Burroughs Wellcome Co. v. Barr Laboratories, Inc.

Decision Date22 July 1993
Docket NumberNo. 91-41-CIV-4-H,and 92-156-CIV-4-H.,92-134-CIV-4-H,91-41-CIV-4-H
Citation828 F. Supp. 1208
CourtU.S. District Court — Eastern District of North Carolina
PartiesBURROUGHS WELLCOME CO., Plaintiff, v. BARR LABORATORIES, INC., Defendant. BURROUGHS WELLCOME CO., Plaintiff, v. NOVOPHARM, INC., Defendant. BURROUGHS WELLCOME CO., Plaintiff, v. NOVOPHARM LTD., Defendant.

Thomas Curnin, New York City, Mark Ash, Raleigh, NC, for Burroughs Wellcome Co.

Daniel Webb, Chicago, IL, John A.J. Ward, New Bern, NC, for Barr Laboratories, Inc.

Robert Green, Chicago, IL, Rudolph Ashton, III, New Bern, NC, for Novopharm, Inc. and Novopharm Ltd.

ORDER GRANTING JUDGMENT AS A MATTER OF LAW IN FAVOR OF PLAINTIFF BURROUGHS WELLCOME CO.

MALCOLM J. HOWARD, District Judge.

This matter is before the court on the plaintiff's motion for judgment as a matter of law filed June 30, 1993, and the plaintiffs renewed motion for judgment as a matter of law filed July 5, 1993. Also pending in this matter is the plaintiffs renewed motion for summary judgment filed June 18, 1993.

In the twenty-five months transpiring between the filing of the initial complaint in this consolidated patent infringement action on May 14, 1991, and the commencement of the trial on June 28, 1993, approximately five hundred forty-one pleadings have been filed and dozens of hearings on motions and discovery matters have been conducted by the court. The court has entered eighty-eight written orders and numerous bench rulings. Thus, the court is intimately familiar with the facts of this case and the legal contentions of the parties.

To state that the case has been hotly contested would be an understatement. The parties have amassed learned, experienced and sizable trial teams who have represented their clients zealously and competently.

The administrative complexity of conducting a trial of this magnitude has been enormous for the court and the parties. The sixty-year-old courtroom in New Bern, North Carolina, has been converted into a contemporary "high tech" facility utilizing "real time" court reporting and six computer-integrated video display monitors. It is highly conceivable that the cost of this trial for the parties exceeds $100,000 per day, in addition to the time and expense associated with this court and the jury. As this case enters its fourth week of trial, the parties estimate, somewhat conservatively the court suspects, that the trial will last an additional six to eight weeks.

With this preamble, the court will state briefly a synopsis of the procedural and factual background of the case. A more detailed statement of the procedural and factual background of the case can be found in the court's order dated June 3, 1993, denying plaintiff's motions for partial summary judgment. 828 F.Supp. 1200.

PROCEDURAL BACKGROUND

Plaintiff Burroughs Wellcome Co., ("BW Co."), a research-oriented pharmaceutical company, owns and controls six United States patents covering various methods of using azidothymidine ("AZT") in the treatment of persons infected with the Human Immunodeficiency Virus ("HIV"). BW Co. manufactures and sells AZT under the brand name Retrovir. At issue in this case is the proper naming of inventors on the following six patents owned by BW Co.: 1) U.S. Patent No. 4,724,232, filed September 17, 1985, issued February 9, 1988; 2) U.S. Patent No. 4,828,838, filed October 21, 1987, issued May 9, 1989; 3) U.S. Patent No. 4,833,130, filed October 20, 1987, issued May 23, 1989; 4) U.S. Patent No. 4,837,208, filed October 20, 1987, issued June 6, 1989; 5) U.S. Patent No. 4,818,538, filed October 21, 1987, issued April 4, 1989; and 6) U.S. Patent No. 4,818,750, filed October 20, 1987, issued April 4, 1989. The court will refer to these patents collectively as "the BW Co. patents."

Defendants Barr and Novopharm Ltd. filed Abbreviated New Drug Applications ("ANDA") with the Food and Drug Administration ("FDA") on March 19, 1991, and June 26, 1992, respectively, seeking approval to manufacture and distribute a generic equivalent of Retrovir. Both Barr and Novopharm Ltd. certified to the FDA, pursuant to 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271(e), that the BW Co. patents were either invalid or not infringed by the filing of their ANDAs. Barr asserted noninfringement for the reason, inter alia, that two scientists employed by the National Institutes of Health ("the NIH"), Dr. Samuel Broder and Dr. Hiroaka Mitsuya, were coinventors of the subject matter claimed in the six BW Co. patents but had not been named as inventors on the patents. Because Barr received a nonexclusive license from the NIH to exploit any patent rights the NIH, as the employer of Dr. Broder and Dr. Mitsuya, might have in the BW Co. patents, Barr alleged that its ANDA was not an act of infringement.

Similarly, Novopharm Ltd. asserted that Dr. Broder and Dr. Mitsuya were coinventors of the subject matter claimed in the BW Co. patents, but in support of its contention that the BW Co. patents were invalid. Novopharm Ltd. contended that BW Co. omitted Dr. Broder and Dr. Mitsuya from the BW Co. patents with the intent to deceive the patent office and thereby engaged in inequitable conduct before the patent office. Novopharm Ltd. asserted that this alleged inequitable conduct invalidated the BW Co. patents.

STATEMENT OF FACTS

The BW Co. patents name the following five scientists employed by BW Co. as inventors: Dr. Janet Rideout; Dr. David Barry; Dr. Sandra Lehrman; Ms. Martha St. Clair; and Dr. Phillip Furman (collectively referred to as "the BW Co. inventors"). BW Co. is a world leader in antiviral therapy and experienced in retroviruses. BW Co. has been a leader in all aspects of the development of nucleoside analogs, particularly in their use as effective antiviral compounds.

The BW Co. inventors first began screening compounds for potential use as an AIDS therapy in 1984. In mid-1984, when the scientific community learned that AIDS was caused by a retrovirus, now referred to as HIV, the BW Co. inventors, specifically Ms. St. Clair, began screening compounds for antiretroviral activity against two murine retroviruses.1

On October 29, 1984, Dr. Rideout selected AZT, identified as BW Co. compound 509U81, for testing in the murine screens. Ms. St. Clair tested AZT in the murine screens and reported that AZT showed significant activity against FLV and HaSV at low concentrations. After obtaining these positive results, the BW Co. inventors met on December 5, 1984, to discuss patenting the use of AZT to treat patients infected with HIV. After subsequent meetings held in early January 1985, the BW Co. patent committee recommended that a patent application covering the use of AZT as an AIDS therapy be prepared for future filing.

On February 4, 1985, BW Co. sent a sample of AZT under the code name Compound S to Dr. Broder at the NIH for screening against HIV in human cells. In the letter accompanying the sample, Dr. Lehrman informed Dr. Broder that Compound S had been tested in murine and feline leukemia virus systems and that preliminary data was available showing that HIV replication had been inhibited at certain concentrations. Dr. Lehrman suggested that Dr. Broder screen Compound S at concentrations of 1, 5, 10, and 50 micromolars.

By February 6, 1985, a draft patent application for filing in the United Kingdom was prepared by BW Co. employees and its patent agents and attorneys. This draft application did not name the inventors, but it disclosed how to make various pharmaceutical formulations of AZT in an effective dosage range for the purpose of treating HIV infections in humans. The dosage ranges disclosed in the draft patent application encompassed the recommended dosage ranges approved by the FDA in 1987. Based upon the information contained in the draft patent application, three expert witnesses on behalf of BW Co.2 and one expert witness designated by Barr3 stated in depositions that the draft patent application teaches one of ordinary skill in the art how to use AZT to treat patients infected with HIV. The draft patent application was reduced to final form and filed in the United Kingdom on March 16, 1985.

Dr. Mitsuya tested Compound S against HIV in human cells in mid-February 1985. His tests demonstrated that Compound S was active against HIV. On February 20, 1985, Dr. Broder phoned Dr. Lehrman to report the results of Dr. Mitsuya's testing.

DISCUSSION

Rule 50(a) of the Federal Rules of Civil Procedure provides that a court may grant judgment as a matter of law during a jury trial when, after a party has been fully heard on the issue, "there is no legally sufficient evidentiary basis for a reasonable jury" to find in favor of that party on that issue. In ruling on a Rule 50(a) motion, the court must consider all of the evidence in the light most favorable to the nonmoving party and determine "whether reasonable triers of fact could draw only one conclusion." Bond v. Morton Buildings, Inc., 815 F.Supp. 944, 945 (S.D.W.Va.1993). To avoid judgment as a matter of law, the nonmoving party must come forward with more than a scintilla of evidence to support the material aspects of his case. Id.; see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250-52, 106 S.Ct. 2505, 2511-12, 91 L.Ed.2d 202 (1986).

Under Rule 56, summary judgment is proper where "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." The standard for summary judgment under Rule 56 is very similar to the standard for judgment as a matter of law under Rule 50(a).

Inventorship

The above facts are found by the court to be fully supported by the record. The parties and the court agree that the only real dispute in this case is the appropriate legal standard that will apply to these facts. The parties candidly...

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