The Bayh-Dole Act of 1980 grants universities the right to elect to take title in any patent application and patent that was made by their researchers with the support of the Government, e.g., NIH. 35 USC s. 200 et seq. This clears the path for universities and other non-profit institutions to license the patents, potentially exclusively, to commercial entities (like big Pharma) that, hopefully will fund further research and eventually bring a drug to market. Prior to 1980, the Government kept title, and was responsible for licensing such technology. However, due to a lack of resources and red tape, most Government-funded inventions never saw “the light of day.”
Posts Tagged ‘biotechnology news’
In July of 2011, I wrote a post for this blog on BSC v. J&J, a Fed. Cir. decision in which four J&J patents claiming stents eluting rapamycin, a drug that inhibits restenosis after balloon angioplasty, were held invalid for failure to meet the requirements of the written description requirement of s. 112 (1) [now s. 112(a)]. While the specification only disclosed stents releasing rapamycin, the claims used broader language, such as “rapamycin or a macrocyclic triene analog of rapamycin.” While such analogs were known, none were named in the specification. Still, J&J must have felt that they had a fighting chance, since a specification need not describe that which is known to the art.
A three-judge panel of Moore, Bryson and Gajarsa found that the claims failed to meet the WDR. However, instead of explaining why the specification read in combination with the knowledge available to the art about rapamycin analogs fails the UC v. Lilly WDR standards, Moore and Bryson relied on the deficiencies they found in the specification:
“Given the absence of information regarding structural characteristics of [rapamycin analogs] in the specification, the unpredictability of the art and the nascent state of using drug eluting stents…we affirm the [grant of SJ]. The patent laws do not reward an inventor’s invitation to other researchers to discover which of the thousands of macrocyclic lactone analogs of rapamycin could conceivably work in a drug-eluting stent.”
Paul Cole, Professor of Intellectual Property Law at Bournemouth University and European Patent Attorney at Lucas & Co, Warlingham, Surrey, UK discusses yesterdays Myriad ruling by the Supreme Court.
How does yesterday’s Supreme Court decision match international opinion on the patentability of biological material? From a European and indeed from an Australian standpoint it can be said with some confidence: not so well.
The USPTO has now made its policy clear in a letter from Andrew H Hirshfeld, Deputy Commissioner for Patent Examination Policy to the Patent Examining Corps:
“As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101. Claims clearly limited to non-naturally-occurring nucleic acids, such as a cDNA or a nucleic acid in which the order of the naturally occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible. Other claims, including method claims, that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.
The entire commentary can be downloaded here: Myriad Commentary.
Today, the Supreme Court ruled that a naturally occurring DNA sequence is a product of nature, and not patent-eligible simply because it has been “isolated.” (A copy of the ruling can be found at the end of this post.) However, the Court “split the baby” and held that cDNA is patent eligible, because it is not naturally-occurring, e.g, is sufficiently man-made. The core rationale was that Myriad did not create a composition of matter “with markedly different characteristics from anything found in nature,” taking language from what commentators consider dicta in Chakrabarty. In other words, genes, though they can be defined by their chemical structure, are not “new…composition(s) of matter” under s. 101.
The Court rejected the Fed. Cir.’s two opinions (e.g., authored by Judge Lourie) that severing chemical bonds “that bind gene molecules together” yielded new compounds and, oddly to this ex-chemist, stated that “[t]he claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section” but instead “focus on the genetic information encoded in the BRCA1 and BRCA2 genes”[Emphasis added]. In other words, the Court bought the somewhat metaphysical argument made by the ACLU attorney representing AMP et al (or the one professor found to have standing) that DNA molecules are simply repositories and transmitters of information. Maybe we practitioners are lucky the Court didn’t rule that they also were patent-ineligible as abstract ideas – a popular category these days.