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Drug advertising in the context of social media
  • Gowling WLG
  • USA, Canada
  • January 22 2016

Both in the U.S. and in Canada, advertising of prescription pharmaceutical products is highly regulated and can raise various challenges, which are


Medical diagnostic claims and Bilski
  • Gowling WLG
  • USA
  • September 6 2010

In the long awaited decision in Bilski v. Kappos, the U.S. Supreme Court has concluded that the machine-or-transformation (“MOT”) test is not the sole arbiter of patentable subject matter for “processes” under section 101 of the U.S. Patent Act.


Medical diagnostic claims and Bilski
  • Gowling WLG
  • USA
  • July 9 2010

In the long awaited decision in Bilski v. Kappos, the U.S. Supreme Court has concluded that the machine-or-transformation (“MOT”) test is not the sole arbiter of patentable subject matter for “processes” under section 101 of the U.S. Patent Act.


Obama moving to renegotiate biologics exclusivity period
  • Gowling WLG
  • USA
  • January 20 2010

In the United States, biologics are not regulated under the Hatch-Waxman Act, which governs approval of conventional generic "small molecule" pharmaceuticals.


U.S. Senate votes against bill allowing Americans to import prescription drugs
  • Gowling WLG
  • USA
  • January 20 2010

In December, the Senate rejected an amendment by Senator Dorgan to allow American pharmacies and drug wholesalers to import federally approved drugs from abroad.


U.S. drug prices challenged
  • Gowling WLG
  • USA
  • January 20 2010

In December, brand pharmaceutical companies defended themselves before the House Energy and Commerce health panel against complaints over reports, including one by the AARP (which represents 40 million older Americans), that drug prices continued to outstrip inflation in 2009.


U.S. FDA contemplates new rules for internet-delivered health information
  • Gowling WLG
  • USA
  • December 3 2009

In recognition of the increasing use of the Internet by consumers for health-related information, the FDA is seeking to determine whether it needs to regulate the promotion of drugs and medical devices on the Internet.


U.S. patients receive greater access to unapproved medications
  • Gowling WLG
  • USA
  • August 21 2009

Seriously ill patients will have greater and easier access to unapproved medicines due to new USFDA regulations.


U.S. bill considers access to Canadian pharmaceuticals
  • Gowling WLG
  • USA, Canada
  • July 27 2009

Recently, the U.S. Senate amended the $43 billion Department of Homeland Securities Bill to allow Americans to purchase prescription drugs from Canadian internet pharmacies.


FTC report on follow-on biologics
  • Gowling WLG
  • USA
  • June 24 2009

Earlier this month, U.S. lawmakers debated the key issue of the exclusivity period afforded to biologic drugs - those drugs manufactured using living tissue and micro-organisms.