Federal Circuit Affirms BPAI’s Unpatentability Ruling on Natures Remedies’ Weight Loss Drug

Holding:

The U.S. Court of Appeals for the Federal Circuit has affirmed the rejection by the Board of Patent Appeals and Interferences (“BPAI”) of a patent claim relating to weight reduction capsules. Specifically, the BPAI ruled that claim 2 of U.S. Patent No. 5,945,107 (the “’107 patent”) held by Natures Remedies, Ltd. was anticipated by a reference entitled “The Effect of Medi-Tab Capsules on the Ventricular Emptying Time” (the “Medi-Tab Application”) – a reference which was submitted to a Danish regulatory organization more than one year prior to the December 8, 1997 priority date of the patent-at-issue. On appeal, the Federal Circuit affirmed the BPAI’s finding that the regulatory submission was publicly available more than year before Remedies filed its patent application. The Federal Circuit reasoned that a Danish official’s testimony that the Medi-Tab application was kept open for public’s inspection created a prima facie case that such submission was publicly accessible. The burden of proof of showing that the submission was not publicly available falls on Remedies. But Remedies failed to discharge such burden. Under the Danish trade-secrecy law, regulatory submissions are kept secret when they are of "material importance" to a company's "economy." Specifically, Remedies failed to 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.

Detailed Summary:

Remedies filed this appeal against a decision of the BPAI” affirming the rejection of claim 2 of U.S. ’107 patent as unpatentable under 35 U.S.C. § 102(b).

Remedies manufactures and distributes herbal products. In 1999, it obtained the ’107 patent, entitled “Compositions and Methods for Weight Reduction.”

The BPAI affirmed the rejection of claim 2 as anticipated by the Medi-Tab Application. The Medi-Tab Application, which was submitted to the Scientific-Ethical Committee of Copenhagen in Denmark (the “Copenhagen Committee”), sought approval for clinical testing of Medi-Tab capsules on the emptying time of the human stomach, and was dated April 10, 1996, more than a year prior to the December 8, 1997, priority date of the ’107 patent.

In determining that claim 2 of the ’107 patent was anticipated by the Medi-Tab Application, the BPAI relied upon the declaration of Unna Scherer, who served as Secretary for the Copenhagen Committee. Scherer declared that the Medi-Tab Application has been kept in the Committee’s files since April 10, 1996 and has been open to inspection by the public.

The BPAI determined that the Scherer declaration was “impartial evidence” sufficient to establish a prima facie case that the Medi-Tab Application was “publically available” and therefore a “printed publication” under 35 U.S.C. § 102(b). In an effort to rebut this prima facie showing, Remedies submitted the declaration of Henrik B. Sanders, a Danish attorney.

But the BPAI 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. The BPAI held that 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.” Remedies then timely appealed to the Federal Circuit.

In this appeal, the Federal Circuit noted that parties did not dispute that the Medi-Tab Application teaches every element of claim 2. Nor did they dispute that it was submitted to the Copenhagen Committee on April 10, 1996, more than one year before the December 8, 1997, priority date of the ’107 patent. According to the Federal Circuit, the narrow issue on appeal was whether the Medi-Tab Application was accessible to the public and therefore a “printed publication” under 35 U.S.C. § 102(b).

The Federal Circuit agreed with the BPAI’s finding that the declaration of Unna Scherer, the Secretary for the Copenhagen Committee, was sufficient to establish a prima facie case that the Medi-Tab Application was publicly accessible more than one year prior to the ’107 patent’s critical date. 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.” Opinion. p. 5. The public accessibility of the Medi-Tab Application was further supported by the Copenhagen Committee’s indexing protocol.

Because Scherer’s declaration established a prima facie case of public availability, the onus was on Remedies to demonstrate that the Medi-Tab Application was not accessible to interested members of the public, the Federal Circuit wrote.

Remedies, however, failed to carry its burden. The only piece of evidence it submitted to demonstrate lack of accessibility was a declaration from Sanders, a Danish attorney. The Federal Circuit however agreed with the BPAI’s holding that Sanders did not establish that the information in the Medi-Tab Application was “of material importance” to Remedies’ financial interests. Thus, as the BPAI correctly concluded, his declaration was inadequate to demonstrate that the Medi-Tab Application would have been exempt from disclosure under Article 12(1).

The BPAI’s determination as to public accessibility, moreover, was supported by the fact that the Medi-Tab Application itself contains no restrictions on public dissemination, the Federal Circuit added. To the contrary, the application states the results of the study would be “published in an international gastro-enterological medical publication.” Id., p. 8.

On the basis of the foregoing, the Federal Circuit affirmed the BPAI’s rejection of claim 2 of the ‘107 patent as unpatentable under 35 U.S.C. Section 102(b).

Also See:

USPTO to Implement Inventor’s Oath or Declaration Provisions of the Leahy-Smith America Invents Act

U.S. Patent and Trademark Office Seeks Public Input on Proposed Fees

USPTO to Test New Post Final Rejection Option

USPTO Expands Patent Law School Clinic Certification Pilot Program

USPTO Launches Small Business Innovation Research Pilot Program