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Documents on Intellectual Property, Pharmaceuticals
 

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HTMLClaim Construction, Findings of Fact, and Indefiniteness in the Wake of Teva v. Sandoz
Gregory A. Castanias, Calvin P. Griffith, Tharan Gregory Lanier, Matthew J. Silveira, Jennifer L. Swize; Jones Day;
Legal Alert/Article
May 14, 2015, previously published on April 2015
In its January 2015 decision in Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., the United States Supreme Court held, contrary to the Federal Circuit's longstanding practice, that a district court's claim constructions are to be reviewed on appeal under the two-part test set forth in Federal Rule...

 

HTMLFDA Rejects Otsuka’s Assertions of Orphan Drug Exclusivity for Abilify®, Allowing Generics to Proceed
Scott S. Liebman, Mark E. Waddell; Loeb & Loeb LLP;
Legal Alert/Article
May 7, 2015, previously published on May 1, 2015
The FDA last week granted several pharmaceutical companies approval to market generic versions of the bestselling antipsychotic drug Abilify® (aripiprazole), despite the assertions of the drug’s patent-holder, the Japanese pharmaceutical company Otsuka, that the company remained entitled...

 

HTMLCourt Refused to Grant Protective Order Covering NOA
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
March 6, 2015, previously published on January 21, 2015
In the context of a proceeding brought pursuant to the NOC Regulations, Mylan sought a confidentiality that would allow it to designate portions of its Notice of Allegation (NOA) as confidential and shield it from public disclosure.

 

HTMLMinister’s Decision to Grant NOA to Generic Company Set Aside, as the Generic did not Comply with the NOC Regulations
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
March 6, 2015, previously published on January 21, 2015
In this proceeding, Pfizer sought to judicially review the Minister of Health’s decision to grant Teva a NOC for exemestane. A company called GMP filed an ANDS for exemestane. However, it sent a NOA to Pfizer for atorvastatin. Health Canada issued a NOC to GMP for exemestane. Teva then filed...

 

HTMLPTAB Denies Request to Use Covered Business Method Review for Orange Book-Listed Patents
Jennifer L. Blackburn Ph. D., Leslie T. Grab Ph. D., Tina W. McKeon; Kilpatrick Townsend Stockton LLP;
Legal Alert/Article
February 6, 2015, previously published on January 16, 2015
The Patent Trial and Appeals Board (PTAB) denied the request to review four Orange Book-listed patents owned by Jazz Pharmaceuticals, Inc. under the covered business method (CBM) review procedure. The CBM petitions filed by Amneal Pharmaceuticals, Par Pharmaceutical, and Roxane Laboratories...

 

HTMLNew Patent Eligibility Guidance: USPTO Tones Down the Rhetoric
Jana Nelson, William L. Warren; Sutherland Asbill & Brennan LLP;
Legal Alert/Article
February 6, 2015, previously published on December 18, 2014
On December 15, 2014, the U.S. Patent and Trademark Office issued its long-awaited Interim Guidance on Patent Subject Matter Eligibility (published in the Federal Register on December 16, link here: [(79 Fed. Reg. 74618)]). The Guidance supersedes the guidelines for determining patent eligibility...

 

HTMLALJ Bullock Denies Motion to Compel in Certain Hemostatic Products (337-TA-913)
Katherine Cappaert, Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
November 27, 2014, previously published on November 17, 2014
On October 27, 2014, Chief ALJ Charles E. Bullock issued the public version of Order No. 20 (dated October 7, 2014) in Certain Hemostatic Products and Components Thereof (Inv. No. 337-TA-913).

 

HTMLALJ Bullock Grants Joint Motion To Terminate Investigation In Certain Antivenom Compositions (337-TA-903)
Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
November 27, 2014, previously published on November 20, 2014
On November 13, 2014, Chief ALJ Charles E. Bullock issued Order No. 62 in Certain Antivenom Compositions and Products Containing the Same (Inv. No. 337-TA-903).

 

Adobe PDFThe Battle of Pharmaceutical Patents in Brazil
Igor Simões; Simões Intellectual Property - Brazil;
Legal Alert/Article
November 27, 2014, previously published by Valor Economico Newspaper on December 15, 2004
This article is one of the most cited in the field of industrial property in Brazil until the present day, with over 25 citations in master’s theses, doctoral and legal and scientific articles. It has replicated in over 50 web pages. On August 19, 2014 reached 2360 hits on the search for the...

 

Adobe PDFOpportunities for the Launch of Generic and Similar Drugs in Brazil
Deborah Portilho, Igor Simões; Simoes Intellectual Property - Brazil;
Legal Alert/Article
November 27, 2014, previously published by UPpharma
Every pharmaceutical company must bear in mind the fact that the launch of new products invariably requires a careful research concerning the industrial property rights of third parties, particularly those relating to trademarks and patents. It turns out that some national companies only began to...

 


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