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America Invents Act › Inter Partes Review (IPR) Proceeding › Pharmaceutical Patents

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... more +
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 -
MoFo Life Sciences

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

MoFo Life Sciences on

As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

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

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

[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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

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

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

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

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

[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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2020

Schwabe, Williamson & Wyatt PC on

PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2019

Schwabe, Williamson & Wyatt PC on

PATENT CASE OF THE WEEK - BioDelivery Sciences Int’l, Inc. v. Aquestive Therapeutics, Inc., Appeal Nos. 2019-1643, -1644, -1645 (Fed. Cir. Aug. 29, 2019) - Our case of the week this week focuses on Section 314(d)—the...more

McDermott Will & Emery

Mootness on Appeal from PTAB

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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

WilmerHale

Federal Circuit Patent Updates - January 2019

WilmerHale on

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

Troutman Pepper

Why Biotech and Pharma Patents Survive IPR

Troutman Pepper on

When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more

Troutman Pepper

Supreme Court Holds That AIA On-Sale Bar Applied To Secret Sales

Troutman Pepper on

In an inter-partes review proceeding (IPR), a challenger can rely only on patents and printed publications to challenge the validity of a patent claim. ...more

Jones Day

Sen. Hatch Introduces Hatch-Waxman Integrity Act

Jones Day on

Sen. Orrin Hatch has introduced a bill that would augment the Hatch-Waxman Act, limiting challengers ability to proceed with patent challenges both in court and at the PTAB. Following is the introduction of the “Hatch-Waxman...more

Knobbe Martens

Patent Law Update for Medical Device Companies 2018 (Presentation)

Knobbe Martens on

Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for October 2018?

Morrison & Foerster LLP on

This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more

Troutman Pepper

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

Troutman Pepper on

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

Goodwin

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

Goodwin on

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

Esquire Deposition Solutions, LLC

U.S. IPR Patent Review Process Legality Has Been Upheld

Esquire Deposition Solutions, LLC on

Houston-based oilfield services company Oil States International, Inc. challenged the legality of inter partes review (IPR), a patent review process that allows the Patent Trial and Appeal Board (PTAB) to hold hearings with...more

McDermott Will & Emery

IPR Petition for Hair Loss Treatment Patent Restored

McDermott Will & Emery on

In an unusual ruling, the Patent Trial and Appeal Board (PTAB) granted a petitioner’s request for rehearing and instituted inter partes review (IPR) on a previously denied ground, finding that it previously had applied an...more

Knobbe Martens

The Saint Regis Mohawk Tribe is not entitled to Sovereign Immunity at the PTAB

Knobbe Martens on

The PTAB dismissed the Saint Regis Mohawk Tribe’s attempt to avoid IPR of patents covering Restasis®, which Allergan transferred to the Tribe in a highly publicized patent deal. See Allergan and the Saint Regis Mohawk Tribe...more

Troutman Pepper

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

Troutman Pepper on

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

Troutman Pepper

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

Troutman Pepper on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Lessons Learned from AIA Invalidity Proceedings in the Bio/Pharma Space

McDonnell Boehnen Hulbert & Berghoff LLP on

September 16, 2016, marked the fourth anniversary of the effective date for the invalidity proceedings before the Patent Trial and Appeal Board (PTAB or Board) created by the America Invents Act (AIA). These new AIA...more

Troutman Pepper

Bass Continues Fishing; Pharma Seeks Sanctuary

Troutman Pepper on

It’s time for an update on Kyle Bass’s efforts to rid America of the pharmaceutical patents that support high priced drugs. Between February and September 2015, at least eleven investment funds organized by J. Kyle Bass and...more

WilmerHale

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

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Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more

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