BP response

That was Wyeth v. Levine, in which the Court decided that a state tort lawsuit by a woman who had lost an arm because of an intravenous use of Phenergan (an antinausia drug) was not preempted by the fact that Phenergan had been approved by FDA.  But I think that decision probably turns on some FDA-specific issues and may not have much precedential value in other industries. 

 

The Court drew on American Honda v. Geier's discussion which distinguished "minimal" schemes of federal regulation (which merely set a floor on safety standards but allow states to set higher standards through state legislation or state tort lawsuits), vs. "optimal" schemes of federal regulation (in which the fed carefully balances costs and benefits of regulating an industry and seeks to set both a ceiling and a floor for safety standards that can be imposed on the industry).  FDA regulation had for over sixty years been considered to be a scheme of minimal regulation that only sets a floor on drug safety--a minimal safety standard to be supplemented through state tort law and regulation of medical practice, etc.  In 2006, the politicized FDA of that time had made some utterances in the preamble to a guidance document to the effect that FDA regulation now should be considered an optimal scheme of regulation which preempts state tort lawsuits against pharmaceutical companies.  Wyeth tried to latch onto those statements by FDA and get the court to give deference to them and make a ruling that FDA regulation now was an optimal scheme of regulation that should preempt state tort lawsuits against drug manufacturers.  The Court didn't buy it.  Wyeth v. Levine served to put to bed an attempt earlier this decade by a politicized FDA to aid attempts to eliminate lawsuits against pharmaceutical manufacturers.  So it was dealing with an odd set of circumstances particular to the drug industry.

Copyright content providers lose control of DVR market

Who should derive revenue from remote DVR systems? According to a panel of the Second Circuit Court of Appeals, the revenue should not go to the content providers. This decision, grounded in three very narrow interpretations of the Copyright Act, works a shift of potentially significant revenue away from content providers. Hopefully, it will be challenged and reversed on rehearing.

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Does the future of patent law portend compulsory licensing by judicial fiat?

I hope not, but that is one risk created by the Supreme Court’s decision in the Ebay case and by the actions of some courts who have denied permanent injunctions in successful infringement cases. But the fact that a permanent injunction does not issue after a judgment of infringement does not mean that the infringer (by losing the case) obtains a right to use the patent owner’s property in the future.  It simply means that the court declined to add the coercive force of an injunction to the statutory right to exclude as to future infringing conduct.

           

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Standards Setting Organizations: deference to the market

Many industries function under technological standards that shape the technology, the products, and the focus of competition. But standards-setting groups have become competition focuses themselves, such as in the debate about “open document” versus “open xml” as a standard. 

 

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E-Commerce should not be over-regulated

We wake up one morning and discover that a question we have been asking for the last decade or two may now be the wrong one. The question was: how can we use law to enable businesses to use e-commerce? The question now seems to be: how can we shape law to support e-commerce without over-regulating it?

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Reverse engineering is not an inviolate right

Reverse engineering is not an inviolate right

      Actually, contracts control. I can have a privilege to do something, but then can waive that privilege. So too the privilege to make limited copies for purposes of some forms of reverse engineering.

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