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In inter partes proceeding Apple Inc. v. Rensselaer Polytechnic Institute et al., IPR2014-00320, Petitioner Apple sought a second request for rehearing, before an expanded panel of the PTAB, on the Board's decision not to...more
Now that we have a growing body of statistics on the Inter Partes Review proceedings created by the America Invents Act, it is interesting to see how the proceedings are being resolved. With the significant attention given to...more
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
Stewart Title Guaranty Co. v. Segin Software, LLC -
In determining whether a Covered Business Method (CBM) patent review should be instituted, the Patent Trial and Appeal Board (Board) referred to the Supreme Court’s...more
Vibrant Media, Inc. v. General Electric Co. -
Addressing the issue of whether secondary considerations for non-obviousness showing commercial success of a system allegedly infringing a patent could rebut prima facie...more
Rackspace US, Inc. v. Personal Web Techs., LLC -
Addressing the one-year time frame for completing inter partes review (IPR) in the context of a stay request, the U.S. Patent and Trademark Office’s (PTO) Patent Trial...more
On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User...more
In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge...more
July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more
In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more
Sandoz announced yesterday that the FDA accepted its Biologics License Application (BLA) for filgrastim. This marks the first acceptance of a biosimilars application (351(k)) filed under the pathway created by the Biologics...more
In late May, the FDA released a draft guidance document detailing its best practices for developing trademarks for drugs. The draft guidance, entitled Best Practices in Developing Proprietary Names for Drugs, can be found...more
For patents granted on applications filed on or after June 8, 1995, the enforceable patent term begins on the day the patent issues and generally expires 20 years from the earliest effective filing date of the application. ...more
A New York State Division of Tax Appeals administrative law judge (ALJ) recently ruled in favor of a medical device and technology company on the question of whether patent license fees that the company charged to its...more
Braintree Laboratories, Inc. v. Breckenridge Pharmaceuticals, Inc.
Case Number: 1:12-cv-06851-AJN (Dkt. 69) -
Judge Nathan approved the parties’ proposal to maintain the case on administrative hold pending...more
In nearly identical decisions released on May 27, 2014, Sandoz Canada Inc v Canada, 2014 FC 501 (Sandoz) and ratiopharm Inc v Canada, 2014 FC 502 (ratiopharm), the Federal Court of Canada held that some licensees of patents...more
A federal court has endorsed the Federal Trade Commission’s authority to adopt regulations under the Hart-Scott-Rodino (HSR) Act that target specific industries. In Pharmaceutical Research and Manufacturers of America v....more
The U.S. Commerce Department recently announced its plan to transition oversight of the non-profit Internet Corporation for Assigned Names and Numbers (ICANN), which manages Internet domain names and addresses, to a...more
New market exclusivity opportunities emerge for pharmaceutical companies.
In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more
March 16, 2014, marks the eighteen-month anniversary of the inter partes review ("IPR") system of challenging issued patents at the Patent Office. We thought that this would be an appropriate time to look back at the last...more
As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal...more
In a long-awaited decision, the Federal Circuit ruled en banc to uphold the the de novo standard for appellate review of claim construction issues, which was previously established in another en banc decision, Cybor Corp. v....more
While Patent Owners have finally succeeded in having claims survive an inter partes review proceeding, no Patent Owner has yet to find the magic formula that successfully navigates a motion to amend. In a Final Written...more
Presented with a challenge to patent term adjustments as determined by the Patent and Trademark Office (PTO) under 35 U.S.C. § 154(b), the U.S. Court of Appeals for the Federal Circuit held that post-allowance delays are ...more
Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more
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