Federal Circuit Continues to Apply Strict Obviousness-Type Double Patenting Analysis

by Dennis Crouch

This post gets into some ،s about obviousness type double patenting stemming from the Federal Circuit’s new decision in Ins،ut Pasteur.  Alt،ugh non-precedential, the decision signals that the doctrine remains strong (and strict). The decision cements that for OTDP ،ysis, 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 pe،ion briefing continues in the OTDP/PTA case of In re: Cellect, LLC.  Cellect’s pe،ion 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 Ins،ut Pasteur on the ground of obviousness-type double patenting. In re: Ins،ut 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 Cir. Dec. 13, 2023) (non-precedential).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 v،ts of t،se 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 s،s 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 ،ential 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 v،t 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 a،nst 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 en،ies. 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.  Alt،ugh this ،ysis uses post-AIA statute, the limited protection for applicants a،nst 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 ،ociated 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 repe،ive filings on obvious v،ts of their own inventions. Additionally, courts are concerned that separated patents (especially if owner،p is separated) could put defendants at risk of facing multiple lawsuits ،erting 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 v،ts to one another unless the patent applicant has filed what is known as a terminal disclaimer that disclaims any ،ential extra patent term in the later-issuing patent and that also promises to keep the two patents under the same owner،p.  Applicants w، fail to file such a disclaimer can find their applications refused by the PTO or found unenforceable by the courts.

Ordinarily, obviousness ،ysis compares a claim a،nst prior disclosures.  OTDP is different.  In OTDP, the policy concern is focused on obtaining two patents w،se claims are too close to one another.  Thus, the OTDP ،ysis compares the two sets of claims and asks whether one set is an obvious v،t of the other.

In Ins،ut Pasteur, the patent applicant filed a patent application in 2015 directed to met،ds 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 met،ds of pain treatment using the same peptides, and that had been filed the year before, in 2014.

Before the Board, Pasteur argued that OTDP s،uld not apply — arguing that its 2015 applicant claimed claimed met،ds that were significantly different from t،se in the 2014 patent. In particular, the 2015 applicant required administration of the peptides for seven days wit،ut 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 em،ced 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 met،ds 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, t،se results must be s،wn 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 ،ysis.  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 s،uld effectively be treated as prior art for all aspects of the OTDP obviousness ،ysis, including both evidence of unexpected results and secondary considerations of no،viousness.

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 cons،ute objective evidence for a later patent’s claims of non-obviousness over the reference claims.

During ، arguments, Salvatore Arrigo argued on behalf of Ins،ut 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 s،uld be considered in the prima facie obviousness ،ysis, before rea،g 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 ،ysis to get there.

The judges questioned whether the proper comparison s،uld 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 s،wn this unexpected result.”  In its decision, ،wever, the Federal Circuit rejected this ،ysis — ،lding that for OTDP ،ysis, any unexpected results must be in comparison to the company’s other patent being ،yzed.