Source: http://blogs.law.widener.edu/nanolaw/category/bionanotechnology/
Timestamp: 2019-04-20 08:48:20+00:00

Document:
In 2010, the U.S. Supreme Court issued a closely-watched decision on patentable subject matter under § 101 of the Patent Act, Bilski v. Kappos, 130 S. Ct. 3218 (2010). The Court has now granted cert in another case on patentable subject matter – Prometheus Laboratories, Inc. v. Mayo Collaborative Services, in which the Federal Circuit Court of Appeals held in 2010 that certain medical inventions met the requirements of patentable subject matter in § 101. Prometheus was the sole and exclusive licensee of certain patents that claim methods for determining the optimal dosage of thiopurine drugs used to treat gastrointestinal and non-gastrointestinal autoimmune diseases. When Prometheus sued Mayo for patent infringement, Mayo filed a motion for summary judgment of invalidity, arguing that the patents in question were invalid because they claimed subject matter unpatentable under the Patent Act, 35 U.S.C. § 101. Specifically, Mayo argued that the patents impermissibly claimed natural phenomena – i.e. the correlations between drug metabolite levels and efficacy and toxicity – and not patentable inventions. In 2008, the district court granted Mayo’s motion for summary judgment of invalidity.
In 2009, the Federal Circuit reversed and upheld the patents under the “machine or transformation” test (the sole test at the time). The U.S. Supreme Court then decided Bilski v. Kappos, which we discussed in this blog a year ago. In Bilski, the Court rejected the “machine or transformation” test as the definitive test of patentability, relegating that test to one factor – “a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under § 101.” 130 S. Ct. at 3227. The Supreme Court then granted Mayo’s petition for certiorari in the Prometheus lawsuit, vacated the Federal Circuit’s 2009 decision, and remanded the case for further proceedings consistent with Bilski. The Federal Circuit decided the case on briefs, without further oral argument, and held, in light of Bilski, that Prometheus had recited patentable subject matter under § 101. 628 F.3d 1347 (Fed. Cir. 2010). Once again, the Supreme Court granted certiorari, and the Court will hear the case in the term that begins in October, 2011.
628 F.3d at 1354 (quoting Bilski, 130 S.Ct. at 3230) (emphasis added). This is the core of the issue to be decided by the Supreme Court.
As my co-blogger, Eric Laury, now J.D., stated in his earlier post about Bilski, “biotech and nanotech patents are not theoretically involved with . . . a machine nor do they transform matter.” Bilski was good news for the bionanotech industry, but the case left loose ends. Now it appears that the Supreme Court will take another step in the direction of defining patentable subject matter for the brave new world of modern inventions. Nanotech firms, particularly those working in the area of biotechnology, should be closely watching the Supreme Court’s next move.
I suspect the fact that the Court granted cert a second time in Mayo v. Prometheus may not be a good sign for Prometheus. It may mean that the Court had been expecting the Federal Circuit to reach the opposite result and wants to set the record straight. On the other hand, the Court may further refine its definition of patentable subject matter under § 101 in a way that may achieve middle ground between innovation and patent protection.
Earlier I reported here on Microsoft Corp. v. i4i Limited Partnership, then subsequently on the oral argument before the U.S. Supreme Court. The case arose from a patent infringement dispute relating to the method for editing computer documents, but generated wide-ranging interest in the business community, including developers of nanotechnology-based inventions, because of the broad legal issue addressed. i4i sued Microsoft for patent infringement, and Microsoft defended on the ground that i4i’s patent was invalid. The federal district court gave a jury instruction that the invalidity of a patent had to be proved by “clear and convincing” evidence. Despite Microsoft’s arguments that it should be easier to prove invalidity of a patent (such as by applying a preponderance-of-the-evidence standard) in patent infringement litigation, the federal district court, Federal Circuit Court of Appeals, and the U.S. Supreme Court (in an 8-0 decision) all decided that the clear and convincing standard applied.
Justice Sotomayor, writing for the unanimous Court, 131 S. Ct. 2238 (2011), based the Court’s decision squarely on Section 282 of the Patent Act, 35 U.S.C. § 282, which provides a presumption of validity to patents, and on longstanding common-law doctrines. The Court deferred to the judgment of Congress in the Patent Act, saying that “[w]here Congress has prescribed the governing standard of proof, its choice controls absent ‘countervailing constitutional constraints.” (p. 2244) No such constraints existed here. Addressing Microsoft’s other argument – that a preponderance standard should apply where, as here, not all evidence in the case had been before the PTO during the patent examination process – the Court said that information could be a factor in the jury’s decision, but did not warrant a different standard of proof. (p. 2250-51).
For nanotechnology firms with existing patents on inventions or in the R&D process, the Court’s decision is good news. It provides a strong measure of certainty and economic stability to stakeholders investing in and promoting the patented technologies. It also allows firms to bring patent infringement claims while maintaining some sense of security about their own patent’s validity. Taken together with the 2010 Supreme Court case of Bilski v. Kappos, 129 S. Ct. 2735 (2010), which retained a broad definition for patentable subject matter, Microsoft v. i4i should provide nanotech patent holders with plenty of reason to be pleased.

References: § 101
 v. 
 v. 
 § 101
 § 101
 v. 
 § 101
 § 101
 v. 
 § 101
 v. 
 § 282
 v. 
 v.