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America Invents Act › Hatch-Waxman

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: Biologics at the PTAB: Statistics and Insights into Notable Biologics Decisions

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

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

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

Haug Partners LLP

NHK-Fintiv Frustration: Status of the Current Challenges and the Uncertain Fate of the PTAB’s Discretionary Denial of IPRs

Haug Partners LLP on

Several challenges have been made recently to the Patent Trial and Appeal Board’s (“PTAB’s or Board’s”) controversial practice of denying inter partes review (IPR) petitions based on the status of parallel infringement...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

Jones Day

Confidential FDA Communications as Prior Art in Hatch-Waxman Litigation

Jones Day on

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

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

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

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

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

Foley & Lardner LLP

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

Foley & Lardner LLP on

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

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

McDermott Will & Emery

On-Sale Bar Under the America Invents Act

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit interpreted the scope of the on-sale bar provision, 35 USC § 102(a)(1), under the America Invents Act (AIA) and held that claims are invalid where there is public disclosure of...more

WilmerHale

Federal Circuit Patent Updates - May 2017

WilmerHale on

Chen, J. The estoppel provision of pre-AIA section 317(b) did not serve as a bar to maintain an inter partes reexamination where district court invalidity claims had been dismissed without prejudice. On the merits, affirming...more

Polsinelli

Federal Circuit Clarifies AIA On-Sale Bar Provision Applies Where Existence of Sale Is Public

Polsinelli on

Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787...more

McDermott Will & Emery

En Banc Court Ties On-Sale Bar to Commercial Sale in Accordance with Uniform Commercial Code

McDermott Will & Emery on

In a unanimous en banc decision, the US Court of Appeals for the Federal Circuit established the circumstances under which a product manufactured according to product-by-process claims is invalid under the “on-sale bar” of 35...more

WilmerHale

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

WilmerHale on

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

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

Troutman Pepper on

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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

McGuireWoods LLP

IPR Broader Review Standard Upheld by Narrow Federal Circuit Majority

McGuireWoods LLP on

On July 8, 2015, the full Federal Circuit decided not to reconsider en banc (before all the judges) the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) standard to construe patents broadly for inter...more

McDonnell Boehnen Hulbert & Berghoff LLP

The Iron Law of Unintended Consequences - (with apologies to Robert Michels)

McDonnell Boehnen Hulbert & Berghoff LLP on

It is a certainty that no matter what action is taken (by an individual, a group, or especially a legislative body) that there will be unintended consequences. It is also true that those unintended consequences, like the...more

King & Spalding

Intellectual Property Newsletter - December 2012

King & Spalding on

In This Issue: ..News From the Bench: - Clarification of the “Vitiation Test” when applying the Doctrine of Equivalents. - The “Success More Likely Than Not” and “Ordinary Observer” Standards for a...more

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

America Invents Act: Limitation on Joinder

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

On September 16, 2011, the America Invents Act (AIA) ushered in major changes to the U.S. patent system, including changes affecting assertion of patent infringement against multiple, unrelated accused infringers. Effective...more

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

Advantages Of Inter Partes Review In Hatch-Waxman Cases

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

Originally published in Law360, New York on November 15, 2012. Signed into law by President Obama on Sept. 16, 2011, the America Invents Act represents the most sweeping changes to U.S. patent law in over 60 years....more

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