In the shadow of its recent, precedent-challenging In re Cellect decision, the Federal Circuit illustrated the pedestrian application of its obviousness-type double patenting jurisprudence in affirming the Patent Trial and Appeal Board's rejection on ODP grounds in In re Institut Pasteur.

The case arose in an appeal during ex parte prosecution of rejections on ODP grounds of claims directed to methods for treating pain using opiorphin, one of a number of preparations of peptides derived from human Basic Proline-rich Lacrimal Protein (BPLP) in Application No. 14/730,396 ("'396 Application"). Claim 17 is representative:

17. A method for treating pain comprising administering a dose of 10-300 mg/day of a peptide consisting of the sequence Gln-Arg-Phe-Ser-Arg (SEQ ID NO:2) or Glp-Arg-Phe-Ser-Arg (SEQ ID NO:55) for 7 days.

The claims in the '396 patent were rejected over several claims of related U.S. Patent No. 9,403,871, claims 1 and 6 being representative:

1. A method for treating pain comprising administering an effective amount of an isolated peptide consisting of up to 15 amino acids to a human subject,
wherein the peptide comprises the sequence Glu-Arg-Phe-Ser-Arg (SEQ ID NO: 3) or Glp-Arg-Phe-Ser-Arg (SEQ ID NO: 7),
wherein the peptide exhibits an inhibitory property against a neutral endopeptidase or an aminopeptidase and
wherein the peptide has the same amino acid sequence as that found within human Basic Proline-rich Lacrimal Protein (SEQ ID NO:2) or differs from the amino acid sequence found within SEQ ID NO:2 by two or less amino acid substitutions. . . .

6. The method of claim 1, comprising administering a dose of 10-100 mg of the peptide.

(where for the biochemically curious the abbreviation "Glp" stands for pyroglutamate).

The co-owned '871 patent was filed a little more than one year before the '396 application. The basis for the ODP rejection asserted by the Examiner was that "it would have been 'obvious for one of ordinary skill in the art to treat chronic pain by the methods of claims [of the '871 patent] which would require treatment for several days, 7 included.'" In Pasteur's earlier appeal to the PTAB, the Board agreed with the Examiner that "pain" as recited in the '871 patent includes "acute pain" and "chronic pain such as arthritis or inflammatory bowel disease." It is important to note in view of this reasoning that there is a fine line to be drawn between assessing ODP based on the claims of a related patent having patentably indistinct claims and considering the teachings of the specification of such a related patent. Here, the significance of the disclosure of such a related patent is in how the terms recited in the claims are interpreted (e.g., with regard to claims reciting "pain" to include "chronic pain" in view of how "pain" is construed in view of the specification).

In addition, in the Board's view, the '871 recited a claim term for an "effective amount" of the peptide used in the claimed method that encompassed within its scope the 10-100 mg dosage recited in claim 6 of the '396 application. Finally, with regard to the "7 day" limitation the Board held that chronic or persistent pain would be understood by the skilled worker to be subject to a 7-day course of treatment.

Applicant's response to the Board's affirmance of this rejection in the earlier appeal was to continue prosecution by filing an amendment, exemplified in the opinion as follows:

17.[] A method for treating pain in a human patient comprising administering a dose of 1 mg/kg to 2mg/kg at 10-300 mg/day of a peptide consisting of the sequence Gln-Arg-Phe-Ser-Arg (SEQ ID NO:2) or Glp-Arg-Phe-Ser-Arg (SEQ ID NO:55) to the patient for 7 days without inducing pharmacodependence or tolerance in the patient.

These amendments were of no avail, the Examiner asserting an ODP rejection to these claims. According to the Examiner, simple math yielded a daily dosage of 80-160mg for an average-sized patient (80kg), which daily dosages were within the scope of the '871 patent claims used to support the earlier ODP rejection previously affirmed by the Board (and not appealed to the Federal Circuit). As for the limitation to avoid pharmacodependence or tolerance to the drug, the Board held that this limitation simply reflected "[t]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, [that] does not render the old composition patentably new to the discovered," citing Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999).

Not deterred, applicants filed a declaration by one of the inventors, who attested that "'opioid receptor agonists, such as morphine' are the 'most efficient drugs to alleviate severe pain' but their 'clinical usefulness has been limited by the development of tolerance and dependence that occurs after long-term treatment.'" Further, the declarant attested that "'it was expected that opiorphin could induce tolerance and dependence – just as morphine does' and 'opiorphin's lack of the detrimental side effects of opioids – tolerance and dependence – was surprising and unexpected.'" Thus, the declarant attested that the invention claimed in the '396 application "fulfill[ed] a long-felt need for efficient pain-controlling compounds without the detrimental side effects of opioids – tolerance and dependence."

The Examiner was unimpressed, finding in the declaration admissions that the analgesic properties of opiorphin were known in the art at the recited dosages, despite acknowledging the declarant to attest that "further research found opirphin [sic] to have a minimal adverse morphine-associated effect and to produce analgesic potency, and concludes that this effect was surprising and unexpected." For the Examiner, the declaration admits that "the instant method of treatment of pain uses the same drug and the same dose as taught by the '871 patent," and so "[t]he only remaining disputed difference between the scope of the instant claims and the claims of the '871 patent is the duration of the treatment." The latter distinction had been before the Board previously and although further research had adduced evidence of the mechanism of pharmacodependence this was just an instance of discovery of new properties of the drug which knowledge did not render the claims patentable, according to the Examiner in maintaining the ODP rejection. Finally, regarding the assertion that the claimed invention satisfied the objective indicia of non-obviousness, the Examiner's position was that these claims recited "an identical process of administering the same drug to treat the same pathology, which is expected to produce identical results" and the recited adjustments in dose and treatment time were "a finite number of identified, predictable solutions, and one of ordinary skill in the art would have recognized that the results of this adjustment are predictable."

The Board affirmed, based on the inclusion of chronic pain in the methods claimed in the'871 patent and that "there is no dispute here that the '871 patent's claims teach treating chronic pain with the same drug, at the same dose, for the same duration as presently claimed." Under these circumstances if this treatment regimen did not induce tolerance or pharmacodependence that was an inherent property of the treatment and did not render the '396 claims patentably distinct sufficient to overcome the ODP rejection.

The Federal Circuit affirmed, in an opinion by Judge Clevenger, joined by Judges Taranto and Stoll. The opinion notes that the Board had relied on its decision in the first appeal of these claims that addressed the limitations argued by Pasteur in this second appeal to be wanting. The Federal Circuit considered the Board's decision to be supported by substantial evidence as a consequence, including "concessions" by Pasteur at oral argument regarding the identity of the drug and the dosage between the '871 patent claims and the '396 application claims. The panel also held that the Board's conclusion that the lack of tolerance or pharmacodependence in the '396 application claims was an inherent property of the claimed method also was supported by substantial evidence. With regard to the objective indicia, the opinion also finds substantial evidence supported the Board's conclusions of obviousness under the ODP doctrine. In particular, the Federal Circuit agreed that the '396 application claims did not satisfy a long-felt need over the '871 patent claims because practice of the method claimed in the '871 patent would satisfy that need.

Unlike the patentee in Cellect, of course, Pasteur will be able to bring these claims to grant by filing a terminal disclaimer. However, this will result in a patent expiration date for these claims to be March 18, 2025 instead of (at a minimum) May 26, 2029 (subject to patent term adjustment for the time spent appealing the rejection before the Board and Federal Circuit). These calculations provide ample explanation for Pasteur's efforts in overcoming the asserted ODP rejections without filing a terminal disclaimer.

In re Institut Pasteur (Fed. Cir. 2023)
Nonprecedential disposition
Panel: Circuit Judges Taranto, Clevenger, and Stoll
Opinion by Circuit Judge Clevenger

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