Supreme Court Declines to Hear Idenix Case: Dispute Surrounding the Enablement Standard for Biotechnology Patents Continues

February 12, 2021

On January 19, 2021, the Supreme Court denied a petition for certiorari to hear the Idenix Pharmaceuticals LLC v. Gilead Sciences Inc. case (941 F.3d 1149 (Fed. Cir. 2019)). In the underlying district court litigation, the jury found the Idenix patents were infringed, awarding it $2.5 billion in damages. But, the district court overturned the verdict and granted judgement as a matter of law finding the patents invalid for lack of enablement, and the Federal Circuit affirmed. To revive its damages claim, Idenix filed a petition to reverse the Federal Circuit's decision. The petition addressed whether a genus claim is not enabled if it encompasses a large number of compounds or whether, as the Supreme Court has previously recognized, enablement is a context-specific jury question (as well as a related written description issue that will not be discussed further).... Read more

PTAB Issues Two New Precedential and One Informative Opinions on Section 325(d)

April 17, 2020

The PTAB recently designated two decisions as precedential and one decision as informative with respect to 35 U.S.C. § 325(d). These cases discuss the Board's process for deciding when to use their discretion to deny institution because a Petition raises issues that the Patent Office previously considered in other proceedings (e.g., during prosecution, prior reexams).... Read more

Battle of the Biologics: Lilly's IPRs Clear Six Teva Patents

March 5, 2020

Several companies have received FDA approval for antagonist antibodies against calcitonin gene-related peptides. These so-called anti-CGRP biologic drugs are a relatively new type of injectable medication for preventing migraines without side effects.<... Read more

Four Decisions Designated Informative on 101: Positive Trend for Life Sciences?

July 2, 2019

In January, 2019, the USPTO issued new guidance about what constitutes an abstract idea that is ineligible for protection under Section 101. Among other things, the guidance emphasized that claims otherwise reciting a judicial exception (i.e., not patentable), would be permitted if they were directed to some type of practical application. See our previous post for more details.... Read more


Category: PTAB 101

PTAB Issues Two New Precedential Opinions On Discretion to Deny Review - Implications for Generics

May 9, 2019

The PTAB designated two decisions as precedential this week (in addition to several in previous weeks), both relevant to the Board's discretion to deny review. These cases illustrate that the PTO is in the process of designating precedential opinions on a number of issues, in line with revised Standard Operating Procedure 2 for designating precedential and informative decisions. See my previous posts on other recent precedential decisions here and here.... Read more

Biologic Patent Transparency Act - New Bill Aimed at Biologics

March 12, 2019

A bipartisan group of senators sponsored a bill this week—the Biologic Patent Transparency Act, S. 659—aimed at making patent information associated with biologics easier to identify and easing the approval process for biosimilar manufacturers encountering patent roadblocks.... Read more

Hedge Your Bets in TC 1600 PGRs

November 30, 2018

Post grant reviews (PGRs) have proven to be more popular in the biotechnology space (TC 1600) than any other art unit, with 42—or 28.1%—of the PGRs filed to date classified as TC 1600 patents.[1] By way of comparison, TC 1600 makes up just 10.1% of all IPRs filed to date.  Perhaps not surprisingly, PGRs are appealing for challengers of biotechnology patents because written description, enablement, and indefiniteness can all be raised, and these § 112 hurdles tend to be more challenging in the unpredictable arts of TC 1600. <... Read more

PTAB Confirms It Will Apply Broad Petitioner Estoppel Post-SAS

November 8, 2018

The IPR estoppel provision was originally intended as a check against patent challengers attacking patents serially in the USPTO or other forums based on grounds that were raised or "reasonably could have been raised" in the original IPR. Although the Federal Circuit has interpreted estoppel narrowly, district courts were split, and estoppel's impact has remained in flux for several years.... Read more

Two Herceptin® Patents Survive IPR: A Lesson in Separately Arguing Motivation to Combine and Reasonable Expectation of Success

October 4, 2018

Motivation to combine and reasonable expectation of success are separate requirements that must be independently considered. By capitalizing on shortcomings in the petitions related to separately arguing these issues, Genentech was able to save two of three patents covering its blockbuster drug Herceptin®.... Read more

Travatan Z® Patent Survives IPR: A Lesson in Successfully Arguing Hindsight Bias

September 27, 2018

Hindsight bias is not simply an old chestnut argued ad infinitum in response to obviousness challenges. In this week's final written decision in IPR2017-01053 upholding all claims of U.S. Patent No. 8,268,299, the PTAB illustrated that—under the right circumstances—this argument can have teeth.... Read more