News & Analysis as of

America Invents Act Pharmaceutical Industry

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 -

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

by Pepper Hamilton LLP 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

Fed. Cir. in Helsinn v. Teva Declines Limiting the Requirements of the “On Sale” Bar

In Pfaff v. Wells Electronics, 525 US 55 (1988), the Supreme Court attempted to focus the factors invoking the on-sale bar of s.102, by holding that the claimed invention must both be the subject of a “commercial sale”...more

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

by Dickinson Wright on

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

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

by 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

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

Chemistry & Nanotechnology Developments to Watch in 2017

As cases and outcomes make their way into the news this year, we will be watching the following developments closely and sharing them with the IP community....more

Where do we go from here? The evolving landscape of molecular diagnostics

by DLA Piper on

"Innovate or die." The adage has been in use for decades, but it holds true today. The world of molecular diagnostics is a rapidly evolving and competitive field. With the advancement in sequencing technologies and the scale...more

Year in Review: The Top-Five Legal Developments of 2016

by Goodwin on

Here are our picks for the top-five most significant legal developments in the world of biosimilars in 2016: ..Congress passed and President Obama signed the 21st Century Cures Act. Among other things, the Act modifies...more

Case shows ever-changing nature of patent law

by Thompson Coburn LLP on

The America Invents Act (AIA), passed almost five years ago, continues to substantially change patent law in the United States — and questions about the law’s effects are still being litigated. One important question...more

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

by 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

Post-Grant Review Roils Patent Litigation Waters

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

by Pepper Hamilton LLP 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

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

by 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

Big Pharma Seeks Exemption From Patent Law

by Tucker Arensberg, P.C. on

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

by Pepper Hamilton LLP 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

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

by Foley & Lardner LLP on

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

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

by Morrison & Foerster LLP on

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

Life Sciences Litigation Update - May 2015

Trends in Post-grant Review of Orange Book Patents. The America Invents Act’s post-grant challenges (“AIA proceedings”) continue to grow as an option for companies challenging a patent’s validity. In the first full fiscal...more

Group of National and State Organizations Asks Congress to Enact Legislative Reforms to Maintain Strong Patent System

Last month, more than 90 national and state advocacy organizations sent a letter to the leadership of the House and Senate Judiciary Committees, urging Congress to enact legislative reforms that will maintain a strong and...more

Biogen MA, Inc. v. Japanese Foundation for Cancer Research (Fed. Cir. 2015)

The Federal Circuit affirmed a decision by the U.S. District Court for the District of Massachusetts that it lacked subject matter jurisdiction under 35 U.S.C. § 146 pursuant to changes in the statute provided by the...more

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

by Pepper Hamilton LLP on

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

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

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

Patent Trial and Appeal Board Issues First IPR Decisions on Orange Book-Listed Patents

by Katten Muchin Rosenman LLP on

On December 9, 2014, the Patent Trial and Appeal Board (PTAB) issued final decisions in three inter partes review (IPR) proceedings filed by Amneal Pharmaceuticals challenging three patents listed in the Orange Book for...more

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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