Category Archives: ANDA

Make This For Me! Retaining Contractor to Manufacture Patented Product Does Not Trigger On-Sale Bar

Author: Alex Kwan-Ho Chung, Ph.D.
Editor: Lauren J. Dreyer

Last week, the Federal Circuit (en banc) unanimously held that mere sale of services by a contract supplier to manufacture a patent product for the inventor—without transfer of title to the patented embodiments or the right to market the same—does not constitute a “commercial sale” of the invention to trigger the 35 U.S.C. § 102(b) on-sale bar. The Medicines Co. v. Hospira, Inc., Nos. 2014-1469, -1504, slip op. (Fed. Cir. July 11, 2016) (en banc).

Under the on-sale bar, an issued patent is invalid if its embodied “invention” was “on sale” by anyone more than one year before filing an application for the patent (the “critical date”). According to the Supreme Court’s two-prong Pfaff framework, the claimed invention was “on sale” if, before the critical date, it was (i) the subject of a commercial sale or offer for sale; and (ii) ready for patenting. The sole issue of the en banc appeal was the first prong. Continue reading

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Patent Owner’s Particular Fax Qualified as Invalidating Offer for Sale of Drug Despite Omission of Safety and Liability Terms

Author: Alex Kwan-Ho Chung
Editor: Jeff T. Watson

In Merck & Cie v. Watson Laboratories, Inc., Nos. 15-2063, -2064 (Fed. Cir. May 13, 2016), the Federal Circuit found Merck’s patent invalid under the on-sale bar of 35 U.S.C. § 102(b) because Merck sent a particular fax to a vendor constituting a commercial offer for sale.

Applying traditional contract law principles, the Federal Circuit noted that the particular fax from Merck to a potential strategic partner, Weider, was a directed response to Weider’s request to purchase (not an unsolicited price quote); contained “all the required elements [including price, delivery, and payment terms] to qualify as a commercial offer for sale”; and was notably unqualified with the sender’s assurance to “arrange everything.” Merck’s failure to deliver was not dispositive because, according to the Court, Merck’s offer for sale, even if unconsummated, was sufficient to raise the on-sale bar.

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Teva’s Imported Generic Enoxaparin Products Manufactured Using Particular Quality Control Process Are Not “Made By” Patented Process Under 35 U.S.C. § 271(g)

Author: Hsin-Yuan (Charles) Huang, Ph.D.
Editor: Aaron Gleaton Clay

In Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., Nos. 14-1274, 14-1277 (Fed. Cir. Nov. 10, 2015), a divided Federal Circuit affirmed a district court’s summary judgment determination that Teva’s importation of generic versions of enoxaparin, which are manufactured outside the U.S. by particular processes directed to ensuring product batches meet certain quality requirements, did not infringe Momenta’s method patent claims under 35 U.S.C. § 271(g). Continue reading

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