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

NOTE: Pursuant to Fed. Cir. R. 47.6, this disposition
is not citable as precedent. It is a public record.
United States Court of Appeals for the Federal Circuit
05-1545
MASSACHUSETTS EYE AND EAR INFIRMARY,
Plaintiff/Counterclaim Defendant-
Appellant,
and
EVANGELOS S. GRAGOUDAS, M.D.
and JOAN W. MILLER, M.D.,
Counterclaim Defendants-
Appellants,
v.
NOVARTIS OPHTHALMICS, INC.,
Defendant-Appellee,
and
QLT, INC.,
Defendant/Counterclaimant-
Appellee,
and
THE GENERAL HOSPITAL CORPORATION,
Intervenor-Appellee.
__________________________
DECIDED: October 6, 2006
__________________________
Before NEWMAN, MAYER, and LINN, Circuit Judges.
LINN, Circuit Judge.
Massachusetts Eye & Ear Infirmary (“MEEI”), Dr. Evangelos S. Gragoudas, and
Dr. Joan W. Miller (“Dr. Miller”) (collectively, “appellants”) appeal from the judgment of
the United States District Court for the District of Massachusetts, Case No. 01-CV-
10747, granting Novartis Ophthalmics, Inc.’s, QLT, Inc.’s, and the General Hospital
Corp.’s (collectively, “appellees”) motion for partial summary judgment that Dr. Julia
Levy (Dr. Levy) was a co-inventor of U.S. Patent No. 6,225,303 (“the ’303 patent”).
Mass. Eye & Ear Infirmary v. Novartis Ophthalmics, Inc., 353 F. Supp. 2d 170 (D. Mass.
2005) (“Inventorship Order”). Because we conclude that there are genuine issues of
material fact with regard to whether Levy made a significant contribution to the 900
mW/cm2 upper limit of the claimed irradiance range, we reverse the grant of partial
summary judgment and remand for further proceedings.
I. BACKGROUND
MEEI is the owner of the ’303 patent, which relates to a method of treating
choroidal neovascularization (“CNV”) by photodynamic therapy (“PDT”). CNV refers to
the proliferation of unwanted, leaky new blood vessels in the choroid, a vascular layer
underlying the retina. PDT is a procedure involving the administration of a
photosensitive drug 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.
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The ’303 patent issued from a continuation application claiming priority to an
earlier patent application, filed jointly by researchers from MEEI, Massachusetts
General Hospital, and QLT, which led to the issuance of U.S. Patent No. 5,798,349(“the ’349 patent”). The ’349 patent lists as inventors Dr. Levy of QLT, Drs. Miller and
Grougadas of MEEI, and Drs. Tayyaba Hassan and Ursula Schmidt-Erfurth of
intervenor General Hospital Corp. Only Drs. Miller and Gragoudas of MEEI are named
as inventors on the ’303 patent.
The written descriptions of the ’303 patent and the ’349 patent are identical. The
claims of the ’303 patent include an irradiance range of “about 300 mW/cm2 to about
900 mW/cm2” that results in a “shortened treatment time.” ’303 patent, col. 15, ll. 20-28.
The United States Patent and Trademark Office (“PTO”) initially rejected, on
obviousness-type double patenting grounds, the patent application that resulted in the
’303 patent. In response, MEEI pointed out to the examiner that the claims of the ’349
patent made no reference to the irradiance of the laser light or to the length of the
treatment time. The PTO, in turn, suggested that MEEI amend the pending claims to
add the phrase “in a shortened treatment time” and MEEI accepted the change. The
PTO thereafter issued the ’303 patent.
On May 1, 2001, MEEI sued QLT and Novartis Ophthalmics for infringement of
the ’303 patent. QLT filed a counterclaim alleging, among other things, correction of
inventorship under 35 U.S.C. § 256 to add the researchers of Massachusetts General
Hospital and QLT as co-inventors. After the close of discovery, Massachusetts General
Hospital and QLT filed a joint motion for correction of inventorship and sought summary
judgment on that issue. QLT submitted a statement of undisputed facts pursuant to
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Local Rule 56.1. MEEI “did not dispute” some of the facts, but contested the
“characterization of those facts.”
On January 25, 2005, the district court issued a Memorandum and Order on
Massachusetts General Hospital’s and QLT’s joint motion, concluding that Dr. Levy had
contributed significantly to the upper end of the irradiance range claimed in the ’303
patent, and treating MEEI’s failure to controvert the facts in the statement of undisputed
facts as admissions. Inventorship Order, 353 F. Supp. 2d at 174-75. Subsequently,
MEEI filed a motion to amend its response to paragraphs 115 and 120 of QLT’s
statement of undisputed facts to replace the phrase “does not dispute” with “denies.”
The district court denied the motion. Pursuant to Rule 54(b), the district court entered
final judgment on July 14, 2005.
The appellants timely appeal to this court. We have jurisdiction pursuant to 28
U.S.C. § 1295(a)(1).
II. ANALYSIS
A. Standard of Review
“We review a district court’s grant of summary judgment de novo.” Ethicon Endo-
Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 1309, 1315 (Fed. Cir. 1998). Summary
judgment is appropriate “if the pleadings, depositions, answers to interrogatories, and
admissions on file, together with the affidavits, if any, show that there is no genuine
issue as to any material fact and that the moving party is entitled to a judgment as a
matter of law.” Fed. R. Civ. P. 56(c). “In determining whether there is a genuine issue
of material fact, the evidence must be viewed in the light most favorable to the party
opposing the motion, with doubts resolved in favor of the opponent.” Chiuminatta
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Concrete Concepts, Inc. v. Cardinal Indus., Inc., 145 F.3d 1303, 1307 (Fed. Cir. 1998).
Inventorship is a question of law that we review without deference. Caterpillar, Inc. v.
Sturman Indus., 387 F.3d 1358, 1376 (Fed. Cir. 2004).
B. Discussion
The appellants argue that the district court erred in granting summary judgment
because there is a genuine issue of material fact as to whether Levy made a significant
contribution to the conception before it was complete. Specifically, the appellants argue
that the district court erred in concluding that the conception of the invention by Drs.
Miller and Gragoudas was not complete in 1992, and that there was nothing significant
about the 900 mW/cm2 irradiance value. The appellants further argue that the district
court erred by concluding that there was clear and convincing evidence of sufficient
corroboration. Finally, MEEI argues that the district court abused its discretion in
denying its motion to clarify its factual responses.
The appellees respond that based upon undisputed facts, the district court
correctly determined that Dr. Levy contributed significantly to the conception of the
claimed irradiance range. Specifically, the appellees argue that MEEI admitted that Dr.
Levy was the first to propose using an irradiance of 900 mW/cm2. The appellees further
argue that Dr. Levy’s contribution to the claimed irradiance range is sufficiently
corroborated, based on MEEI’s admission and on additional evidence including the
contemporaneous documentary record. Finally, the appellees argue that the district
court did not abuse its discretion in denying MEEI’s motion to amend its response.
The district court concluded that “the undisputed facts clearly and convincingly
show[ed] that Dr. Levy conceived of the upper end of the irradiance range.”
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Inventorship Order, 353 F. Supp. 2d at 176. However, in doing so, the district court
failed to appreciate the presence of a number of genuine issues of material fact. First,
the district court failed to consider the fundamental question of whether the named
inventors had already conceived of a broader range including the 900 mW/cm2 upper
limit recited in the claims. If they had, then the district court would have had to consider
the question of whether the claimed narrower range is of any consequence, and thus
whether any contribution by Dr. Levy of that upper limit reflects an inventive
“contribution to the claimed invention that is not insignificant in quality, when that
contribution is measured against the dimension of the full invention.” Acromed Corp. v.
Sofamor Danek Group, Inc., 253 F.3d 1371, 1379 (Fed. Cir. 2001) (internal quotations
omitted).
As to the 900 mW/cm2 upper end of the irradiance range, the district court based
its conclusion on the following four “undisputed” facts: (1) Dr. Levy insisted that Dr.
Miller test 900 mW/cm2; (2) Dr. Miller had never tested 900 mW/cm2 before
collaborating with QLT; (3) 900 mW/cm2 became the upper end of the irradiance range
claimed in independent claims 1 and 9 of the ’303 patent; and (4) 900 mW/cm2 is the
highest irradiance level at which a practitioner may safely administer PDT in the manner
claimed by the ’303 patent. Id.The appellants do not dispute facts (2) and (3) stated above. Regarding fact (1),
paragraph 115 of QLT’s statement of undisputed facts states that “Levy insisted that the
protocol evaluate four different irradiance levels, including 900 mW/cm2.” MEEI’s
response to paragraph 115 stated that “MEEI does not dispute the ‘facts’ set forth in
¶ 115,” but it noted its disagreement with QLT’s characterization of the those facts.
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Consistent with the language of Local Rule 56.1, which states that “[m]aterial facts of
record set forth in the statement . . . will be deemed for purposes of the motion to be
admitted by the opposing parties unless controverted by the statement required to be
served by opposing parties,” the district court did not err in concluding that MEEI
admitted the facts set forth in ¶ 115. See Stonkus v. City of Brockton Sch. Dep’t, 332
F.3d 97, 102 (1st Cir. 2003). Further, we cannot say that the district court abused its
discretion in denying MEEI’s motion to amend its response. See Ramsdell v. Bowles,
64 F.3d 5, 7 (1st Cir. 1995) (acknowledging the district court’s great leeway in the
application and enforcement of its local rules). Nevertheless, MEEI’s admission is
restricted to the specific statement in ¶ 115, namely that Levy insisted that the protocol
evaluate four different irradiance levels, including 900 mW/cm2. The mere insistence by
Dr. Levy does not, as the district court concluded, “show that the parties do not dispute
that QLT’s Dr. Levy contributed to the conception of the upper end of the 300 mW/cm2
to 900 mW/cm2 irradiance range.” Inventorship Order, 353 F. Supp. 2d at 174.
Regarding (4), the district court’s conclusion that 900 mW/cm2 was the highest
irradiance level at which a practitioner may safely administer PDT was based in part on
its assessment that the 1992 experiments using 1200 mW/cm2 and 1800 mW/cm2 were
unsuccessful. See id. at 178. The appellants, citing Miller’s submissions to QLT,
contend that Miller recognized that irradiances as high as 1200 mW/cm2 were both safe
and effective. Drawing inferences in favor of the appellants, there is a genuine issue of
material fact regarding the highest irradiance level at which a practitioner may safely
administer PDT. Moreover, there is no evidence to suggest what level of damage
05-1545 7
caused at high irradiance levels renders the PDT “unsafe.” These are questions that
remain for resolution at trial.
As to the significance of the 900 mW/cm2 upper limit, although the appellants do
not dispute the fact that Dr. Miller had never tested at the specific value of 900 mW/cm2,
they contend that her first set of experiments in 1992 involved performing PDT at
specific irradiances of 300 mW/cm2, 600 mW/cm2, 1200 mW/cm2, and 1800 mW/cm2.
The appellants contend that on the basis of these experiments, Dr. Miller concluded that
irradiances up to 1200 mW/cm2—including the specific irradiance value of 900
mW/cm2—were useful for PDT treatment of age-related macular degeneration. Thus,
the appellants argue that Dr. Levy’s insistence on evaluating at 900 mW/cm2 was not a
significant, and thus inventive, contribution because the testing conducted by Drs. Miller
and Gragoudas in 1992 on healthy animals evinced conception of the entire irradiance
range prior to any suggestion of testing at the claimed upper limit of 900 mW/cm2. The
appellees, on the other hand, contend that because the 1992 experiments involved
monkeys with normal choroidal vessels, they could not demonstrate closure of CNV.
Thus, the appellees argue that Dr. Levy’s insistence on testing at 900 mW/cm2 was a
significant contribution. The district court improperly determined that because “900
mW/cm2 is the upper limit claimed in the ’303 patent, the critical inquiry is whether Dr.
Miller or Dr. Levy conceived of this specific figure.” The upper limit of the claim is
nothing more than that. The suggestion of an upper limit of a claim limitation does not
necessarily constitute an inventive contribution if the upper limit is contained within a
previously conceived broader range and is of no demonstrated significance. See
Burroughs Wellcome Co. v. Barr Labs., Inc.., 40 F.3d 1223, 1229 (Fed. Cir. 1994)
05-1545 8
(noting that “each inventor must contribute to the joint arrival at a definite and
permanent idea of the invention as it will be used in practice”). Further, the district
court’s reliance on the testimony of MEEI’s patent law expert to support its conclusion
that Dr. Levy made a significant contribution is misplaced. The patent law expert
testified that a proposed experiment to test 200 mW/cm2, 250 mW/cm2, 300 mW/cm2,
and 600 mW/cm2 could not serve as the basis for conception of a range of 300 mW/cm2
to 900 mW/cm2 because the experiments did not test beyond 600 mW/cm2. Based on
this testimony, the district court improperly concluded that an inventor must actually test
at 900 mW/cm2 to conceive a range of 300 mW/cm2 to 900 mW/cm2. Testing at exactly
the end points of a range is not necessarily required for a conception of that range. See
Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.3d 1570, 1575 (Fed. Cir. 1985) (holding
that ranges found in an applicant’s claims need not correspond exactly to those
disclosed in a parent application).
Because a trier of fact could conclude that Dr. Miller’s 1992 tests amounted to a
conception of the full irradiance range claimed, thus rendering any contribution by Dr.
Levy of the claimed upper limit of no inventive consequence, the district court’s grant of
summary judgment was in error.
III. CONCLUSION
In sum, we conclude that summary judgment was incorrectly granted based on
the presence of genuine issues of material fact as to both the significance of the 900
mW/cm2 upper limit and the contribution, if any, made my Dr. Levy with respect thereto.
Accordingly, we reverse the grant of partial summary judgment and remand to the
district court for further proceedings.
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IV. COSTS
No costs.
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