If seeds can be patented, what prevents a competitor from changing just a few neutral molecules in a copy of the seed genome and calling it a new invention?

Expert response from Professor Drew Kershen

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

Monday, 23/11/2015 17:13

Competitors could change just a “few neutral molecules” in a gene and apply to get a patent on that changed gene (or seed). But whether the competitor would be successful is very doubtful, in my opinion, in light of the fact that the changes involve a “few neutral molecules.”

In order to gain a patent, under the general (utility) patent laws of the United States, the person applying for the patent must satisfy four statutory requirements: new, useful, non-obvious and adequately described. Let’s briefly discuss each statutory requirement in light of the facts presented in the question – changes involving a “few neutral molecules.”

New – Has this gene ever been discussed, publicized, used publicly anywhere in the world before? If “no,” then the gene is “new.”  But if “yes,” then the gene is not new and the patent examiner would deny the application.  Let’s concede that this gene is “new” for the purpose of this statutory requirement.

Adequately Described – Let’s concede that the patent application adequately describes the gene (seed) or presents a proper biological deposit as the description.

Useful – The patent application must disclose at least one specific use or utility for the gene. Let’s concede that the patent application states a specific use or utility for the gene (seed).

I have conceded that the gene in question can meet three of the four statutory requirements for gaining a patent. However, it is the fourth requirement that likely presents, in my opinion, an insurmountable barrier.

Non-obvious – This statutory requirement requires that the patent application show a “non-obvious” invention – i.e., an inventive step. The patent application must show that what is claimed is an inventive step that persons familiar with the state of the art would not have obviously developed. As the question describes the changes as involving “a few neutral molecules,” I am very doubtful that the patent application shows an inventive step. I think the patent examiner would decline the patent on the grounds that others familiar with the art of genetic manipulation would also easily know how to make these changes of a “few neutral molecules.” Thus, the patent examiner would reject the application on the ground that the application does not meet the “non-obvious” requirement of the statute.

In addition to the general (utility) patent law, the United States also has a Plant Variety Protection Act (PVPA) that allows a sub-patent form of intellectual property in a plant variety, called a plant variety certificate.  Lawyers call the PVPA a sub-patent form of intellectual property because the PVPA statutory requirements are less demanding than the statutory requirements of the general (utility) patent law.

However, the Plant Variety Protection Act (PVPA) has statutory requirements. The PVPA examiner will not issue a PVPA certificate unless the PVPA application provides evidence satisfying each statutory requirement. These statutory requirements are: new, distinct, stable, uniform and reasonably described (including a biological deposit as the description).

Of these five PVPA statutory requirements, I think the “distinct” requirement likely cannot be met by an application that shows only changes of a “few neutral molecules.” If indeed the changes are of a “few neutral molecules,” the examiner would decide, in my opinion, that the seed does not show any distinct phenotypic or genetic differences from the parental seed. Thus, the PVPA applicant has not shown that it has created a “distinct” variety worthy of a PVPA certificate.

In summary, the questioner is correct that a competitor could apply to gain intellectual property rights for a gene (seed) with changes in a “few neutral molecules.” But I opine that the competitor’s application likely would fail to meet statutory requirements for either a general (utility) patent or a PVPA certificate.

Expert response from Professor Drew Kershen

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

Monday, 23/11/2015 17:13

Competitors could change just a “few neutral molecules” in a gene and apply to get a patent on that changed gene (or seed). But whether the competitor would be successful is very doubtful, in my opinion, in light of the fact that the changes involve a “few neutral molecules.”

In order to gain a patent, under the general (utility) patent laws of the United States, the person applying for the patent must satisfy four statutory requirements: new, useful, non-obvious and adequately described. Let’s briefly discuss each statutory requirement in light of the facts presented in the question – changes involving a “few neutral molecules.”

New – Has this gene ever been discussed, publicized, used publicly anywhere in the world before? If “no,” then the gene is “new.”  But if “yes,” then the gene is not new and the patent examiner would deny the application.  Let’s concede that this gene is “new” for the purpose of this statutory requirement.

Adequately Described – Let’s concede that the patent application adequately describes the gene (seed) or presents a proper biological deposit as the description.

Useful – The patent application must disclose at least one specific use or utility for the gene. Let’s concede that the patent application states a specific use or utility for the gene (seed).

I have conceded that the gene in question can meet three of the four statutory requirements for gaining a patent. However, it is the fourth requirement that likely presents, in my opinion, an insurmountable barrier.

Non-obvious – This statutory requirement requires that the patent application show a “non-obvious” invention – i.e., an inventive step. The patent application must show that what is claimed is an inventive step that persons familiar with the state of the art would not have obviously developed. As the question describes the changes as involving “a few neutral molecules,” I am very doubtful that the patent application shows an inventive step. I think the patent examiner would decline the patent on the grounds that others familiar with the art of genetic manipulation would also easily know how to make these changes of a “few neutral molecules.” Thus, the patent examiner would reject the application on the ground that the application does not meet the “non-obvious” requirement of the statute.

In addition to the general (utility) patent law, the United States also has a Plant Variety Protection Act (PVPA) that allows a sub-patent form of intellectual property in a plant variety, called a plant variety certificate.  Lawyers call the PVPA a sub-patent form of intellectual property because the PVPA statutory requirements are less demanding than the statutory requirements of the general (utility) patent law.

However, the Plant Variety Protection Act (PVPA) has statutory requirements. The PVPA examiner will not issue a PVPA certificate unless the PVPA application provides evidence satisfying each statutory requirement. These statutory requirements are: new, distinct, stable, uniform and reasonably described (including a biological deposit as the description).

Of these five PVPA statutory requirements, I think the “distinct” requirement likely cannot be met by an application that shows only changes of a “few neutral molecules.” If indeed the changes are of a “few neutral molecules,” the examiner would decide, in my opinion, that the seed does not show any distinct phenotypic or genetic differences from the parental seed. Thus, the PVPA applicant has not shown that it has created a “distinct” variety worthy of a PVPA certificate.

In summary, the questioner is correct that a competitor could apply to gain intellectual property rights for a gene (seed) with changes in a “few neutral molecules.” But I opine that the competitor’s application likely would fail to meet statutory requirements for either a general (utility) patent or a PVPA certificate.