Category Archives: Industry Focus

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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The BPCIA’s 180-Day Commercial Marketing Notice Provision is Mandatory for Applicants Exchanging Patent Information Under § 262(l)(2)(A).

Author: Yieyie Yang, Ph.D.
Editor: Aaron Gleaton Clay

The BPCIA’s 180-Day Commercial Marketing Notice Provision is Mandatory for Applicants Exchanging Patent Information Under § 262(l)(2)(A).

In its recent decision, Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), the Federal Circuit further interpreted the commercial marketing notice provision of the Biologics Price Competition and Innovation Act (“BPCIA”) and held that the 180-day commercial marketing notice provision under § 262(l)(8)(A) is mandatory even where the applicant exchanges patent information under § 262(l)(2)(A), affirming the district court’s grant of a preliminary injunction against Apotex.

The Federal Circuit reinforced its previous holding in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), that the word “shall” in § 262(l)(8)(A) was mandatory and expanded its application to circumstances in which (l)(2)(A) patent information is exchanged. To the Court, the mandatory nature of the notice provision is supported by the statutory language throughout the BPCIA. The Court also reasoned that market entry 180 days after the afforded 12-year exclusivity period was not inconsistent with § 262(k)(7), which only establishes the earliest date for approval, and that such “delay” would be rare since newer biosimilar applicants would seek approval long before the 12-year exclusivity period expires. The Court further emphasized that the legislative history confirmed that the aim of the 180-day notice period is to avoid uncertainties and deficiencies associated with the two-stage litigation contemplated by § 262(l). Finally, rejecting Apotex’s argument to the contrary, the Court concluded that the 180-day notice provision did not conflict with § 262(l)(9), as a declaratory judgment action under § 262(l)(9) is not the sole remedy for violating § 262(l)(8)(A).

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The Federal Circuit IP Blog Turns 1 — A Review of the Most Popular Posts From the Past Year

Author: Elizabeth D. Ferrill

On the anniversary of our first year, we thought we’d take a look back at the most popular posts from the past year. In just over 100 posts, these five rose to the top:


  1. Ariosa Diagnostics v. Sequenom Among the Most Important Federal Circuit Decisions From 2015 – This post from January 2016 was our most popular post, with more than 800 reads, covering a case that seems likely to have far-ranging implications for patents on diagnostic methods. Sequenom has filed for certiorari at the Supreme Court, so you will likely hear more from us on this topic in the future.
  2. Why Did I Say That? Knowledge of Person of Ordinary Skill Gleaned From Applicant’s Specification – In October 2015, this post seems to strike a chord with readers, perhaps for its timely discussion of an appeal from the PTAB, or perhaps for its amusing, yet educational title.
  3. “Sloppy” Attorney Arguments Not Litigation Misconduct, but Attorney’s Fees Still Possible – The issue of attorneys’ fees has been hot. This July 2015 post covered the continuing saga of when fees are awarded and when they are not.
  4. Teva’s “Molecular Weight” Patent Claims Found Indefinite – In another popular summer 2015 post, readers learned about indefiniteness in the pharmaceutical arts, when the Federal Circuit applied the “reasonable certainty” standard from Nautilus.
  5. Getting Priorities Straight: Patents Have No Presumptive Entitlement to Priority Date of Provisional Applications – In September 2015, many readers continued to be interested in Federal Circuit reviews of PTAB decisions, including this one on the subject patent’s true priority date.

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