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Results: 1-10 of 41,713

Amgen and Apotex do the biosimilar patent dance
  • Foley & Lardner LLP
  • USA
  • August 27 2015

Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex


Contract manufacturing is a commercial transaction for purpose of “on-sale” bar
  • McDermott Will & Emery
  • USA
  • August 27 2015

Addressing the application of the on-sale bar under 102(b), the U.S. Court of Appeals for the Federal Circuit found that the claims of an asserted


Direct infringement motion to dismiss under Form 18 granted
  • McDermott Will & Emery
  • USA
  • August 27 2015

Addressing pleading requirements for direct and indirect infringement, the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s


Shall means shall . . . unless it doesn’t
  • McDermott Will & Emery
  • USA
  • August 27 2015

Addressing issues of first impression related to the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which the U.S. Court of Appeals


Will the TELE-MED Act of 2015 really change licensure rules?
  • Foley & Lardner LLP
  • USA
  • August 26 2015

Congress is reviewing legislation designed to permit telemedicine providers to treat Medicare patients across state lines without the need for


Kyle Bass loses round 1 of IPR attack against pharmabiotech patents
  • Foley & Lardner LLP
  • USA
  • August 26 2015

On August 24, 2015, the Patent Trial and Appeal Board (PTAB) declined institution of two petitions filed by Coalition For Affordable Drugs for Inter


Worth the read: interpreting unclear Medicare regulations and FCA liability - U.S. ex rel Parker v. Space Coast Medical Associates, L.L.P.
  • Phelps Dunbar LLP
  • USA
  • August 26 2015

I commend to you the analysis of the Middle District of Florida opinion, U.S. ex rel Space Coast Medical Associates, LLP, 2015 WL 1456122 (M.D. Fla


New York Federal Court issues first interpretation of “identified” under the Affordable Care Act’s 60-day rule
  • Gordon & Rees LLP
  • USA
  • August 26 2015

In Kane v. Healthfirst, Inc. et al., a New York federal court became the first court to interpret when the clock starts running on the 60 days


Recent improvements to the Florida Health Care Surrogate Act
  • Berger Singerman LLP
  • USA
  • August 26 2015

A "Designation of Health Care Surrogate" is a written document naming someone to make health care decisions for an individual (the "principal") or


Will NYSDEC's Audit Agreement for retail pharmacies provide a path to increased compliance?
  • Manatt Phelps & Phillips LLP
  • USA
  • August 26 2015

Federal and state hazardous waste handling and disposal requirements, which were established to address issues related to industrial waste generators