Epstein mentions Jaffe/Lerner
Professor Epstein of the Law School at the University of Chicago mentioned Jaffe and Lerner's Innovation and Its Discontents:
Patents. Relman is equally fearless when he takes on the patent issues. He references the interesting work of Adam Jaffe and Josh Lerner, Innovation and Its Discontents (2004), who think that the standards for patents are too lax, and thinks that it supports the charges that Marcia Angell makes in her book (which I have reviewed unfavorably) that too many patents are given for me-too drugs that do not represent real product advances. But Jaffe and Lerner are talking about a different problem. Me-too drugs are not double-click patents. No one doubts that the spate of me-too drugs on the marketplace meet whatever patent standards Jaffe and Lerner would propose; and they surely meet the recent Supreme Court standards of nonobviousness in KSR International v.. Teleflex (2006), which dealt with the positioning of sensors in gas pedals. How could these me-too drugs not be nonobvious extensions of existing molecules when the FDA requires that they go through separate testing. Two molecules may look similar but their behaviors could be quite different, so the hard matter never concerns patentability, which is a given, but regulatory approval.
IPBiz notes
#1. The recent Supreme Court case of KSR was in the year 2007, not in 2006. [127 S. Ct. 1727, 167 L. Ed. 2d 705 (2007)]
#2. As perhaps seen more clearly in the debate in India [and in the praise by certain folks in India over the KSR decision], Professor Epstein is quite wrong about the asserted irrelevance of KSR to me-too drugs. Professor Epstein separately should read the contents of In re Deuel, criticized by the Supreme Court in KSR.
#3. Professor Epstein ought to look in more detail at the "interesting" work of Jaffe and Lerner. For example, Is the Jaffe/Lerner Analysis of Patent Law Correct?
#4. As to patentability issues, Professor Epstein should look into the recent enantiomer case, or, in a more conventional area, "In re '639 litigation."
Patents. Relman is equally fearless when he takes on the patent issues. He references the interesting work of Adam Jaffe and Josh Lerner, Innovation and Its Discontents (2004), who think that the standards for patents are too lax, and thinks that it supports the charges that Marcia Angell makes in her book (which I have reviewed unfavorably) that too many patents are given for me-too drugs that do not represent real product advances. But Jaffe and Lerner are talking about a different problem. Me-too drugs are not double-click patents. No one doubts that the spate of me-too drugs on the marketplace meet whatever patent standards Jaffe and Lerner would propose; and they surely meet the recent Supreme Court standards of nonobviousness in KSR International v.. Teleflex (2006), which dealt with the positioning of sensors in gas pedals. How could these me-too drugs not be nonobvious extensions of existing molecules when the FDA requires that they go through separate testing. Two molecules may look similar but their behaviors could be quite different, so the hard matter never concerns patentability, which is a given, but regulatory approval.
IPBiz notes
#1. The recent Supreme Court case of KSR was in the year 2007, not in 2006. [127 S. Ct. 1727, 167 L. Ed. 2d 705 (2007)]
#2. As perhaps seen more clearly in the debate in India [and in the praise by certain folks in India over the KSR decision], Professor Epstein is quite wrong about the asserted irrelevance of KSR to me-too drugs. Professor Epstein separately should read the contents of In re Deuel, criticized by the Supreme Court in KSR.
#3. Professor Epstein ought to look in more detail at the "interesting" work of Jaffe and Lerner. For example, Is the Jaffe/Lerner Analysis of Patent Law Correct?
#4. As to patentability issues, Professor Epstein should look into the recent enantiomer case, or, in a more conventional area, "In re '639 litigation."
posted by Lawrence B. Ebert at 12:05 PM
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