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Are Personalized Medicine Claims Patentable in the US? - Mark F. Vickers, Ph.D., Patent Agent

 

March 01, 2011

The field of personalized medicine brings hopes of medical treatment(s) tailored to individual patients based on that individual’s unique molecular, proteomic, metabolomic, etc. profile(s).  

Personalized medicine patents and patent applications often include the comparison of data sets of a control population versus a test population and identify correlations with, for example, therapeutic treatment approaches, patient outcomes and the like.   

There has been an evolving line of cases in the United States (US) that has brought into question whether certain personalized medicine claims constitute patent eligible subject matter under 35USC§101.  

In the US, there are three exclusions as to what constitutes patent eligible subject matter under 35USC§101, and include: (i) laws of nature, (ii) physical phenomenon and (iii) abstract ideas.  It is considered that these exceptions are part of the storehouse knowledge free to all and reserved exclusively to none.  It is noted, however, that the US Supreme Court has also established that “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection”.   

Opponents of such personalized medicine US patents and applications have argued that such subject matter is patent ineligible for patent protections on the basis that such claims preempt all practical use of naturally occurring correlations. 

In the US Prometheus case, claim 1 is directed, in part, to a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising (a) administering a drug […] and (b) determining the level of 6-thioguanine […], wherein […].  Claim 46 was directed, in part, to a method of optimizing therapeutic efficacy and reducing toxicity associated with the treatment of an immune-mediated gastrointestinal disorder, comprising (a) determining the level of 6-thioguanine […], wherein […]. (underlined emphasis added). 

Prometheus has been closely watched as it has wound through the US Courts.  The  US District Court for the Southern District of California (District Court) granted a summary judgment of invalidity against the patent in question, on the basis that it was not directed to patent eligible subject matter under 35USC§101.  On appeal, the US Federal Circuit reversed the summary judgment of invalidity, holding that the claimed subject matter was patent eligible.  This first US Federal Circuit decision was granted certiorari to the US Supreme Court which vacated and remanded the first US Federal Circuit judgment (a GVR Order).   

On December 17, 2010 the US Court of Appeals for the US Federal Circuit released its (second) decision in the case of Prometheus Laboratories Inc., v. Mayo collaborative Services (“Prometheus”).   

On remand, the US Federal Circuit again reversed the District Court’s summary judgment of invalidity and held that the claims in Prometheus are drawn to statutory subject matter.  

The District Court framed the question as “[i]n light of the Supreme Court’s decision in Bilski, patent eligibility in this case turns on whether Prometheus’s asserted claims are drawn to a natural phenomenon, the patent of which would entirely preempt its use as in Benson or Flook, or whether the claims are drawn only to a particular application of that phenomenon as in Diehr’.    

It was noted that the “claims recite specific treatment steps, not just the correlations themselves.  And the steps involved a particular application of the natural correlations: the treatment of a specific disease by administering specific drugs and measuring specific metabolites.”  

Accordingly, the District Court held that the claims recited “a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy or toxicity, and thus do not wholly preempt all used of the recited correlations.” 

The District Court also confirmed that the claims met the machine-or-transformation test as they “transform an article into a different state or thing and this transformation is central to the purpose of the claimed process.  The transformation is of the human body and of its components following the administration of a specific class of drugs and the various chemical and physical changes of the drugs’ metabolites that will enable their concentrations to be determined.” 

This decision provides some guidance from the US Federal Circuit on what may constitute patent eligible subject matter within personalized medicine technologies. 

This article first appeared in the March 2011 edition of the Perlaw Reporter.