Chapter §8.02 The Process of Inventing

• Jurisdiction: United States

§8.02 The Process of Inventing

Because qualifying as an inventor under U.S. patent law turns on contributing to the conception of an invention, an understanding of what conception entails in the context of the overall inventive process is needed.

[A] Patent Law's Construct of Inventing: A Two-Step Process

U.S. patent law has historically viewed the process of inventing as involving two steps; first, the mental act of "conception," followed by the tangible/physical act of "reduction to practice." The Federal Circuit has expressed that "[t]he primary legal criteria of patent-focused invention are 'conception' and 'reduction to practice' . . . ."¹⁰ Both these criteria are explained in further detail below. For purposes of determining who is an inventor, conception is the key.

[1] Conception

[a] Definition

Conception is the mental part of the process of inventing. "Conception exists when a definite and permanent idea of an operative invention, including every feature of the subject matter sought to be patented, is known."¹¹ Conception is commonly defined as the "formation in the mind of the inventor, of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice,"¹² a definition that has "remained essentially unchanged for more than a century."¹³

A bare idea is not enough; it is sufficiently definite to constitute a conception only " 'when the inventor has a specific, settled idea, a particular solution to the problem at hand, not just a general goal or research plan he hopes to pursue.' "¹⁴ "Conception is complete when one of ordinary skill in the art could construct the apparatus without unduly extensive research or experimentation."¹⁵

The Federal Circuit's 2013 decision in Dawson v. Dawson and Bowman¹⁶ illustrates the complexities of determining, sometimes many years after the fact, whether an inventor had conceived a given claimed invention by a certain date, or whether at that time he possessed merely a "general goal or research plan." As distilled by the dissent, the dispute in Dawson was "whether Dr. Dawson conceived his invention while employed at the University of California, San Francisco ("UCSF"), or instead after he joined InSite, a pharmaceutical manufacturer."¹⁷ The majority in Dawson agreed with InSite rather than UCSF, affirming an interference decision by the USPTO.

In abbreviated form, the key facts of Dawson are as follows: In the summer of 1997, Dr. Chandler Dawson, then an employee of the University of California, San Francisco (UCSF), gave a presentation at a World Health Organization (WHO) meeting focused on treating trachoma, a bacterial infection of the eye. Dr. Dawson's presentation concerned the potential use of the antibiotic azithromycin to control trachoma. No such commercial product was available at the time of his presentation, but Dr. Dawson proposed five existing vehicles to administer azithromycin topically to the eye. One of the vehicles Dawson specifically listed was "Durasite," a delivery depot comprised of acrylic acid polymers. The Durasite product was being manufactured by InSite Vision Inc. ("InSite"). Regarding the composition of a potential azithromycin ointment, Dr. Dawson wrote a paper for the WHO meeting stating that it would be "like the 0.5% erythromycin ointment" already on the market.

Shortly after the WHO presentation, Dr. Dawson asked a clinical fellow to contact a Dr. Lyle Bowman at InSite for assistance in creating an azithromycin-based medicine that could be applied topically to the eye. The clinical fellow did so, also sending Dr. Bowman 100 milligrams of azithromycin.

Meanwhile, and on his own initiative, the clinical fellow also contacted pharmacist Dr. Charles Leiter about delivery vehicles for use with azithromycin. In August 1997, Dr. Leiter prepared samples of an eye ointment that contained 0.5% azithromycin by weight in a carrier of mineral oil and petrolatum. The clinical fellow applied some of Dr. Leiter's ointment to his own eye, later testifying that he did so "not to treat an infection, but to establish for [himself] that the medication was safe, and well-tolerated—that it would not cause significant discomfort or distress as applied."¹⁸

By February 1998, Dr. Dawson was actively working with InSite, whose chemists believed that azithromycin was an ideal compound to use with their Durasite vehicle. At that time, however, no final product had yet been developed and testing was still required. UCSF was then unaware of Dawson's collaboration with InSite.¹⁹

On March 31, 1999, Dr. Dawson and Dr. Bowman jointly filed a patent application in the USPTO directed to a method of treating the eye with an azithromycin-based eye medication, assigning their rights to InSite. The application led to the issuance (in 2001 and 2003, respectively) of U.S. Patent Nos. 6,239,113 and 6,569,443, both titled "Topical Treatment or Prevention of Ocular Infections." Representative claim 3 of InSite's '113 patent recited specific ranges or formulations for an antibiotic suspension for treating an eye:

A process for treating an eye, which comprises:

topically applying an aqueous polymeric suspension of an azalide antibiotic, wherein said suspension comprises water,

0.01% to 1.0% of an azalide antibiotic, and

0.1 to 10% of a polymeric suspending agent which is a water-swellable water-insoluble cross-linked carboxy-vinyl polymer which comprises at least 90% acrylic acid monomers and 0.1% to 5% cross-linking agent.

Azithromycin is an "azalide antibiotic" as recited in claim 3, and the "polymeric suspending agent," per UCSF, was the Durasite vehicle of InSite.

Representative claim 1 of InSite's '443 patent more broadly recited:

A process for treating an eye, comprising:

topically applying an azalide antibiotic to an eye in an amount effective to treat infection in a tissue of the eye, wherein said topically applying comprises supplying a depot of a composition containing said azalide antibiotic on the eye.

In 2007, UCSF sought to provoke an interference by filing a patent application that named Dr. Dawson as the sole inventor and generally copied the specification and claims of InSite's '113 and '443 patents (Dr. Dawson declined to join UCSF's submission). The USPTO declared interferences between the UCSF application and InSite's patents. As the junior party in the interference, UCSF bore the burden of proving by a preponderance of the evidence that Dr. Dawson, alone, had conceived the invention recited in the interference counts (which tracked the two patent claims quoted above) before the March 1999 filing date of the Dawson/Bowman patent application that had been assigned to InSite. UCSF chose to rely primarily on documentary evidence that it believed corroborated Dr. Dawson's sole conception, and did not take the testimony of Dawson or Bowman. Specifically, UCSF adopted the position that documents reporting Dr. Dawson's 1997 WHO presentation were evidence that corroborated his sole conception, and that Dr. Leiter's preparation of the ointment incorporating 0.5% azithromycin further corroborated that sole conception.

After "lengthy" proceedings, the USPTO Board in 2011 found that UCSF had failed to carry its burden of proving sole conception by Dr. Dawson alone. The Board determined that before Dr. Bowman became involved, Dr. Dawson "did not fully appreciate how [his] idea was to be implemented in actual practice"; rather, Dawson only "had a general idea for a future research plan to come up with a composition for topical azithromycin to be applied to the eye to treat infection."²⁰

A divided panel of the Federal Circuit affirmed the USPTO in Dawson. In an opinion authored by Judge Bryson and joined by Judge Wallach, the majority first noted that the case at bar was "unusual" because "[w]e are asked to decide whether and when an invention formed definitely, permanently, and particularly in the mind of the alleged inventor, but to do so without any testimony from the supposed inventor himself."²¹ The majority agreed with the Board that the WHO documents relied on by UCSF at best "announce[d] a general idea, acknowledge[d] many of the difficulties associated with making that idea operative, and offer some thoughts on how one might proceed. . . ."²² The WHO report, describing 1997 Dawson's WHO meeting presentation as a "preliminary" report on the "possibility" of developing a topical application of azithromycin and recommending that "Dawson continue to work with [others] to develop a topical application and report back at the next meeting," fell short of a " 'definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.' "²³

Moreover, UCSF had failed to show that Dawson solely conceived the specific concentration ranges for the antibiotic and the polymeric suspending agent that were recited in the interference count corresponding to claim 3 of InSite's '113 patent. Nothing in the record showed that Dr. Dawson knew...