If the US Federal Government has classified Genetically Engineered food products as Substantially Equivalent to common food product currently in the market and thus declined to regulate them, how can they be patented? I thought patents were reserved for inventions or something that was unique and proprietary and required protection from rampant exploitation? Besides, how can patent natural products that come from nature?

Expert response from Professor Drew Kershen

Earl Sneed Centennial Professor of Law (Emeritus), University of Oklahoma, College of Law

Wednesday, 30/09/2015 17:21

To answer this question, I will separate its three questions and answer each question alone.

 

Question 1:  If the US Federal Government has classified Genetically Engineered food products as Substantially Equivalent to common food products currently in the market and thus declined to regulate them, how can they be patented?

 

When the FDA reviews a GE food to assess whether it is substantially equivalent, the evaluation is based on the submitted data as showing that the GE food is as safe and nutritious as the common food product.  In other words, the FDA has the task of insuring the safety and nutrition of foods.  FDA classification as substantially equivalent means that the GE food is safe and nutritious.

 

The FDA evaluation of safety and nutrition is a completely different task than the task of the United States Patent and Trademark Office (USPTO) – the federal agency that awards patents.  The USPTO, through its patent examiners, determines whether a patent application meets the statutory requirements for earning a patent.  Those statutory requirements are that the patent application establish that the product, for which a patent is sought, is new (novel), useful (utilitarian), non-obvious (involves an inventive step), and properly described (so that a person skilled in the same field can understand the patent).

 

The key to answering Question 1 is to understand that the FDA and the USPTO are asking and answering different questions under distinct statutory authority and responsibility.

 

Let me give an analogy.  Let us assume that a manufacture of a muffler (catalytic converter) applies to environmental agencies to have the muffler approved as meeting the standards of the Clean Air Act for the removal of pollutants from automobile engine exhaust.  The environmental agencies will evaluate the submitted data.  If these agencies classify that muffler as meeting Clean Air Act standards, the agencies effectively declare that muffler is substantially equivalent to already approved mufflers.  The manufacturer of the new muffler thereby receives approval to sell the new muffler.

 

But the fact that the environmental agencies approve the new muffler as “substantially equivalent” to already approved mufflers says nothing about whether the manufacturer could obtain a patent on the new muffler.  The manufacture would have to submit a patent application and the USPTO would have to decide whether the new muffler satisfied the four statutory requirements for obtaining a patent.  And, the fact that the USPTO might grant a patent says nothing about whether the new muffler will satisfy the pollution standards set by the Clean Air Act.  Different questions; different statutory requirements.

 

Your question also says that the FDA declines to regulate GE foods.  The FDA reviews all new foods through a voluntary system of consultation to evaluate whether these new foods are as safe and nutritious as the foods already on the market.  The FDA handles GE foods just as it handles other new foods.  Biotechnology companies have consulted on every GE food with FDA.  After evaluating the data, the FDA has determined that every GE food on the market is safe and nutritious – i.e. substantially equivalent to common food products.  Hence, the FDA, through the voluntary consultation system, has in fact regulated GE foods.  FDA has determined that the GE foods on the market are safe and nutritious.

 

 

Question 2:  I thought patents were reserved for inventions or something that was unique and proprietary and required protection from rampant exploitation?

 

Your thought is correct that patents are for unique and proprietary inventions – i.e. inventions that satisfy the four requirements of the federal statute on patents.  Biotechnology companies, just like any other patent applicant, must file a patent application that convinces the USPTO that the statutory requirements are met. 

 

Once the USPTO grants a patent, the patent holder is entitled to protection of that patented product from use by others without the patent holder’s permission.  Biotechnology companies, like other patent holders, have invested time, money, and effort in creating the GE crop.  Patents provide a limited-time monopoly to the patent holder so that the patent holder can recover these invention costs and gain a profit.  The patent law and the patent thus provide an incentive for inventiveness.  Like other inventors, biotechnology companies gain protection for their patented products.

 

The Supreme Court of the United States has decided three cases that especially make clear the points set forth in the preceding paragraphs to Question 2.  Those three cases are Diamond versus Chakrabarty (1980), JEM Ag Supply versus Pioneer Hi-Bred International (2001), and Bowman versus Monsanto (2013).  

 

Question 3.  Besides, how can [somebody] patent natural products that come from nature?

 

Under the U.S. patent law and Supreme Court decisions, a person cannot patent a “product of nature.”  Determining what is a “product of nature” -- in contrast to the four patentable subjects under U.S. law -- i.e.  “machine, article of manufacture, a composition of matter” or a patentable process (method) – is a complex, difficult distinction, especially in agriculture and pharmaceuticals.  Two Supreme Court cases are particularly helpful in understanding the concept of “product of nature”: Funk Brothers Seed Co. versus Kalo Inoculant Co. (1948) and Association for Molecular Pathology versus Myriad Genetics, Inc. (2013).

         

Biotechnology patents, as a factual and legal matter, have not been heavily disputed as “products of nature” because biotechnology patents involve products that do not exist in nature and that are new (novel) for the statutory requirements.  The major argument against biotechnology patents has been that “living matter” (i.e. bacteria, plants, and animals, excluding human beings) is not a patentable subject.  The Supreme Court of the United States, and patent courts and bodies around the world, have ruled repeatedly that “living matter” is a patentable subject.