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HTMLFDA Gives Guidance on Compounding for Human Use
Duane Morris LLP;
Legal Alert/Article
July 23, 2014, previously published on July 14, 2014
In July 2014, the U.S. Food and Drug Administration (FDA) released five documents containing policies and proposals that affect both traditional compounding pharmacies and outsourcing facilities that compound drugs for human use.

 

HTMLFDA Contemplates Further Revisions to "Off-Label" Drug Marketing Rules and Guidance
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
According to recent reports, FDA is reevaluating longstanding policies regarding the marketing of pharmaceutical products for "off-label" uses, such as when a manufacturer promotes an otherwise approved product for an indication, age group, or dosage that has not been approved. As...

 

HTMLPayers, Pension Plans, Pharmacies Ask FDA Not to Give Unique Names to Biosimilars
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
Earlier this month, a group of 32 companies and organizations, including health insurers, pharmacies, labor unions, and pension plans, urged FDA not to require distinct names for biosimilar products, explaining that such a policy would undermine the potential cost savings generated by such generic...

 

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...

 

HTMLFTC Rule Targeting Pharma Licenses Is Upheld by Federal Judge
Jordana Goodman; Sunstein Kann Murphy Timbers LLP;
Legal Alert/Article
July 21, 2014, previously published on June 2014
Last November, the Federal Trade Commission (“FTC”) announced a rule requiring advance notice of proposed exclusive patent license agreements in the pharmaceutical industry that exceed $75.9 million in value. Upon receipt of such a notice, the FTC or the Justice Department may then...

 

HTMLThe Federal Court finds two Generic Company’s Allegations to be Unjustified
Adrian J. Howard, Beverley Moore, Chantal Saunders, Ryan Steeves; Borden Ladner Gervais LLP;
Legal Alert/Article
July 21, 2014, previously published on July 10, 2014
Two PM (NOC) decisions relating to the same patent were recently released by the Federal Court. In both cases, the applications were allowed, prohibiting the Minister from issuing an NOC to both Cobalt and Apotex for their generic versions of Allergan’s drug. The Court’s reasons are...

 

HTMLWhy Are Method of Treatment Claims and Method of Manufacture Claims Subject to Scrutiny Under the USPTO Patent Subject Matter Eligibility Guidance?
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
July 18, 2014, previously published on July 15, 2014
The USPTO has asked for written comments on its patent subject matter eligibility guidance by July 31, 2014. In this article, I discuss why therapeutic method claims and method of manufacture claims should not be subject to scrutiny under the USPTO’s multi-factored § 101 analysis.

 

Adobe PDFThe Use of Botulinum Toxin Products in Cosmetic Applications - What’s the Litigation Risk?
Donna Marie Baloy; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
July 17, 2014, previously published on June 2014
Botulinum toxin products such as Botox® and Dysport® are used cosmetically for temporary improvement in the appearance of glabellar lines (“frown lines”) and lateral canthal lines (“crow’s feet”) in adults. Essentially, these products employ a neurotoxin,...

 

HTMLCanada Patent Litigation: Federal Court Rules “Enhanced Disclosure” Requirement for Sound Prediction Applies Only To “New Use” Patents
Sanjaya Mendis, David Tait; McCarthy Tétrault LLP;
Legal Alert/Article
July 17, 2014, previously published on July 11, 2014
On July 2, 2014, Mr. Justice Rennie of the Federal Court released his judgment and reasons in Astrazeneca Canada Inc v. Apotex Inc., 2014 FC 638 dismissing AstraZeneca’s action for infringement and granting Apotex’s counterclaim for a declaration that Canadian Patent 2,139,653 (the...

 

HTMLFederal Circuit Looks for a Different Kind of Unexpected Results in BMS v. Teva
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
July 9, 2014, previously published on July 2, 2014
In Bristol-Myers Squibb Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed the district court’s finding that BMS’s Baraclude® patent is invalid as obvious. In so doing, the court gave little weight to unexpected results characterized as reflecting a difference in...

 


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