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
7/14/2015
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Disclosure ,
Generic Drugs ,
Manufacturers ,
On-Sale Bar ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Transfer of Title
In Daiichi Sankyo Co. v. Lee, the Federal Circuit upheld the USPTO’s post-Wyeth Patent Term Adjustment (PTA) procedures, and found that the USPTO did not abuse its discretion when it limited the Interim Procedures to...more
In Mohsenzadeh v. Lee, the Federal Circuit affirmed the district court’s decision that the USPTO’s delay in issuing a Restriction Requirement in a parent application does not earn Patent Term Adjustment (PTA) for the ensuing...more
In 2008, the Federal Circuit determined that claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 were invalid for obviousness-type double patenting (OTDP) over a related parent patent, in part because the ‘068 patent was filed...more
6/27/2015
/ Divisional Applications ,
Double Patent ,
OTDP ,
Patent Applications ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reissue Patents ,
Safe Harbors ,
USPTO
The Federal Circuit decision in Microsoft Corp. v. Proxyconn, Inc., addressed several important issues relating to post-grant patent trials conducted by the USPTO Patent Trial and Appeal Board (PTAB), including the PTAB’s...more
6/24/2015
/ Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Inter Partes Review (IPR) Proceeding ,
Microsoft ,
Motion to Amend ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Post-Grant Review ,
Remand ,
USPTO
In a June 15, 2015 Federal Register Notice, the USPTO announced the Expedited Patent Appeal Pilot program, which will run until 2,000 ex parte patent appeals are expedited under the program, or until June 20, 2016, whichever...more
On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court's finding that Sequenom’s claims are invalid under 35 USC § 101. The court's...more
6/15/2015
/ Diagnostic Method ,
Inventions ,
Mayo v. Prometheus ,
Myriad ,
Patent Applications ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Preemption ,
Preliminary Injunctions ,
Sequenom ,
Summary Judgment
The tenuous nature of an exclusive licensee’s standing to enforce a patent was something I learned early in my legal career, when I was a judicial clerk at the Federal Circuit. In Alps South LLC v. Ohio Willow Wood Co., the...more
On June 3, 2015, the Federal Circuit heard oral arguments in Amgen v. Sandoz regarding the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). As reflected in Judge Lourie’s...more
While Sequenom’s appeal of the district court’s summary judgment of invalidity of U.S. Patent 6,258,540 under 35 USC § 101 has been pending at the Federal Circuit, the USPTO has been considering the validity of the patent...more
In ArcelorMittal France v. AK Steel Corp., the Federal Circuit found that the addition of a dependent claim to a reissue application improperly broadened the scope of the original independent claims beyond the two-year period...more
On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more
The Federal Circuit issued its remand decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., this time affirming the district court decision that Limelight was not liable for infringing Akamai’s patents because...more
In Sukumar v. Nautilus, Inc., the Federal Circuit took its first look at the standing requirements to bring a false marking case under the American Invents Act (AIA). The court rejected Nautilus’ arguments that only “market...more
The Federal Circuit is set to hear oral arguments in Amgen v. Sandoz on June 3, but in the meantime has granted Amgen’s motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market until...more
In the few weeks since I first wrote about Kyle Bass and the Coalition for Affordable Drugs he formed to challenge Orange Book-listed patents that he believes “have little value other than to drive up prescription drug...more
Representatives Sensenbrenner (R-WI) and Conyers (D-MI) have introduced the “Grace Period Restoration Act of 2015? (H.R. 1791) to “correct the drafting problem in the Leahy-Smith American Invents Act relating to the grace...more
In its decision on remand from the Supreme Court, the Federal Circuit once again held the Biosig patent claims not indefinite, reversing the district court decision to the contrary. The decision came in Biosig Instruments,...more
The comment period for the USPTO’s proposed patent quality initiatives is open until May 6, 2015, and the Office of Inspector General for the Commerce Department has given stakeholders plenty to think about in its final...more
Neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject...more
In Apotex Inc. v. Daiichi Sankyo, Inc., the Federal Circuit held that Apotex has standing to seek a declaratory judgment that it does not infringe Daiichi Sankyo’s patent, even though Daiichi Sankyo has disclaimed the patent...more
As I write this there’s a voice in my head saying, “Be careful what you wish for!” but it has been five months since Sequenom was argued at the Federal Circuit, and the court has yet to issue its decision. In the meantime,...more
In Exela Pharma Sciences, LLC v. Lee, the Federal Circuit held that the USPTO’s decision to revive a patent application “is not subject to third party collateral challenge” under the Administrative Procedures Act (APA). In so...more
We know from Novartis v. Lee that a patent application does not earn “B delay” type Patent Term Adjustment (PTA) from the time an RCE is filed until a Notice of Allowance is issued, but an application still can earn PTA for...more
Judge Seeborg of the U.S. District Court for the Northern District of California issued an order in Amgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and...more