Mass Eye and Ear Inf v. QLT Phototherapeutic

CourtCourt of Appeals for the First Circuit
DecidedFebruary 18, 2005
Docket03-1682
StatusPublished

This text of Mass Eye and Ear Inf v. QLT Phototherapeutic (Mass Eye and Ear Inf v. QLT Phototherapeutic) is published on Counsel Stack Legal Research, covering Court of Appeals for the First Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mass Eye and Ear Inf v. QLT Phototherapeutic, (1st Cir. 2005).

Opinion

United States Court of Appeals For the First Circuit

Nos. 03-1682 03-1683 03-1725

MASSACHUSETTS EYE AND EAR INFIRMARY, Plaintiff/Counterclaim Defendant, Appellant/Cross-Appellee,

v.

QLT PHOTOTHERAPEUTICS, INC., Defendant.

QLT, INC., Counterclaim Plaintiff, Appellee/Cross-Appellant,

MASSACHUSETTS EYE AND EAR INFIRMARY, EVANGELOS S. GRAGOUDAS, M.D., JOAN W. MILLER, M.D., Counterclaim Defendants, Appellants/Cross-Appellees.

APPEALS FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Joseph L. Tauro, U.S. District Judge]

Before

Torruella, Circuit Judge, Gibson,* Senior Circuit Judge, and Lipez, Circuit Judge.

Kenneth B. Herman, with whom James F. Haley, Jr., Christopher J. Harnett, Gerald J. Flattmann, John P. Hanish, Bindu Donovan,

* Hon. John R. Gibson, of the Eighth Circuit, sitting by designation. Fish & Neave, Christine M. Roach, M. Ellen Carpenter and Roach & Carpenter PC, were on brief, for appellants. Donald R. Ware, with whom Barbara A. Fiacco, Jessica M. Silbey, Mark A. Reilly and Foley Hoag LLP, were on brief, for appellee/cross-appellant.

June 16, 2005

-2- TORRUELLA, Circuit Judge. The noble pursuit of curative

technologies birthed Visudyne, a drug that treats the leading cause

of vision loss in people over age fifty. That success involved the

efforts of multiple institutions, and the common drive for

financial returns now brings us a dispute over rights to the income

stream of the fastest growing ophthalmic drug in history.

The entire range of claims articulated by plaintiff-

appellant was dismissed by the district court on summary judgment.

The bulk of the opinion that follows consists of our de novo review

of these dismissals. We must also address defendant-appellee's

cross-appeal of several discovery-related rulings. Following a

review of the factual background, considered in the light most

favorable to the appellant, we will begin our analysis.

I. Factual Background

A. Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an ocular

disease that is the predominant cause of vision loss in people over

age fifty. The illness takes two forms: "wet" and "dry." The wet

form, though only accounting for ten percent of the cases of age-

related macular degeneration, leads to the debilitating condition

known as choroidal neovascularization ("CNV" or "neovasculature"),

responsible for ninety percent of cases of AMD vision loss.

Neovasculature refers to conditions characterized by the

proliferation of unwanted blood vessels.

-3- In 1989, several researchers at Massachusetts General

Hospital's ("MGH") Wellman Laboratories of Photomedicine began

investigating the use of photosensitive drugs to treat eye diseases

such as AMD involving neovasculature. In March 1991, the MGH

researchers met with Dr. Julia Levy of appellee QLT

Phototherapeutic ("QLT") to discuss the possibility of utilizing

benzoporphin derivatives ("BPD" or "derivatives") developed by QLT

for the treatment of AMD. Levy agreed to provide MGH the BPD

needed for research trials.

The Massachusetts Eye and Ear Infirmary ("MEEI" or "the

Infirmary"), a medical institution located next to, but distinct

from, MGH, also sought out QLT's BPD for photodynamic therapy

research. Dr. Joan Miller joined the Infirmary in the fall of 1991

and soon proposed conducting studies using BPD on monkeys. In

March 1992, Miller applied to MEEI to investigate the use of BPD to

treat neovasculature. Pursuant to Dr. Miller's application, MEEI

and QLT signed a material transfer agreement ("MTA") in which MEEI

would receive BPD at no cost in exchange for providing QLT the

results of Miller's pre-clinical studies for use in QLT's

regulatory filings and patent disclosures.

In September 1992, following their successful monkey

trials, which demonstrated the potential use of photodynamic

therapy with BPD, Dr. Miller and her MEEI colleague, Dr. Gragoudas,

presented their data confidentially to QLT representatives visiting

-4- Boston. Within the next two years, MEEI and QLT entered into two

more material transfer agreements of similar tenor.

B. Confidential Disclosure Agreement

QLT had interest in commercial applications of the

Infirmary's experimental monkey trials and, in May 1993, QLT and

Dr. Miller entered into a Confidential Disclosure Agreement

("CDA"). As part of this agreement, QLT promised "not to use the

Confidential Information for any purpose other than the evaluation

of Products under the terms of this Agreement" and "to maintain

Confidential Information in confidence." The parties agreed that

"misuse or improper disclosure of Confidential Information would

irreparably harm the business of the disclosing party or that

party's affiliates." Pursuant to the CDA, Miller continued to

provide MEEI's confidential research results to QLT, including

results of MEEI research not funded by QLT.

In July 1993, at Dr. Miller's request, QLT agreed to fund

further experiments by the Infirmary involving the treatment of

neovasculature in monkeys with the derivatives. The results of

these studies, as well as other studies not funded by QLT, were

shared with QLT in November 1994, in a report entitled the

Preclinical BPD-MA Pharmacology Study for Macular Degeneration

("Bolus Study").

-5- C. QLT Partnership with CIBA Vision

In late 1993, QLT contacted the company CIBA Vision1 to

commercialize the use of photodynamic therapies with BPD to treat

age-related macular degeneration. QLT provided CIBA Vision with

MEEI's confidential research results without first informing MEEI.

In February 1994, CIBA Vision sought full access to Dr. Miller's

research results to pursue a "high potential opportunity." QLT

agreed to share with CIBA Vision the "plans and results of our

ocular programme," which included Dr. Miller's research.

Dr. Miller learned of QLT's negotiations with CIBA Vision

in the Spring of 1994. In March, she expressed concern about the

confidentiality of MEEI's research results to Julia Levy and Edwin

Levy of QLT, who assured her that QLT had not disclosed and would

not disclose in the future any of MEEI's trade secret information.

Dr. Miller then flew to Switzerland "to get CIBA Vision excited in

the technology," but during that meeting, and subsequent meetings

with CIBA Vision representatives in July and October of 1994 she

presented only summaries of her research.

On May 31, 1994, CIBA Vision and QLT executed a Letter of

Intent to enter into a strategic partnership for commercializing

the use of photodynamic therapy to treat neovasculature arising

from age-related macular degeneration. The Letter recognized that

QLT had "significant non-clinical evidence" -- some of which came

1 CIBA Vision is today known as Novartis Ophthalmics, Inc.

-6- from Miller's research -- showing the success of the therapy for

this application. The Letter indicated that "[e]ach party will

manage the patent portfolio in collaboration with the other party."

QLT announced the partnership to the public and MEEI announced

that:

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