News & Analysis as of September 21, 2024

Inter Partes Review (IPR) Proceeding

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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 -

Federal Court Invalidates Dosing Patent Based On Clinical Trials Disclosure

MoFo Life Sciences on 6/10/2024

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

Latest Federal Court Cases - January 2020

Schwabe, Williamson & Wyatt PC on 1/14/2020

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

OSI Pharmaceuticals, LLC v. Apotex Inc. (Fed Cir. 2019)

McDonnell Boehnen Hulbert & Berghoff LLP on 10/9/2019

Last week, the Federal Circuit overturned an obviousness determination in an inter partes review by the Patent Trial and Appeal Board in OSI Pharmaceuticals LLC v. Apotex Inc. The Court also reaffirmed its holdings in...more

U.S. Court Of Appeals For The Federal Circuit Has Held That Neither State Agencies Nor Indian Tribes Enjoy Sovereign Immunity,...

Ladas & Parry LLP on 7/16/2019

On July 20, 2018 in Saint Regis Mohawk Tribe, Allergan, Inc. v. Mylan Pharmaceuticals Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (Dyk, Moore and Reyna JJ) held that Native American (“Indian”) Tribes do...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

Why Biotech and Pharma Patents Survive IPR

Troutman Pepper on 2/21/2019

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

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

Troutman Pepper on 1/29/2019

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

Sen. Hatch Introduces Hatch-Waxman Integrity Act

Jones Day on 12/26/2018

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

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

Morrison & Foerster LLP on 11/7/2018

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

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

Troutman Pepper 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

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

Esquire Deposition Solutions, LLC on 6/15/2018

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

IPR Petition for Hair Loss Treatment Patent Restored

McDermott Will & Emery on 6/11/2018

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

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

Troutman Pepper 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

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

Troutman Pepper 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

Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)

McDonnell Boehnen Hulbert & Berghoff LLP on 4/5/2017

In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more

Post-Grant Review Roils Patent Litigation Waters

Sheppard Mullin Richter & Hampton LLP on 5/27/2016

The America Invents Act (AIA) has had a profound impact on patent litigation, particularly surrounding inter partes and other post-grant proceedings. Below, Manish K. Mehta, who handles patent litigation across an array of...more

Bass Continues Fishing; Pharma Seeks Sanctuary

Troutman Pepper on 4/1/2016

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

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

WilmerHale on 3/28/2016

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

Big Pharma Seeks Exemption From Patent Law

Tucker Arensberg, P.C. on 10/5/2015

Implementation of the America Invents Act (“AIA”) has brought substantial changes to the patent law of the United States over the last several years. One of the most significant provisions of the AIA was the creation of inter...more

Post-Grant Challenges in Life Sciences: A Midyear Assessment

Troutman Pepper on 10/5/2015

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

Will New PTAB Rules Impact IPRs Filed By Kyle Bass Hedge Fund?

Foley & Lardner LLP on 8/24/2015

On August 19th, the USPTO released a new set of proposed rules related to post-grant proceedings before the Patent Trial and Appeal Board (PTAB). Among the many offered rules was the addition of a “Rule 11-type certification”...more

Representatives Seek Protections for Hatch-Waxman and BPCIA in Innovation Act

McDonnell Boehnen Hulbert & Berghoff LLP on 8/7/2015

Last month, in a letter to Congressional leadership, 79 Members of Congress expressed their support for the Innovation Act (H.R. 9) but sought inclusion of language in the bill "to preserve the integrity of the Drug Price...more

PTAB to Consider Motion for “Abuse of Process” Sanctions Against Kyle Bass Hedge Fund IPR Petition

Morrison & Foerster LLP on 6/16/2015

In a recent order, the Patent Trial and Appeals Board (PTAB) indicated that it will consider a motion for sanctions based on a claim of “abuse of process” in Inter Partes Review (IPR) proceedings filed by the Coalition for...more

Analysis of Inter Partes Review and Post-Grant Review in the Life Sciences Industry Through First Quarter 2015

Troutman Pepper on 5/13/2015

The recently established inter partes review (IPR) and post-grant review (PGR) of the America Invents Act have been in the spotlight lately, especially now that the life sciences industry has begun to utilize these...more

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

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