Dawson v. Dawson and Bowman
106 U.S.P.Q. 2d (BNA) 1313, 2013 WL 1188942, 710 F.3d 1347 (2013)
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Rule of Law:
Conception of an invention is the formation of a definite and permanent idea of the complete and operative invention in the inventor's mind, such that only ordinary skill would be necessary to reduce it to practice. A general goal or research plan that identifies a problem and suggests a potential path to a solution, but leaves key questions of efficacy, formulation, and application unanswered, does not constitute conception.
Facts:
- In the summer of 1997, Dr. Chandler Dawson, an employee of the University of California, San Francisco (UCSF), gave a presentation at a World Health Organization (WHO) meeting about the possibility of developing a topical azithromycin treatment for the eye infection trachoma.
- A WHO report on the presentation stated that a topical formulation was not yet available and that key issues like efficacy, dosing schedule, pharmacological characteristics, and toxicity would need to be determined.
- Dr. Dawson's presentation materials listed Durasite as one of several potential delivery vehicles and suggested an ointment could be made 'like the 0.5% erythromycin ointment' but acknowledged problems with ointments.
- After the meeting, Dr. Dawson asked a colleague, Dr. Chern, to enlist Dr. Lyle Bowman of InSite Vision to help create a suitable formulation.
- While waiting for a response from Dr. Bowman, Dr. Chern independently asked a pharmacist, Charles Leiter, to prepare a sample ointment.
- On August 4, 1997, Leiter prepared a 0.5% azithromycin ointment with a mineral oil and petrolatum base, which Dr. Chern then applied to his own eye solely to test for comfort and tolerability, not for efficacy against infection.
- In February 1998, a grant request written in part by Dr. Dawson stated he was 'now working with InSite' but reiterated that the 'immediate hurdle' was testing for drug levels and tissue absorption.
- On March 31, 1999, Drs. Dawson and Bowman jointly filed a patent application for a topical azithromycin eye treatment, assigning their rights to InSite.
Procedural Posture:
- UCSF filed a patent application naming Dr. Dawson as the sole inventor in order to provoke an interference proceeding against two patents issued to Drs. Dawson and Bowman and assigned to InSite.
- The Board of Patent Appeals and Interferences declared two interferences, with UCSF as the junior party (bearing the burden of proof) and InSite as the senior party.
- After lengthy proceedings, the Board ruled in favor of InSite, finding that UCSF had failed to prove by a preponderance of the evidence that Dr. Dawson had solely conceived of the invention prior to his collaboration with InSite.
- UCSF appealed the Board's decision on conception to the U.S. Court of Appeals for the Federal Circuit.
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Issue:
Does proposing a general research plan for a topical eye treatment, which identifies a potential antibiotic and delivery vehicle but expressly states that efficacy, dosage, and formulation still need to be determined, constitute a complete conception of the invention under patent law?
Opinions:
Majority - Bryson, J.
No. Proposing a general research plan does not constitute a complete conception of the invention. Conception is complete only when the inventor has a specific, settled idea of the complete and operative invention, so clearly defined that only ordinary skill would be necessary to reduce it to practice without extensive research or experimentation. Here, Dr. Dawson's idea in 1997 was merely a 'general goal or research plan.' The WHO documents described his work as a 'preliminary report on the possibility' and explicitly stated that critical elements like efficacy, dosing, and pharmacological properties still needed to be determined. This falls short of the 'definite and permanent idea' required for conception. UCSF failed to prove Dawson had conceived of the specific concentrations or formulation of the claimed invention, and the creation of a simple ointment by a third party for a tolerance test did not corroborate a complete conception of an effective treatment.
Dissenting - Reyna, J.
Yes. Dr. Dawson's work in 1997 constituted a complete conception of the invention. Conception is the 'work of the brain, not of the hands,' and occurs when the inventor's idea is complete, even if further experimentation is needed to reduce it to practice. At the WHO conference, Dr. Dawson disclosed all the essential features of the invention: treating an eye by topically applying an azalide antibiotic (azithromycin) in an amount effective to treat infection (0.5%, by analogy to erythromycin) via a depot (listing Durasite as an option). This was a 'definite and permanent idea' sufficient for a person of ordinary skill to proceed with implementation. The majority and the Board improperly required proof of reduction to practice, conflating the mental act of conception with the physical act of building and testing the invention.
Analysis:
This decision reinforces the high evidentiary standard for proving conception in patent law, particularly for chemical and pharmaceutical inventions. It clarifies that an inventor must have conceived of a specific and operative invention, not just a promising research direction. The ruling makes it more difficult to establish an early conception date based on preliminary reports or academic presentations that identify problems and potential solutions without providing a concrete, workable formula. For future cases, this holding emphasizes the need for inventors to document not just their goals, but the specific, settled details of their proposed solution to prove they had a 'complete and operative' idea.
