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HTMLUSPTO Issues Guidance for Examining Process Patents
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
March 11, 2014, previously published on March 7, 2014
On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products“ Guidance, advising examiners and the public of...

 

HTMLUSPTO Issues New Guidelines on Subject Matter Eligibility Under 35 USC 101 in View of Myriad and Prometheus
Benjamin A. Berkowitz, Courtenay C. Brinckerhoff, Jeanne M. Gills, Antoinette F. Konski, Stephen B. Maebius; Foley & Lardner LLP;
Legal Alert/Article
March 10, 2014, previously published on March 5, 2014
The USPTO issued new guidelines for determining if claims are eligible for patenting in light of the Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. -132...

 

Adobe PDFDoes Myriad Alter the Patentability of Natural Products?
Leslie Kushner, Robert S. Schwartz; Fitzpatrick, Cella, Harper & Scinto;
Legal Alert/Article
March 10, 2014, previously published on March 2014
Whether the US Supreme Court’s June 13 2013 ruling in Association for Molecular Pathology v Myriad Genetics, Inc, 133 S Ct 2107 (2013) — that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated” — is...

 

HTMLUSPTO to Apply Myriad Beyond Isolated DNA
Antoinette F. Konski; Foley & Lardner LLP;
Legal Alert/Article
March 10, 2014, previously published on March 5, 2014
Today, the United States Patent and Trademark Office (“USPTO”) issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35 U.S.C. §101, as applied to patent-eligibility. See...

 

HTMLUSPTO Issues New Patent Subject Matter Eligibility Guidelines
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
March 10, 2014, previously published on March 5, 2014
The USPTO has issued new patent subject matter eligibility guidelines to aid examiners in applying the principles of Myriad and Prometheus to any claim “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products.” The guidelines include a general...

 

HTMLBaxter Files New 337 Complaint Regarding Certain Hemostatic Products
Alexander B. Englehart, Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
March 7, 2014, previously published on March 5, 2014
On February 28, 2014, Baxter International Inc. of Deerfield, Illinois, Baxter Healthcare Corp. of Deerfield, Illinois, and Baxter Healthcare SA of Switzerland (collectively, “Baxter”) filed a complaint requesting that the ITC commence an investigation pursuant to Section 337.

 

HTMLTakeda Prevacid SoluTab Patent Valid, But Not Infringed
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
February 27, 2014, previously published on February 24, 2014
In Takeda Pharmaceutical Company Ltd. v. Zydus Pharmaceuticals USA, Inc., the Federal Circuit reversed the district court’s finding that Zydus’s proposed generic product infringed Takeda’s Prevacid® SoluTab™ patent, but agreed with the district court that Zydus had...

 

HTMLReflecting on the First Year of CDRH’s 510(k) Refuse to Accept Policy
Jeffrey N. Gibbs, Allyson Mullen; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
February 27, 2014, previously published on February 26, 2014
The end of 2013 marked the first anniversary of CDRH’s Refuse to Accept Policy for 510(k)s (the “RTA”). FDA, Guidance for Industry and FDA Staff, Refuse to Accept Policy for 510(k)s (December 2012). Therefore, we thought it would be a good time to reflect on how well the RTA has...

 

HTMLBiomet Hip Implant Settlement Surpasses $56 Million
Katie Nealon; Brayton Purcell LLP;
Legal Alert/Article
February 25, 2014, previously published on February 21, 2014
Metal-on-metal hip implants were once praised as the latest advancement in joint replacement, but since their introduction into the medical world, they have caused more harm than good. We have previously reported on Johnson & Johnson's DePuy settlement that reached $4 billion and affected over...

 

HTMLFDA Issues Final Rule and Guidance on Electronic MDR Reporting
Allyson B. Mullen; Hyman Phelps McNamara P.C.;
Legal Alert/Article
February 24, 2014, previously published on February 19, 2014
On February 14, 2014, FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit MDRs in an electronic format (the “Final Rule”). 79 Fed. Reg. 8832 (Feb. 14, 2014). The Final Rule does not materially...

 


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