THE USPTO isn't exactly renowned for patent quality; it's known as the 'go-to office' for quick and easy patents and it's also known for its ridiculous number of patents (recently exceeded 10 million).
Last week, in Natural Alternatives International, Inc. v. Iancu, the Federal Circuit affirmed a determination by the U.S. Patent and Trademark Office Patent Trial and Appeal Board in an inter partes reexamination affirming the Examiner's rejection of the challenged claims of U.S. Patent No. 8,067,381 as being anticipated or obvious over the cited prior art, as well as the Board's denial of the patentee's request for rehearing. The '381 patent is owned by Appellant Natural Alternatives International, Inc. ("NAI").
The inter partes reexamination was requested by Woodbolt Distributors, LLC, which had been involved in district court litigation with NAI concerning the '381 patent. In its request, Woodbolt asserted that the priority claim of the '381 patent was defective because NAI "deliberately and expressly terminated" its claim to the benefit of the first four priority applications by breaking the chain of priority between the fourth and fifth priority applications.
A federal appeals court on Tuesday said a patent owned by Roche Molecular Systems Inc on a method of detecting tuberculosis should not have been granted, handing a win to rival diagnostics company Cepheid Inc.
This recognition significantly reduces the precedential effect of the BRCA1 decision and provides, perhaps, a way for a future panel to distinguish claims to primers from this precedent. Judge O'Malley reminds her colleagues and us that the BRCA1 decision did not rule on the patent eligibility of PCR primer claims and does not compel the result the Court announced here.
Judge O'Malley's concurrence also notes that this case, unlike the BRCA1 case, contains unresolved questions of material fact that, while disregarded by the Court may provide another basis for distinguishing the BRCA1 decision. Citing the distinctions drawn by the Supreme Court in Myriad between genomic DNA and cDNA, Judge O'Malley opines that while the BRCA1 opinion sets forth the basis for finding the PCR primer claims to be patent ineligible, "it is not clear from the BRCA1 opinion or record why we reached this conclusion. The lack of record evidence underlying BRCA1's conclusion on this point is important in light of the record in this case." She then goes on to recite the factual distinctions argued by Roche regarding the differences between the claimed primers and the sequences as they occur in nature (including the differences in strandedness, complementarity ("a primer comprising a nucleotide sequence of ATCG is complementary to, but unquestionably different from, a natural DNA strand comprising a sequence of TAGC"), the presence of a 3' hydroxyl group, the linearity of the primers versus the circular nature of bacterial DNA, and that natural "primers" comprise RNA and not DNA). All these facts were adduced from expert testimony and thus for Judge O'Malley raise "genuine issue of material fact" that are not appropriate for summary judgment. Judge O'Malley also notes that the claimed primers here have a markedly different function, unlike the genomic DNA in Myriad, due to the presence of the 3' hydroxyl group which permits PCR amplification to occur. Judge O'Malley apprehends that the patentee in this case raised factual issues not addressed in the Court's BRCA1 decision, and thus, "unlike the appellants in Myriad and in BRCA1, here, Roche submitted evidence of record that, at the very least, raises genuine issues of material fact as to whether there exists anything in nature that both has the structure and performs the function of the claimed primers." Accordingly, she believes not only that the BRCA1 decision does not compel the Court's conclusion here, but that the question should be taken up en banc to clarify the law regarding the patent eligibility of oligonucleotide primers and perhaps methods of using such primers to amplify targeted portions of DNA.
While this concurring opinion is a welcome ray of sunshine on a cloudy day, the practical effects of this, like so many Federal Circuit decisions on eligibility, is to incentive non-disclosure of inventions such as these, with the concomitant injury to progress that trade secret protection of diagnostic methods is almost certain to create. It should be self-evident that this outcome is contrary to the Constitutional mandate underlying the patent system, but it appears the current constitution of the Court is unconcerned with this outcome. Perhaps Chief Judge Woods of the Seventh Circuit was right after all.