by Dennis Crouch
This post gets into some weeds about obviousness type double patenting stemming from the Federal Circuit’s new decision in Institut Pasteur. Although non-precedential, the decision signals that the doctrine remains strong (and strict). The decision cements that for OTDP analysis, any comparison of unexpected results or long-felt need must be made to the applicant’s own earlier patent claims, not the closest “prior art.” The court also endorsed reliance on inherency to satisfy claim limitations not found in earlier claims.
I’ll note here en banc petition briefing continues in the OTDP/PTA case of In re: Cellect, LLC. Cellect’s petition has been supported by 10 amicus briefs. The PTO responsive brief is due December 14, 2023.
The Federal Circuit recently affirmed a PTAB rejecting claims in a patent application filed by Institut Pasteur on the ground of obviousness-type double patenting. In re: Institut Pasteur, No. 2022-1896 (Fed. Cir. Dec. 13, 2023) (non-precedential). This case provides additional insight into the doctrine of obviousness-type double patenting and the ongoing high bar set by the Federal Circuit for overcoming such rejections. Opinion by Judge Clevenger, joined by Judges Taranto and Stoll.
Obviousness-type double patenting is a judge-made doctrine designed to prevent applicants from extending patent rights first obtaining an earlier-expiring patent and then obtaining a later-expiring patent with claims that are obvious variants of those in the earlier patent. The policy goal is to prevent unjustified timewise extension of exclusive patent rights. The doctrine was particularly relevant for patent applications filed prior to 1995 because patent term was calculated at 17 years after patent issuance. Today, patent term starts ticking as soon as the patent application — making it much more difficult to stagger patent rights in order to evergreen protection. (Note that one way to differentiate patent timing is through PTA — and that is being challenged in the Cellect case discussed above.) In addition, the doctrine is designed to protect potential defendants from unfairly facing multiple infringement lawsuits.
The Gap in 102 for Self-Harming Prior Art: Everyone knows that you cannot obtain a patent that merely claims an obvious variant of the prior art. 35 U.S.C. 103. Section 102 of the Patent Act defines prior art, and includes an important exception that is incredibly relevant to the OTDP situation. In particular, we know that the first-inventor-to-file provision found in 102(a)(2) spells out, as the name suggests, that a prior-filed patent application (once it becomes public) will serve as prior art against a later filed patent application. The important exception for OTDP purposes is that Congress limited the first-to-file provision of 102(a)(2) to applies only in cases where the two competing patent applications name different inventors and are owned by different entities. In other words, Congress carved out an exception such that your own earlier-filed patent application does not qualify as prior art that could invalidate your later-filed application under 102(a)(2), even after the earlier application publishes. Although this analysis uses post-AIA statute, the limited protection for applicants against self-harming prior art also existed in the pre-AIA statute.
What we have here is a gap in the scope of prior art within the statute associated with the patentee’s own pre-filing activities. Courts have acknowledged that these filings by patent applicants are not prior art under the statute, but recognize policy concerns that justify limiting applicants’ rights anyway. Specifically, courts want to prevent applicants from unjustly extending patent protection with repetitive filings on obvious variants of their own inventions. Additionally, courts are concerned that separated patents (especially if ownership is separated) could put defendants at risk of facing multiple lawsuits asserting what is essentially the same invention.
The judge made solution then is to act in equity to bar an applicant from obtaining or enforcing to patents that are obvious variants to one another unless the patent applicant has filed what is known as a terminal disclaimer that disclaims any potential extra patent term in the later-issuing patent and that also promises to keep the two patents under the same ownership. Applicants who fail to file such a disclaimer can find their applications refused by the PTO or found unenforceable by the courts.
Ordinarily, obviousness analysis compares a claim against prior disclosures. OTDP is different. In OTDP, the policy concern is focused on obtaining two patents whose claims are too close to one another. Thus, the OTDP analysis compares the two sets of claims and asks whether one set is an obvious variant of the other.
In Institut Pasteur, the patent applicant filed a patent application in 2015 directed to methods of treating pain by administering opiorphin. The examiner rejected the pending claims as obvious over the claims of a different Pasteur patent directed to similar methods of pain treatment using the same peptides, and that had been filed the year before, in 2014.
Before the Board, Pasteur argued that OTDP should not apply — arguing that its 2015 applicant claimed claimed methods that were significantly different from those in the 2014 patent. In particular, the 2015 applicant required administration of the peptides for seven days without inducing drug dependence or tolerance, whereas the 2014 patent did not specify any particular duration of treatment or recite the lack of dependence/tolerance. The PTAB rejected that distinction and instead affirmed the examiner’s rejection, finding that the 2014 patent embraced treatment of chronic pain, so it would have been obvious to administer the therapy for over seven days. The Board also found that avoiding dependence/tolerance would be an inherent result of carrying out the methods of Pasteur’s earlier 2014 patent.
On appeal, the Federal Circuit affirmed the Board’s decision strictly applying obviousness-type double patenting. The court reiterated that when unexpected results are used to rebut a prima facie case of obviousness, those results must be shown to be unexpected compared to the closest prior art (here, Pasteur’s 2014 patent). In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Pasteur failed to make that comparison. The court also endorsed the Board’s use of inherency to fill in the missing claim limitation of dependence/tolerance as part of the obviousness analysis. The trick here that the court played, is that this “closest prior art” precedent comes from ordinary obviousness cases, not OTDP cases. See Baxter. And, as you recall, Pasteur’s 2014 patent is not prior art. Here, the court made the leap that it should effectively be treated as prior art for all aspects of the OTDP obviousness analysis, including both evidence of unexpected results and secondary considerations of nonobviousness.
Regarding secondary considerations, the Federal Circuit affirmed the Board’s dismissal of Pasteur’s long-felt need evidence. Pasteur had argued there was a long-felt need for pain medication that avoids issues of drug tolerance and dependence. However, the court endorsed the Board’s finding that any such need was already satisfied by Pasteur’s 2014 patent claims. In other words, in obviousness-type double patenting, where reference claims satisfy a long-felt need, that need does not constitute objective evidence for a later patent’s claims of non-obviousness over the reference claims.
During oral arguments, Salvatore Arrigo argued on behalf of Institut Pasteur before the panel of Judges Taranto, Clevenger, and Stoll. Arrigo emphasized that unexpected results are an “integral part” of determining obviousness under Graham v. John Deere. He argued that the unexpected lack of tolerance and dependence when administering the claimed peptide for 7 days should be considered in the prima facie obviousness analysis, before reaching a conclusion on obviousness:
You have to look at the unexpected results first to figure out if it’s obvious. If you don’t, it’s always an expected results are always going to be inherent 100 percent of the time because you’ve already reached obviousness before considering. It’s part of the obvious analysis to get there.
The judges questioned whether the proper comparison should be to morphine or to the closest prior art, the claims of the ‘871 patent. Mr. Arrigo maintained morphine was the appropriate comparison “because the prior art is just this giant genus and no one within that genus ever did anything that would have shown this unexpected result.” In its decision, however, the Federal Circuit rejected this analysis — holding that for OTDP analysis, any unexpected results must be in comparison to the company’s other patent being analyzed.
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December 14, 2023 at 12:03AM
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Federal Circuit Continues to Apply Strict Obviousness-Type Double Patenting Analysis - Patently-O
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