Pinpointing Invention Conception Date in a Patent Interference

Pinpointing Invention Conception Date in a Patent Interference

n Dawson v. Dawson [an enhanced version of this opinion is available to lexis.com subscribers], the Federal Circuit considered an unusual case with a question that often arises in interferences: when did the inventor invent the subject matter at issue. While the decision does not break new ground in the law of conception, it highlights the issues that can arise when an inventor changes employment before an invention has been reduced to practice.

The Invention at Issue

The invention at issue relates to methods of treating eye infections using topical azalide antibiotics. Dr. Dawson worked on the invention while he was at the University of California, San Francisco ("UCSF"), but did not file a patent application directed to the invention until he was at InSite Vision Incorporated. The basic question presented by this case is whether Dr. Dawson had conceived the invention while he still was at UCSF.

Dr. Dawson was working at UCSF in the summer of 1997, when he attended "the inaugural meeting of the World Health Organization ("WHO") Alliance for the Elimination of Trachoma." As noted by the Federal Circuit, Dr. Dawson gave a presentation at the meeting "related to the topical use of an antibiotic called azithromycin to control trachoma."

According to the Federal Circuit opinion, soon after the WHO meeting, Dr. Dawson asked a colleague affiliated with UCSF, Dr. Chern, to seek the assistance of Lyle Bowman, an employee at InSite Vision Incorporated, to develop a topical ophthalmic azithromycin composition.

In late July, Dr. Chern also reached out to Dr. Leiter, another colleague affiliated with UCSF who was a pharmacist. By August 4, 1997, Dr. Leiter had prepared a 0.5% azithromycin ointment with a mineral oil and petrolatum carrier. According the Federal Circuit decision, there was no evidence that Dr. Chern had contacted Dr. Leiter at Dr. Dawson's request.

By 1998, Dr. Dawson was working at InSite. On March 31, 1999, Dr. Dawson and Dr. Bowman filed a patent application directed to "Topical Treatment or Prevention of Ocular Infections." The application named both Dawson and Bowman as joint inventors, and was assigned to InSite. The application eventually led to the two patents at issue in the interference: U.S. Patent 6,239,113 (granted May 29, 2001) and U.S. Patent 6,569,443 (granted May 27, 2003).

On May 8, 2007, UCSF filed its own patent application naming only Dr. Dawson as the inventor and claiming priority to the InSite patent applications, in order to provoke an interference with the InSite patents. According to the Federal Circuit decision, UCSF "generally copied the specification and claims from the '113 and '443 patents." Dr. Dawson did not sign an Inventor's Declaration for the UCSF application, but it was filed on his behalf under the procedures of 35 USC § 118.

The Interferences

The USPTO declared two interferences between the UCSF application and each of the InSite patents.

Interference 105,719 involved the '113 patent and contained the following count:

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% crosslinking agent.

Interference 105,729 involved the '443 patent and contained the following count:

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.

Because the UCSF application had the latest priority date, UCSF was the junior party in both interferences. Thus, UCSF "bore the burden of proving, by a preponderance of the evidence, that Dr. Dawson alone had conceived of the inventions recited in the counts prior to March 1999."

The USPTO Board found that UCSF failed to carry its burden, and the Federal Circuit found no reason to overturn the Board decision. As the Federal Circuit noted, UCSF's case was unusual in that it did not put on any testimony from Dr. Dawson, but relied on contemporaneous disclosures, such as those made at the WHO meeting.

Establishing a Date of Conception

The Federal Circuit began its analysis with a restatement of settled law surrounding conception:

[Conception] is 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.'" Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986) (quoting 1 Robinson on Patents 532 (1890)) [enhanced version].

[Conception is complete when] "all that remains to be accomplished, in order to perfect the art or instrument, belongs to the department of construction, not creation." 1 Robinson 532.

"Conception is complete only when the idea is so clearly defined in the inventor's mind that only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation." Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994).

"An idea is definite and permanent 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." Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994) [enhanced version].

"Because it is a mental act, courts require corroborating evidence of a contemporaneous disclosure that would enable one skilled in the art to make the invention." Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994).

The Federal Circuit found no reason to disturb the Board's finding that UCSF had not shown that Dr. Dawson had a complete conception of the invention before the InSite application was filed. The court stated:

At best, as the Board found, the WHO Report and WHO document announce a general idea, acknowledge many of the difficulties associated with making that idea operative, and offer some thoughts on how one might proceed (including by listing a few potential delivery vehicles). The WHO document is entitled "Potential Use of Topical Azithromycin in Trachoma Control Programmes," and the WHO Report describes Dr. Dawson's presentation as a "preliminary report on the possibility of developing a topical application of azithromycin," while "recommend[ing] that [Dr.] Dawson continue to work with [others] to develop a topical application and report back at the next meeting."

As the court noted, "a 'preliminary' statement about a 'possibility' or 'potential use,' alongside a recommendation for continued work and a 'report back' in the future, falls short of a 'definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.'"

The Federal Circuit also noted a lack of evidence of conception of specific aspects of the interference counts, such as the strength of the formulations and the specific carriers.

Conception Versus Reduction to Practice

One of UCSF's arguments on appeal was that "the Board improperly required a showing of reduction to practice in order to prove conception." This arguments was based on the Board's requirement for a showing that "Dr. Dawson knew his invention would be effective to treat an actual infection." According to UCSF, Dr. Dawson "did not need to know that his invention would work to satisfy conception [but] need[ed] only to have conceived that his topical use of azithromycin would be effective."

The Federal Circuit found that this line of argumentation was "based on an erroneous view of what is needed to prove conception." The Federal Circuit explained:

Quite apart from reduction to practice, conception requires that the inventor know how his "'definite and permanent idea of the complete and operative invention . . . is hereafter to be applied in practice.'" ... In other words, part of the conception inquiry asks whether the inventor "possess[ed] an operative method of making [the invention]." .... So while UCSF is correct that "an inventor need not know that his invention will work for conception to be complete," ... there is a critical difference between conceiving a way to make an idea operative and knowing that a completed invention will work for its intended purpose. The Board held that UCSF's evidence of sole conception by Dr. Dawson was insufficient to prove the former.

Clear as mud, right?

Judge Reyna's Dissent

Judge Reyna dissented from the majority opinion. In his view, UCSF had presented sufficient evidence to show that Dr. Dawson had conceived of the invention while still employed by UCSF, and that his later work at InSite related to reduction to practice.

How Did This Case Get This Far?

The Federal Circuit notes that InSite filed "cross-appeals from the Board's failure to rule that all of the claims in UCSF's application are unpatentable under 35 U.S.C. §§ 102(b) and 135(b)." While the court ruled that the cross-appeals were "inappropriate because they do not present the prospect of enlarging InSite's rights or lessening those of UCSF," they seem to be compelling arguments on the merits.

The InSite patents were granted years before the UCSF application was filed. How could the InSite patents not anticipate the claims under 35 USC § 102(b)? How could the copied claims not be barred by 35 USC § 132(b)? Isn't 35 USC § 132(b) meant to be a statute of repose that spares a party from having to defend its claims in an interference proceeding brought years too late?

The answer appears to lie in the priority claim in the UCSF application to the earlier InSite patent applications. Because the UCSF application was filed while an InSite application still was pending and named Dr. Dawson as the inventor, UCSF was able to claim priority under 5 USC § 120 to the earlier InSite applications, and avoid the consequences of both § 102(b) and § 135(b).

Read other articles by Foley & Lardner attorneys.

For more information about LexisNexis products and solutions connect with us through our corporate site