Evans Medical Ltd. v. American Cyanamid Co.

Citation11 F.Supp.2d 338
Decision Date10 June 1998
Docket NumberNo. 96 Civ. 3529(WCC).,96 Civ. 3529(WCC).
PartiesEVANS MEDICAL LTD., Medeva PLC, SmithKline Beecham Biologicals S.A., SmithKline Beecham Biologicals Manufacturing S.A. and SmithKline Beecham Corporation, Plaintiffs, v. AMERICAN CYANAMID COMPANY, Takeda Chemical Industries, Ltd. and American Home Products Corporation, Defendants. AMERICAN CYANAMID COMPANY, Takeda Chemical Industries, Ltd. and American Home Products Corporation, Counterclaim Plaintiffs, v. EVANS MEDICAL LTD., Medeva PLC, SmithKline Beecham Biologicals S.A., SmithKline Beecham Biologicals Manufacturing S.A. and SmithKline Beecham Corporation, Counterclaim Defendants.
CourtU.S. District Court — Southern District of New York

Richards & O'Neil, LLP, New York City (Edward L. Powers, of counsel), Robins, Kaplan, Miller & Ciresi L.L.P., Atlanta, GA, (A. James Anderson, Brent J. Kaplan, of counsel), Robins, Kaplan, Miller & Ciresi L.L.P., Minneapolis, MN (Michael V. Ciresi, Ronald L. Schutz, of counsel), Popovich & Wiles, PA, Minneapolis, MN (Thomas E. Popovich, Patrick J. O'Connell, of counsel), for Plaintiffs Evans Medical Ltd. & Medeva PLC.

Briccetti & Calhoun, White Plains, NY (Vincent L. Briccetti, of counsel), Covington & Burling, Washington, DC (William D. Iverson, Michael A. Dawson, Adriana S. Luedke, of counsel), for Plaintiffs SmithKline Beecham Biologicals S.A., SmithKline Beecham Biologicals Mfg. S.A. and SmithKline Beecham Corp.

Kenyon & Kenyon, New York City (Paul H. Heller, George E. Badenoch, Estelle J. Tsevdos, Frederick H. Rein, of counsel), for Defendants and Counterclaim Plaintiffs American Cyanamid Co., Takeda Chemical Industries, Ltd. and American Home Products Corp.

OPINION AND ORDER

WILLIAM C. CONNER, Senior District Judge.

This is an action for alleged infringement of three United States patents on acellular antigens and vaccines for pertussis, or whooping cough. The patents were issued in the name of Pavel Novotny on applications filed by his employer, Burroughs Wellcome Foundation Ltd. ("Burroughs Wellcome"). Plaintiff Medeva PLC ("Medeva") purchased the vaccine business of Burroughs Wellcome and the patents were assigned to Medeva's subsidiary, plaintiff Evans Medical Ltd. ("Evans"), which granted an exclusive license under the patents to plaintiff SmithKline Beecham Biologicals S.A. ("SmithKline"). Plaintiffs charge that the patents are infringed by a composite "DTaP" vaccine for diphtheria, tetanus and pertussis sold in the United States by defendants American Cyanamid Co. ("American Cyanamid") and American Home Products Corp. ("American Home Products") under the brand name ACEL-IMUNE®, and incorporating acellular pertussis antigens produced in Japan by defendant Takeda Chemical Industries Ltd. ("Takeda"). The action is before the Court on a welter of pretrial motions.

Defendants have moved: (1) for a ruling by the Court under Markman v. Westview Instruments, Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), construing the patent claims and for summary judgment that the claims, as so construed, have not been infringed by defendants' accused vaccine; (2) for summary judgment that the patents in suit are invalid because their specifications (all of which are identical) fail to disclose the best mode of practicing the invention known to the patentee at the time the applications were filed, as required by 35 U.S.C. § 112; (3) for summary judgment that the patents are invalid under 35 U.S.C. § 102 because the claimed inventions were anticipated by a prior patent of defendant Takeda and by the prior sale and use of Takeda's antigen in this country; (4) for summary judgment that the patents are invalid under 35 U.S.C. §§ 102 and 103 because the claimed inventions were anticipated by or obvious in view of a March 1985 article co-authored by Novotny, Juan Montaraz (a doctoral student under Novotny's supervision), and Juraj Ivanyi; (5) for an order in limine excluding certain testimony of plaintiffs' patent law expert Gerald Bjorge; and (6) for an order in limine excluding certain testimony of Tom Bozzo or any other witness regarding FDA approval of defendants' vaccine.

Plaintiffs have moved: (1) for partial summary judgment that the patents in suit are not anticipated by the prior patents and publications cited by defendants; (2) for partial summary judgment that, for purposes of determining whether the patent specification satisfies the best mode requirement of 35 U.S.C. § 112, the January 1990 deposit in the European Collection of Animal Cell Cultures of a hybridoma which secretes a monoclonal antibody used in purification of the patented antigen relates back to the May 1, 1985 filing of the parent U.S. application; (3) for an order pursuant to 35 U.S.C. § 256 directing correction of the patents in suit to add Montaraz as an inventor; (4) for an order compelling defendants to return certain inadvertently produced documents; (5) for an order in limine excluding the expert testimony of Dr. Alison Weiss; and (6) for an order in limine excluding evidence at trial of related litigation in the United Kingdom.

Following a background discussion, the motions will be discussed serially. Unless otherwise indicated, all of the background facts recited herein are undisputed.

BACKGROUND

Development of pertussis vaccines

Pertussis, or whooping cough, is one of the most common serious diseases of infants, with an estimated 50 million cases annually causing 600,000 deaths. A vaccine introduced in the late 1940's strikingly reduced the incidence of the disease in developed countries where large scale immunization programs were undertaken. But that vaccine was prepared from chemically killed whole cells of Bordetella pertussis ("B. pertussis"), the bacterium which causes whooping cough, and caused serious side effects in a significant number of those inoculated, including fever and persistent screaming. This resulted in curtailment of the immunization programs and a concomitant increase in the incidence of the disease.

The vaccines involved in the present case are acellular, incorporating not whole bacterial cells but selected proteinaceous material extracted from the outer membrane of B. pertussis bacteria by, for example, treatment with an amino acid solution. This breaks down the proteins of the outer membrane into fragments comprising long strands of amino acids connected in a sequence which determines the properties and behavior of the material. The extracted material is then subjected to a series of purification steps designed to increase the concentration of a particular protein, now known as pertactin, which has been found to have excellent immunogenic effect against B. pertussis infection. The pertactin strands have a number of active sites or epitopes which are recognized by the defensive white blood cells, or B lymphocytes, of the inoculated patient as characteristic of B. pertussis bacteria, thereby stimulating the lymphocytes to produce antibodies which will attack B. pertussis bacteria in the event of a later infection and provide effective immunity without the serious side effects of whole cell vaccines. Acellular antigens containing pertactin are currently in widespread use in vaccines for B. pertussis, frequently in composite DTaP vaccines designed to immunize against diphtheria and tetanus as well.

The patents in suit

Plaintiffs have sued on three U.S. patents: No. 5,237,052 (the "'052 patent"), No. 5,438,120 (the "'120 patent") and No. 5,648,080 (the "'080 patent"). (Exhs. 1-3 to Defs.' Motions for Summ. J.1) All three patents have identical specifications and are based upon the same parent U.S. application, Serial No. 929,257, filed May 1, 1985, which claims priority based upon the United Kingdom specification Serial No. 8,412,207, filed May 12, 1984.

The patents were issued in the name of Pavel Novotny and were based in part on work done in the laboratory of Burroughs Wellcome by Novotny's student assistant, Juan Montaraz, who used the research as the basis for his doctoral thesis and as the subject of an article entitled "Identification of a 68-Kilodalton Protective Protein Antigen from Bordetella bronchiseptica," published in the March 1985 issue of INFECTION AND IMMUNITY in the names of Montaraz, Novotny and Juraj Ivanyi (the "Montaraz et al. article").

The common specification of the patents in suit identifies the desired antigen as "proteinaceous material associated with adenylate cyclase activity" (referred to by the acronym ACAP) and as having an isoelectric point ("pI")2 of "about 7," "a relative molecular weight of about 67,000 to 73,000, particularly 69,000"3 and a "proline:glutamic acid ratio of about 1:1."4 The specification discloses a preferred process of preparing the patented antigen. The first step of this process, denominated "Example 1," involves incubating a culture of B. pertussis cells with an aqueous amino acid buffer with a pH of about 3 for 10-20 hours at 30-45° C. The mixture is centrifuged at 100,000g to separate the cells and particulate matter. The supernatant extract is then subjected to a multi-step purification process, the several steps being respectively denominated "Examples 2(a), 2(b) and 3."

"Example 2(a)" consists of separating the fractions of the extracted outer membrane material by chromatography in a DEAE-Trisacryl column.5 The retained protein molecules are eluted from the column by flushing with an 0.2M NaCl buffer.

"Example 2(b)" consists of preparative flat-bed isoelectric focusing ("IEF") in a granulated gel.6 The eluate from Example 2(a) is embedded in the gel. After electrophoresis, the material which collects in the band at a pI of 7 is scraped from the field and dissolved in distilled water. The gel suspensions are placed in columns and eluted with an 0.2M ammonium bicarbonate buffer at pH 7.0 to produce a gel-free eluate.

"Example 3" consists of further purification of the separated protein...

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