CAFC- March 12, 2009-Herbal patent claims held anticipated under 102(b)

The patent at issue claimed a composition which promotes weight loss using a combination of herbs(Guarana, Damiana and Paraguay), wherein one herb is capable of inhibiting gastric emptying and another herb is capable of increasing metabolic rate.

Federal circuits affirmed that this claim was anticipated by Medi-tab capsules whose clinical testing reports were submitted to Danish authorities one year prior to the priority date of the patent at issue. Medi-Tab capsules contain three herbal extracts: Guarana, Damiana and (Yerbe) Maté, which is another term for the herb Paraguay.

In determining that the patent was anticipated by the Meditab data, CAFC relied on declaration of Scherer, director of Scientific-Ethical Committee of Copenhagen in Denmark where the Medi-tab capsule registration was carried out. To rebut this evidence defendents has submitted declaration from a Sanders a Danish attorney who stated that “Since the formulation for the Slimming Product disclosed in the [Medi-Tab] Application would be regarded as “information on technical plan or processes or on operation or business procedures or the like, the [Medi-Tab] Application is covered by the exception in article 12(1), 2° of The Danish Open File Act, and would not have been available to the public before the effective filing date of [the] U.S. Patent Application”

CAFC concluded that Sanders’ declaration failed to establish that the Medi-Tab Application would have qualified for exemption from disclosure under Article 12(1) of the Danish Open Files Act. In order to be exempt from disclosure under that provision, information must be of such “material importance to the economy of the person or enterprise” that a request for access to the information will be refused. Sanders, however, failed to demonstrate that the information in the Medi-Tab Application was of “material importance” to Remedies’ “economy.”
CAFC observed that the Medi-Tab Application stated that the results of the Medi-Tab study would be “published in an international gastro-enterological medical publication,” and that this undercut Remedies’ assertion that information in the application was intended to be kept confidential.
As per 102- “A person shall be entitled to a patent unless . . . the invention was patented or described in a printed publication in this or a foreign country . . . more than one year prior to the date of the application for patent in the United States.” This statutory “bar is grounded on the principle that once an invention is in the public domain, it is no longer patentable by anyone.”

Both parties agreed that Medi-Tabs teach each and every element of the claim. They also agree that it was submitted to Danish authorities more than year before the priority date. The issue here was whether the Medi-Tab Application was accessible to the public and therefore a “printed publication” under 35 U.S.C. § 102(b).
Scherer stated, based upon her “personal knowledge” that the Medi-Tab Application was a “public record” that had “been open to inspection by the public” since April 10, 1996 “in accordance with the rules in the Danish Open Files Act.” The board’s determination as to public accessibility, moreover, is supported by the fact that the Medi-Tab Application itself contains no restrictions on public dissemination. To the contrary, the application states the results of the study would be “published in an international gastro-enterological medical publication.” Furthermore, the application indicates that volunteers participating in the study will be provided with the project number of the clinical trial notification—presumably so that they could access information about the study in the Copenhagen Committee’s index. The fact that there is nothing in the Medi-Tab Application evidencing an intent to keep its contents confidential serves to buttress the board’s determination that it was publically available prior to the ’107 patent’s critical date