Supreme Court Invalidates Two Patents Claiming Screening Methods Under 35 U.S.C. § 101
On March 20, 2012, the Supreme Court of the United States issued a unanimous decision in Mayo Collaboration Services v. Prometheus Laboratories invalidating two patents under 35 U.S.C. § 101, as claiming, non-patentable subject matter, i.e., laws of nature, without sufficient additional method steps to justify issuance of a patent.
The patents in question were drawn to methods for optimizing a therapeutic regime for specific diseases by a method which determined, via blood testing, whether the dosage of a drug was too high or too low. In brief, the three steps of the main claims called for (i) administering a dosage of the drug to a subject with the disease in question, and (ii) determining the level of the drug in the subject, and then (iii) comparing the level to specific values, where a level below one value indicated a need to increase the dosage, and a level above a second value indicated a need to decrease the drug.
The Court held that the claims implicitly incorporated a law of nature into the comparison step, because the specification (but not the claims), indicated that the higher value in the comparison was a cut-off for toxic side effects. The Supreme Court indicated that while this was not a known law of nature, it was one, nonetheless, i.e., at levels above the given value, the drug in question was toxic.
Recognizing that all patent claims to some extent implicate laws of nature the Court looked to the steps claimed for applying them to assess patentability. The Court held that while there were “administering,” “determining,” and “comparing” steps in the claims, these steps were well understood, routine, conventional activities for one of ordinary skill in the art and were insufficient to convert a law of nature into a patentable invention. As the Court stated:
“To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately .”
The Court analyzed other Supreme Court decisions addressing 35 U.S.C. § 101, including Diamond v. Diehl, 450 US 175 (1981), which found a patent to satisfy 35 U.S.C. § 101 because it integrated use of an equation in conjunction with other steps which “transformed the process into an inventive application of the formula,” and Parker v. Flook, 437 US 584 (1978), which held that, if one put the equation used in the claims to the side, there was no inventive concept to the claim, i.e., it was “conventional or obvious.”
Interestingly, while the Court’s statements suggest that consideration of novelty and obviousness factored into their holding, it expressly declined an invitation posed by the Solicitor General to base analysis on 35 U.S.C. § 102 and § 103, or to incorporate considerations of laws of nature into analysis under these statutes.
It is, of course, too soon to predict how the USPTO and the lower courts will apply this decision to other method patents other than those related to comparative screening, but it is expected that business method patents will be subject to the same analysis. We suggest that in presenting claims which involve comparative screening, such as those involved in the patents at issue, care should be taken to include at least one step which is believed to be sufficient to render the claims patentable without the inclusion of the law of nature, such as for example, a specific protocol unique to the screening that is not necessarily conventionally practiced. We also suggest that the Court’s admonition that not all laws of nature are “known,” let alone “well known,” but nonetheless, if ultimately laws or nature will not perforce support of a patent claim.
We suggest that holders of patents which claim diagnostic methods generally, and diagnostic screening methods in particular, consider a review of these patents to determine if narrowing reissue applications are in order. While issues of intervening rights may arise as a result of these proceedings, they may preserve the validity of the patent. Applicants with patent applications that present these types of claims should consider reviewing these, and if necessary, either incorporate additional material in the pending claims or amend the claims to avoid potential application of this decision upon examination.