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Results:1-10 of 218

FDA Issues Guidance Documents on the “Deemed to be a License” Transition Provision of the BPCIA
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 16 2019

The Biologics Price Competition and Innovation Act (“BPCIA”) requires applications to market a biological product be submitted for review by the FDA


New 101 Guidelines Give Applicants Two Bites at the Apple at Step 2A
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 9 2019

On January 7, 2019, the United States Patent and Trademark Office (USPTO) published its “2019 Revised Patent Subject Matter Eligibility Guidance”


Two Asserted Lantus Patents CancelledCommercial Success Evidence Insufficient Because of Blocking Patents
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 8 2019

On December 12, 2018, the U.S. Patent and Trademark Appeal Board (PTAB) ruled in favor of Mylan in its inter partes review (IPR) proceedings. It


FDA Proposes Amendment to the Definition of “Biological Product”
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 7 2019

The FDA recently proposed an amendment to its regulations defining the term “biological product.” The proposed amendment incorporates changes made by


PTAB Prepares to Convene its First Precedential Opinion Panel to Address Joinder Under 35 U.S.C. 315(c)
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • January 2 2019

The Patent Trial and Appeal Board (“the PTAB” or “the Board”) is preparing for its first instance of the newly created Precedential Opinion Panel


The Continuing Evolution of Obviousness Type Double Patenting
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • December 22 2018

Prior to 1994, the term of a U.S. patent was 17 years from the date of issuance. When the Uruguay Round Agreements Act (“URAA”) changed the term to


The PTAB Rejects a “Benefits-Plus-Relationship” Standard For Determining Real Parties-in-Interest
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • December 6 2018

The PTAB, on November 27, 2018, released the public version of Unified Patents, Inc. v. Realtime Adaptive Streaming, LLC, IPR2018-00883, Paper 29 (P


PTAB Final Written Decision Finds All Claims (1-5) of U.S. Patent No. 8,821,873 Obvious Over the Combination of Five Prior Art References
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • December 3 2018

As we previously reported, one of three Pfizer IPR petitions filed in April 2017 against Biogen-owned patents claiming methods of treatment with


USMCA Assailed as Exacerbating High Drug Prices
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA, Mexico, Canada
  • November 15 2018

On November 5, 2018, twenty-nine organizations representing various groups including insurance companies, patient and consumer advocacy groups


Amendments on Amendments: USPTO Proposes Changes to the Motion to Amend Practice in AIA Trials
  • Rothwell, Figg, Ernst & Manbeck, PC
  • USA
  • November 12 2018

The United States Patent and Trademark Office (“USPTO” or the “Office”) recently proposed new AIA trial procedures aimed at boosting the success rate