United States District Court, D. Massachusetts
DUSA PHARMACEUTICALS, INC.
v.
BIOFRONTERA INC., BIOFRONTERA BIOSCIENCE GMBH, BIOFRONTERA PHARMA GMBH, and BIOFRONTERA AG
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 ...