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America Invents Act Prior Art 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 -
Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[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

[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

McDonnell Boehnen Hulbert & Berghoff LLP

Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)

Joint inventorship has been called "one of the muddiest concepts in the muddy metaphysics of patent law" because the "exact parameters of what constitutes joint inventorship are quite difficult to define." Mueller Brass Co....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 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

Foley & Lardner LLP

Personalized Cancer Therapy Found Nonobvious

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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

Goodwin

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

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Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more

McDermott Will & Emery

Merely Articulating a Goal Does Not Provide Reasonable Expectation of Success

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court non-obviousness decision, finding that a prior art reference that articulates a goal without explaining how that goal is achieved does not provide a...more

Jones Day

Confidential FDA Communications as Prior Art in Hatch-Waxman Litigation

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The Situation: In a Hatch-Waxman litigation, the claims recite oxymorphone with less than 0.001% of an impurity called 14-hydroxymorphinone. The prior art includes confidential communications from the FDA to oxymorphone...more

Troutman Pepper

Why Biotech and Pharma Patents Survive IPR

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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

White & Case LLP

Supreme Court Says America Invents Act Did Not Alter On-Sale Bar

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Squib of Holding and Key Implication: The United States Supreme Court, in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., held on January 22, 2019 that "a commercial sale to a third party who is required to keep...more

Nutter McClennen & Fish LLP

Supreme Court Ruling in Helsinn Provides Much-Needed Clarity for Inventors

On January 22, the Supreme Court clarified an important issue of patent law that had been left open since the enactment of the America Invents Act several years ago. ...more

Morrison & Foerster LLP

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

Troutman Pepper

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

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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

Jones Day

High Court to Hear Helsinn v. Teva, Resolve AIA Secret Sales Question

Jones Day on

On June 25, 2018, the United States Supreme Court agreed to review the Federal Circuit's decision in Helsinn Healthcare v. Teva Pharmaceuticals, No. 17-1229. In Helsinn, the Federal Circuit considered whether the America...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

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Clarifies the On-Sale Bar Under the AIA: No Public Disclosure of the Invention Is Required if the Existence of the...

Under 35 U.S.C. § 102, the on-sale bar generally holds that the sale of a patented invention more than one year before the filing date invalidates the patent. Before the America Invents Act (AIA), courts held that...more

Foley & Lardner LLP

Are Secret Sales Prior Art Under The AIA?

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In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit found that a publicly-announced “Supply and Purchase” agreement triggered the on-sale bar under pre-AIA 35 USC § 102(b) and under AIA 35 USC §...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Clarifies the On-Sale Bar under AIA

Last week the Federal Circuit in Helsinn Healthcare v. Teva Pharmaceuticals clarified the scope of the on-sale bar rule under the America Invents Act (AIA). The on-sale bar in general means that a sale or an offer to sale of...more

Weintraub Tobin

Federal Circuit Holds Non-Public Sales Can Still Satisfy The On-Sale Bar For Patents Under The AIA

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In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the United States Court of Appeals for the Federal Circuit recently ruled that the America Invents Act’s (“AIA”) did not change the meaning of the on-sale bar...more

Dorsey & Whitney LLP

Public Sales Remain Prior Art After AIA Even Without Disclosing Invention

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Public sales which do not themselves disclose an invention nonetheless continue to be available as prior art events after the America Invents Act (AIA). Innovators must file US patent applications within one year of any sale...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Denies Inter Partes Review Petitions Against Two Acorda Patents

One of the statistics gleaned from Director Michelle Lee's recent blog on the post-issuance review provisions of the America Invents Act is that only 42% of inter partes review petitions have been granted over the past three...more

Foley & Lardner LLP

Contract Manufacturing Makes Angiomax Patents Invalid Under On Sale Bar

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In The Medicines Company v. Hospira, Inc., the Federal Circuit held that a transaction with a contract manufacturer gave rise to an on sale bar that invalidated The Medicines Company’s Angiomax® patents. Are the facts of this...more

McDonnell Boehnen Hulbert & Berghoff LLP

PGR Report -- The Attack of 35 U.S.C. § 112

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more

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