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Slipping Through the Cracks of the § 271(e)(1) Safe Harbor

The US Court of Appeals for the Federal Circuit affirmed that the majority of the batches of an accused biosimilar manufactured by Hospira were not protected by the Safe Harbor exemption of § 271(e)(1), and that patent infringement damages were not unreasonable, notwithstanding that none of the accused product had been sold. Amgen Inc. v. Hospira, Inc., Case Nos. 19-1067; -1102 (Fed. Cir., Dec. 16, 2019)(Moore, J.).

EPO is a glycoprotein that regulates red blood cell development. Recombinant versions of EPO are used to treat anemia. One example is Amgen’s product Epogen. In 2014, Hospira submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) requesting approval for its EPO biosimilar. Amgen then sued Hospira for infringement of its patent directed to methods of producing EPO isoforms and its patent directed to recombinant cells producing EPO at certain rates. Specifically, Amgen asserted that 21 pre-approval batches of EPO manufactured by Hospira infringed various claims of these patents.

Hospira appealed.

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Garage Door Opener Dispute Highlights Importance of Disavowal

In a pair of opinions, the US Court of Appeals for the Federal Circuit addressed appeals arising out of the Chamberlain Group and One World Technologies’ patent infringement dispute concerning garage door opener technology. In the first appeal of a limited exclusion order issued by the USITC, the Federal Circuit reversed and vacated the USITC’s determination of infringement after finding that it was premised on an incorrect claim construction. Techtronic Industries Co. Ltd. v. Int’l Trade Comm’n, Case No. 18-2191 (Fed. Cir., Dec. 12, 2019) (Lourie, J.). In the second appeal, the Court held the PTAB’s finding that the challenged claims were anticipated was supported by substantial evidence. Chamberlain Group, Inc. v. One World Techs., Inc., Case No. 18-2112 (Fed. Cir., Dec. 17, 2019) (Hughes, J.).

The Chamberlain Group asserted various garage door opener technology patents against One World, including a patent directed to “an interactive learn mode” that assists users in installation and operation of a garage door opener.

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Data Processing Software Checks Out as Patent Eligible

PATENTS / SUBJECT MATTER ELIGIBILITY / ABSTRACT IDEA

Addressing an issue of software subject matter eligibility, the US Court of Appeals for the Federal Circuit reversed the district court’s judgment on the pleadings under 35 USC § 101, finding claims related to error checking patent eligible. Koninklijke KPN N.V. v. Gemalto M2M GMBH et al., Case Nos. 18-1862, -1864, -1865 (Fed. Cir. Nov. 15, 2019) (Chen, J).
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Supreme Court: PTO Not Entitled to Attorney’s Fees in District Court Appeals

PATENTS / PTO ATTORNEY’S FEES

In a unanimous decision authored by Justice Sotomayor, the Supreme Court of the United States held that the US Patent and Trademark Office (PTO) is not entitled to recover its attorney’s fees in an appeal to a district court from an adverse decision of the Patent Trial and Appeal Board (PTAB) under 35 USC § 145. Peter v. NantKwest, Inc., Case No. 18-801 (Supr. Ct. Dec. 11, 2019) (Sotomayor, Justice).

The question posed in this case was:

[W]hether such “expenses” [in § 145 proceedings] include the salaries of attorney and paralegal employees of the United States Patent and Trademark Office (PTO).

The answer was a resounding “no.”

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