Patent Law Digest 5143; Chisum on Patents 16.05.
1. METHYL AMINOLEVULINATE HYDROCHLORIDE (MAL HYDROCHLORIDE). A patent covered a compound (MAL), which was the active ingredient in a drug used in photochemotherapy to treat actinic keratoses. U.S. Pat. No. 6,034,267. USPatNo6034267
a. The compound was a methyl ester of a known compound (ALA), which was the active ingredient in another drug previously approved for the same therapeutic use.
b. PTO DENIAL OF EXTENSION. The PTO denied term extension for the patent on MAL. It reasoned that the MAL-based drug was not a first marketing of the drug because the two compounds (MAL and ALA) were the same drug product. The PTO relied on the extension statute’s definition of a drug product as meaning active ingredient. It found that MAL and ALA were the same active ingredient because they involved the same “active moiety.” The PTO relied on Pfizer Inc. v. Dr. Reddy’s Laboratories, Ltd., 359 F.3d 1361 (Fed. Cir. 2004).
c. The Federal Circuit held that the PTO erred. The methyl ester was eligible for extension because it was separately patented and was the active ingredient in a drug product that required separate FDA approval. Pfizer was distinguishable. Pfizer did not address whether extension was available for a substantively changed product. Rather, Pfizer held that changing the salt of a patented compound did not avoid infringement of an extended patent because the “active moiety” was the same and the patent covered both salts.
2. STATUTE; DRUG PRODUCT; FIRST PERMITTED COMMERCIAL MARKETING; ACTIVE INGREDIENT. Under 35 U.S.C. Section 156, an extension for a patent claiming a product is available if the product was subject to regulatory review and the FDA permission to market it was “the first permitted commercial marketing” of the product. 35 U.S.C. § 156(a)(5)(A). “Product” is defined as a “drug product,” which is denied as “the active ingredient of … a new drug .. including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.” 35 U.S.C. § 156(f)(2)(A).
3. ACTIVE INGREDIENT; PART RESPONSIBLE FOR PHARMACOLOGICAL PROPERTIES? The PTO argued that “active ingredient” meant “active moiety,” which meant “the part responsible for pharmacological properties.”
a. This interpretation of the statute was not correct. Case law held that a compound could be an “active ingredient” within the meaning of the statute only if the compound itself was in the drug.
b . MAL: PROPERTIES DIFFERING FROM ALA. Even if the interpretation were correct, the MAL would meet the interpretation because the patent on MAL illustrated that MAL’s biological properties differed from those of ALA even though their chemical structures were similar.
4. GLAXO (1990) DISTINGUISHABLE? The PTO sought to distinguish Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 393 (Fed. Cir. 1990), which upheld “extending term of patent on a new separately patentable ester, although salts of the same acid had previously been approved.”
a. PFIZER (2004). The PTO argued that Glaxo did not construe “active ingredient” and was, therefore, not in conflict with Pfizer Inc. v. Dr. Reddy’s Laboratories, Ltd., 359 F.3d 1361 (Fed. Cir. 2004).
b. Pfizer and Glaxo were not in conflict for a reason different from that the PTO suggested.
c. The court noted that Pfizer addressed whether infringement of an extended patent was avoided by changing from one salt of a compound to another. The change had no effect on the product’s activity because “the active moiety” was unchanged. The patent owner had included both salts in its patent and had provided data to the FDA on both salts. Thus, “Pfizer did not concern a different, separately patented product requiring full regulatory approval.”
5. DEFERENCE TO AGENCY INTERPRETATION. The PTO argued that a court should defer to the views of an agency administering an ambiguous statute under the principles of Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), and Skidmore v. Swift & Co., 323 U.S. 134 (1944). As held in Glaxo, the definitions in Section 156(f)(2) have “a common and unambiguous meaning,” which leave no “gap” for an administrative agency to fill. Thus, “neither Chevron nor Skidmore permits a court to defer to an incorrect agency interpretation.”