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 -
News & Analysis as of

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

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

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

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

Docs @ BIO -- Federal District Court vs. the PTAB

Yesterday, BIO 2014 presented a session entitled "Navigating Patent Challenges Under the America Invents Act" during which the presenters analyzed the differences between patent challenges in Federal District Court and before...more

More Q&A from Webinar on Top Patent Law Stories of 2013

On Tuesday, we presented a live webinar on the "Top Patent Law Stories of 2013." The webinar covered ten of the fourteen stories that made it onto Patent Docs seventh annual list of top biotech/pharma patent stories. Posts...more

Top Three Stories of 2013

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

The Futility of Petitioning Congress (After the Fix Is In): Stakeholders Tell Judiciary Committee What's Wrong with Goodlatte Bill...

What everybody doesn't seem to know is how to get Congress to listen to the needs of the innovation community when well-heeled sectors put their lobbying and financial support in favor of legislation purportedly aimed at...more

Applied Biosystems Seeks PTA for 2007 Patent

On August 21, 2013, Life Technologies, Corp., Life Technologies, Ltd., Applied Biosystems LLC, and Molecular Probes, Inc. (collectively, “Plaintiffs”) brought suit in the U.S. District Court for the Eastern District of...more

Dey, L.P. v. Sunovion Pharmaceuticals, Inc. (Fed. Cir. 2013)

Enactment of the Leahy-Smith America Invents Act in 2011 focused the patenting community on the changes of U.S. patent law from "first to invent" under the 1952 Patent Act to "first inventor to file" under the AIA as the...more

Pro Te Solutio - Vol. 6 No. 1 February 2013

In This Issue: - Can Experts Testify as to the Ethics or State of Mind of Corporate Defendants? - Patent Reform for Biotech Companies - United States v. Caronia and its Implications for Off-Label...more

Does The Experimental Use Exception Survive The AIA?

Now that the March 16, 2013 effective date of the first-to-file provisions of the Leahy-Smith America Invents Act (AIA) is fast-approaching, I have been reviewing the commentary in the USPTO’s February 14, 2013 Federal...more

Skadden's 2013 Insights: Global Litigation

New legal ground is expected to be broken this year in areas of importance to companies and their directors, officers and executives. We see those developments coming from around the globe and defining the litigation...more

Top Stories of 2012: #12 to #15

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories. For 2012, we identified fifteen stories that were covered on Patent Docs last year that...more

Clinical Trials as Potentially Invalidating Public Uses: Current Issues and Future Questions Under the Leahy-Smith America Invents...

Originally published in BNA’s Patent, Trademark & Copyright Journal on 09/28/2012. When is a clinical trial an invalidating public use of an invention? Courts have struggled with this question — one particularly...more

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