Monday, December 21, 2020

Apotex loses its appeal at CAFC as to “a method of administering an antifolate to a mammal"

The outcome:
Apotex, Inc. appeals from the judgment of the district court in a patent-infringement suit brought by Eli Lilly & Company under the Hatch-Waxman Act, 21 U.S.C. § 355. The district court granted Lilly’s motion for summary judgment of infringement, holding that prosecution history estoppel does not bar Lilly from asserting infringement of certain claims of U.S. Patent No. 7,772,209 under the doctrine of equivalents. Because we discern no error in the district court’s decision, we affirm.

Festo is quoted:
The district court correctly concluded that prosecution history estoppel does not bar Lilly from asserting infringement by equivalents. The intrinsic record demonstrates that Lilly did not narrow the scope of its claims when it amended the claims reciting the administration of “ALIMTA” to instead recite the administration of “pemetrexed disodium.” A narrowing amendment is required to invoke estoppel. See id. (“Prosecution history estoppel arises when a patent applicant narrows the scope of his claims during prosecution for a reason ‘substantial[ly] relating to patentability.’” (alteration in original) (quoting Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 1366–67 (Fed. Cir. 2003) (en banc))).
The matter of using a tradename in a claim arose
Moreover, the prosecution history confirms that the inventors used “ALIMTA” in the original claims—and the Examiner understood the term—as Lilly’s trade name for pemetrexed disodium. Specifically, the Examiner rejected the claims of the ’821 application on the ground that the improper use of a trade name in the claims renders the claims indefinite. In doing so, the Examiner cited MPEP § 2173.05(u), which, as of the date of the rejection, provided that “[i]f the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph.” MPEP § 2173.05(u) (2004). The provision further provides that the “claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product,” and that the “value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product.” Id. For these reasons, the MPEP instructs examiners that “the use of a trademark or trade name in a claim to identify or describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name.” Id. Following Patent Office procedure, the Examiner in this case rejected the claims of the ’821 application as indefinite because they improperly used the trade name “ALIMTA.” In response to the rejection, Lilly canceled its claims reciting the trade name and pursued claims using the generic name for the same substance, which mooted the rejection.


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