Patent Docs

Rubin v. General Hospital Corp. (Fed. Cir. 2013)

By Donald Zuhn --

On March 28, the Federal Circuit in Rubin v. General Hospital Corp. affirmed judgment by the District Court for the District of Massachusetts dismissing the suit brought by Drs. Berish Rubin and Sylvia Anderson against The General Hospital Corporation requesting correction of U.S. Patent Nos. 7,388,093 and 7,407,756, which are assigned to General Hospital.  The '093 and '756 patents are directed to genetic mutations that cause the inherited disease Familial Dysautonomia (FD), also known as Riley-Day Syndrome, and methods for detecting FD.

Drs. Rubin and Anderson at the Department of Biological Sciences of Fordham University, and Drs. Slaugenhaupt and Gusella at Massachusetts General Hospital, had been independently conducting research to determine the genetic mutations disclosed in the '093 and '756 patents.  Drs. Rubin and Anderson identified two mutations in the gene encoding IkB kinase complex-associated protein that cause FD, and on December 20, 2000, submitted a paper describing these mutations to the American Journal of Human Genetics.  When submitting the paper, Dr. Rubin asked the Editor of the journal to not send the paper to Dr. Gusella and his colleagues at Mass General for peer-review.  On December 22, 2000, the Editor sent the abstract for the paper to Dr. Gusella.  Dr. Gusella declined to review the full paper, and on December 28, 2000, Drs. Gusella and Slaugenhaupt submitted their own paper identifying the same two mutations to the same journal (as of October 2000, Dr. Gusella had noted that his group had identified 184 candidate mutations, and as of December 12, 2000, further noted that the responsible mutations had not yet been identified).  Both papers were published in the January 22, 2001 issue of the journal.

On January 6, 2001, Drs. Gusella and Slaugenhaupt filed a provisional application describing the two mutations and claiming their diagnostic use.  On January 17, 2001, Drs. Rubin and Anderson filed their own provisional application describing the two mutations and claiming their diagnostic use.  The application filed by Drs. Gusella and Slaugenhaupt eventually resulted in the issuance of the '093 and '756 patents.  During prosecution of their application, Drs. Rubin and Anderson decided not to initiate an interference in the U.S. Patent and Trademark Office, despite the examiner's suggestion that they do so.

Rather than initiate an interference, Drs. Rubin and Anderson filed suit against Mass General seeking correction of inventorship of the '093 and '756 patents under 35 U.S.C. § 256.  They argued that Dr. Gusella's receipt of their abstract permitted Dr. Gusella's group to select and confirm the identity of the FD mutations and file their provisional patent application, and Drs. Rubin and Anderson asked to be substituted as the inventors of the '093 and '756 patents, or added as joint inventors.  Granting Mas General's motion for summary judgment, the District Court held that the inventorship could not be changed under § 256 because there was no "collaboration" between the two teams of scientists, and that Drs. Rubin and Anderson could not be added as joint inventors because they did not meet the requirements of § 116 for joint invention.  With respect to the correction of inventorship, the District Court also held that the complete substitution of inventorship is not a matter for § 256, but rather, is a claim for priority of invention of the subject matter, and priority should be resolved in an interference, not under § 256.

On appeal, the Federal Circuit determined that "the district court correctly ruled that the independent relationship between these teams of scientists, and the nature of this communication of information, do not support joint invention in accordance with §116, or warrant change or substitution of inventorship under §256."  The panel added that:

We agree with the district court that, whatever actions were taken after the Rubin/Anderson Abstract appeared uninvited on Dr. Gusella's desk, ultimately the dispute is of priority of invention; that is, which team was the first to conclusively identify the operative mutations.  The district court recognized that even if Drs. Gusella and Slaugenhaupt had completed this identification before they saw the Rubin/Anderson identification, it would still be necessary to determine priority of invention in order to resolve the patent rights.

The panel, therefore, concluded that the District Court acted within its authority in directing the parties to the USPTO to determine priority of invention, and affirmed the District Court's judgment of dismissal.

Rubin v. General Hospital Corp. (Fed. Cir. 2013)
Nonprecedential disposition
Panel: Circuit Judges Newman and Bryson and District Judge Fogel
Opinion by Circuit Judge Newman

Dawson v. Dawson (Fed. Cir. 2013)

By Donald Zuhn --

On March 25, the Federal Circuit in Dawson v. Dawson affirmed a determination by the Board of Patent Appeals and Interferences that the University of California, San Francisco (UCSF) failed to establish sole conception by Dr. Chandler Dawson of the claimed inventions in two patents assigned to InSite Vision Inc.  The case involved an interference between two patents, U.S. Patent Nos. 6,239,113 and 6,569,443, which name Dr. Dawson and Dr. Lyle Bowman as inventors and which are assigned to InSite, and an application which names Dr. Dawson as the sole inventor and which is assigned to UCSF.  The patents and application ay issue are directed to a method for topically treating and preventing infections of the eye.

In 1997, at a meeting of the World Health Organization Alliance for the Elimination of Trachoma, Dr. Dawson, who was employed by UCSF, gave a presentation on the topical use of an antibiotic called azithromycin (at right) to control trachoma (a bacterial infection of the eye).  A report of the meeting ("WHO Report") was subsequently released, which included a discussion of Dr. Dawson's presentation.  A second document ("WHO document"), which may have been an outline of Dr. Dawson's presentation, provided a similar discussion of the presentation.

Shortly after the meeting, Dr. Dawson asked Dr. Kenneth Chern to enlist the assistance of Dr. Bowman, an employee at InSite (a company involved in the research and development of ophthalmic products), in creating a suitable ophthalmic medication with azithromycin that could be applied topically to the eye.  Dr. Chern sent 100 mg of azithromycin to Dr. Bowman for formulating as a topical preparation.  Three weeks later, after not hearing back from Dr. Bowman, Dr. Chern sent azithromycin to Dr. Charles Leiter, a pharmacist associated with the same foundation as Dr. Chern, to formulate as an ointment or suspension.  Dr. Leiter prepared an ointment using a mineral oil and petrolatum carrier and containing 0.5% azithromycin by weight.  Upon receipt, Dr. Chern applied some of the ointment to his own eye to determine whether it could be well-tolerated, and informed Dr. Dawson of the results of his experiment.  Dr. Dawson subsequently left UCSF to work at InSite, and after joining InSite, was named with Dr. Bowman on a patent application that led to the issuance of the '113 and '443 patents.

Almost four years after the '443 patent issued, UCSF filed a patent application naming Dr. Dawson as an inventor, and copying the specification and claims from both the '113 and '443 patents in order to provoke an interference.  The BPAI declared two interferences between the InSite patents and UCSF's application, naming UCSF as the junior party (and therefore UCSFD 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 InSite's March 31, 1999 filing date).  The count in Interference 105,719, which tracks claim 3 of the '113 patent, recites:

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.

The count in Interference 105,729, which tracks claim 1 of the '443 patent, recites:

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.

On the issue of conception, the Board determined that UCSF had failed to prove sole conception by Dr. Dawson, finding that that Dr. Dawson did not fully appreciate how his idea was to be implemented in actual practice, and that it was only after Dr. Bowman became involved that "'something' significant happened," leading to the March 1999 filing of Dr. Dawson's and Dr. Bowman's application.  UCSF appealed the Board's decision, contending the Board erred in finding that Dr. Dawson did not conceive of the claimed inventions by himself prior to his collaboration with Dr. Bowman.

In a majority opinion written by Judge Bryson and joined by Judge Wallach, the Federal Circuit began by noting "that the nature of the evidence presented in this case is unusual," as the Court was "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."  Instead of providing testimony from Dr. Dawson, UCSF contended that the WHO Report and the WHO document prove Dr. Dawson's conception, and that Dr. Leiter's preparation of an ointment for Dr. Chern provided further corroboration.  The Court, however, disagreed with UCSF's contention, stating that "[a]t best, . . . 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 Court explained (citations omitted) that:

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."  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.'"

Stating that "[t]he inadequacy of UCSF's showing is equally clear in the context of the specific interference counts," the Court noted that UCSF's evidence failed to establish conception of the specific concentrations in the '719 count, and further, that UCSF failed to establish that Dr. Dawson on his own determined "an amount effective to treat infection in a tissue of the eye" as recited in the '729 count.

The Court also noted that the ointment prepared by Dr. Leiter for Dr. Chern did not establish that Dr. Dawson alone conceived of the subject matter of the counts because "[t]here is no evidence that Dr. Dawson instructed Dr. Chern to contact Dr. Leiter or otherwise had any direct connection to the preparation of the ointment."

On appeal, UCSF argued that the Board's decision on conception was infected by several errors in claim construction and admission of evidence.  In response to UCSF's argument that the preamble of the '719 count should not have been read as limiting, and that treatment can be proactive and can thus occur absent an active infection, the Court countered that "[t]he proper meaning and scope of the preamble . . . is irrelevant to our conclusion that UCSF failed to prove sole conception by Dr. Dawson."  In response to UCSF's argument that the Board erred in considering statements from the specifications of the '113 and '443 patents on the ground that those statements were inadmissible hearsay, the Court noted that "UCSF adopted the words in the '113 and '443 patents as its own when it 'copied' those words into the patent application that provoked these interferences."  In response to USCF's argument that the Board erred by failing to consider statements made by InSite in an opposition to a European patent application concerning the topical use of azithromycin (InSite had stated in opposition proceedings that the WHO document "disclos[es] . . . why topical azithromycin preparations for eye treatment are highly desirable" and provides "a concrete disclosure [of] how such preparations can be obtained" and "suggestions [on] how [they] could be made"), the Court determined that the Board did not abuse its discretion by following its general rule against giving controlling weight to documents from foreign patent proceedings.  The Court also pointed out that the Board had properly noted that the instant case involved the issues of conception and reduction to practice and not lack of novelty or inventive step, the latter of which were at issue in the opposition.

Writing in dissent, Judge Reyna stated that:

The record before us demonstrates that Dr. Dawson possessed a definite and permanent idea of his complete and operative invention when, in the summer of 1997, he delivered a related presentation at a conference of the World Health Organization ("WHO").  At that time, Dr. Dawson was employed by UCSF, not InSite.  Consequently, I find that Dr. Dawson, through UCSF, satisfied his burden of demonstrating prior conception.

The dissent continued by asserting that the WHO Report and WHO document teach each of the limitations of the '729 count, and establish that he had possession of each recited feature.  In particular, the WHO references disclose (1) treating an eye, (2) topically applying an azalide antibiotic (i.e., azithromycin) (3) an effective dose ("Dr. Dawson suggested that his azithromycin formulation would use the same dosage known for erythromycin," and the dose "0.5% by weight[] is used throughout Dr. Dawson's patent as a preferred formulation), (4) supplying a depot containing the azalide antibiotic ("[b]oth references contain the same table listing five alternative delivery depots, one of which is [InSite's] Durasite").  The dissent concluded that "Dr. Dawson's WHO presentation and the accompanying report disclose each element of at least the '729 count, and as such, the two WHO references are sufficient to demonstrate Dr. Dawson's prior conception."

With respect to Dr. Chern's experiment with Dr. Leiter's ointment, the dissent explained that:

In the interference proceeding, the Board considered whether Dr. Chern's experiment showed reduction to practice before the critical date.  The Board held that Dr. Chern's experiment could not be reduction to practice because Chern had not applied the ointment to an actual infection.  The Board based its determination on its construction of "treating" an eye, which it construed as "retarding or suppressing infection in a tissue of" an eye.  Because Dr. Chern had not applied the ointment to treat an actual infection, the Board held that Dr. Chern did not reduce Dr. Dawson's invention to practice.  The Board erred in two fundamental aspects.  First, the term "treating an eye" in the preamble of the count is not limiting.  Second, "treating an eye" does not require an actual infection.

The dissent concluded by stating that:

The question is:  because Dr. Dawson's WHO presentation demonstrated conception and Dr. Chern's experiment demonstrated reduction to practice, what is left to establish inventorship?  The majority opinion leaves open for interpretation whether commercialization is required for full conception.

But conception does not require commercialization, nor does commercialization establish initial invention.  On the contrary, the record shows that Dr. Dawson conceived his invention at UCSF.  He turned to Dr. Bowman at InSite only for assistance in commercializing his invention.

Dawson v. Dawson (Fed. Cir. 2013)
Panel: Circuit Judges Reyna, Bryson, and Wallach
Opinion by Circuit Judge Bryson; dissenting opinion by Circuit Judge Reyna

Vanderbilt Univ. v. ICOS Corp. (Fed. Cir. 2010)

    By Donald Zuhn --

Last month, in Vanderbilt Univ v. ICOS Corp., the Federal Circuit affirmed a decision of the District Court for the District of Delaware finding that Plaintiff-Appellant Vanderbilt University had failed to prove that Vanderbilt scientists Drs. Jackie Corbin, Sharron Francis, and Sekhar Konjeti were joint inventors of U.S. Patent Nos. 5,859,006 and 6,140,329.  The '006 and '329 patents are directed to compounds and methods for treating erectile dysfunction, including the compound tadalafil, a PDE5 inhibitor and the active ingredient in the drug Cialis®.

Drs. Corbin and Francis were among the first to discover PDE5, which is a phosphodiesterase enzyme that binds to and hydrolyzes cGMP.  In 1989, Glaxo Inc. entered into an agreement with Dr. Corbin to underwrite his research of cGMP analogs.  In 1990, Dr. Corbin sent an abstract to Glaxo Group Ltd. (a U.K.-based subsidiary of Glaxo Inc.) disclosing his discovery that the potency of cGMP analogs is enhanced by adding a phenyl ring at the 8-position.  Building upon their research on cGMP analogs, the Vanderbilt scientists modified a PDE inhibitor in 1991 by attaching a phenyl ring to the 8-position of the compound and an electron-donating hydroxyl group at the 4 position of the phenyl ring, thus creating a PDE inhibitor that was 160 times more potent at inhibiting PDE5 than the original compound.  In a letter to Vanderbilt's general counsel, Dr. Corbin disclosed possible therapeutic uses for the new PDE inhibitor, including the treatment of male impotence.

At the end of 1991, Dr. Corbin mentioned his work on PDE5 inhibitors to Dr. Barry Ross, a scientist at Glaxo Group Ltd., and in January of 1992, he sent a research proposal to Glaxo Group Ltd. outlining his test results.  In February, Drs. Corbin and Francis discussed the proposal with Dr. Ross, and later that month, Dr. Corbin sent a more detailed research proposal to Dr. Ross.  In March, Glaxo's research facility in France tested 26 compounds for PDE5 inhibition, and in early April, Dr. Ross forwarded copies of Dr. Corbin's detailed research proposal to certain Glaxo scientists at the French facility.  In late April, Glaxo scientists at the French facility tested another 29 compounds for PDE inhibition.  That testing led to the identification of a lead compound.  Dr. Alain Claude-Marie Daugan, the named inventor on the '006 and '329 patents, discovered tadalafil (at left) after modifying that lead compound.  Prior to the discovery of tadalafil, Glaxo assigned its interest in the compounds to Defendant-Appellee ICOS Corp.

In 2005, Vanderbilt brought suit against ICOS, seeking to correct inventorship of the '006 and '329 patents under 35 U.S.C. § 256 by adding Drs. Corbin, Francis, and Konjeti as joint inventors.  According to Vanderbilt, the identification of the lead compound by Glaxo scientists at the French facility could not have been accomplished without the use of Dr. Corbin's detailed research proposal, and tadalafil could not have been identified from that lead compound without relying on the Vanderbilt scientists' work.  The District Court, however, found for ICOS, determining that the Vanderbilt Scientists could not be co-inventors because they never "conceived the specific chemical structure of the compound claimed [i.e., tadalafil] or the compound with all of its components."  In support of its decision, the District Court cited Bd. of Educ. ex rel. Bd. of Trustees of Fla. State Univ. v. Am. BioScience Inc., 333 F.3d 1330 (Fed. Cir. 2003), which the Court said "precludes the result plaintiff seeks:  namely, that the contribution of a molecular scaffold in the context of one molecule . . . renders the disclosing party or parties inventors of a different family of molecules containing the same scaffold."  Notwithstanding this finding, the District Court noted that "[t]his is not to say that Corbin, Francis, and Konjeti did not make contributions to Daugan's inventive process; only that, under the applicable law, these contributions fall more into the category of 'prosaic' contributions because they did not conceive the invention as claimed."

On appeal, Vanderbilt argued that Dr Corbin's disclosure of his detailed research proposal to Glaxo Group Ltd. led to the identification by Glaxo scientists at the French facility of a lead compound incorporating the same molecular scaffold as Vanderbilt's PDE5 inhibitors.  At trial, ICOS initially argued that Glaxo scientists at the French facility independently discovered the compounds that were tested for PDE5 inhibition through their knowledge of the vasorelaxation effect of beta-carbolines, which was allegedly gleaned in part from a May 1992 paper.  However, Glaxo's internal records indicated that the compounds were first tested in April 1992, before that paper was published.  ICOS then "backed away" from this story and instead argued that the lead compound was identified in the April 1992 search by looking to the structure of a compound identified in Glaxo's earlier March 1992 search.  This second story was supported by the testimony of Glaxo's scientists at the French facility, who testified that they did not have any knowledge about the Vanderbilt scientists' research until June 1993, long after the April 1992 search had been performed.  In response, Vanderbilt argued that in view of its changing story, Glaxo lacked credibility, and Vanderbilt suggested that Glaxo's scientists used the detailed research proposal to guide their structure searches in April 1992.  In addition, Vanderbilt argued that the key modification to the lead compound that yielded tadalafil was the addition of an electron-donating substituent on the phenyl ring based upon the work of the Vanderbilt scientists.

Noting that "Vanderbilt admits that no direct evidence supports its claims to joint inventorship," and further, that ICOS countered Vanderbilt's arguments with direct evidence supporting its claim of sole identification of the lead compound and independent discovery of tadalafil, the Federal Circuit agreed with the District Court that Vanderbilt had failed to meet its burden of showing joint inventorship by clear and convincing evidence.  The Federal Circuit did agree with Vanderbilt that "the district court opinion contains some erroneous statements regarding the law of joint inventorship and a misunderstanding of the relevance of American BioScience to the facts of this case," but concluded that "[t]hese errors, however, do not affect the outcome of this appeal and are therefore harmless in context."  With regard to the District Court's "misunderstanding," the Federal Circuit noted that while "[t]he district court understood our decision in American BioScience to require that each co-inventor have an independent conception of the final compound for a chemical invention, . . . [s]uch an interpretation is clearly wrong under our established precedent.  Instead, a group of co-inventors must collaborate and work together to collectively have a definite and permanent idea of the complete invention."  The Federal Circuit also noted that "the district court's statement that 'the contribution of a molecular scaffold in the context of one molecule' could never rise to the level of joint inventorship for 'a different family of molecules containing the same scaffold' is in error."  Nevertheless, the Federal Circuit determined that:

[T]he district court, however, did not rest its opinion solely on this interpretation of our case law.  The district court correctly noted that conception requires identification of the specific chemical structure of the compound.  The parties agree that Dr. Daugan was the first to conceive of tadalafil.  After a careful review of the evidence, the district court concluded that the parties' respective stories about whether the Vanderbilt Scientists contributed to the identification of [Glaxo's lead compound] were "equally plausible" and that Vanderbilt failed to produce any evidence of joint invention of tadalafil.  For Vanderbilt to succeed in its inventorship claim, it must carry its burden of proof of demonstrating that the Vanderbilt Scientists contributed to the claimed invention with clear and convincing evidence.  See Hess v. Advanced Cardiovascular Sys., Inc., 106 F.3d 976, 980 (Fed. Cir. 1997).  The district court's findings demonstrate that under the correct legal test, Vanderbilt did not carry its burden.  Thus, any erroneous interpretations of our case law were harmless error.

In his opinion concurring in part and dissenting in part, Judge Dyk "respectfully dissent[ed] from the majority's conclusion that the district court's legal error was harmless," stating that the District Court's findings were "either contradictory or infected by the court's legal error."  Judge Dyk's disagreement lay not with Vanderbilt's argument concerning tadalafil, but rather with Vanderbilt's argument concerning Glaxo's identification of the lead compound.  Here, he notes that "[t]he district court found that the Vanderbilt scientists did in fact make contributions to Glaxo's work, a point the majority ignores."  Judge Dyk also pointed to ICOS' changing story regarding the identification of the lead compound at trial.  He concludes that:

There are two possible ways to interpret the district court's findings, either of which requires a remand.  The first is that the district court's findings are directly contradictory.  The court could not have properly found that the Vanderbilt scientists made a contribution to the identification of [Glaxo's lead compound] if it were "equally plausible" that they did not make a contribution.  . . .  The alternative is that the district court found that Vanderbilt did not establish by clear and convincing evidence that the Vanderbilt scientists' contributions were sufficient to make them joint inventors.  The problem with this interpretation of the finding is that it is obviously tainted by the district court's view that in order to be joint inventors, the Vanderbilt scientists must have "conceived the 'specific chemical structure of the compound' claimed or 'the compound with all of its components,' or communicated that compound to Glaxo."

Stating that "the district court found that the Vanderbilt scientists made some contribution, [but] has not told us exactly what that contribution was or why that contribution was not enough to make the Vanderbilt scientists joint inventors under the correct standard," Judge Dyk believed that the District Court's decision should have been vacated and remanded.

Vanderbilt Univ. v. ICOS Corp. (Fed. Cir. 2010)
Panel: Chief Judge Michel and Circuit Judges Clevenger and Dyk
Opinion by Circuit Judge Clevenger; concurring in part and dissenting in part opinion by Circuit Judge Dyk