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Gen-Probe Inc. v. Becton Dickinson and Co.

United States District Court, S.D. California

September 28, 2012

GEN-PROBE INCORPORATED, Plaintiff,
v.
BECTON DICKINSON AND COMPANY, Defendant.

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Alexander Enrico Long, Stephen P. Swinton, Latham and Watkins, San Diego, CA, Dean G. Dunlavey, Latham and Watkins LLP, Costa Mesa, CA, for Plaintiff.

Barbara Fiacco, Brian C. Carroll, Donald R. Ware, Sarah Cooleybeck, Foley Hoag LLP, Boston, MA, Erica Pascal, John Allcock, Richard Thomas Mulloy, DLA Piper LLP, San Diego, CA, for Defendant.

ORDER:

• DENYING BECTON DICKINSON'S MOTION TO DISMISS FOR LACK OF SUBJECT MATTER JURISDICTION

• GRANTING GEN-PROBE'S MOTION FOR SUMMARY JUDGMENT OF INFRINGEMENT OF '308 PATENT

• DENYING BECTON DICKINSON'S MOTION FOR SUMMARY JUDGMENT OF INVALIDITY OF ' 308 PATENT

• DENYING BECTON DICKINSON'S MOTION FOR SUMMARY JUDGMENT OF INVALIDITY OF THE AUTOMATION PATENTS

• GRANTING IN PART AND DENYING IN PART GEN-PROBE'S MOTION FOR PARTIAL SUMMARY JUDGMENT OF INFRINGEMENT AND NO INVALIDITY OF THE AUTOMATION PATENTS

• GRANTING BECTON DICKINSON'S MOTION FOR SUMMARY JUDGMENT OF NON-INFRINGEMENT

Docket Nos. 301, 333, 368, 369, 372, 381, 411, 443, 469, 473, 475, 476.

ROGER T. BENITEZ, District Judge.

This is a patent infringement action brought by Plaintiff Gen-Probe Incorporated (" Gen-Probe" ) alleging that Defendant Becton Dickinson & Company (" Becton Dickinson" ) infringes its Automation [1]

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and Cap Patents.[2] One motion to dismiss and five motions for summary judgment are before the Court: [3] (1) Becton Dickinson's Motion to Dismiss for Lack of Subject-Matter Jurisdiction; (2) Becton Dickinson's Motion for Summary Judgment of Invalidity of the '308 Patent; (3) Becton Dickinson's Motion for Summary Judgment of Invalidity of the Automation Patents; (4) Gen-Probe's Motion for Summary Judgment of Infringement of the '308 Patent; (5) Gen-Probe's Motion for Partial Summary Judgment of Infringement and No Invalidity of the Automation Patents; and (6) Becton Dickinson's Motion for Summary Judgment of Non-Infringement of the Automation Patents. The motions have been fully briefed and the Court heard oral argument on June 21, 2012, August 30, 2012, and September 12, 2012. The Court rules as follows.

BACKGROUND

The Automation Patents at issue in this action result from Gen-Probe's development of a single automated instrument to detect a target nucleic acid indicative of the presence of a target pathogen within a sample. The Cap Patents describe a specimen collection vessel that allows the contents of the vessel to be sampled by an automated device.

In this action, Gen-Probe accuses Becton Dickinson of infringing claims of the Automation Patents and Cap Patents through the use and sale of the VIPER XTR and BD Max, Becton Dickinson's automated nucleic acid test instruments, and numerous penetrable cap products.

The Automation Patents describe an automated method of nucleic acid-based testing where the automated analyzer detects the presence of a particular pathogen in a sample. Nucleic acid-based testing involves the creation of a complementary nucleotide sequence that a target pathogen will bind to through complementary base pairing. The complementary nucleotide sequence is used as a probe. The probe is introduced to a sample that may contain the target nucleic acid. If the target binds to the probe, it indicates that the target nucleic acid is present in the sample. The Automation Patents automate the steps of this process in a single instrument. The Cap Patents use a seal or seals on a collection vessel that are penetrated by a fluid transfer device. The seal or seals, in conjunction with the core structure, are intended to prevent the release of aerosols from the sample and limit contamination from fluid on the fluid transfer device after removal.

DISCUSSION

" Summary judgment is appropriate when there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. However, summary judgment should be granted only when no reasonable jury could return a verdict for the nonmoving party. In determining whether there is a genuine issue of material fact in dispute, the evidence must be viewed in the light most favorable to the nonmoving party, and all reasonable inferences must also be drawn in favor of the nonmovant." Fin Control Sys. Pty, Ltd. v. OAM, Inc., 265 F.3d 1311, 1317 (Fed.Cir.2001) (internal citations and quotations omitted).

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I. Motion to Dismiss for Lack of Subject-Matter Jurisdiction

Becton Dickinson moves to dismiss Gen-Probe's claims for infringement of the Automation Patents. Becton Dickinson claims Gen-Probe lacks standing to assert infringement because it does not possess complete ownership of the Automation Patents. Becton Dickinson asserts that Mark Toukan is an omitted inventor of the Automation Patents based on his work on a luminometer and Gen-Probe has not obtained assignment of his ownership rights.

Gen-Probe hired RELA to design an instrument that would automate Gen-Probe's nucleic acid testing. Toukan worked on the luminometer module of the instrument for RELA as an independent contractor from October 1996 to October 1997. The luminometer is the detection step of the automated process. RELA assigned all its rights in the invention to Gen-Probe.[4]

Becton Dickinson has produced evidence that Toukan contributed to the development of a prototype of the luminometer described in the May 1998 provisional application of the Automation Patents. The May 1998 provisional application contains a common specification that includes drawings of the luminometer that are almost identical to Toukan's drawings of his prototype. Additionally, Becton Dickinson has produced evidence that Toukan was the engineer responsible for the luminometer design while at RELA and passed his work on to Ralph Burns when he left the project. Becton Dickinson has also produced evidence that Gen-Probe sought an assignment of Toukan's potential ownership rights based on his work on the luminometer.

Gen-Probe has produced evidence that many of the components of Toukan's prototype were designed by other engineers before Toukan started work on the project, Toukan's design did not work, particularly within an integrated instrument, and that Burns redesigned the luminometer through significant trial and error and experimentation to resolve problems with Toukan's design.

" Patent issuance creates a presumption that the named inventors are the true and only inventors." Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed.Cir.1998). Becton Dickinson conceded at the August 30, 2012 hearing that it bears the burden of proving Toukan's inventorship. Inventorship must be proven by clear and convincing evidence. Id. Becton Dickinson has not carried its burden.

Becton Dickinson argues there are no material disputes of fact concerning inventorship and the Court should find that Toukan is an inventor as a matter of law. But, " [i]nventorship is a mixed question of law and fact: The overall inventorship determination is a question of law, but it is premised on an underlying question of fact." Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1362 (Fed.Cir.2004); see also Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed.Cir.1997) (" The determination of whether a person is a joint inventor is fact specific" ). As explained below, the facts underlying the inventorship determination are disputed. Because the subject-matter jurisdiction determination turns on disputed issues of fact, the Court applies the standards for summary judgment.[5] Trentacosta v. Frontier Pac. Aircraft Indus., Inc., 813 F.2d 1553, 1558 (9th Cir.1987).[6]

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There are disputed issues of fact concerning when conception occurred. " Conception is the touchstone of inventorship, ... the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice." Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1227-28 (Fed.Cir.1994) (emphasis added). While reduction to practice is not required, " [c]onception is complete only when the idea is so clearly defined in the inventor's mind that only ordinary skill would be necessary to reduce the invention to practice, without extensive research or experimentation. " Id. at 1228 (emphasis added). Becton Dickinson has produced evidence of Toukan's contributions to the luminometer, including the drawings of his design that appear in the specification, but Gen-Probe has produced evidence that Burns engaged in significant trial and error experimentation to arrive at the design that was operative and that Toukan admitted that his luminometer prototype was not complete when he passed his work on to Burns.

Additionally, there are disputed issues of fact concerning the quality of Toukan's contribution in light of the work of prior engineers. " [T]o be a joint inventor, an individual must make a contribution to the conception of the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention." Fina, 123 F.3d at 1473. The Toukan drawings in conjunction with Toukan's time on the project suggest his contribution to the analyzer could be considered " not insignificant," but Gen-Probe's evidence that most of the components Toukan relied on in his work came from prior engineers and evidence that Burns made significant changes to the luminometer to make it operational as part of the analyzer suggest otherwise. Whether Toukan's contribution was not insignificant in quality depends on disputed issues of fact.

Because there are disputed issue of fact concerning Toukan's inventorship, the Court DENIES Becton Dickinson's Motion to Dismiss for Lack of Subject Matter Jurisdiction.

II. Invalidity

A. Written Description Requirement[7]

Becton Dickinson moves for summary judgment of invalidity of the asserted claims of the '308 Patent arguing the specification lacks a description of a penetrable cap without a filter.[8] Becton Dickinson also moves for summary judgment of invalidity of the asserted claims of the Automation Patents arguing that the specification only describes the performance of an automated assay in a single, open reaction receptacle moved from one location to another using a transport mechanism.[9]

" Compliance with the written description requirement is a question of fact, but is amenable to summary judgment in cases where no reasonable fact finder could return a verdict for the non-moving party." PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1307 (Fed.Cir.2008). The written description

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requirement ensures that the claims do " not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Atl. Research Mktg. Sys., Inc. v. Troy, 659 F.3d 1345, 1354 (Fed.Cir.2011). " [T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.Cir.2010). The description does not need to track the asserted claims verbatim, it need only " indicate to a person skilled in the art that the inventor was ‘ in possession’ of the invention as later claimed." PowerOasis, 522 F.3d at 1306 (quoting Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed.Cir.1985)).

" To overcome the presumption of validity of patents, the accused must show that the claims lack a written description by clear and convincing evidence." Hynix Semiconductor, Inc. v. Rambus, Inc., 645 F.3d 1336, 1351 (Fed.Cir.2011). Because these motions are before the Court on summary judgment, to prevail, Becton Dickinson " must submit such clear and convincing evidence of invalidity so that no reasonable jury could find otherwise." Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d ...


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