Massachusetts Eye & Ear Infirmary v. Novartis Ophthalmics, Inc.

353 F. Supp. 2d 170, 2005 U.S. Dist. LEXIS 1231, 2005 WL 195370
CourtDistrict Court, D. Massachusetts
DecidedJanuary 25, 2005
DocketCIV.A. 01-10747-EFH
StatusPublished
Cited by2 cases

This text of 353 F. Supp. 2d 170 (Massachusetts Eye & Ear Infirmary v. Novartis Ophthalmics, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Massachusetts Eye & Ear Infirmary v. Novartis Ophthalmics, Inc., 353 F. Supp. 2d 170, 2005 U.S. Dist. LEXIS 1231, 2005 WL 195370 (D. Mass. 2005).

Opinion

MEMORANDUM AND ORDER

HARRINGTON, Senior District Judge.

I. Introduction

This is a patent infringement case involving a type of laser treatment for patients suffering from certain eye diseases. Defendant QLT, Inc. (“QLT”) brought the instant summary judgment motion, arguing that pursuant to 35 U.S.C. § 256 the Court should correct inventorship of United States Patent No. 6,225,303 (the “ ’303 patent”). Because the Court rules that QLT’s researcher, Dr. Julia Levy, significantly contributed to the upper end of the 300 mW/cm 2 to 900 mW/em 2 irradiance range claimed in the ’303 patent, the Court grants in part QLT’s Motion to Correct Inventorship. 1

II. Background

Plaintiff Massachusetts Eye and Ear Infirmary (“MEEI”) brought this suit alleging that Defendants QLT, Inc. and Novartis Ophthalmics, Inc. (“Novartis”) infringed the ’303 patent by manufacturing, using, selling, and marketing Visudyne for use in ocular therapy. In its answer, QLT raised twelve affirmative defenses and asserted seven counterclaims. One of those counterclaims, correction of inventorship, is the subject of the instant summary judgment motion.

The ’303 patent, entitled “Use of Green Porphyrins to Treat Neovasculature in the Eye,” claims methods for treating choroidal neovascularization and age-related macular degeneration using photody-namic therapy. The choroid is a vascular layer underlying the retina in the eye. Choroidal neovascularization refers to the proliferation of unwanted new blood vessels in the choroid, which can result in a form of age-related macular degeneration. *172 Photodynamic therapy is a procedure involving the administration of a photosensitive drug (called a “photosensitizer” or “dye”) into the bloodstream, accumulation of the drug in the target tissue, and activation of the drug by light, causing photochemical destruction of the target tissue. Green porphyrin dyes include a class of photosensitive drugs called benzoporphy-rin derivatives (“BPD”), which are produced under license by Defendant QLT. One particular type of BPD, known as BPD-MA or verteporfín, is sold by QLT’s marketing partner and licensee, Defendant Novartis, under the trademark “Vi-sudyne.” Photodynamic therapy involves the use of a low-intensity laser that shines light upon, or “irradiates,” the eye. “Ir-radiance,” which is measured in milliwatts per centimeter squared, is a technical term used in connection with lasers that refers to the intensity of laser light delivered to the target area.

Irradiance lies at the heart of this dispute because the ’303 patent is inventive over United States Patent No. 5,798,349 (the “ ’349 patent”) only because the ’303 patent claims an irradiance range that results in a “shortened treatment time.” Both the ’303 patent and the ’349 patent issued from the same ultimate parent application, United States Application Serial No. 08/209,473 (the “ ’473 application”). All of the researchers involved in this lawsuit are named inventors on the ’349 patent: Dr. Julia Levy of QLT, Dr. Joan Miller and Dr. Evangelos Gragoudas of MEEI, and Dr. Tayyaba Hasan and Dr. Ursula Schmidt-Erfurth of Intervenor The General Hospital Corporation (“MGH”). In contrast, only Dr. Miller and Dr. Gra-goudas of MEEI are named inventors of the ’303 patent. Furthermore, both patents are entitled “Use of Green Porphyrins to Treat Neovasculature in the Eye,” both have virtually identical specifications, and both patents have substantially similar claims.

The only meaningful difference between the ’303 patent and the earlier-issued ’349 patent is that independent claims 1 and 9 of the ’303 patent set forth an irradiance range of 300 mW/cm 2 to 900 mW/cm 2 that results in a “shortened treatment time,” whereas the ’349 patent does not claim a specific irradiance range. Indeed, the United States Patent and Trademark Office (“PTO”) initially rejected on obvious-type double patenting grounds United States Application Serial No. 09/347,382 (the “ ’382 application”), a continuation application claiming priority through the ’349 patent that eventually issued as the ’303 patent. According to the PTO, the ’382 application was not inventive over the ’349 patent because the claims of the ’349 patent already covered the irradiance range claimed in the ’382 application, namely, 300 mW/cm 2 to 900 mW/cm 2 . In response, MEEI pointed out that in reaching its decision the PTO had not looked solely to the claims of the ’349 patent, but had improperly relied on the ’349 patent’s specification. 2 MEEI explained that the claims of the ’349 patent made no reference to the irradiance of the laser light or to the length of treatment time. In turn, the PTO suggested that MEEI could avoid double patenting by adding the phrase “in a shortened treatment time” to pending claims 21 and 29 of the ’382 application, both of which claims set forth the 300 mW/cm 2 to 900 mW/cm 2 irradiance range. MEEI accepted this change, and it amend *173 ed claims 21 and 29, which issued as independent claims 1 and 9 of the ’303 patent.

The collaboration that resulted in the issuance of both the ’303 and ’349 patents began in the late 1980s and early 1990s when researchers from QLT, MEEI, and MGH variously began collaborating on projects involving photody-namic therapy and green porphyrins. This collaboration involved Dr. Julia Levy of QLT, Dr. Joan Miller and Dr. Evangelos Gragoudas of MEEI, and Dr. Tayyaba Hasan, Dr. Ursula Schmidt-Er-furth, and Dr. Reginald Birngruber of MGH. The collaboration spanned many years and the parties dispute the contributions each made to certain inventions. Thus, the Court will recount only those portions of the collaboration necessary to decide this motion: the 1992 experiments performed by MEEI’s Dr. Miller and the 1993 experiments in which Dr. Miller collaborated with QLT’s Dr. Levy. Both the 1992 and 1993 experiments were conducted before the March 14, 1994 filing of the ’473 application, the ultimate parent application of both the ’303 and ’349 patents.

The following summary of the 1992 and 1993 experiments is derived from QLT’s Local Rule 56.1 Statement of Undisputed Facts (“Statement of Undisputed Facts”) and MEEI’s response thereto. In 1992, Dr. Miller and Dr. Gragoudas, along with other researchers, became involved in two sets of experiments using photodynamic therapy on monkeys. Dr. Miller and Dr. Gragoudas designed the first set of experiments, which were then conducted by Dr. Miller. These experiments consisted of performing photodynamic therapy on monkeys with normal choroidal vessels at irra-diances of 300 mW/cm 2 , 600 mW/cm 2

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353 F. Supp. 2d 170, 2005 U.S. Dist. LEXIS 1231, 2005 WL 195370, Counsel Stack Legal Research, https://law.counselstack.com/opinion/massachusetts-eye-ear-infirmary-v-novartis-ophthalmics-inc-mad-2005.