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HTMLFDA to focus on Laboratory Developed Tests
McDonald Hopkins LLC;
Legal Alert/Article
August 19, 2014, previously published on August 13, 2014
The Food and Drug Administration (FDA) provided notice to Congress on July 31, 2014 of its intent to issue draft guidance regarding regulatory oversight of laboratory developed tests (LDTs), including reporting and premarket submission requirements. The FDA treats LDTs as a subset of in vitro...

 

HTMLSham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators?
Robert L. Magielnicki; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 19, 2014, previously published on August 12, 2014
Under what is commonly known as “Noerr-Pennington immunity,” persons exercising their First Amendment right to petition the government for redress are generally immune from antitrust liability, even though their actions may harm competition or competitors. The Supreme Court has...

 

HTMLFDA Declines to Issue Rulemaking for Section 505(b)(2) NDA Therapeutic Equivalence Ratings
Duane Morris LLP;
Legal Alert/Article
August 18, 2014, previously published on August 11, 2014
On July 23, 2014, the Food and Drug Administration (FDA) issued its response to two citizen petitions submitted by AbbVie Inc. (AbbVie) and Auxilium Pharmaceuticals, Inc. (Auxilium) requesting that FDA initiate notice-and-comment rulemaking under the Administrative Procedure Act (APA) to establish...

 

HTMLThe Second Circuit Limits the Obligation of A Monopolist to Deal with Competitors
John J. Elliott, Irving Scher; Greenberg Traurig, LLP;
Legal Alert/Article
August 18, 2014, previously published on August 14, 2014
When does breaching a contract also violate the antitrust laws? On June 9, 2014, a unanimous panel of the Second Circuit affirmed a district court ruling that an alleged monopolist patent-holding drug manufacturer’s alleged breach of an agreement to supply the patented drug to competing...

 

HTMLNo Bones About It: Tenth Circuit Permits Narrowest Market Definition and Raises the Bar for an Entry Defense When Reinstating Monopolization Suit
Robert G. Kidwell, Dionne C. Lomax, Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
August 15, 2014, previously published on August 11, 2014
On August 5, 2014, the Tenth Circuit Court of Appeals reinstated claims of monopolization and attempted monopolization under Section 2 of the Sherman Act brought by a manufacturer of surgical bone mills against a competitor. In reversing the district court's grant of summary judgment for the...

 

Adobe PDFMost Favored Nation Clauses: Do they Limit Free Competition or are they Pro Competitive?
Claudio Lizana, Lorena Pavic; Carey;
Legal Alert/Article
August 15, 2014
Recently, the U.S. Department of Justice ("DOJ") began reviewing a number of contracts which it calls "contracts that reference rivals". One type of such contracts is those containing Most Favored Nation Clauses ("MFN Clauses").

 

HTMLFederal Circuit Finds That FDA Citizen Petition Could Give Rise to Antitrust Liability
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
August 11, 2014, previously published on August 7, 2014
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 Newman wrote a dissenting opinion warning against the chilling effect...

 

HTMLLegislators and Groups Urge FDA to Require Sex-Specific Data, Labeling in New Action Plan
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
Members of Congress and interest groups are pressuring FDA to promote sex-specific clinical research and product labeling, as the Agency develops an action plan to address deficiencies in the way industry collects, analyzes, and communicates demographic data.

 

HTMLFDA Accepts First Application for Biosimilar Product
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
August 5, 2014, previously published on July 2014
In a significant step for generic biologic products, FDA accepted for review the first application for a biosimilar product. If approved, it could be the first biosimilar product to enter the U.S. market under the nearly five-year-old Biologics Price Competition and Innovation Act...

 

HTMLFDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
August 5, 2014, previously published on August 4, 2014
Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that certain tests used by health care professionals that diagnose and treat...

 


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