Dawson v. Dawson

• Decision Date: 25 March 2013
• Docket Number: Nos. 2012–1214,2012–1216,2012–1217.,2012–1215,s. 2012–1214
• Citation: 710 F.3d 1347
• Parties: Chandler DAWSON, Appellant, v. Chandler DAWSON and Lyle Bowman, Cross–Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

710 F.3d 1347

Chandler DAWSON, Appellant,

v.Chandler DAWSON and Lyle Bowman, Cross–Appellant.

Nos. 2012–1214, 2012–1215, 2012–1216, 2012–1217.

United States Court of Appeals,Federal Circuit.

March 25, 2013.

Steven B. Kelber, Berenato & White, LLC, of Bethesda, Maryland, argued for appellant.

Joel M. Freed, McDermott Will & Emery, LLP, of Washington, DC, argued for cross-appellant. With him on the brief were Natalia Blinkova and Aamer Ahmed.

Before REYNA, BRYSON^*, and WALLACH, Circuit Judges.

Opinion for the court filed by Circuit Judge BRYSON.

Dissenting opinion filed by Circuit Judge REYNA.

BRYSON, Circuit Judge.

This is a patent interference case concerning a method for topically treating and preventing infections of the eye. The patents and patent applications at issue describe well-known challenges in treating eyes and with topical eye treatments in particular. For example, antibiotics that are applied topically must be able to reach and penetrate the targeted tissue, and many antibiotics are not suitable for such a task. In addition, medications must be designed to minimize irritation and avoid toxic responses in the eye. The inventions at issue in this case claim to overcome such difficulties through a process for topically applying an azalide antibiotic to the eye; the question in the underlying interference proceedings was who conceived of the inventions, and when.

I

The relevant events begin in the summer of 1997, at the inaugural meeting of the World Health Organization (“WHO”) Alliance for the Elimination of Trachoma. Trachoma is a bacterial infection of the eye that can lead to blindness. Chandler Dawson and Thomas Leitman, who at the time were both employed by the University of California, San Francisco (“UCSF”), attended the WHO meeting on behalf of the Francis I. Proctor Foundation, an ocular disease research institution affiliated with UCSF. At the meeting, Dr. Dawson gave a presentation related to the topical use of an antibiotic called azithromycin to control trachoma.

The WHO released a report of the meeting, entitled Report of the First Meeting of the WHO Alliance for the Global Elimination of Trachoma (“WHO Report”), that contains a discussion of Dr. Dawson's presentation. The report stated that although oral azithromycin had been used successfully against trachoma, “a topical azithromycin preparation to treat the eye directly [wa]s not available” at that time. The report listed several benefits of a topical trachoma treatment and also a number of objections to such a treatment, including that “[n]o product is available” and that the “[e]fficacy and dosing schedule” would need to be determined. Similarly, the report acknowledged that even after a product was developed, it would need to be tested for “pharmacological characteristics ... and toxicity in the eye.” The report pointed out that “several vehicles” were available to administer drugs topically, and it listed a few of them, including a product called Durasite. It did not, however, rank those options, and it expressed uncertainty about how the “persistence of [azithromycin] may occur in the external eye with adequate topical delivery.” The report's conclusion referred to Dr. Dawson's “preliminary report on the possibility of developing a topical application of azithromycin” and recommended that Dr. Dawson “continue to work with The Edna McConnell Clark Foundation and Pfizer Inc. to develop a topical application and report back at the next meeting.”

A second document from the WHO conference is entitled Potential Use of Topical Azithromycin in Trachoma Control Programmes (“WHO document”) and is attributed to Dr. Dawson. UCSF contends that the WHO document was Dr. Dawson's outline for his presentation. The document largely tracks the WHO Report and contains many of the same statements about the current unavailability of a topical azithromycin formulation and objections to its use. The most relevant difference between the two documents is the addition of the following three sentences in the second document's discussion of delivery vehicles: “Because azithromycin has a low solubility in aqueous solutions, one obvious preparation would be an ointment like the 0.5% erythromycin ointment. The problems with ointments for trachoma treatment are well known.... Ointments are difficult to apply and poorly tolerated....”

Shortly after the WHO meeting, Dr. Dawson sought help from others in developing his idea. He asked Kenneth Chern, a clinical fellow at the Proctor Foundation, to contact Lyle Bowman, an employee at InSite Vision Incorporated, a company engaged in research and development of ophthalmic products. Because Dr. Dawson did not have experience in preparing ophthalmic medication formulations, he suggested that Dr. Chern enlist Dr. Bowman's assistance in creating a suitable ophthalmic medication with azithromycin that could be applied topically to the eye. Dr. Chern spoke with Dr. Bowman and followed up with a letter dated July 10, 1997. The letter conveyed Dr. Chern's “interest [ ] in making a topical preparation and testing the compound” and asked Dr. Bowman to report back if he was successful in formulating a topical preparation. Along with 100 milligrams of azithromycin, Dr. Chern enclosed “several articles which describe different concentrations of azithromycin as used in experimental studies as well as information about the minimum inhibitory concentrations that are necessary for killing bacteria.”

A few weeks later, on July 31, 1997, Dr. Chern contacted a pharmacist associated with the Proctor Foundation named Charles Leiter. According to Dr. Chern, he did so because he had not yet heard back from Dr. Bowman in response to his July 10 letter; there is no indication that Dr. Chern contacted Dr. Leiter at Dr. Dawson's request. Dr. Chern sent Dr. Leiter some azithromycin and asked to be notified “if [Dr. Leiter was] success[f]ul in making an ointment or suspension from the powder.” Dr. Chern noted that they were “looking to compare [Dr. Leiter's preparation] with erythromycin 0.5% ointment.” The same day, Dr. Chern wrote to Pfizer to request more azithromycin, explaining that they were “investigating the possible formulation and use of azithromycin as a drop or suspension” and needed more to “continue [their] studies.”

In response to Dr. Chern's request, Dr. Leiter prepared an ointment that used a mineral oil and petrolatum carrier to release the antibiotic. The label is dated August 4, 1997, and indicates that the ointment contained 0.5% azithromycin by weight. Dr. Leiter gave three tubes of his formulation to Drs. Chern and Leitman, and Dr. Chern applied some to his own eye. Dr. Chern stated 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.” Dr. Chern then told Drs. Dawson and Leitman about his experience.

From that point forward, UCSF contends that Dr. Dawson was no longer involved in UCSF's efforts to develop a topical azithromycin treatment. In February 1998, however, the Proctor Foundation submitted a grant request for additional funds related to trachoma research. A section of that request entitled “Associated Studies on Trachoma” is said to have been written by Dr. Dawson. That section conveyed many of the same concerns with, and objections to, topical azithromycin use that were reflected in the WHO Report and the WHO document, often word-for-word. In addition, the request reported that Dr. Dawson was “now working with InSite” and that “[c]hemists at InSite ... feel that azithromycin is an ideal compound to use with their ‘Durasite’ vehicle.” But it also stated that no final product had been developed and asserted, for example, that “the primary problem is to determine if azithromycin is absorbed to the tissue after topical application to the eye” and that “[t]he immediate hurdle to the development of a topical form of azithromycin is testing the drug levels in the conjunctiva.”

On March 31, 1999, Drs. Dawson and Bowman submitted a patent application for their invention. They signed a declaration of joint inventorship and assigned their rights to InSite. The application eventually led to the issuance of the two patents at issue in this case—U.S. Patent No. 6,239,113 (“the '113 patent”), which issued on May 29, 2001, and U.S. Patent No. 6,569,443 (“the '443 patent”), which issued on May 27, 2003. Both patents are entitled “Topical Treatment or Prevention of Ocular Infections,” and the specifications point out many of the difficulties with topical eye treatments that had been noted earlier by Dr. Dawson and others during the development process.

II

On May 8, 2007, in order to provoke an interference, UCSF filed a patent application that named Dr. Dawson as the sole inventor and generally copied the specification and claims from the '113 and '443 patents. Dr. Dawson, however, declined to join UCSF's submission. The Patent and Trademark Office's Board of Patent Appeals and Interferences declared two interferences between UCSF's application and the two InSite patents. Interference 105,719 contains the following count (“the '719 count”), which tracks claim 3 of the '113 patent:

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.

Interference 105,729 contains the following count (“the '729 count”), which tracks claim 1 of the '443 patent:

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...