State and Local Policy as a Tool to Complement and Supplement the FDA Law

With the recent passage of the Family Smoking Prevention and Tobacco Control Act of 2009, the U.S. Food and Drug Administration now has the authority to regulate tobacco sales, marketing, and use. Though this law is a beneficial step, some gaps remain. There are significant merits to state and local governments enacting local laws to fill these gaps. State and local governments can also effectively partner with the Food and Drug Administration in enforcing various provisions of the law. There are a great deal of local policy options available to state and local governments. This Article provides both recommendations and questions about how to effectively enforce Food and Drug Administration law.

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IN RE BERNARD L. BILSKI AND RAND A. WARSAW

At first glance, the Federal Circuit’s categorical rejection of the “useful, concrete, and tangible result” test announced in State Street in favor of the machine-or-transformation test for patent-eligible subject matter could be seen as the death knell for business method and software patents.  If the Court upholds Bilski, software patents issued in the past 20 years, as well as many business method patents, might be invalidated.  However, this might not be the case.  Gene Quinn, a patent attorney and the founder of IPWatchdog.com observes that, “[i]n fact, based on what is going on at the USPTO one could make a convincing argument that it is actually getting easier to obtain patents that relate to software and computer related processes.

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PRINCO CORPORATION AND PRINCO AMERICA CORPORATION V. INTERNATIONAL TRADE COMMISSION

In affirming the ITC’s holding as to Princo’s first tying claim, the court found that a reasonably broad reading of the Lagadec patent (Sony’s digital method) would support a finding of infringement where anyone practiced the Phillips analog method, currently used as the industry standard.  Under the broad construction, since neither patent could be practiced without infringing the other, the court found the Lagadec patent to be essential to the patent pool.  However, the Federal Circuit vacated and remanded Princo’s claim of patent misuse.  The court found persuasive Princo’s argument that Phillips and Sony violated anti-trust law by agreeing not to compete, and remanded the issue to the ITC to determine whether  there was in fact such an agreement and whether the Lagadec method could realistically compete with the Orange Book standard.

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