In a decision that likely came as no surprise to anyone, the Federal Circuit upheld the constitutionality of IPR proceedings as provided for by the America Invents Act. With an analysis of two pre-1900 Supreme Court cases...more
Last week, we analyzed the Federal Circuit's Dynamic Drinkware, LLC v. National Graphics, Inc. case from early September. In that case, the Federal Circuit held that an IPR petitioner did not adequately demonstrate that an...more
It is well accepted that in order to establish that a patent is entitled to claim priority to a previously filed provisional application, it must be shown that the claims of the patent have written description support in the...more
10/28/2015
/ Disclosure ,
Inter Partes Review (IPR) Proceeding ,
Patent Applications ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
Priority Disputes ,
Provisional Applications ,
Written Descriptions
On October 19, 2015, the Supreme Court granted certiorari in two related cases: Halo Electronics, Inc. v. Pulse Electronics, Inc. (Supreme Court docket number 14-1513) and Stryker Corp. v. Zimmer, Inc. (Supreme Court docket...more
10/20/2015
/ Abuse of Process ,
Attorney's Fees ,
Bad Faith ,
Certiorari ,
Corporate Counsel ,
Enhanced Penalties ,
Intellectual Property Protection ,
Non-Practicing Entities ,
Octane Fitness v. ICON ,
Patent Infringement ,
Patent Litigation ,
Patent Trolls ,
Patents ,
SCOTUS ,
Willful Infringement
Earlier this week, in the Achates Reference Publishing, Inc. v. Apple Inc. case, the Federal Circuit reaffirmed the holding in In re Cuozzo Speed Techs., LLC that it could not review any decision by the Patent Trial and...more
10/2/2015
/ America Invents Act ,
Apple ,
Covered Business Method Proceedings ,
Cuozzo Speed Technologies ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Real Party in Interest ,
Versata
Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more
9/14/2015
/ aBLA ,
Biologics ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
FDA Approval ,
Injunctive Relief ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Sandoz v Amgen
On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more
9/11/2015
/ Amgen ,
Amicus Briefs ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
En Banc Review ,
FDA Approval ,
First Impression ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition For Rehearing ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
On August 25, 2015, the United States Patent and Trademark Office published a "Request for Comments on a Proposed Pilot Program Exploring an Alternative Approach to Institution Decisions in Post Grant Administrative Reviews"...more
Earlier this week, we noted that parties wishing to challenge IPR Final Written Decisions from the PTAB on appeal to the Federal Circuit would face an uphill challenge. However, even if that challenge is extremely difficult,...more
8/6/2015
/ Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Inter Partes Review (IPR) Proceeding ,
Microsoft ,
Motion to Amend ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
Prior Art
One of the first IPR petitions ever filed, IPR2012-0006, was related to biotechnology -- specifically DNA sequencing. Illumina, Inc. filed that petition, and two others, IPR2012-00007 and IPR2013-00011, against patents owned...more
As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more
7/24/2015
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
As we reported earlier, the Federal Circuit recently affirmed the PTAB's Final Written Decision in the Versata Development Group v. SAP America, Inc. case -- the first appeal under the covered business method ("CBM") patent...more
7/17/2015
/ America Invents Act ,
Appeals ,
Covered Business Method Patents ,
Covered Business Method Proceedings ,
Cuozzo Speed Technologies ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review
Earlier this week, the Federal Circuit issued an order denying a petition for rehearing en banc in the In re Cuozzo Speed Technologies, LLC case. As we have previously reported, this case was the first appeal of the first...more
7/10/2015
/ America Invents Act ,
Amicus Briefs ,
Appeals ,
Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Intellectual Property Owners Association ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Petition For Rehearing ,
PHRMA ,
Post-Grant Review ,
SCOTUS ,
Teva v Sandoz ,
USPTO
The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more
Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more
4/4/2015
/ Abbreviated New Drug Application (ANDA) ,
Apotex ,
Declaratory Judgments ,
Federal Jurisdiction ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Jurisdiction ,
Medicare Modernization Act ,
Mylan Pharmaceuticals ,
Noninfringement ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Subject Matter Jurisdiction
Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a...more
12/10/2014
/ Amgen ,
Biosimilars ,
Declaratory Judgments ,
Hoffman LaRoche ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Subject Matter Jurisdiction
The Federal Circuit made it clear earlier today that district courts should freely grant stays in view of Covered Business Method ("CBM") patent reviews instituted by the Patent Trial and Appeal Board ("PTAB"). In Versata...more
Anyone that has been monitoring the outcome of district court cases recently will be aware of the perils of not including sufficient information, or not timely supplementing, preliminary infringement or invalidity contentions...more
As we have previously reported, the USPTO has been seeking feedback on the PTAB trial proceedings established by the Leahy-Smith America Invents Act. A Federal Register notice from June 27, 2014, contained a "Request for...more
The Supreme Court will begin its 2014-2015 term next Monday. Last year, the Court heard a record number of patent law cases, at least for recent history. Nevertheless, it is scheduled to hear another one on October 15. ...more
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
6/27/2014
/ America Invents Act ,
Covered Business Method Patents ,
Inter Partes Review (IPR) Proceeding ,
Non-Practicing Entities ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pending Legislation ,
Pharmaceutical Industry ,
Post-Grant Review
Earlier today, Senator Patrick Leahy (D-VT), Chairman of the Senate Committee on the Judiciary, announced that he was taking the Patent Transparency and Improvements Act of 2013 (S. 1720) off the Committee's agenda. He cited...more
In two closely watched cases, the Supreme Court yesterday issued its opinions in Octane Fitness, LLC v. ICON Health & Fitness, Inc. (Supreme Court docket number 12-1184) and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc....more
As we reported earlier today, the Supreme Court issued opinions in the Octane Fitness, LLC v. ICON Health & Fitness, Inc. (Supreme Court docket number 12-1184) and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc. (Supreme...more
Last Thursday, Sen. McCaskill, along with Sen. Rockefeller, introduced the "Transparency in Assertion of Patents Act" (S. 2049). Of course, several other bills are currently pending in the Senate that have been introduced by...more