Pronova Biopharma Norge v. Teva Pharmaceuticals, et al.

Docket Nos. 2012-1498, -1499

September 12, 2013


Brief summary: Anticipating public use found where doctor was provided patented composition without any confidentiality restriction.

Summary: Teva appealed DC final judgment for Pronova that its US 5,656,667 and 5,502,077 patents relating to fish oils (for the product Lovaza®) were infringed, not obvious or anticipated by prior public use, and not proven unenforceable due to inequitable conduct. The FC panel reversed the DC determination regarding anticipation for prior public use. Teva alleged several public uses of the claimed compositions but only one of these was determined to be invalidating. Dr. Victor Skrinska of St. Vincent Charity Hospital was provided liquid vials that Pronova conceded met all the limitations of the asserted ‘667 claims. It determined that Skrinska has tested the compositions to confirm content, discussed the compositions with colleagues, and administered capsules to himself and others. The opinion reviewed the legal standard of public use under 35 USC § 102(b) and precedential case law (Dey, FC 2013; Invitrogen, FC 2005). In Dey, the court found no public use where only the clinical trial administrator, who was bound by a confidentiality agreement, was informed of the claimed formulation and stability characteristics. The Invitrogen decision explained that either public accessibility or commercial exploitation (requiring more than “a secret offer for sale”) would qualify as “public use” (e.g., without a confidentiality agreement). It was also explained that the “ready for patenting” requirement under Pfaff (US 1998) also “applies equally to the public use bar of § 102(b).” Several prior decisions were reviewed, including Allied Colloids, FC 1995 (public use “when ‘a completed invention is used in public, without restriction'”); W.L. Gore, FC 1983 (public use determination reversed because “looking at the machine in operation does not reveal” claimed limitations); Egbert, US 1881 (women’s corset worn in public without limitation or restriction); Lough, FC 1996 (public use where claimed boat motor seals were installed and tested on boat which was later sold without restriction); Eolas, FC 2005 (demonstration to “two Sun Microsystems employees without confidentiality agreements” found invalidating); Beachcombers, FC 1994 (demonstration of prototype at a party for guests to view); Moleculon Research, FC 1986 (no public use where “inventor retained control over the puzzle’s use”); Dey, FC 2013 and Janssen, FC 2005 (no public information regarding nature of tested formulation); Motionless Keyboard, FC 2007 (no public use where keyboard prototype shown to potential investors was not plugged in and “only provided a visual view”). Here, Skrinska was provided “a small (100 ml) liquid sample of a K80 product…including a certificate of analysis…which shows that the product meets the limitations of the asserted claims” and the related “correspondence makes no mention of any confidentiality restrictions” (and, Pronova did not argue that any were either requested or given or any restriction to experimental use) and he publicly shared the information with other doctors (non-confidentially). Thus, the disclosure to Skrinska (“one highly skilled in the art, with the full ability to know, understand, and fully disclose the invention to others”) “without any confidentiality or understanding” was found to constitute a release into the public domain for the purposes of § 102(b). The DC decision was therefore reversed.

This entry was posted in Anticipation (35 USC 102), Public Use. Bookmark the permalink.

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