Next up is Dr. Anja Schmitt, comparing Myriad and Mayo to EPO practice, and describing gene patents and diagnostic method patents in the EPO.
Human gene patents
The basic question of human gene patents–as will be familiar to those who followed the Myriad litigation–is whether isolated DNA is a product of nature/mere discovery, or a man-made product with technical character. In the Myriad case, claims covered isolated DNAs for the BRCA1 and BRCA2 genes which are useful for identifying a predisposition to breast cancer.
At the EPO, on the other hand–using the same sources of law as Dr. Nichogiannopoulou mentioned before–genes are patentable as long as they disclose the industrial applicability and the function of the gene and/or its encoded protein.
According to Rule 29(1), simple discoveries of human genes are not patentable, but under Rule 27(a), isolated biological materials are patentable, even if previously occurring in nature, and under Rule 29(2), elements isolated from the human body, including partial or whole gene sequences, may constitute a patentable invention, even if structurally identical to natural elements.
Of course there’s a “but,” though – the industrial application must be disclosed (Rule 29(3)), along with a credible “function” at the molecular, cellular, or physiological level, or any other use (e.g., diagnostic use). Note that this lets you get a patent on the product–the isolated DNA–not just on the specific use. The Board of Appeals has consistently agreed with this position.
Dr. Schmitt follows up with how Myriad’s case played out in the EPO. Myriad received patents on isolated nucleic acids and diagnostic methods; however, these patents were subject to heavy opposition and appeal by 9 separate parties (including Greenpeace!). The final version of the patent was quite limited, but not based on any ethical appeals; instead, they lost priority because of some technical sequence differences (for EPO patent wonks, it was a Rule 123(2) problem).
Overall, DNA patents are fine as long as you stick the word “isolated” in front of the DNA claim and disclose a use – very broadly, including for medicine, diagnosis, receptors/drug targets, enzymatic activity, or other uses.
Diagnostic Methods
Dr. Schmitt turns to diagnostic methods, addressed in the U.S. by the Supreme Court in Mayo v. Prometheus in 2012. Prometheus’ patents including 3 steps – administering a drug, measuring the metabolite concentration, and a “wherein” step reciting correlations useful for adjusting dosage. The Supreme Court held that this claimed a law of nature and was consequently invalid.
At the EPO, in contrast, the patent was granted in 2005 because the correlation was considered non-obvious; no opposition was filed, and it’s still a valid patent.
In general, diagnostic methods are regarded as inventions with technical character and are thus patentable, no matter whether a natural principle. So methods of diagnosis, prognosis, determining drug response, specific modes of drug administration, and specific dosage regimens are all patentable, as long as they’re carried out in vitro. Only novelty, inventive step, and disclosure sufficiency of disclosure are barriers.
Read posts on the other presentations:
Part I: Dr. Aliki Nichogiannopoulou, EPO
