In re Nature’s Remedies: Foreign Regulatory Submission Invalidates Patent Under 102(b)

In re Natures Remediesssp_temp_capture.jpg (Fed. Cir. 2009) (nonprecedential)

In October of 2005, a third party (Jemo-Pharm) submitted a request for ex parte re-examination of Natures Remedies patented claim covering an herbal composition of guarana, damiana, and yerbe-mate claimed to cause weight loss. More than one year before Remedies’ filing date, an anticipating composition had been submitted to a Danish regulatory organization as part of a request for approval for clinical testing. (The decision is unclear, but implies that the submission was done by Remedies).

A Danish official provided testimony that the submission was a public record and was open for inspection since its date of submission. Remedies’ expert, however, argued that a Danish trade-secrecy law would have prevented such inspection. The BPAI accepted the open-access line of argument and found the submission invalidating prior art under 35 USC 102(b). The patentee appealed – arguing that the official submission was not sufficiently publicly accessible to be considered 102(b) prior art.

On appeal, the Federal Circuit affirmed – finding that the regulatory submission was publicly available more than one year before Remedies filed its application. The court began by recognizing that the official’s testimony created a prima facie case that the submission was publicly accessible – shifting the burden to the patentee. Of course, BPAI factual findings such as this will be affirmed with a finding of “substantial evidence.”

Because [the Danish Official's] declaration established a prima facie case of public availability, the onus was on Remedies to demonstrate that the [regulatory submission] was not accessible to interested members of the public. Remedies, however, failed to carry its burden.

Under the Danish trade-secrecy law, the regulatory submissions are kept secret when they are of “material importance” to a company’s “economy.” It appears that Remedies could have proven its case but failed to provide evidence to the Board.

Attorney argument, however, cannot take the place of record evidence. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997); Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). Here, the evidence of record does not establish that Remedies intended to keep the formulation of the Medi-Tab capsule confidential until after the study had been completed and a patent application had been filed.

Rejection affirmed

Notes:

  • 102(b) looks at prior art that was “described in a printed publication” more than one year prior to the date of application for the US patent. Implicit within ‘publication’ is a notion that the material is publicly accessible. Notably, however, there is generally no need to prove that the material was actually accessed. Thus, in this case, there is no discussion of whether the regulatory submission was ever seen by anyone.
  • Read the case
  • Reexam No. 90/007,785 (look it up in PAIR).
  • In some ways, this case is simply an extension of the Pivonka v. Axelrod case where the Federal Circuit held that the applicant has waived arguments by failing to present them at the Board of Patent Appeals.

7 thoughts on “In re Nature’s Remedies: Foreign Regulatory Submission Invalidates Patent Under 102(b)

  1. Michael, if you’re saying that IDS’ing something is an admission that it’s prior art, you’re wrong. Submitting something on an IDS is absolutely NOT and admission that’s it’s prior art. That’s why most practitioners err on the side of caution in IDSing – if it’s not prior art, you can explain why, but if it is and you didn’t IDS, go show that it’s not inequitable conducts. But if you admit it’s prior art in the application or a declaration, then you’re stuck.

  2. In any case, Natures Remedies had an easy solution too, just file your patent application before you submit any information to an outside party. Had they filed their provisional before submitting to the Danish office, then this would not have been prior art at all.

  3. Two additional “printed publication” bars upheld without a “printed publication” in the conventional plain meaning of those words were some un-catalogued but accessable Canadian patent application drawings [not in any foreign equivalents and withdrawn before the patent was published], and In re Wyer, 655 F.3d 221 (CCPA 1981) (An Australian patent application kept on microfilm at the Australian Patent Office was a “printed publication”).
    So this “In re Natures Remedies” case had a predictable remedy, thanks to a very thorough prior art investigation only litigants can usually afford.
    [The fact that a 102 bar is such a conveniently easy way for a court to dispose of a patent case probably does not help those arguing against it.]

  4. To Mr. Morgan: I totally agree with you. After In re Klopfenstein and the CAFC’s inexcusable redefinition of publication – “public accessiblility” as the standard has become a joke.

    However, I cannot say that I disagree with the outcome of In re Nature’s. The ruling is at least consistent with a fair interpretation of “printed publication.”

  5. In view of a long-standing and consistently broad and strict CAFC interpretation of “printed publications” bars to cover things that are NOT “printed,” such as an unknown single typed copy of a paper in any single library anywhere in the world in any language, as long as it is catalogued there, plus, more recently, posters posted at technical conventions, and the next logical step is any accessable internet posting, it certainly seems time to remove the now-misleading word “printed”.

  6. Who is Sherer? If this is an inventor who submitted it in a declaration (and IDS?) then of course the case is decided correctly… he submitted it as a reference which is showing that it is available as prior art under 102(b).

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