UCB v. Accord, Appeal no. 2016-2610 et al. (Fed. Cir., May 23, 2018) may be headed to the Supreme Court, which prompted me to take another look at this opinion. This was a decision in Hatch-Waxman litigation, in which a split Fed. Cir. panel affirmed the district court’s ruling that the valuable patent in suit, RE38,551, that covers the anti-epileptic drug lacosamide was not anticipated, obvious, or invalid for obviousness-type double patenting. Judge Stoll wrote the opinion, joined by Judge Bryson. Judge Prost dissented.
The most interesting parts of this lengthy opinion, apart from the thorough review of obviousness-type double patenting were the effort by the panel to draw the line between the obviousness of resolving an R/S mixture that contains the active R compound and obviousness due to the motivation provided by a “lead compound.” There was quite a lot of prior art for the defendants to piece together to get to the fairly simple structure of lacrosamde: BzN(H)-C(O)-CH(MeOMethyl)-N(H)C(O)Me. The key substituents were Benzyl (Bz)(R), the unsubstituted methyl at the other end of the molecule (R1) and the methyoxymethy goup (R3).
To briefly summarize some of the prior art, the inventor had published a number of papers, one of which disclosed a lacrosamide-like molecule with an MeON(H)- group as R3. The inventor had two earlier patents contained broad generic claims, but neither of which claimed lacrosamide per se. (The ‘301 patent was not prior art to the ‘551 patent and was only relevant to the obviousness-type double patenting rejectioin.) Worse yet, it seemed, was a thesis by LeGall that disclosed a racemic mixture of R/S lacrosamide and stated that it “may have good activity.” However, Le Gall also speculated that aromatic groups at R3 would be more bioactive.
After much deliberation, the USPTO has published a Final Rule mandating that the claim construction standard articulated by the Fed. Cir. in Phillips v. AWH Corp., 415 F.3d 1301 (Fed. Cir. 2005), and used by federal district courts, will replace the broadest reasonable interpretation (BRI) standard currently used by the PTAB in Inter partes review (IPR), post grant review (PGR) and transitional program for covered business patents (CBM), collectively “AIA Proceedings”. See Fed. Reg., 83, 51340 (October 11, 2018). The Final Rule is applicable to all AIA proceedings petitions filed on or after the effective date of November 13, 2018.
Two points are of some interest and raise some questions. The Phillips standard will not be applied to reissue or ex parte reexamination proceedings, even though the prosecution history is complete regarding the patents under review. One commentator has suggested that the Phillips standard should be applied in prosecution, but at first, I did not see how this is possible with an incomplete prosecution history. But consider; the Examiner uses BRI to interpret the claims and then locates prior art to establish a prima facie case that the claim fails under 102, 103 and/or 112. The Applicant must rebut the rejections, and often uses Phillips-type evidence to meet that burden (such as limiting disclosures in the specification of a prior art patent). So maybe we are closer to the general applicability of the Phillips standard to claim interpretation than we think.
Anyone familiar with the fate of claims to primers used in PCR, to amplify a stretch of target DNA in order to determine whether or not a significant mutation is present, could write the opinion in this appeal (No. 2017-1690 (Fed. Cir., October 9, 2018)). The target gene in this case was the M. tuberculosis (“MTB”) gene, rboB. The presence of this gene is diagnostic for MTB and the presence of certain single site mutations indicate that the MTB strain is rifamycin resistant.
The claims in question in U.S. Patent No. 5643723 [Eds. Note: I wrote and prosecuted this patent.], were directed to small genus of specific primers and to a diagnostic assay using PCR to detect the presence or absence of identified “signature nucleotides” in the rboB gene in a patient’s DNA sample. If you want to skip to the most interesting part of this post, you can skip the next six paragraph’s and start with my comments on Judge O’Malley’s concurring opinion.
From this dreary starting point, the affirmation of the district court’s grant of S.J. of invalidity under s. 101 was inevitable. Judge Reyna (writing) relied on In re BRCA1 – & BRCA2 – Based Hereditary Cancer Test Patent Lit., 774 F.3d 755 (Fed. Cir. 2014) (“BRCA 1”) and, of course, on Myriad, 569 US 576 (2013), summarizing pages of Mayo/Alice analysis by stating that “Those primers ‘are not distinguishable from the isolated DNA found patent ineligible in Myriad’ and thus are not patent eligible” (citing BRCA1). The panel then rejected Roche’s argument that primers are “chemically and structurally distinct from any nucleic acid that occurs in nature or that can be isolated from naturally occurring DNA.”
Posted in Section 101
Tagged biotechnology patent law, BRCA DNA, Federal Circuit, Judge O'Malley, M. tuberculosis, MTB, Myriad, nucleotides, PCR, Section 101, Warren Woessner
Although Director Iancu’s address primarily aims at the difficulty of determining when a claim is directed to an abstract idea, his precursor guiding light is clearly the late Judge Giles Rich. Notably, Iancu quotes from Judge Rich. These quotes are all taken from Judge Rich’s lengthy opinion In re Bergy, 596 F.2d 952 (CCPA 1979):
“[Judge Rich] said at the time that problems [with s. 101 jurisprudence] can arise due to the unfortunate… though clear commingling of distinct statutory provisions which are conceptually unrelated, namely those pertaining to categories of invention in s. 101 which may be patentable, and to the conditions of patentability [ss. 102, 103, 112].”
“The genius of the 1952 Patent Act, of which Judge Rich is widely viewed as a principal author, was that it characterized the bases for patentability. Our recent s. 101 case law mushes them all up again. As Judge Rich said, this ‘may lead to distorted legal conclusions,’ And it has. And it must end.”
“Section 101 itself lists four categories [of invention]: process, machine, manufacture, and composition of matter. The judicial exceptions should likewise be clearly categorized. As Judge Rich explained, when we deal with s. 101, “the sole question… is whether the invention falls into a named category, not whether it is patentable.’’
“Judge Rich was again perceptive, which he noted 40 years ago that ‘To provide the option of making such a rejection under either 101 or [a condition for patentability] is confused and therefore bad law.’” Continue reading