          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.




05-1545                                 2
      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




05-1545                                  3
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




05-1545                                    4
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.”




05-1545                                   5
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.




05-1545                                  6
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.




05-1545                                   9
                 IV. COSTS

     No costs.




05-1545          10
