Holding: Under pre-AIA Section 102(e), a disclosure by a different inventive entity is excluded as a reference only if it reflects the collective work of the inventive entity named in the patent and thus is not “by another.”
Merck appeals the PTAB decision in an inter partes review finding US Patent No. 7,713,947 and US Patent No. 8,377,903 to be unpatentable as obvious over a PCT patent application to Bodor and a scientific article published by Stelmasiak. In 2002, Serono, which was later bought by Merck, partnered with Ivax Corporation to develop an oral version of cladribine to treat multiple sclerosis (“MS”). Under this agreement, Serono agreed to conduct clinical trials to determine the dose, safety, and efficacy of oral cladribine tablets while Ivax would develop the oral dosage suitable for commercial sale. Serono and Ivax exchanged confidential information at a meeting in August 2003. Three of the four inventors of the patents-in-suit attended this meeting for Serono, and a Dr. Dandiker, one of the inventors of the Bodor reference was present for Ivax.
In December 2003, Serono sent Ivax a draft of a dosing regimen that included administering oral cladribine tablets for 5 consecutive days in each of two months; administering a placebo for 4 months, and then not administering any pills for 6 months. In March 2004, Dr. Bodor and Dr. Dandiker filed the Bodor PCT application, which published in October 2004, less than one year before the effective filing date of the ‘947 Patent and the ‘903 Patent. The Bodor reference discloses administering an oral cladribine-cyclodextrin complex to treat MS according to a dosing regimen that requires 10mg of cladribine given once per day for 5 to 7 days in the first month, repeated for 5 to 7 days in the second months, and followed by 10 months of no treatment.
During the IPR, Merck argued that Dr. De Luca, one of four inventors listed for the ‘947 Patent and ‘903 Patent, provided an inventive contribution to the dosing regimen described in the Bodor reference. However, the PTAB found Merck’s evidence of Dr. De Luca’s inventive contribution to be lacking. In the alternative, the PTAB also found that since Drs. Bodor and Dandiker were at least co-inventors of the disclosure in the Bodor reference, then the Bodor reference is still “by another” and qualifies as prior art.
Under pre-AIA § 102(e), a patent is anticipated if “the invention was described in . . . a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent.” In finding the Bodor reference to be prior art, the PTAB followed the decision in In re Land,[1] which stated that a prior disclosure is only excluded as prior art when there is complete identity between the patent and the inventive identity of the prior disclosure. Under Land, an individual inventor constitutes a different inventive entity than that same inventor working jointly with another. However, this does not guarantee that the individual inventor’s prior disclosure is prior art to the joint invention. In some instances, the individual inventor may discuss the joint invention with the other inventor. If the prior disclosure describes the joint invention, then it is not prior art, even if the prior disclosure is made individually, since the joint invention had to have been invented before the prior disclosure.
The Federal Circuit upheld the PTAB’s decision finding the Bodor reference to be prior art. For a disclosure to not be “by another,” and not qualify as prior art under the pre-AIA Section 102(e), the disclosure must reflect the work of the inventor of the patent in question. When the patent is a product of joint inventors, the prior disclosure must reflect the joint work of the same inventive entity named in the patent to not be considered prior art. This requires the prior disclosure to represent the collaborative invention, not just the contribution of the single individual or separate inventive entity behind the prior disclosure. This does not require all of the inventors of the patent to be named in the prior disclosure; however, the joint work of all the inventors must be shown in the prior disclosure to avoid the prior disclosure being found as prior art.
As an alternative argument, Merck claimed that the PTAB’s decision is contrary to several provisions of the MPEP. For example, Section 2132.01 of the MPEP states that “[a]n inventor’s or at least one joint inventor’s disclosure of his or her own work within the year before the application filing date cannot be used against the application as prior art.” However, the Federal Circuit found this argument to be unpersuasive. The ruling under Land controls the legal definition of “by another” and Merck cannot claim lack of knowledge of the rule of law due to contrary language in the MPEP. Additionally, despite the alleged contrary language, the MPEP does include an explanation of the definition provided by Land in Section 2136.04.
[1] In re Land, 368 F.2d 866 (CCPA 1966)
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