By Jay Pattumudi
April 8, 2011 | Guest Commentary | Recently, the Court of Appeals for the Federal Circuit reaffirmed its earlier ruling on patentability of medical treatment methods in Prometheus Laboratories v. Mayo Collaborative Services, after remand from the United States Supreme Court, post-Bilski, which held that a method of hedging in the energy commodities as an unpatentable abstract idea. So what is the prescription for making a medical treatment patent-eligible subject matter, and why should you be interested? Persons in drug discovery and clinical research may want to patent new ways of medical treatments. However, researchers still need to be wary of making broad claims that are directed to patent-ineligible subject matter under 35 U.S.C. Section 101, which would include claims directed to a law of nature, natural phenomenon or an abstract idea.
Making a medical treatment claim patent-eligible should involve applying natural phenomenon and include specific treatment steps. In Prometheus, the patents involved methods of optimizing drugs used to treat gastrointestinal and non-gastrointestinal autoimmune diseases by measuring metabolite levels and then reducing or increasing drug dosage accordingly. If a given metabolite level was too low, then the drug dosage should be increased, while a high metabolite level indicated a need to decrease drug dosage to minimize toxic side effects. There, the patent claims included a specific application of drugs for treating specific diseases, rather than being directed to an unpatentable idea of calibrating drug dosages to treat disease or an unpatentable use of natural correlations. (e.g., a correlation between levels of a drug metabolite and toxicity.)
A patent-eligible medical treatment should also include a specific treatment regimen involving an administration of specific drugs for specific diseases and testing for specific metabolites, if applicable. In Prometheus, the claims involved treatment of specific diseases by administering specific drugs and testing for specific metabolites. Claiming a general treatment disease protocol for all gastrointestinal diseases would not pass muster. Also, gathering data for any use of natural correlations between metabolite levels and drug efficacy would not constitute a patentable step. Researchers hoping to patent a medical treatment method should include specificity, for example, references to specific diseases, specific drugs and specific metabolites.
Making a medical treatment method patent-eligible may also involve a central, transformative step. Such a treatment method may include an administration of a drug from a defined group in order to remedy the effects of an undesired condition. Under the CAFC’s machine-or-transformation test, one of the grounds for making a process patent-eligible subject matter under section 101 involves transforming a particular article into a different state or thing, provided that the transformation is central to the purpose of the claimed process. Although Bilski rejected the CAFC test as the exclusive test for determining patent-eligible subject matter, it remains a valid investigative tool.
In Prometheus, the treatment regimen was patent-eligible because the human body was transformed when a drug for treatment of an immune-mediated gastrointestinal disorder was administered. Although the metabolism of a particular drug relies upon natural processes, the transformation, e.g., treating a patient, is itself not a “natural process.” Researchers thus claiming a treatment regimen should include a defined method that is central to the treatment regimen, such as administering a specific drug for a specific disease.
Certain experimental protocols would not make a transformative step “central” to a medical treatment regimen but some others would. For example, merely gathering data without application would be insufficient. (e.g., observing natural phenomena.) But administering a drug for treating a specific drug as part of a treatment regimen would make the administering step transformative and central. Also determining a metabolite level for assessing drug effectiveness was held to be a central part of a treatment regimen because the use of laboratory techniques to measure metabolites is not merely “data-gathering.” Such measuring of metabolites enables possible adjustments for optimizing therapeutic efficacy or reducing toxicity; making the transformative step central to a treatment process would more likely allow researchers to claim new methods of medical treatment in patents.
Thus, the prescription for making a medical treatment method patent-eligible appears to involve:
- Specificity: e.g., giving specificity to claim limitations;
- Practical Application: e.g., practically applying a natural process to defined methods of treatment for specific diseases using particular drugs; (for example, a treatment regimen for a disease rather than a data-gathering algorithm of natural correlations for determining clinical abnormalities.)
- Central Transformative Effect: e.g., making a transformative effect central to the claims.
From a reading of the ruling, researchers claiming medical treatment methods should apply a natural process, rather than claiming a natural process or a correlation. Furthermore, specific drugs for a specific disease as part of an administrative step would make such a transformative step central to the treatment regimen. If this is the case, researchers will likely have claims that are patent-eligible subject matter. Just what the doctor ordered.
Jay is a senior patent attorney at Bruzga and Associates. Charles Bruzga, managing partner, and Andrew Smith, intern, offered comments on early drafts of the article. This commentary does not represent any legal advice nor represents the views of the law firm.