Written by Dan Hart, Ph.D. and Jeffrey Wu, Ph.D.

I. Overview

The Supreme Court recently declined to hear several patent cases, thus leaving the decisions by the Federal Circuit intact. Issues that were not taken up by the Supreme Court include (1) whether performing patented methods for assessing the quality of pharmaceutical compositions is an act of patent infringement by virtue of constituting “making” a product using a patented method and whether practicing such methods is protected from being an act of infringement under the “safe harbor” provisions of the patent law (Amphastar), (2) the patent eligibility of methods developed based on the discovery of biological principles (Genetic Technologies), and (3) the appealability of the USPTO’s Patent Trial and Appeal Board’s decision to terminate inter partes review proceedings after such proceedings have been initiated (GEA Process). The Federal Circuit’s decisions in Amphastar, Genetic Technologies, and GEA Process which were left intact by the Supreme Court are summarized below.

II. Making a Product Using a Patented Method and Safe Harbor Provisions under the Hatch-Waxman Act

Under Section 271(g) of the patent law, it is an act of infringement to offer to sell or to sell within the United States a product which is made by a process patented in the United States. However, the “safe harbor” provisions in Section 271(e) of the patent law provide that it is not an act of infringement to practice a patented method solely for uses reasonably related to the development and submission of information to the Food and Drug Administration (FDA).

In Momenta Pharmceuticals, Inc. v. Teva Pharmaceuticals, Inc. the patent at issue related to a process for quality control testing of each batch of a drug after the drug had been synthesized. The Federal Circuit first considered whether performing the patented method constituted selling a product “made” by a process patented in the United States. The court concluded that, because the drug had already been synthesized prior to performing the patented method, the drug had not been “made” using the patented process. Accordingly, the court determined that there was no infringement under Section 271(g) of the patent law.

Next, the Federal Circuit considered whether the “safe harbor” provisions of Section 271(e) of the patent law protected the submission of the quality control information obtained using the patented methods to the FDA from being an act of infringement. In particular, Section 271(e) of the patent law protects certain forms of drug testing needed for FDA approval from being an act of infringement but does not shield post-approval testing for “information that may be routinely reported to the FDA.” The Federal Circuit found that post-approval activities of quality control testing each and every batch of a drug fell within the category of “information that may be routinely reported to the FDA” and was not protected by the “safe harbor” provisions.

In deciding not to hear the appeal from the Federal Circuit decision, the Supreme Court declined the opportunity to consider whether the terminology “made” within Section 271(g) of the patent law refers only to methods for manufacturing a product. The Supreme Court also declined the opportunity to consider whether the safe harbor provisions of Section 271(e) protect post-approval quality control testing.

III. Patent Eligibility

Recent Supreme Court decisions have found that patent claims directed to a natural law are not eligible for patent protection unless they contain an “inventive concept” that provides something significantly more than a patent on the natural law itself. The “inventive concept” cannot be supplied by features which are well known, conventional or routine.

In Genetic Technologies, Limited v. Merial LLC, the patent at issue was based on a natural phenomenon known as “linkage disequilibrium,” through which certain coding regions and non-coding regions in DNA tend to be inherited together more frequently than random chance would dictate. In particular, the patent related to a method of detecting a coding region allele by amplifying and analyzing a linked non-coding region sequence.

The Federal Circuit found that the claims covered “essentially all applications, via standard experimental techniques of the law of linkage disequilibrium to the problem of detecting coding sequences of DNA” and that the claim “relies on the existence of linkage disequilibrium . . . indisputably a universal, inherent feature of human DNA.” Consequently, the Court found that the claims were directed to a natural law.

Next, the Court found that the process of examining a non-coding sequence to detect a coding allele was a mental process step that did not provide an inventive concept because it merely sets forth a routine comparison that could be performed by the human mind. It found that the novelty of this step resulted entirely from the novelty of the discovery of a new natural law – linkage disequilibrium. For this reason, it found that there was no “inventive concept” and that the claims were patent-ineligible.

In deciding not to hear the appeal from the Federal Circuit decision, the Supreme Court declined the opportunity to provide further guidance regarding the patent eligibility of biotechnology-based inventions.

IV. Appealability of Decisions Relating to Institution of Inter Partes Review Proceedings

Section 314(d) of the patent law provides that the determination whether to institute an inter partes review (IPR) is final and nonappealable. In GEA Process Engineering Inc. v. Steuben Foods, Inc., GEA Process filed petitions requesting the Patent Trial and Appeal Board (PTAB) to institute IPR proceedings against patents owned by Steuben Foods. The Board instituted IPR proceedings on five IPR petitions. The IPR petitions listed GEA Process as the sole real-party-in-interest. However, during discovery, Steuben Foods discovered and that GEA Procomac, an affiliate of the petitioner, had also helped to pay for the IPR petition expenses. Steuben Foods sought termination of the IPR proceedings on the assertion that GEA had violated Section § 312(a)(2) of the patent law, which provides that an IPR petition may be considered only if the petition identifies all real parties in interest. The PTAB agreed and terminated all five of the IPR proceedings it had previously instituted.

The Federal Circuit found that it lacked jurisdiction to hear the appeal. It held that its authority to review IPR decisions was limited to the PTAB’s decisions regarding the patentability of the claims in the patents. In particular, the Court found that § 314(d) of the patent law rendered the PTAB’s decision to terminate the previously instituted IPR proceedings final and nonappealable.

In deciding not to hear the appeal from the Federal Circuit decision, the Supreme Court declined the opportunity to address the appealability of the PTAB’s decision to terminate an IPR proceeding after the proceeding has been initiated.