|May 2, 2013|
Previously published on April 30, 2013
In the wake of the Supreme Court oral arguments in the Myriad “gene patent” case, most commentators are predicting that the Court will uphold the patent-eligibility of non-naturally occurring DNA sequences (such as cDNA), but will decide that even “isolated” forms of naturally occurring DNA cannot be patented under 35 USC § 101. I have heard some say that such a decision would “harmonize” U.S. patent law with European patent law, but that is not correct.
Most entities secure patent protection in European countries by obtaining a patent from the European Patent Office (EPO) and then validating that EP patent in specific countries of interest. The prosecution and grant of EP patents is governed by the European Patent Convention (EPC), which specifically provides for the patenting of biotechnological inventions. As explained in the EPO brochure, “Patents on life?”
[A] gene which existed in an organism before but was “hidden” from the public in the sense of having no recognized existence, can be patented when it is isolated from this organism or when it is produced by means of a technical process and all other requirements of patentability are fulfilled.
This means that
[A]n invention related to gene sequences can be patented as long as the industrial application [e.g., usefulness] of the sequence is disclosed in the application.
Thus, genes, proteins, enzymes, antibodies, viruses, cells, microorganisms, plants and animals generally can be patented in Europe. On the other hand, DNA sequences without a known function, genetically modified animals which suffer but are not associated with a substantial medical benefit, plant varieties, animal varieties, human embryos and processes which involve the use and destruction thereof, human germ cells and human-animal chimeras cannot be patented.
The French and German Exceptions
France and Germany do have restrictions on patenting human genes, but these restrictions apply only to national patents (e.g., patents obtained directly in France or Germany), not to EP patents that are validated in France or Germany.
France prohibits patents to human genes, in article L611-18 of the Code de la propriété intellectuelle:
Le corps humain, aux différents stades de sa constitution et de son développement, ainsi que la simple découverte d’un de ses éléments, y compris la séquence totale ou partielle d’un gène, ne peuvent constituer des inventions brevetables.
On the other hand, the same article expressly provides for patents on specific uses of genes
Seule une invention constituant l’application technique d’une fonction d’un élément du corps humain peut être protégée par brevet. Cette protection ne couvre l’élément du corps humain que dans la mesure nécessaire à la réalisation et à l’exploitation de cette application particulière. Celle-ci doit être concrètement et précisément exposée dans la demande de brevet.
The legality of these restrictions does not appear to have been tested, and some believe that they may be invalid because they conflict with European law. See, e.g., Gold and Carbone, “Myriad Genetics: In the Eye of the Policy Storm,” Appendix B (Detailed Legal Analysis of Gene Patents, Competition Law and Privacy Law) (The Innovation Partnership).
Germany expressly provides for the patenting of “isolated” human genes, but requires a “use” restriction in the claims.
Section 1a of the German Patent Act provides in paragraph (2):
An element isolated from the human body ... including the sequence or partial sequence of a gene, may constitute a patentable invention even if the structure of that element is identical to that of a natural element.
Under paragraph (3), such sequences only can be patented if the application describes “the function fulfilled by the sequence.” This requirement is similar to the EPC “industrial applicability” requirement and the U.S “utility” requirement.
On the other hand, paragraph (4) states:
Where the subject matter of an invention is a sequence or a partial sequence of a gene, the structure of which is identical to the structure of a natural sequence or partial sequence of a human gene, the use thereof ... shall have to be included in the patent claims.
Notably, even the French and German restrictions are limited to human genes. While the Myriad patents relate to human gene sequences, because the Supreme Court is analyzing patent-eligibility under the “product of nature” exception to § 101, its decision is not likely to draw a distinction between human genes and genes from other organisms.
Australia, Canada, and Japan
Australia, Canada, and Japan also permit the patenting of human genes, under circumstances similar to the EPC. That is, the genes must be “isolated” and the patent application must teach how the genes are useful or have “industrial applicability.” Further, these countries (and the EPO) grant patents on genetic tests, which the Supreme Court made more difficult to patent in the U.S. by its decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, which held that the discovery of a correlation between a physical parameter (e.g., blood metabolite levels) and a medical condition (e.g., a need for an increased or decreased dose of a drug) is not patent-eligible because it relates to a natural phenomenon.
The U.S. Will Stand Alone
As the foregoing review shows, if the Supreme Court decides that even “isolated” forms of naturally occurring DNA sequences cannot be patented under 35 USC § 101, the U.S. will stand alone among countries such as Australia, Canada, Europe, and Japan. The U.S. already stands apart with the difficult decision in Prometheus v. Mayo. It is disappointing to see the Supreme Court take U.S. patent law down a path that restricts the types of inventions that can be patented regardless of how novel, non-obvious and useful they are.