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Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications

This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more

Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

Amgen, Inc. (“Amgen”) has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA-2014-P-1771) on October 29, 2014 (“Petition”) requesting...more

PTAB: Claims for Method of Authenticating a Website are Patentable under Alice and Section 101

In a CBM petition filed by petitioners PNC Bank, U.S. Bank, and Bancorp, the petitioners sought review of U.S. Patent No. 7,631,191, which claims a method of authenticating a web page. The petition challenged the validity of...more

Beyond Borders: The Power to Block the International Flow of Digital Files

With the advance of digital technology, courts are being forced to deal with the legal ramifications beyond the borders of the United States. In a previous post, we discussed the potential impact of the decision in Motorola...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more

Patent Office Extends AFCP 2.0 and QPIDS Pilot Programs to September 2015

The United States Patent and Trademark Office (USPTO) just announced it has extended the After Final Consideration Pilot program (AFCP 2.0) and the Quick Path Information Disclosure Statement program (QPIDS), which are now...more

IP Newsflash - October 2014 #2

Patents to a “Specific Technological Process” Fall on the Pleadings as Abstract Ideas - On September 22, 2014, Judge George H. Wu (C.D. Cal.) ruled on the pleadings that two Planet Blue patents relating to “the idea of...more

Broad Language In Specification Can Provide Written Description Support

ScriptPro, LLC v. Innovation Associates, Inc. - In reviving a patent owner’s patent infringement lawsuit, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s summary judgment that a patent was...more

Sham-Wow! Antitrust Liability May Attach to Sham Administrative Petitions

Addressing whether the “sham” exception to Noerr-Pennington immunity is limited to sham litigation in courts, the U.S. Court of Appeals for the Federal Circuit vacated a lower court’s summary judgment of no antitrust...more

PTAB to Apple: No Third or Fourth Bite at the Apple

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

Inter Partes Review – Parties Favor Settlement Over Board Decisions

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

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

First Application of Alice Corp. Decision to Covered Business Method Patent Review

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

Patentee Owner Must Show a Nexus Between Alleged Commercial Success and the Claimed Technology

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

The Importance of the One-Year AIA Timeline

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

FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

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

Federal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability

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

FDA Accepts First Biosimilar Application under New Approval Pathway

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

Finally, A Biosimilar Application Has Been Accepted By The FDA

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

FDA Accepts the First Biosimilar Application under the BPCIA

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

FDA Draft Guidance - Best Practices for Developing Drug Trademarks

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

What is Patent Term Adjustment and Why Does It Matter?

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

Division of Tax Appeals Rules Patent License Fees Not Subject to Sales Tax in New York

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

Purgation Case Still Held Up

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

Court Endorses FTC Authority To Require Special Reporting for Pharmaceutical Licenses

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

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