Last week, the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc. Justice Thomas, writing for a unanimous Court, ruled that isolated DNA sequences are not patent eligible. The Court did permit the patent claims to isolated cDNA to stand.
The gene patent saga filed by the ACLU on behalf of a large number of plaintiffs has finally come to an end. After 4 years of litigation and 2 trips to the Supreme Court, the law is that isolated DNA is no longer eligible for patent protection. cDNA, however, remains patentable.
Given the recent Supreme Court decisions on patent eligibility under § 101, the only surprising thing about the opinion was that they did not strike down all of the claims. Myriad retains its claims to methods of screening patients for the genetic mutation that indicates a higher propensity for breast and ovarian cancers, and it retains its claims to complementary DNA (cDNA).
The opinion did not seem to conflate patent eligibility with novelty or obviousness as in Mayo v. Prometheus. The opinion in Myriad started with the statutory language and then turned to the judicial exceptions for “laws of nature, natural phenomena, and abstract ideas.” The Court then quoted extensively from Mayo to expound on these exceptions:
without [these] exception[s], there would be considerable danger that the grant of patents would “tie up” the use of [basic tools of scientific and technological work] and thereby “inhibit future innovation premised upon them.”
This idea from Mayo is that patents inhibit research and development instead of encouraging it. It has been thought for years that one of the purposes of patents is to provide an incentive to innovate. These statements bring that premise into question.
And, of course, by definition a patent will “tie up” the claimed subject matter. That’s the whole point: to be able to exclude others from copying the claimed invention.
In the analysis of the isolated DNA, the Court held that Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. “Myriad did not create anything,” according to the Court. “[S]eparating [the] gene[s] from [the] surrounding genetic material is not an act of invention.” The PTO apparently thought otherwise for about 30 years. The Supreme Court whisks it all away without providing support for the contention that is does not constitute an act of invention.
The Court did recognize that cDNA is not naturally occurring. It may retain some characteristics of the isolated DNA, but it is generally created in the lab and does not exist in the human body. Therefore, cDNA is still patent eligible.
Finally, the Court seemed to try to give some hope and encouragement to the biotechnology industry:
- The Court noted that no method claims were included in its opinion. Innovative methods of manipulating the genes would still be patent eligible.
- The Court noted that new applications of knowledge about particular genes may still remain patent eligible.
- The Court noted that it provided no opinion on the patent eligibility of DNA in which the order of the naturally occurring nucleotide sequences has been altered.
On the third point, the Court did not provide guidance. How much alteration is required for patent eligibility?
Justice Scalia wrote a rather bizarre opinion concurring in part and concurring in the judgment.
I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.
This is something to keep in mind regarding these cases. The judges and juries who must ultimately rule on them will very rarely understand the science behind them. They are usually not this candid in admitting their lack of understanding.
How will this opinion affect the biotechnology industry? Given this and other recent Supreme Court opinions on patentable subject matter, it seems that patents in the area of personalized medicine will be difficult to obtain and enforce. Many biotechnology companies are working on ways to grow organs that can be transplanted into the human body to replace defective organs. The goal is for these organs to be as similar to the natural organs as possible. This opinion seems to indicate that such organs could not be patented. HT: IPWatchdog.
Given the extensive costs of research in these areas, will companies continue to make large scale investments? The Supreme Court seems to be arguing, somewhat contrary to historical understandings, that patent inhibit rather than encourage research. Monopoly profits for the limited term of the patent are set to encourage companies to make large initial upfront investments.