For Lawyers, Scientists & Other Inquisitives

An America watcher's observations about "life": Science, Law, Politics, Education, Humor, . . .

Inventions You Can Patent

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After a long silence, the Supreme Court has recently (2012-2013) re-opened its thoughts on a threshold question: what kind of inventions are patentable?

By way of background, scientific principles/laws are not patentable (in legalese, “non-patentable subject matter”); what is patentable are the applications of this knowledge.  For example, law books are fond of quoting the famous equation E = mC2 as a something that cannot be patented. The policy basis behind this prohibition is that, if such fundamental knowledge is patented by someone, others cannot explore/develop the practical applications of this equation, and thus limit the “progress of useful arts”, a constitutional requirement for granting a patent in the United States.

Similarly, naturally occurring things substances and life forms cannot be patented.

Applying these legal principles,, the Supreme Court invalidated two patents, which I discuss  in this short publication.  The first patent (The Prometheus Case) deals with a method for individualization of the dose of a drug based on its (and metabolites)  blood concentrations form  from previous doses. In other words, this invention is an application of the principles of therapeutic drug monitoring.  The second patent (The AMP Case)  deals with the patenting of certain genes, and after several years of litigation in the lower courts, the Court finally concluded in 2013 that certain genes indicative of a women’s risk for breast cancer are not patentable because they are naturally occurring substances.

I welcome your thoughts and comments, especially from scientists, my major target audience.

Biosimilars Litigation in the United States: Amgen v. Sandoz

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I  gave a talk  on biosimilars litigation in the US.  The June 1 program  was  sponsored by the Faculty of Law, University of Copenhagen, Denmark.  Slides from my presentation are available here.

A good part of the talk discussed the Amgen v. Sandoz case, which worked its way up to the United States Supreme Court.  The two questions before this Court were:

  • Is it mandatory for the biosimilars applicant (i.e., the generic company) to share application and information with the original developer of the biological product (i.e., the brand name company)
  • Can the 180-day notice of first commercial marketing by the biosimilars applicant to the reference product sponsor be given prior to FDA approval of the biosimilars application?

 July 9, Update: On June 12, the Supreme Court answered these questions (subject of a later post).  Yes, I am behind (an extended European trip can do that for you).