On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the Federal Circuit decision in CellzDirect, and notes that the Supreme decision denying certiorari in Sequenom “does not elevate” the significance of the panel decision in that case. Continue reading this entry
In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016, and also could impact the production of the Celltrion/Hospira products sold abroad. This complaint is separate from the pending biosimilar litigation and based on alleged actual infringement of a patent directed to specific cell culture media compositions used to produce infliximab.
Continue reading this entry
Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to shorten that exclusivity period to expedite biosimilar market entry. Most recently, on June 23, 2016, Illinois Congresswoman Jan Schakowsky and Senators John McCain (R-AZ) and Sherrod Brown (D-OH) introduced the “Price Relief, Innovation, and Competition for Essential Drugs” (PRICED) Act in the U.S. House of Representatives and Senate. The bills would amend the “first licensure” provisions of the BPCIA to shorten the market exclusivity period for new biologics from 12 to 7 years. Similarly, the President’s budget for fiscal year 2017 recommended “prohibiting additional periods of exclusivity for brand biologics due to minor changes in product formulations.”
The USPTO has launched a new after final program available starting today, July 11, 2016. The Post-Prosecution Pilot Program (P3) combines features of the After Final Consideration Pilot 2.0 (AFCP 2.0) and Pre-Appeal Brief Conference Pilot programs, and adds a feature that stakeholders have been clamoring for–Applicant participation in the process. The P3 program will run through January 12, 2017, or the date the USPTO has accepted 1,600 compliant requests. However, each individual technology center will accept only 200 compliant requests, so the program could close earlier in a given technology center. Continue reading this entry
The Federal Circuit ruled that the cryopreservation methods at issue in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., are patent eligible under 35 USC § 101. It therefore vacated and remanded the decision of the U.S. District Court for the Northern District of Illinois that held the claims invalid on summary judgment. The Federal Circuit distinguished the claims at issue from other method claims invalidated under recent patent eligibility jurisprudence, and provided additional guidance on when methods that exploit a natural phenomenon are not “directed to” non-eligible subject matter. Continue reading this entry