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HTMLSupreme Court Of Canada Denies Leave To Appeal From Decision Clarifying Available Disgorgement Remedies In Competition And Consumer Protection Claims
Michelle T. Maniago, Alessandra V. Nosko; Borden Ladner Gervais LLP;
Legal Alert/Article
September 18, 2014, previously published on September 8, 2014
On Thursday, September 4, 2014, the Supreme Court of Canada dismissed the plaintiffs’ motion for leave to appeal in Wakelam v. Wyeth Consumer Healthcare/Wyeth Soin de Sante Inc. The leave application arose from a 2014 British Columbia Court of Appeal decision that clarified whether plaintiffs...

 

HTMLConsidering Sex-Specific Variation for Personalized Medicine
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
September 4, 2014, previously published on September 2, 2014
Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a particular cancer therapy. In some instances, the prediction of clinical...

 

HTMLBundled Discounts Subject to Section 1/Clayton 3 Scrutiny In the Absence of Market Power and Substantial Foreclosure?
Bruce A. Colbath; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 28, 2014, previously published on August 25, 2014
Bundled discount programs have received significant antitrust scrutiny over the past decade, even though these marketing programs may benefit both consumers and competition. Typically, bundled discounts have been evaluated as either exclusive dealing or tying arrangements under Section 1 of the...

 

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The Food and Drug Administration (FDA) provided notice to Congress on July 31, 2014 of its intent to issue draft guidance regarding regulatory oversight of laboratory developed tests (LDTs), including reporting and premarket submission requirements.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...

 

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").

 

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...

 

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...

 

HTMLFDA Continues to Bolster Regulation of Compounding Pharmacies
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
Legal Alert/Article
July 22, 2014, previously published on July 2014
Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight of compounding pharmacies. DSQA amended section 503A of the Food, Drug, and Cosmetic Act ("FDCA") to clarify the scope of...

 


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