DUSA Pharmaceuticals, Inc. v. Biofrontera Inc.

          MEMORANDUM AND ORDER ON CLAIM CONSTRUCTION

          RICHARD G. STEARNS, UNITED STATES DISTRICT JUDGE.

         In this multifaceted intellectual property dispute, plaintiff DUSA Pharmaceuticals, Inc., accuses defendants Biofrontera Inc., Biofrontera Bioscience GMBH, Biofrontera Pharma GMBH, and Biofrontera AG (collectively Biofrontera) of patent infringement and misappropriation of trade secrets.^[1] Before the court are the parties' briefs construing the disputed claim terms of the two asserted patents - U.S. Patents Nos. 8, 216, 289 (the '289 patent) and 9, 723, 991 (the '991 patent). The court heard argument pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), on March 12, 2019.

         THE ASSERTED PATENTS

         The '289 and the '991 patents are both entitled “Illuminator for Photodynamic Therapy, ” and list as inventors Scott Lundahl, Rebecca Kozodoy, Ronald Carroll, and Elton Leppelmeier. The '289 patent was issued on July 10, 2012, from an application dated December 16, 2010. The '991 patent was issued on August 8, 2017, from an application dated May 20, 2014. The application for the '991 patent is a continuation of the application for the '289 patent, which is itself a continuation in a long line of applications dating back to 1998. The two patents share the same specification.

         The asserted patents are directed to improvements in photodynamic treatment (PDT) technology.

Photodynamic therapy or photochemotherapy is currently being proposed to treat several types of ailments in or near the skin or other tissues, such as those in a body cavity. For example, PDT is being proposed to treat different types of skin cancer and pre-cancerous conditions. In PDT, a patient is administered a photoactivatable agent or precursor of a photoactivatable agent^[2]which accumulates in the tissue being diagnosed or treated. An area of the patient which includes the tissue being diagnosed or treated is then exposed to visible light. The visible light causes chemical and/or biological changes in the photoactivatable agent which in turn selectively locate, destroy or alter the target tissue while at the same time causing only mild and reversible damage to other tissues in the treatment area.

'289 patent, col. 1, ll. 36-50. “For therapeutic reasons it is desirable to have a power output which is uniform in intensity and color. In particular, it is highly desirable to have an illuminator with a spectral output that overlaps to a large extent with the optical activation spectrum of the target photosensitizer.” Id., col. 2, ll. 24-28. However, “[c]onventional illuminators do not produce visible light that is sufficiently uniform in intensity over a contoured surface.” Id., col. 2., ll. 37-38.

         Objectives of the asserted patents include:

• to provide an improved illuminator for PDT and/or PD [(photodiagnosis)];

• to provide an illuminator for PDT that produces visible light of consistent uniformity in terms of both spectral characteristics and intensity over a diversely contoured surface;

• to provide an illuminator for PDT or PD which produces visible light almost entirely in a selected wavelength range;

• to provide an illuminator for irradiating the face or scalp of a patient;

• to provide a cooling system for improving the irradiance uniformity of an illuminator;

• to provide an illuminator comprising a finite emitter that approximates the uniform output of an infinite plane emitter by varying the spacing of individual light sources within the illuminator; and

• to provide a monitoring system for an illuminator comprising a single visible light sensor monitoring the visible light output of a plurality of light sources and outputting a signal to adjust the visible light output from the plurality [of] light sources.

Id., col. 2, ll. 42-65. To accomplish the stated goals, the patents disclose

[a]n apparatus and method for photodynamic therapy or photodynamic diagnosis using an illuminator comprising a plurality of light sources generally conforming to a contoured surface and irradiating the contoured surface with substantially uniform intensity visible light. The light sources may comprise generally U-shaped fluorescent tubes that are driven by electronic ballasts. Adjustment of the ballast voltage controls the output power of the tubes. The tubes are supported by a sheet-metal or plastic housing and are covered by a polycarbonate shield which directs cooling airflow within the unit and prevents glass-patient contact in the vent of tube breakage. An aluminum reflector located behind the tubes increases both the output irradiance and the uniformity of the output distribution. The spacing of the U-shaped tubes is varied to increase the output at the edges of the illuminator to make the output more uniform. Also, different portions of the tubes are cooled at different amounts, to improve uniformity. A light sensor monitors output from the U-shaped tubes to provide a signal for adjusting the output from the tubes.

Id., Abstract. Figure 1, reproduced infra, illustrates an exemplar of the illuminator described in the asserted patents.

         (Image Omitted)

According to one preferred embodiment illustrated in FIGS. 1-8, seven U-shaped fluorescent tubes 10(1)-10(7) are driven by three electronic ballasts 20. Adjusting the ballast voltage controls the output power of the tubes. The tubes 10(1)-10(7) are supported by a housing 30 and are covered by a polycarbonate shield 40 which directs cooling airflow within the unit and prevents glass-patient contact in the event of tube breakage. An aluminum reflector 50 located behind the tubes increases both the output irradiance and the uniformity of the output distribution.

Id., col. 5, ll. 27-36.

         The '289 patent sets out 19 method claims, while the '991 patent sets out 12 appratus claims. For each patent, claim 1 is ...