Drugs, Microbes, and 35 U.S.C. § 101, Oh my!

Drugs. What is a drug? Any chemical that alters a functional living system is a drug. However, a drug in itself does not have an effect without binding to a receptor. Receptors are macromolecular components found in the cell membrane. Drugs typically bind to receptors through chemical bonds such ionic bonds, covalent bonds (strong), Van der Waals forces (weak), and hydrophilic or lipophilic interactions. Why does any of this matter? The nature of the bond between the drug and the receptor is that drug’s affinity and affinity is one of the two most important qualities of an agonist (a drug that binds to a receptor). The other most important quality is efficacy. Efficacy is the agonist’s ability to activate the receptor and “effect” the living system, producing a response.

An example is caffeine. Caffeine binds to adenosine receptors and acts as antagonist (competes with adenosine and prevents the substance from binding). When adenosine is inhibited I feel more wakeful, for a longer amount of time.The caffeine has altered my system. Although this is the basis of what I got out of Vertebrate Neurobiology class in college my short lesson in Pharmacology unexpectedly answered my question to patents and microbes.

It seems like a frivolous question with an obvious answer but what IS the difference between a drug and a microbe? Microbes can bind to receptors and alter a living system like drugs can. However, microbes are not chemicals. A chemical is defined as “a compound or substance that has been purified or prepared, especially artificially.”  Purify is defined as the removal of contaminants. A contaminant pollutes or adulterates the substance. Is this just semantics? No. This analysis slowly creeps to the heart of why there are so many drugs that are patented day after day and why seeking to patent a microbe could lead to years of litigation. Drugs are a deliberate composition of substances that are for the most part, artificially made. This is why Penicillin could no longer be patented. It was not artificially made, it is derived from mold.

If something is artificial, it is man-made and not made from nature. So where do we draw the line? For example you cannot patent a microbe found in nature but you can patent the process of purifying the microbe like you could patent a purified chemical substance.  35 U.S.C. § 101, provision 43 “Product of nature,” (citing In re Ridgeway). According to the § 101 it is all about process, newness, and usefulness. You have a microbial invention? You want to patent it? Show the court that your invention has a unique process that is not of nature but applies nature in some essence. Show the court that your invention is new and useful. Then you have reached patentable territory because in so many ways your microbe has become a drug.  


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