Re-Election of Obama Keeps Patent Law and Policy on Track

At least Director Kappos does not have to clean out his desk. The re-election of President Obama gives him another four years of job security – if he and his hard-working staff don’t burn out first. No matter what you think of the AIA, Director Kappos has done a remarkable job of proposing implementing regulations for its many new procedures. Apart from issuing rules by the bushel, he has been “tasked” with opening three new satellite offices. He has begun to develop guidance in non-AIA areas such as patenting diagnostic assays post-Prometheus. The defeat of President Obama might well have caused a return to the Rogan years of a “know nothing” [about patent law] Commissioner.

A President Romney surely would have supported repeal of “Obamacare”. No matter what you think of the more controversial parts of the law, it also contains the outline of procedures to approve generic biologicals, a way to cut healthcare costs that is long overdue. At least the players can continue to move forward, and not be put into limbo or returned to the starting line to run a race with new rules.

I have done a series of posts on the tortuous path that President Obama’s Executive Order permitting certain types of research on embryonic stem cells has endured. President Romney surely would have blocked any further funding for research in this still-promising area. How a Republican administration would have reacted to the hopeful developments in gene therapy that were reported yesterday by uniQure will not been known, but Romney/Ryan’s tactics did not involve engaging the scientific community.

It is impossible to predict how the Supreme Court will “evolve” over the next four years, but it seems likely that Justices that are at least centrist in their views will replace as many as three Justices who may be ready to retire within the next three years or so (Ginsberg is 79, Scalia is 76 and Kennedy in 75). The country needs a court that begins with a positive view of the patent system and patent practitioners, and will take an expansive view of patentable subject matter. Since Bilski, we have seen a string of decisions that have explicitly or effectively reduced the scope of patentable inventions. In the fairly near future, the Court may well be called on to decide whether or not methods of medical treatment as well as simple correlative diagnostic assays – the key to personalized medicine – are patentable.

It seems like a hundred years ago that the Court held that utility patents can be issued on plants in J.E.M. Ag Supply v. Pioneer (decided Dec. 2001), and that was a split decision. To apply a version of “Obamacare” to the patent system, I am not advocating the appointment of “liberal”, much less “activist” Justices. Conservative Justices can take anti-science positions (no patents on applying nature’s laws) as can liberal Justices (monopolies on medical treatment hurt consumers), just for different reasons. But is it too much to ask for the appointment of one or more Justices with a technical/scientific background?

On the Federal Circuit bench, Judges Lourie and Newman – both PhD chemists – can’t judicially live forever, and Judge Lourie got lost in the jungle of “abstract ideas” in Myriad. Judge Kimberly Moore – an MIT engineer – does not always “get it” when the issue is biotech, but she is starting to look like Galileo compared to some of her brethren. We need more judges with post-Chakrabarty science degrees at all levels. Maybe this should be my first tweet to the White House.

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