Opinion
Civ. No. 00-2805 (GEB)
January 29, 2003
MEMORANDUM OPINION
This matter comes before the Court upon the motions of the plaintiff Ortho-McNeil Pharmaceutical, Inc. ("Ortho") and the defendant Barr Laboratories, Inc. ("Barr") for summary judgment as to Barr's defense of invalidity due to obviousness. The Court has jurisdiction over this action pursuant to 28 U.S.C. § 1338 (a). For the reasons discussed below, the parties' motions for summary judgment are denied.
I. BACKGROUND
A. PROCEDURAL HISTORY
Ortho is the owner of U.S. Patent No. 4,544,554 (the "`554 Patent"), and U.S. Patent No. 4,616,006 (the "`006 Patent"), which were duly and legally issued on October 1, 1985, and October 7, 1986, respectively. Plaintiff's Statement of Undisputed Material Facts pursuant to L. Civ. R. 56.1 ("Pl. R.56.1 Statement"), ¶ 2. Both patents were invented by Dr. Samuel Pasquale and are entitled "Triphasic Oral Contraceptive." Id. at ¶ 2. Ortho manufactures and markets Ortho Tri-Cyclen, the commercial embodiment of claim 10 of the `554 patent and claim 9 of the `006 patent. Id. at ¶ 1, 3.
The applications leading to the `554 and the `006 Patents were filed on May 4, 1984 and June 13, 1995, respectively, as continuations-in-part of the application issued as U.S. Patent No. 4,530,839 (the "`839 Patent").
On February 16, 2000, Barr filed an Abbreviated New Drug Application ("ANDA") with the FDA seeking approval to manufacture and sell a generic version of Ortho Tri-Cyclen prior to the expiration of the `554 and `006 patents. Id. at ¶ 4. In accordance with the Federal Food, Drug and Cosmetic Act, Barr certified to the FDA that Ortho's patents are invalid, unenforceable against and/or not infringed by Barr's generic version of the drug. Id. at ¶ 5. Written notice of the certification was provided to Ortho and its parent company, Johnson and Johnson. Id. at ¶ 6.
On March 1, 2000, Ortho requested reexamination of the `554 and `006 Patents by the PTO, submitting copies of various prior art that it had learned of since the issuance of these patents, including three of the four principal pieces of prior art relied upon in the instant motion. Id. at ¶ 11. On or about May 8, 2000, the PTO denied each of the Requests for Reexamination. Id. The Detailed Action of Primary Examiner James H. Reamer with respect to the `006 patent provides:
No substantial new question of patentability is raised by the request for reexamination and prior art cited therein for reasons set forth below.
The request indicates that the Journal Officiel reference does not render claims 1 to 10 obvious or anticipated. This Examiner agrees with this position since the teaching in the reference is to a series of tablets which happen to contain the same active ingredient as in the instant composition. There is no teaching in the reference that the disclosed tablets are useful as oral contraceptives. The positions set forth by applicant's (sic) are concurred to by the Examiner.
Therefore, the reference fails to raise a substantial new question of patentability as to any of the patent claims. Accordingly, the request for reexamination is DENIED.
Certification of Thomas Hastings ("Hastings Certif."), Ex. 20. Similarly, the Detailed Action pertaining to the `554 patent provides as follows:
No substantial new question of patentability is raised by the request for reexamination and prior art cited therein for reasons set forth below.
The request indicated that the Journal Officiel reference does not render claims 1 to 8 and 10 anticipated or obvious for various reasons This Examiner agrees with the arguments set forth by applicant's [sic] for patentability over the Journal Officiel reference. The teaching in the reference is for a series of tablets which contain the same active ingredient as present in the composition used by the instant method. The reference does not describe a utility for the disclosed tablets or a method of contraception and does not teach how to use or administer the tablets as a method of contraception even if an oral contraceptive use were implied.Id. at Ex. 19.
On June 9, 2000, Ortho filed the instant action alleging infringement of claim 10 of the `554 patent, claims 7 and 9 of the `006 patent and claims 2, 3 and 7 of the `839 Patent. Pl. R.56.1 Statement, ¶ 7. Subsequently, Ortho covenanted not to sue or otherwise hold Barr liable for the infringement of any claim of the stated Patents except claim 10 of the `554 patent and claim 9 of the `006 Patent. Id. Barr has asserted as a defense to Ortho's infringement action that claim number 10 of the `554 Patent and claim number 9 of `006 Patent are invalid because those claims were obvious in light of the prior art. Id. Both parties now move for summary judgment on Barr's obviousness defense.
B. THE `554 PATENT AND THE `006 PATENT
Claim 10 of the `554 Patent and claim 1, upon which it depends, provide as follows:
10. The contraception method of claim 1 which comprises administering for 21 successive days to a female of childbearing age a combination of 17-ethinylestradiol and norgestimate in a contraceptively effective daily dosage corresponding to 0.035 mg. of 17-ethinylestradiol and 0.180 mg of norgestimate for 7 days; for the next seven days a daily dosage equal to 0.035mg of 17-ethinylestradiol and 0.215 mg of norgestimate; and for the next 7 days a daily dosage equal to 0.035 mg of 17-ethinylestradiol and 0.250 mg of norgestimate; followed by seven days without estrogen and progestogen administration.
1. A method of contraception which comprises administering for 21 successive days to a female of childbearing age a combination of an estrogen and a progestogen in a low but contraceptively effective daily dosage corresponding in estrogenic activity to 0.02-0.05 mg of 17-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone for 5-8 days; for the next 7-11 days an estrogen daily dosage equal to 0.02-0.05 mg of 17-ethinylestradiol and in progestogenic activity to 0.250-1.0 mg of norethindrone; and for the next 3-7 days an estrogen daily dosage equal to 0.02-0.05 mg of 17-ethinylestradiol and in progestogenic activity of 0.35-2.0 mg of norethindrone; followed by 6-8 days without estrogen and progestogen administration, provided that the estrogen daily dosage is the same for each period.
Claim 9 of the `006 Patent provides as follows:
9. A composition according to claim 1 wherein the estrogen daily dosage in all three phases is equivalent to 0.035 mg of 17-ethinylestradiol; and the progestogen daily dosage is equivalent to 0.180 mg of norgestimate in the first phase, 0.215 mg of norgestimate in the second phase and 0.250 mg of norgestimate in the third phase.
Claim 9 depends upon claim 1, which provides as follows:
1. A triphasic oral contraceptive unit consisting of 21 separate dosage units, adapted for successive daily oral administration comprising:
7 dosage units, containing, in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen and progestogen at contraceptively effective dosages corresponding in activity to to 0.02-0.05 mg of 17-ethinylestradiol and in progestogenic activity to 0.065-0.75 mg of norethindrone as the first phase; followed by 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen at a contraceptively effective dosage corresponding in activity to 0.02-0.05 mg of 17-ethinylestradiol and in progestogenic activity to 0.25-1.0 mg of norethindrone as the second phase; followed by 7 dosage units containing in admixture with a pharmaceutically acceptable carrier, a combination of an estrogen at a contraceptively effective dosage corresponding to 0.02-0.05 mg of 17-ethinylestradiol and in progestogenic activity to 0.35-2.0 mg of norethindrone as the third phase, and optionally containing 7 dosage units free of estrogen and progestogen; provided that the estrogen daily dosage is the same in all three phases.
The patents at issue describe a triphasic combination oral contraceptive consisting of the administration of two hormones, norgestimate, a synthetic progestin, and ethinyl estradiol, a synthetic estrogen, for twenty-one consecutive days, followed by seven days without the administration of steroids. Defendant's Statement of Undisputed Material Facts pursuant to L. Civ. R. 56.1 ("Defs. R.56.1 Statement"), ¶ 30. The claims provide for a 7/7/7 regimen wherein the norgestimate dosage increasing from .180 mg to .215 mg to .250 mg at each seven day interval and a constant .035 mg of ethinyl estradiol throughout the regimen. Id. at ¶ 31-32.
Ortho states that Dr. Pasquale's goal in creating the invention, and that of all ordinary skilled artisans in the field of oral contraceptive technology at the time of the invention, was to administer the lowest possible dose of steroids while maintaining contraceptive efficacy and good side effect profiles, including good cycle control. Pl. R.56.1 Statement, ¶ 17. The specifications of `554 and `006 Patents provide, in pertinent part, that
There is a need, therefore, for a combination type contraceptive which contains low concentrations of estrogen and progestogen but is still effective for the prevention of pregnancy.
By the present invention a triphasic oral contraceptive regimen is provided wherein the estrogen dosage is kept constant throughout the 21-day cycle while the progestogen dosage is gradually increased in successive doses. The purpose of the invention is to lower the total monthly steroid dose in the oral contraceptive while still obtaining equivalent bleeding patterns and protection against pregnancy as found with conventional oral contraceptives.
Barr disputes that the invention reflects the goal of lowering the total monthly steroid dose. Def. R.56.1 Response, ¶ 16. Moreover, Barr disputes that the goal of the ordinary skilled artisan at the time of the invention in 1984 was to lower the total steroid dose. Id. at ¶ 12. While Barr concedes that lowering the total steroid dose was indeed a goal of skilled artisans in the 1960s and 1970s, it contends that by the early 1980s steroid dosages had been reduced to the point that skilled artisans were no longer dissatisfied with them and saw no need to reduce them further. Id.
C. THE PRIOR ART
The prior art principally relied upon by Barr includes: (1) a 1979 article published in the American Journal of Obstetrics and Gynecology and written by Dr. Pasquale and three coauthors, entitled "Optimum Dosage of an Oral Contraceptive: A Report on the Study of Seven Combinations of Norgestimate and Ethinyl Estradiol" (the "Norgestimate Article"); (2) a leaflet that accompanied the German version of the contraceptive Ortho-Novum 7/7/7 (the "TriNovum Package Insert"); (3) an entry in the Journal Officiel de la Republique Francaise (the " Journal Officiel reference"); and (4) U.S. Patent No. 3,957,982 (the "`982 Patent"). 1. The Norgestimate Article
In its motion for summary judgment, Barr argues that the Norgestimate Article itself renders the claimed invention obvious.
The Norgestimate Article reports the results of a study of seven different regimens of norgestimate and ethinyl estradiol. Hastings Certif., Ex. 22. Specifically, the study tested norgestimate/ethinyl estradiol monophasic regimens of: (1) .250 mg/.020 mg; (2) .250 mg/.050 mg; (3) .125 mg/.035 mg; (4) .060 mg/.020 mg; (5) .060 mg/.050 mg; (6) .090 mg/.030 mg; (7) .125 mg/.025 mg. Id. The authors examined the contraceptive efficacy, the amount of unscheduled bleeding and the gastrointestinal disturbances experienced for each regimen. Id. The purpose of the study was "to determine an optimum combination of norgestimate and ethinyl estradiol as an oral contraceptive, based on efficacy, safety and side effect patterns." Id. of the regimens tested, the .125 mg/.035 mg regimen was determined to be the optimal combination considering these factors. Id.
In addition, the authors offered predicted results if the level of norgestimate or ethinyl estradiol was increased or decreased from the monophasic .125 mg/.035 mg regimen. Id. The authors concluded that slight reductions of either norgestimate or ethinyl estradiol while the other component remained the same would significantly increase spotting or breakthrough bleeding and pregnancy rate. Id. Slight increases in either norgestimate or ethinyl estradiol while the other component remained the same was not expected to significantly reduce side effects or pregnancy rate. Id.
Specifically, the authors predicted results for four untested monophasic regimens: (1) .125 mg/.025 mg; (2) .125 mg/.045 mg; (3) .100 mg/.035 mg; (4) .150 mg/.035 mg. Hastings Certif., Ex. 22.
Table IV of the Norgestimate Article predicts that a monophasic regimen of .150 mg/.035 mg would decrease the pregnancy rate from .67 to .50, decrease spotting and breakthrough bleeding from 12.0 to 11.4 and increased gastrointestinal disturbance from 14.7 to 15.0. Id. There is no indication from the authors as to whether any of these differences are statistically significant. Id.
There is no dispute that the Norgestimate Article did not study or examine: (1) multiphasic regimens; (2) any of the specific combination dosages identified in the claims-in-suit.
2. The TriNovum Package Insert
The TriNovum package insert describes a triphasic combination oral contraceptive consisting of norethisterone and ethinyl estradiol administered in a 7/7/7 regimen with a constant ethinyl estradiol dosage at .035 mg and a norethisterone dosage increasing from .5 mg to .75 mg to 1.0 mg at each seven day interval throughout the twenty-one day regimen. Hastings Certif., Ex. 26. The TriNovum package insert does not disclose: (1) the use of norgestimate as the progestin; or (2) the dosages of norgestimate corresponding to the stated norethisterone dosages. Pl. R.56.1 Statement, ¶ 25.
3. Journal Officiel Reference
The Journal Officiel reference also describes the specific dosages of norethisterone and ethinyl estradiol in the three separate groups of seven tablets constituting TriNovum. As this Court noted in a previous action between these parties, the Journal Officiel reference does not expressly disclose: (1) that the tablets are part of a method of contraception; (2) the order in which the tablets should be taken; (3) that the tablets should be taken for twenty-one days followed by a seven-day steroid-free interval; or (4) that the tablets should be administered orally. See Ortho-McNeil Pharmaceutical, Inc. v. Barr Laboratories, Inc., Civ. No. 99-235 (GEB) July 23, 2001 Mem. Op. at 3, 8-9. In addition, the reference does not disclose the use of norgestimate or the dosages of norgestimate which would correspond to the stated norethisterone dosages. Pl. R.56.1 Statement, ¶ 27.
4. The `982 Patent
The `982 Patent describes a triphasic combination oral contraceptive in which progestin and estrogen are administered in three phases totaling twenty-one consecutive days. Id. at ¶ 28. The phases were four to six days, four to six days and nine to eleven days with steroids, followed by seven days without the administration of steroids. Hastings Certif., Ex. 29. The first phase requires a low, but contraceptively effective, dosage of estrogen and progestin. Id. The second phase employs estrogen at a dosage one to two times the estrogen dosage in the first phase and progestin at a dosage of one to one and a half times the dosage of the first stage. Id. The dosage of estrogen in the third phase is between the estrogen dosage in the first and second phase and a progestin dosage higher than the progestin dosage in the first and second phases, but not higher than three times the dosage in the first phase. Id. The `982 Patent shows five examples of possible regimens for the invention. Id. One of the five examples exhibits a constant dosage of estrogen throughout all three phases. Id.
It is undisputed that the `982 Patent does not disclose: (1) the use of norgestimate as a progestin; (2) the specific dosages of norgestimate claimed in the `554 and `006 Patents; or (3) the use of a 7/7/7 regimen. Pl. R.56.1 Statement, ¶ 29.
II. DISCUSSION
A. SUMMARY JUDGMENT STANDARD
A party seeking summary judgment must "show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(e); accord Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Orson, Inc. v. Miramax Film Corp., 79 F.3d 1358, 1366 (3d Cir. 1996); Healy v. New York Life Ins. Co., 860 F.2d 1209, 1219, n. 3 (3d Cir. 1988), cert. denied, 490 U.S. 1098 (1989); Hersh v. Allen Prod. Co., 789 F.2d 230, 232 (3d Cir. 1986). The threshold inquiry is whether there are "any genuine factual issues that properly can be resolved only by a finder of fact because they may reasonably be resolved in favor of either party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250 (1986) (noting that no issue for trial exists unless there is sufficient evidence favoring the nonmoving party for a jury to return a verdict in its favor). In deciding whether triable issues of fact exist, the Court must view the underlying facts and draw all reasonable inferences in favor of the non-moving party. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986); Pennsylvania Coal Ass'n v. Babbitt, 63 F.3d 231, 236 (3d Cir. 1995); Hancock Indus. v. Schaeffer, 811 F.2d 225, 231 (3d Cir. 1987).
Rule 56(e) of the Federal Rules of Civil Procedure provides, in relevant part:
When a motion for summary judgment is made and supported as provided in this rule, an adverse party may not rest upon the mere allegations or denials of the adverse party's pleading, but the adverse party's response, by affidavits or as otherwise provided in this rule, must set forth specific facts showing that there is a genuine issue for trial. If the adverse party does not so respond, summary judgment, if appropriate, shall be entered against the adverse party.
Fed.R.Civ.P. 56(e). The rule does not increase or decrease a party's ultimate burden of proof on a claim. Rather, "the determination of whether a given factual dispute requires submission to a jury must be guided by the substantive evidentiary standards that apply to the case." Anderson, 477 U.S. at 255-56.
Under the rule, a movant must be awarded summary judgment on all properly supported issues identified in its motion, except those for which the non-moving party has provided evidence to show that a question of material fact remains. See Celotex, 477 U.S. at 324. Put another way, once the moving party has properly supported its showing of no triable issue of fact and of an entitlement to judgment as a matter of law, for example, with affidavits, which may be "supplemented . . . by depositions, answers to interrogatories, or further affidavits," id., "its opponent must do more than simply show that there is some metaphysical doubt as to material facts." Matsushita, 475 U.S. at 586; see also Anderson, 477 U.S. at 247-48 ("[B]y its very terms, this standard provides that the mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion . . . the requirement is that there be no genuine issue of material fact.").
What the non-moving party must do is "go beyond the pleadings and by [its] own affidavits, or by the" depositions, answers to interrogatories, and admissions on file, `designate "specific facts showing that there is a genuine issue for trial.'" Celotex, 477 U.S. at 324; see also Lujan v. National Wildlife Fed., 497 U.S. 871, 888 (1990) ("The object of [Rule 56(e)] is not to replace conclusory allegations of the complaint . . . with conclusory allegations of an affidavit."); Anderson, 477 U.S. at 249; Big Apple BMW, Inc. v. BMW of N. Am., Inc., 974 F.2d 1358, 1363 (3d Cir. 1992) ("[T]o raise a genuine issue of material fact . . . the [non-moving party] need not match, item for item, each piece of evidence proffered by the movant, but rather must exceed the `mere scintilla' threshold."), cert. denied, 507 U.S. 912 (1993).
"When evaluating a motion for summary judgment, the court reviews the record evidence through the prism of the evidentiary standard of proof that would pertain at a trial on the merits." Eli Lilly Co. v. Barr Laboratories, Inc., 222 F.3d 973, 980 (Fed. Cir. 2000) (citing Anderson, 477 U.S. at 252-53). A defense of invalidity based on a claim of obviousness must be proved by clear and convincing evidence. See Electro Medical Systems, S.A. v. Cooper Life Sciences, Inc., 34 F.3d 1048, 1052 (Fed. Cir. 1994).
Ortho argues that Barr's burden is heavier in light of the PTO's decision on Ortho's petition for reexamination. However, as this Court has previously held, "where a patent survives reexamination, the burden on a party asserting an invalidity defense is not heavier, that is, even in the face of a reexamination proceeding the party asserting the defense still must show by clear and convincing evidence that the patent is invalid." Bayer AG v. Schein Pharmaceutical, Inc., 129 F. Supp.2d 705, 714 (D.N.J. 2001), aff'd, 301 F.3d 1306 (Fed. Cir. 2002). "However, where the specific claim of invalidity, in this case [obviousness], has been presented to the PTO in a reexamination proceeding, the challenger's task may be made more difficult because the Court must consider the PTO's conclusions as evidence of validity." Id. Thus, at trial Barr "must come forward with clear, convincing and specific evidence that would tend to negate the conclusions reached by the PTO." Id. Barr's burden of proof at trial is no heavier, but may be more difficult to meet to the extent that the PTO considered the obviousness issue with respect to the prior art relied upon by the defendant and reaffirmed the claims. The parties dispute whether the examiner considered the prior art relied upon herein.
B. OBVIOUSNESS
Patents are presumed to be valid. 35 U.S.C. § 282. As noted above, the burden is on the party asserting invalidity to prove invalidity by clear and convincing evidence. See Finnigan Corp. v. International Trade Comm'n, 180 F.3d 1354, 1364 (Fed. Cir. 1999).
A patent is invalid for obviousness "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art." 35 U.S.C. § 103 (a). Obviousness is a question of law to be determined by the Court based upon several factual inquiries which inform the decision. See Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966); Sibia Neurosciences, Inc. v. Cadus Pharmaceutical Corp., 225 F.3d 1349, 1355 (Fed. Cir. 2000). Specifically, courts are instructed to consider four factual questions: (1) the scope and content of the prior art; (2) the differences between the claims and the prior art; (3) the level of ordinary skill in the pertinent art; and (4) any secondary indicia of nonobviousness. Id. 1. Defendant's Motion for Summary Judgment
Defendant claims that the Norgestimate Article alone renders the claims-in-suit obvious without consideration of any other prior art references. There is no dispute that a single prior art reference may be sufficient to render a claim obvious. See Sibia, 225 F.3d at 1356. To do so, the defendant must show "a suggestion or motivation to modify the teachings of that reference." B.F. Goodrich Co. v. Aircraft Braking Sys. Corp., 72 F.3d 1577, 1582 (Fed. Cir. 1996). Evidence of such a suggestion may be derived directly from the prior art reference, the knowledge of one of ordinary skill in the art, or from the nature of the problem to be solved. Brown Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1125 (Fed. Cir. 2000); Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1375 (Fed. Cir. 2000), cert. denied, 532 U.S. 974 (2001); Sibia, 225 F.3d at 1356. Therefore, bearing in mind the burden of proof and the summary judgment standard, the question here is whether defendant has demonstrated by undisputed, clear and convincing, evidence, a motivation or suggestion to modify the teachings of the Norgestimate Article to arrive at the claimed invention. Upon examination of the parties' submissions, the Court finds that there are various disputed factual issues which preclude the entry of summary judgment.
As noted, the Norgestimate Article did not study or examine: (1) any of the specific combination dosages identified in the claims-in-suit; or (2) multiphasic regimens. Relying upon deposition testimony of Ortho's expert, Barr maintains that the Norgestimate Article teaches that .125 mg/.035 mg is a minimum combination dosage for contraceptive efficacy and that essentially any dosage of norgestimate above .125 mg with constant ethinyl estradiol at .035 mg would likewise be contraceptively effective. Def. Br. at 16-17. Barr also maintains, based upon Table IV, that the article suggests that an increase in the norgestimate dosage with constant estrogen would lead to an increase in contraceptive efficacy. Def. R. 56.1 Statement, ¶ 21. Ortho disputes Barr's interpretation of the teachings of the Norgestimate Article. Relying in part upon expert testimony and in part upon the plain language of the article, Ortho claims that the article teaches that the monophasic .125 mg/.035 mg dosage is optimal considering the goals of efficacy, low side effects and low steroid dose, and that there is no suggestion to depart from this regimen to administer more steroids. Pl. Resp. Br. at 13-14. Additionally, Ortho maintains that the article specifically teaches that an increase in the progestin would not be expected to produce a reduction in side effects and pregnancy rate. Id. at 14.
Ortho also argues that the prediction of a reduced pregnancy rate in table IV would not suggest a modification of the Norgestimate article to the regimen of the claimed invention because the predicted decrease from 0.67 to 0.50 is not statistically significant. Pl. Resp. Br. at 14 n. 10.
This touches upon a second fundamental dispute relevant to whether a suggestion to modify was present here. Ortho maintains that the goal of Dr. Pasquale in creating the invention and indeed, the goal of the ordinary skilled artisan at the time of the invention, was not only to create a contraceptive effective at preventing pregnancy, but also to lessen side effects and lower the overall steroid dosage. Pl. R. 56.1 Statement, ¶ 13-18. Therefore, there would be no suggestion to modify the dosage to increase the steroid dose. Barr argues, however, that by the time of the invention the ordinary skilled artisan was satisfied with the level of steroid doses generally used, and thus, there was no need to continually attempt to drive the dosages lower. Def. R. 56.1 Response, ¶ 15-18.
As to the modification of the prior art from a monophasic to a triphasic regimen, Barr argues that, at the time of the invention, triphasic oral contraceptive regimens were well known to those skilled in the art, and thus, ordinary skilled artisans would have modified the monophasic regimen of the Norgestimate Article to employ a triphasic regimen. See Pls. Br. at 20-21. Ortho contends that Barr cannot prove a suggestion to modify the Norgestimate Article to employ a triphasic regimen with the higher dosages of norgestimate in the claimed invention because the purpose of the skilled artisan in using a triphasic regimen is to lower the total amount of steroids from monophasic regimens. Pl. R. 56.1 Statement, ¶ 19.
In addition, the parties dispute whether secondary indicia of non-obviousness exist, such as commercial success, unexpected results, or long felt need. Def. Br. at 21-29; Pl. Resp. Br. at 22-28.
These disputed facts are clearly material to the Court's determination of whether a suggestion to modify the Norgestimate Article exists and the resolution of these facts will require the Court to consider and weigh expert testimony from both parties. Accordingly, Barr's motion for summary judgment is denied.
2. Plaintiff's Motion for Summary Judgment
Ortho moves for summary judgment on the grounds that Barr cannot show by clear and convincing evidence that one of ordinary skill in the art would be motivated to combine the various prior art references, the Norgestimate Article, TriNovum Package Insert, and the `982 Patent, to arrive at the claimed invention. To prevail on its motion for summary judgment, Ortho must show that, based upon the undisputed facts, Barr cannot satisfy its burden of coming forward with clear and convincing evidence of obviousness.
To prove obviousness based upon multiple prior art references, Barr must demonstrate by clear and convincing evidence a motivation, teaching or suggestion to combine the prior art to arrive at the claimed invention. See Brown Williamson, 229 F.3d at 1125; Ecolochem, 227 F.3d at 1375. "The suggestion to combine may be found in explicit or implicit teachings within the references themselves, from the ordinary knowledge of those skilled in the art, or from the nature of the problem to be solved." WMS Gaming, Inc. v. International Game Tech., 184 F.3d 1339, 1355 (Fed. Cir. 1999). Ultimately, the question is whether "a skilled artisan, confronted with the same problems as the inventor and with no knowledge of the claimed invention, would select the elements from the cited prior art references for combination in the manner claimed." In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998). To prevent against hindsight analysis, i.e., using the claimed invention as a blueprint from which to work backward, it is essential to "cast the mind back to the time of the invention, to consider the thinking of one of ordinary skill in the art, guided only by the prior art references and the then-accepted wisdom in the field." In re Werner Kotzab, 217 F.3d 1365, 1369 (Fed. Cir. 2000).
Ortho argues that Barr cannot show a motivation to combine the prior art to arrive at the invention because: (1) there is no evidence of a motivation to use norgestimate in a triphasic, rather than monophasic, regimen; (2) the Norgestimate Article teaches away from the claimed invention by requiring that an increase in progestin dosage be accompanied by a decrease in the estrogen dosage; (3) the Norgestimate Article teaches that the .125 mg/ .035 mg regimen is the optimal regimen for achieving contraceptive efficacy, safety and low side effects; (4) there is no evidence of a motivation to arrive at the precise dosages used in the invention. Pls. Br. in Support at 19-25.
These issues are virtually identical to the factual disputes noted above as precluding summary judgment in favor of Barr, see supra, Section II.B.1., and thus, similarly preclude the entry of summary judgment in favor of Ortho. As noted, to resolve these disputes the Court would necessarily have to consider questions of credibility and conflicts in testimony, which cannot be addressed in the context of a Rule 56 motion for summary judgment. Accordingly, Ortho's motion for summary judgment must be denied at this stage of the proceedings, but may be renewed as a motion for judgment as a matter of law under Fed.R.Civ.P. 50 at the close of the defendant's case.
III. CONCLUSION
For the reasons discussed above, Ortho's motion for summary judgment and Barr's motion for summary judgment are denied. An appropriate form of order is filed herewith.
ORDER
This matter having come before the Court upon the motions for summary judgment of the plaintiff, Ortho-McNeil Pharmaceutical, Inc., and the defendant, Barr Laboratories; and the Court having considered the parties' submissions and having heard argument on the matter; and for the reasons stated in the Memorandum Opinion filed herewith;
IT IS this 29th day of January, 2003;
ORDERED that the plaintiffs motion for summary judgment is DENIED; and it is further
ORDERED that the defendant's motion for summary judgment is DENIED;