AMP v. Myriad: The End of Gene Patents?

There are several notable aspects to the Federal Circuit’s recent AMP v. Myriad redecision. Of particular interest is the court’s scientific claims: that because isolated DNA and cDNA sequences are different molecules from genomic DNA, they are not “products of nature” that run afoul of patent eligibility. The court extends this reasoning to conclude that isolated DNA and cDNA are neither “isolated or purified” products of nature because they are covalently cleaved from their surrounding sequences in genomic DNA. Therefore, according to the court, such “molecules” do not exist in nature in an identical form at all. In dissent, Judge Bryson argues that this rationale is no different than allowing patent eligibility to a leaf broken off of a tree branch–an analogy the majority does not substantively engage with (or take seriously).

Also of note is the Federal Circuit’s belief that the Supreme Court’s decision in Mayo did not apply to Myriad’s patents’ composition claims because Mayo concerned itself with only method and system claims. That may very well be a close and faithful reading of Mayo–as discussed elsewhere–but this appears to be precisely the sort of bright-line distinctions for which Supreme Court has repeatedly rebuffed the Federal Circuit. (See eBay, KSR, and Bilski.) Given that Mayo was unanimous, it would be very surprising if the Supreme Court left this thinking untouched on a higher appeal.

The majority also took great pains to dispose of the public policy interests–and voluminous briefing on the subject–in the case:

Before reviewing the applicability of the Supreme Court’s Mayo holding to the claims of the Myriad patents, however, it is important to state what this appeal is not about. It is not about whether individuals suspected of having an in-creased risk of developing breast cancer are entitled to a second opinion. Nor is it about whether the University of Utah, the owner of the instant patents, or Myriad, the exclusive licensee, has acted improperly in its licensing or enforcement policies with respect to the patents. The question is also not whether is it desirable for one company to hold a patent or license covering a test that may save people’s lives, or for other companies to be excluded from the market encompassed by such a patent—that is the basic right provided by a patent, i.e., to exclude others from practicing the patented subject matter. It is also not whether the claims at issue are novel or nonobvious or too broad. Those questions are not before us. It is solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter under 35 U.S.C. § 101 in light of various Supreme Court holdings, particularly including Mayo.

While the legal issues surrounding Myriad will surely be at the coalface of patent law for years to come, the immediate effects of the case on the litigants will likely be negligible. Though the Federal Circuit upheld Myriad’s composition claims, it affirmed the District Court’s grant of summary judgment invalidating the contested method claims–that is, the patent claims directed to the method of using BRCA1/2 mutations to determine breast cancer susceptibility. At this case’s first oral argument, however, plaintiffs’ counsel conceded that his clients could sequence patients’ BRCA1 and BRCA2 genes without Myriad’s patented primers–the (currently) validly patented compositions. Now that Myriad’s patents’ method claims are invalid, it appears that there’s nothing standing the in the plaintiffs’ way from performing the previously patented tests. This surely seems like a Pyrrhic victory for Myriad: it may have won its case on its composition claims, but those patents without their attendant method claims seem relatively worthless. One can’t help but think that other genetic diagnostic companies would be in similar positions.

It would seem that Myriad has made diagnostic gene patents commercially nonviable. Myriad may very well have spelled the end of gene patents as we know them.