Posts Tagged: "law of nature"

The U.S. Department of Commerce’s United States Patent and Trademark Office (USPTO) will host a public forum on May 9, 2014 at the USPTO headquarters in Alexandria, Virginia, to solicit feedback from organizations and individuals on its recent guidance memorandum for determining subject matter eligibility of claims reciting or involving laws of nature, natural phenomena, and natural products (Laws of Nature/Natural Products Guidance). The Laws of Nature/Natural Products Guidance implemented a new procedure to address changes in the law relating to subject matter eligibility in view of recent Supreme Court precedent.

From this perspective, (and setting aside considerations of novelty or obviousness) one might conclude that, rather than claiming some methods with reference to anything that looks like a law of nature in a claim, thus raising the specter of §101, it may be better to claim some methods more broadly so as to avoid such issues – maybe obtaining broader claim scope in any event.

Well, Justice Breyer, the writer of the dissenting opinion in Laboratory Corp. v. Metabolite Laboratories, Inc., finally got his wish. Writing the opinion for a unanimous Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Breyer ruled that a claimed drug dosage calibration method based on previously unknown “precise correlations between metabolite levels [of administered thiopurine drugs] and likely harm or ineffectiveness” was patent-ineligible under 35 U.S.C. § 101 because it “adds nothing to the laws of nature that is not already present when the steps [of the claimed method] are considered separately.” While I’m not surprised that Breyer ruled the claimed method patent-ineligible, his reasoning in Mayo Collaborative Services is, in my view, often nonsensical, and is fraught with unfortunate statements that could potentially eviscerate the patent-eligibility of drug testing methods generally under 35 U.S.C. § 101.

The sky is falling! Those who feel the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. is terrible are right, although many won’t likely fully apprehend the gravity of the situation at first. Those in the biotech, pharmaceutical and chemical industries have just been taken out behind the woodshed and summarily executed by the Supreme Court this morning. An enormous number of patents will now have no enforceable claims. Hundreds of billions of dollars in corporate value has been erased. But that might be a good thing. Immediate attention now must turn to Congress. Thank goodness that the technical amendments to the America Invents Act are outstanding. This will provide a perfect opportunity for Congress to save an industry that employs many millions of people, while at the same time undoing a pathetic, narrow-minded decision of the Supreme Court.

This was a very interesting discussion, although I was surprised at how little Bilski was mentioned. Although the hearing did digress on some tangents, the Justices’ questioning was generally on point and indicative of the difficult questions a case like this presents. Surely, the Court will be thinking of the impact a decision might have on the healthcare industry, as well as the information technology industry. Also, Justices are no doubt aware of other pending cases which may find their way to the Supreme Court, such as AMP v. USPTO, Classen v. Biogen, and the divided infringement cases of McKesson and Akamai. I will leave the reader to reach their own conclusions, but my best guess is that the Court is leaning toward the position that §101 should be a coarse filter and that §102 and §103 would be more appropriate to challenge the validity of the claims in this case. We will learn the answer in the spring.

All in all it seemed to me that the majority of the court seemed more skeptical about the Mayo position and more supportive of the Prometheus position. That being said, it is extremely troubling to contemplate the possibility that Chief Justice Roberts was more in tune with the thinking of Justice Breyer. It is also disheartening to see such a fundamental misunderstanding of patent law on the part of the Chief Justice. At the end of the day the Justices of the Supreme Court will say what the law is on this issue, but sometimes it is hard to imagine a less qualified bunch to opine on a patent issue.