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I'M Still Your Baby: Canada's Continuing Support Of U.S. Linkage Regulations For Pharmaceuticals, Ron A. Bouchard
I'M Still Your Baby: Canada's Continuing Support Of U.S. Linkage Regulations For Pharmaceuticals, Ron A. Bouchard
Marquette Intellectual Property Law Review
Canada's linkage regime for pharmaceuticals, modeled after the originating U.S. Hatch-Waxman regime, was brought in under intense political pressure to balance effective patent enforcement over new and innovative drugs with the timely market entry of lower-priced generic competitors. It has been almost two decades since the regulations were enacted, and to date, there has been little objective assessment as to whether the regulations have, in fact, stimulated innovation and timely generic entry. We recently completed three empirical studies on the linkage between drug approval and drug patenting under the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations). Of particular interest …
Living With Patents: Insights From Patent Misuse, Vincent Chiapetta
Living With Patents: Insights From Patent Misuse, Vincent Chiapetta
Marquette Intellectual Property Law Review
The Author argues that the patent misuse doctrine should be eliminated. Created almost a century ago as a response to patent power, it has now not only outlived its purpose but causes affirmative harm. Other more nuanced approaches, including antitrust law, produce superior results. Although the Federal Circuit has contained the doctrine, it cannot overrule Supreme Court misuse precedent. Accordingly, the Court should abolish the doctrine at the earliest opportunity or, failing prompt action, Congress should add the matter to its ongoing patent reform agenda. The misuse experience also provides valuable insights regarding how we can appropriately live with our …