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HTMLJ&J Withdraws Morcellators From Market Due to Cancer Risk
Annika K. Martin; Lieff, Cabraser, Heimann & Bernstein, LLP;
Legal Alert/Article
August 11, 2014, previously published on August 1, 2014
Johnson & Johnson ("J&J") is asking doctors to return its laparoscopic power morcellators, controversial surgical devices that may inadvertently spread cancer in women being treated for uterine growths called fibroids. The company's Ethicon unit in April suspended sales and...

 

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...

 

HTMLComments on Patent Subject Matter Eligibility Guidance Due by July 31
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
August 2, 2014, previously published on July 28, 2014
This week brings the July 31, 2014 deadline for submitting written comments on two USPTO patent subject matter eligibility guidance documents: The “Myriad-Mayo” Guidance issued March 4, 2014 (for claims involving laws of nature, natural phenomena, and natural products) and the...

 

HTMLHow Long Is Too Long (or Too Short) for Patent Application Pendency?
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
July 25, 2014, previously published on July 18, 2014
The USPTO is requesting input on the “optimal” targets for its patent application pendency metrics. The USPTO’s current targets are 10 months to a first Office Action and 20 months to grant or abandonment. The USPTO wants to know if you think these targets too long, too short, or...

 

HTMLWatson Island LNG and the City of Prince Rupert, B.C. Sign Exclusivity Agreement for Export Terminal
Sutherland Asbill Brennan LLP;
Legal Alert/Article
July 24, 2014, previously published on July 17, 2014
On Wednesday, Watson Island LNG Corp. (WILNG) and the City of Prince Rupert, British Columbia, announced that they have entered into an exclusivity agreement for an LNG export terminal. Under the agreement, WILNG will re-purpose Watson Island, B.C. into a small LNG export terminal. Mayor Jack...

 

HTMLEntrepreneurial Growth and Recruitment Strategy: An Economic Development Formula for Success
Ernest C. Pearson; Nexsen Pruet, LLC;
Legal Alert/Article
July 23, 2014, previously published on July 21, 2014
Historically, most local economic development efforts, or regional efforts among a group of counties, have focused on business recruitment. These efforts have generally been focused on large business recruitment projects. This has often been referred to as the “buffalo hunt.” In...

 

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...

 

HTMLFederal Circuit Holds That Even Functional Claims Require Structural Fence Posts
Courtenay C. Brinckerhoff, Jacob D. Moore; Foley & Lardner LLP;
Legal Alert/Article
July 17, 2014, previously published on July 11, 2014
In AbbVie Deutschland Gmbh v. Janssen Biotech, Inc., the Federal Circuit affirmed the district court decision that found AbbVie’s patents directed to anti-IL-12 antibodies invalid for lack of adequate written description. As between the parties, this decision leaves Centocor free to market...

 

HTMLInsurers Singing the Blues After District Court Denies Motion to Dismiss in Lawsuit Accusing Blue Cross/Blue Shield of Conspiring to Limit Competition
Robert B. Craig; Taft Stettinius & Hollister LLP;
Legal Alert/Article
July 8, 2014, previously published on June 27, 2014
The multidistrict class action litigation challenging an alleged horizontal market allocation by Blue Cross/Blue Shield Association and nearly 40 Blue Cross/Blue Shield Plans around the country will proceed to discovery after a federal judge in Alabama recently denied the defendants’ motion...

 


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