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Documents on Intellectual Property, Pharmaceuticals
 

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Adobe PDFChallenging and Defending Obviousness at the PTAB
Brittany M. Martinez, Bradley J. Van Pelt; Banner & Witcoff, Ltd.;
Legal Alert/Article
June 2, 2015, previously published on Spring/Summer 2015
In the first two-and-a-half years of inter partes review (IPR) precedent, IPRs have proven to be an effective means of challenging the validity of a patent. More than 73 percent of claims originally challenged in IPR petitions have been either cancelled by the patent owner or found unpatentable by...

 

Adobe PDFThe Supreme Court's Impact on IP Rights in 2015
Jordan N. Bodner, Camille Sauer; Banner & Witcoff, Ltd.;
Legal Alert/Article
June 2, 2015, previously published on Spring/Summer 2015
The U.S. Supreme Court has generated quite a few closely-watched intellectual property decisions in 2014, analyzed in Banner & Witcoff’s Spring and Fall 2014 Newsletters. The trend has continued during the start of the 2014-15 term, with decisions on the appropriate standard for reviewing...

 

Adobe PDFStrategies in Inter Partes Review Proceedings for Biotech/Pharma Patents
Robert H. Resis; Banner & Witcoff, Ltd.;
Legal Alert/Article
June 2, 2015, previously published on Spring/Summer 2015
In October 2013, about one year after inter partes review (IPR) proceedings became available, the chief judge of the Federal Circuit called the Patent Trial and Appeal Board (PTAB) a “death squad.” Certainly, a high percentage of early IPR petitioners enjoyed success getting the PTAB to...

 

HTMLCourt of Appeal Raises Issues of Construction and Medical Treatment That Should Be Considered by a Higher Court in Future Cases
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
June 1, 2015, previously published on May 20, 2015
Both Bayer and Cobalt appealed from the Court’s judgment. Both appeals were addressed by the Court of Appeal in this decision.

 

HTMLOntario Court of Appeal Conclusively Dismisses Generic’s Unjust Enrichment Arguments in Section 8 Case
Adrian J. Howard, Beverley Moore, Chantal Saunders; Borden Ladner Gervais LLP;
Legal Alert/Article
June 1, 2015, previously published on May 20, 2015
Apotex has brought a case against Lilly pursuant to s. 8 of the Patented Medicines (Notice ofCompliance) Regulations (the NOC Regulations). As part of the case, Apotex seeks damages pursuant to s. 8, under the Statute of Monopolies (U.K.), the Ontario Statute of Monopolies, and the Trade-Marks Act,...

 

Adobe PDFPOSITA Motivated to Pursue Clinical Development of Therapy Disclosed in Prior Art Despite Potential Safety and Efficacy Hurdles
Robert H. Resis; Banner & Witcoff, Ltd.;
Legal Alert/Article
May 25, 2015, previously published on March 6, 2015
The PTAB recently held that the challenged claims in two patents assigned to Genzyme and one patent assigned to Duke University on methods for treating Pompe disease are invalid.

 

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...

 


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