Biotech, Business Method, and Software Patents Receive a Boost

The determination of what constitutes patent eligible subject matter has been at the forefront of patent law in recent years. The United States Code has long held that “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101. Judicially-created exceptions to eligibility have, however, lead to uncertainty. In 2014, the United States Supreme Court addressed the patent eligibility of an invention for a computer-implemented scheme for mitigating settlement risk, wherein the Court determined that the invention was directed to patent-ineligible subject matter. See Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S. Ct. 2347. In the wake of that decision, there has been heightened dispute and confusion about what qualifies as patent eligible subject matter, as well as the mechanisms used to make that determination. Inventions in fields such as biotech, business methods, and software have been caught in the crosshairs.

In view of this background, a recent court ruling and the USPTO’s response have enhanced the requirements for a determination that an invention is directed to ineligible patent subject matter. In Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018), the Federal Circuit emphasized:

The question of whether a claim element or combination of elements is well-understood, routine and conventional to a skilled artisan in the relevant field is a question of fact. Any fact, such as this one, that is pertinent to the invalidity conclusion must be proven by clear and convincing evidence. See Microsoft Corp. v. i4i Ltd. P'ship, 564 U.S. 91, 95, 131 S. Ct. 2238, 180 L. Ed. 2d 131 (2011).

Berkheimer, 881 F.3d at 1368. The Federal Circuit further expounded that:

Whether something is well understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination. Whether a particular technology is well understood, routine, and conventional goes beyond what was simply known in the prior art. The mere fact that something is disclosed in a piece of prior art, for example, does not mean it was well-understood, routine, and conventional.

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Id. at 1369. In light of these standards, the Federal Circuit in Berkheimer determined that there was a genuine issue of material fact as to whether certain claims perform well-understood, routine, and conventional activities to a skilled artisan, which prevented summary judgment on ineligibility. Id. at 1370.

​In response to the decision, the USPTO in April issued a new set of guidelines for examiners regarding the determination of patent ineligible subject matter. Some examiners previously had a tendency to summarily conclude, without evidentiary support, that an invention was directed to ineligible subject matter. Now, with the new guidelines, examiners are required to support a determination of ineligible subject matter with express statements by the applicant, prior court decisions, publications such as books, or official notice based on personal knowledge of the examiner. If an examiner takes official notice, the applicant can challenge the examiner to provide another type of evidence to support a finding that a claim element is directed to well-understood, routine, and conventional activity.

It remains to be seen what the long-term impact will be of the Berkheimer decision and the new USPTO examination guidelines. Patent ineligibility will now spin on whether there is a sufficient factual basis to support a determination of ineligible subject matter. The bar has been raised.

If you have any questions about patent eligible subject matter, contact your patent attorney to seek advice.