News & Analysis as of July 12, 2025

Patent Litigation

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The Leahy-Smith America Invents Act is a United States federal statute enacted in 2011 aimed at simplifying the U.S. patent system and allowing inventions to be brough to market sooner. The AIA makes significant changes to the patent system, including changing from a first-to-invent scheme to a first-to-file scheme, eliminating interference proceedings and developing post-grant opposition. less -

The PREVAIL Act Is Back. Will It Prevail This Time?

Fish & Richardson on 6/9/2025

On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...more

Delay Is Okay: Final Written Decisions Can Be Issued After Statutory Deadline

McDermott Will & Emery on 11/30/2023

In a matter of first impression, the US Court of Appeals for the Federal Circuit concluded that the Patent Trial & Appeal Board has the authority to issue a final written decision (FWD) in a post-grant review (PGR) proceeding...more

SNIPR Technologies Ltd. v. Rockefeller University (Fed. Cir. 2023)

McDonnell Boehnen Hulbert & Berghoff LLP on 7/17/2023

One of the wonderful (as in, it makes one wonder) and frustrating (which needs no explanation) aspects of patent law is that just when you think a question is settled it either isn't or the conventional interpretation is...more

2021 PTAB Year in Review: Analysis & Trends: Biologics at the PTAB: Statistics and Insights into Notable Biologics Decisions

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 3/24/2022

In June 2021, the US Patent and Trademark Office (USPTO) published an update to its study of America Invents Act (AIA) trials involving challenges to Orange Book-listed and biologic patents from September 16, 2012, through...more

2021 PTAB Year in Review: Analysis & Trends: Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 3/15/2022

Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...more

2021 PTAB Year in Review: Analysis & Trends

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 3/7/2022

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions: Mylan Labs. Ltd v. Janssen Pharmaceutica, N.V.,...

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 2/17/2022

Mylan appealed from a Patent Trial and Appeal Board (Board) discretionary denial of institution of an inter partes review (IPR) proceeding. The Board declined to institute Mylan’s IPR under NHK-Fintiv, a multi-factor analysis...more

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 2/9/2022

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more

Biosimilars 2021 Year in Review

Fish & Richardson on 1/12/2022

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Year in Review: Top Five Legal Developments of 2019 Impacting Biosimilars

Goodwin on 1/2/2020

As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy...more

Personalized Cancer Therapy Found Nonobvious

Foley & Lardner LLP on 10/16/2019

In OSI Pharmaceuticals, LLC v. Aoptex Inc. (Fed. Cir. 2018-1925, Oct. 4, 2019), the Federal Circuit reversed the Patent Trial and Appeal Board’s (Board) decision that certain claims of US Patent No. 6,900,221 were...more

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

Robins Kaplan LLP on 5/9/2019

Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., No. 17-1229, 139 S. Ct. 628 (Jan. 22, 2019) (Thomas, J. delivered the opinion for a unanimous Court), on cert. from the Federal Circuit, 855 F.3d 1356. ...more

Mootness on Appeal from PTAB

McDermott Will & Emery on 4/3/2019

The US Court of Appeals for the Federal Circuit dismissed an appeal of an inter partes review (IPR), finding that the challenger lacked appellate standing because it had terminated its attempts to develop the infringing...more

Waiting To File For A Patent? A Cautionary Tale

Akerman LLP on 2/25/2019

A patent can provide incredible benefits. When a patent is infringed, the patent owner may be entitled to damages from the infringer. Also, the patent owner may be able to receive an injunction against the infringer,...more

Federal Circuit Patent Updates - January 2019

WilmerHale on 2/22/2019

Barry v. Medtronic, Inc. (No. 2017-2463, 1/24/19) (Prost, Moore, Taranto) - Taranto, J. Affirming judgement of no invalidating public use of patents related to methods for correcting spinal column anomalies. Also...more

Attorney General’s Office May Weigh In on Constitutionality of IPRs involving Pre-AIA Patents

Troutman Pepper Locke on 9/20/2018

The 2011 America Invents Act (AIA) provided a variety of new ways to administratively challenge patents, including the now widely used inter partes review (“IPR”) procedure. In two recent appeals of IPR decisions, Genentech...more

Federal Circuit Solicits U.S. Attorney General’s Views on Constitutionality of Subjecting Pre-AIA Patents to Inter Partes Review

Goodwin on 9/17/2018

Genentech recently submitted two opening appellate briefs to the Federal Circuit in connection with its appeals from the Board’s final written decisions in Hospira’s IPRs, IPR2016-01771 and IPR2016-01837, which found that the...more

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

Foley & Lardner LLP on 6/18/2018

On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on...more

Recent PTAB Studies: Expanded Panels and Orange Book-Listed Patents

Foley & Lardner LLP on 4/2/2018

In connection with a recent “Chat with the Chief” webinar, the Patent Trials and Appeal Board (“PTAB”) released two studies – a study of expanded panels and a study of proceedings challenging orange book-listed patents....more

Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc.

Robins Kaplan LLP on 8/3/2017

Case Name: Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc., 855 F.3d 1356, 2017 U.S. App. LEXIS 7650 (Fed. Cir. May 1, 2017) (Circuit Judges Dyk, Mayer, and O’Malley presiding; Opinion by Dyk, J.) (appeal from D.N.J.,...more

PTAB Can Rely on New Evidence Introduced by Petitioner in its Reply

Troutman Pepper Locke on 8/1/2017

In a decision last month, the Court of Appeals for the Federal Circuit gave petitioners in AIA proceedings yet another weapon to invalidate patents – by affirming a Patent Trial and Appeal Board (PTAB) decision that relied,...more

Federal Circuit Returns the On-Sale Bar to Status Quo for AIA Patents

Latham & Watkins LLP on 6/8/2017

Contrary to USPTO guidance, invention details need not be publicly disclosed to trigger on-sale bar for AIA patents. The Leahy-Smith America Invents Act (AIA)1 is widely considered the most significant overhaul of US...more

AIA On-Sale Bar Applies to Publicized Sales, Even When Knowledge of Sale Did Not Disclose the Underlying Invention

Troutman Pepper Locke on 5/30/2017

The Court of Appeals for the Federal Circuit (CAFC) recently construed the on-sale bar provision of 35 U.S.C. 102(a) in a way that will make it easier for petitioners to challenge third party patents. While in an inter-partes...more

Helsinn v. Teva and the Status Quo: The Federal Circuit Opines on the Scope of the AIA's On-Sale Bar

Faegre Drinker Biddle & Reath LLP on 5/9/2017

In a case of first impression, the Federal Circuit recently interpreted the scope of the “on sale” bar under 35 U.S.C. § 102(a)(1) of the America Invents Act (AIA). In Helsinn Healthcare v. Teva Pharmaceuticals, the court...more

Federal Circuit Clarifies Post-America Invents Act “On-Sale” Bar Based on Publicly Announced Sale Agreements: Invalidates Four...

Dickinson Wright on 5/3/2017

On May 1st, the Federal Circuit ruled that the America Invents Act (AIA) did not change the statutory meaning of “on sale” where the existence of a sale was publicly announced prior to patenting, even if the sale did not...more

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