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Results: 1-10 of 1,459

New October 15 deadline for Medicare Part D creditable non-creditable coverage notices
  • McDermott Will & Emery
  • USA
  • October 4 2011

Group health plans that offer prescription drug coverage are required to issue a notice of creditable or non-creditable coverage to Medicare-eligible participants and beneficiaries each year prior to the annual Medicare Part D open enrollment period


Increased European patent protection following a landmark ruling on supplementary protection certificates
  • McDermott Will & Emery
  • European Union
  • August 30 2012

The Court of Justice of the European Union (CJEU) rendered judgment relating to a preliminary reference from the English Court of Appeal, holding that the existence of an earlier marketing authorization (MA) of a pharmaceutical product does not preclude the grant of a Supplementary Protection Certificate (SPC) for a different application of the same product


PA hospital merger may proceed with restrictions on rate negotiations and other conduct in settlement with AG
  • McDermott Will & Emery
  • USA
  • June 8 2012

On June 7, 2012, Pennsylvania, through its Attorney General (AG), filed an antitrust complaint and consent order in U.S. District Court (M.D. Pa.), settling charges that Geisinger Health System's acquisition of Bloomsburg Hospital violated section 7 of the Clayton Act and the state common law prohibition on suppression of competition


Second ANDA filer has jurisdiction in declaratory judgment action
  • McDermott Will & Emery
  • USA
  • May 30 2012

The U.S. Court of Appeals for the Federal Circuit upheld a finding of subject-matter jurisdiction in a declaratory judgment action brought by a generic, even though the brand drug manufacturer had provided the generic with a covenant not to sue on one of the brand’s Orange Book patents


When the PTO shows sound basis for believing two products are the same, it is the applicant’s burden to show they are not
  • McDermott Will & Emery
  • USA
  • May 30 2012

In affirming a decision of the U.S. Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences’ (Board) finding of inherent anticipation, the U.S. Court of Appeals for the Federal Circuit held that once the examiner establishes that the prior art teaches “the same or substantially the same compound,” the burden of proof shifts to applicants to prove that either the claimed structures are different or that the claimed properties are not inherent in the prior art


FDA labels and method claims must be in sync, or ANDA infringement is sunk
  • McDermott Will & Emery
  • USA
  • May 30 2012

The U.S. Court of Appeals for the Federal Circuit recently held that filing a Paragraph IV certification for an Orange Book listed method-of-use patent was not an act of infringement when an NDA holder’s FDA-approved labeling did not include an indication for every use limitation in the asserted Orange Book patent


Thinking outside the HIPAA box
  • McDermott Will & Emery
  • USA
  • May 9 2014

On Wednesday, May 7, the Federal Trade Commission (FTC) held the third of its Spring Seminars on emerging consumer privacy issues. This session


U.S. Department of Labor Issues Proposed Regulations Amending the COBRA Notice Requirements
  • McDermott Will & Emery
  • USA
  • May 6 2014

On May 2, 2014, the U.S. Department of Labor (DOL) Employee Benefits Security Administration (EBSA) issued proposed regulations which seek to amend


The case of ophthalmic drugs in Italy and France: a lesson to learn - parallel antitrust investigations and cooperation between national competition authorities
  • McDermott Will & Emery
  • European Union, France, Italy
  • May 7 2014

The recent investigations into two pharmaceutical companies active in the ophthalmic drugs market in Italy and France serve as a reminder of the


The new normal: big data comes of age
  • McDermott Will & Emery
  • USA
  • May 13 2014

On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is