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|USPTO 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;
March 10, 2014, previously published on March 5, 2014The 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...
|Does Myriad Alter the Patentability of Natural Products?|
Leslie Kushner, Robert S. Schwartz; Fitzpatrick, Cella, Harper & Scinto;
March 10, 2014, previously published on March 2014Whether 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...
|Baxter Files New 337 Complaint Regarding Certain Hemostatic Products|
Alexander B. Englehart, Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
March 7, 2014, previously published on March 5, 2014On 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.
|Reflecting on the First Year of CDRH’s 510(k) Refuse to Accept Policy|
Jeffrey N. Gibbs, Allyson Mullen; Hyman, Phelps & McNamara, P.C.;
February 27, 2014, previously published on February 26, 2014The 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...
|Takeda Prevacid SoluTab Patent Valid, But Not Infringed|
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
February 27, 2014, previously published on February 24, 2014In 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...
|Biomet Hip Implant Settlement Surpasses $56 Million|
Katie Nealon; Brayton Purcell LLP;
February 25, 2014, previously published on February 21, 2014Metal-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...
|FDA Issues Final Rule and Guidance on Electronic MDR Reporting|
Allyson B. Mullen; Hyman Phelps McNamara P.C.;
February 24, 2014, previously published on February 19, 2014On 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...
|FDA Memorandum Outlines Significant Overhaul of Inspection and Compliance Processes|
Jonathan Berman, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
February 24, 2014, previously published on February 2014In an internal memorandum to FDA leadership, Commissioner Margaret Hamburg "chart[s] the course for modifying Agency functions and processes to improve communication and collaboration and to clarify roles and responsibilities and decision rights across all Agency components."
|Considerations If Conceding Infringement Or Designing Around|
Rebecca J. Pirozzolo-Mellowes; Foley & Lardner LLP;
February 19, 2014, previously published on February 18, 2014A decision issued by the Federal Circuit earlier this year raises a few things to have in mind when considering whether to concede infringement and when planning to design around a patent.
|Stem Cells Grown in Lab Prior to Clinical Use as Transplantation Product Are Biological Drugs Subject to FDA Rules|
Colleen K. O'Brien; Semmes, Bowen & Semmes A Professional Corporation;
February 18, 2014, previously published on February 2014In this civil enforcement action, the U.S. Court of Appeals for the District of Columbia Circuit decided whether Defendants, Regenerative Sciences and three (3) individuals (collectively Regenerative Sciences), violated the Federal Food, Drug & Cosmetic Act (FDCA), 21 U.S.C. § 301, et...