Source: http://dc.findacase.com/research/wfrmDocViewer.aspx/xq/fac.20150415_0001222.DDC.htm/qx
Timestamp: 2017-08-21 00:54:10
Document Index: 252167806

Matched Legal Cases: ['§ 119', '§ 146', '§ 146', '§ 102', '§ 135', '§ 41', '§ 135', '§ 102', '§ 3', '§ 3', 'application No. 90', 'Application No. 07']

What does it take to disclose a protein sufficiently so that it can be patented? After 20 years of litigation, the parties are still arguing about it. Abbott GMBH & Co. KG and Yeda Research and Development Co. Ltd. claim competing U.S. patent applications, each based on an earlier-filed foreign patent application. Abbott’s application to patent the TBP-II protein was filed in Germany on May 9, 1989. Yeda filed its application to patent the TBP-II protein nine days later, on May 18, 1989 in Israel. From that few days’ difference in time fortunes might be made. Yeda has been arguing since April 5, 1995 that Abbott’s application was incomplete and infirm, while its own application more fully identified the TBP-II protein and is entitled to priority and U.S. patent protection for the next 17 years. Abbott’s patent has since expired. Here, Yeda raises serious issues.
The current focus is a May 26, 2010 opinion by the Board of Patent Appeals and Interferences that granted Abbott the benefit of the earlier filing date of its first German application. After thorough consideration of the full administrative record, [1] the parties’ briefs and accompanying exhibits, and with the benefit of excellent oral argument, the Court will grant Abbott’s motion for summary judgment and deny Yeda’s motions for summary judgment.
As stated by the Board of Patent Appeals and Interferences (Board)[2] in 2010, “This is an old interference, ” i.e., a claim by one inventor that another has interfered with his invention and the claimant was the first to invent. Administrative Record (AR) [Dkt 89-4] (5/26/10 Board Decision[3]) at 5961.[4] The interference in this case resulted when Yeda asserted that its inventors were the first to disclose a protein[5] called the Tumor Necrosis Factor Binding Protein-II[6] (TBP-II) claimed by Abbott in U.S. Patent No. 5, 344, 915 (the ’915 Patent”). TBP-II was “isolated from the urine of individuals with a fever and from the ascites fluid of individuals with ovarian carcinomas.” Abbott III, 576 F.Supp.2d at 46. TBP-II “binds to, and thereby neutralizes, potentially harmful polypeptides.” Id. at 45.
To prove its priority before the Board and this Court, Abbott relies on application P39 15 072 (’072 Application) to patent TBP-II in Germany, filed on May 9, 1989 by Hans-George LeMaire and three co-inventors, Abbott’s predecessors.[7] Thereafter, on July 15, 1989, Abbott filed application P39 22 089 (’089 Application) in Germany covering the same protein. On May 4, 1990, Abbott filed an International Patent Application (later designated as a U.S. patent application) claiming the benefit of the filing date of the ’072 Application. On September 6, 1994, the U.S. application matured into the ’915 Patent. As described by the Board:
This proceeding had its genesis when Yeda requested an interference with Abbott’s [’915] patent. Application 07/930, 443, Miscellaneous Incoming Letter, filed April 5, 1995. An examiner requested Yeda to make a claim for the purpose of interference. Miscellaneous Office Action, mailed May 15, 1995. Yeda responded by submitting its Claim 67. Application 07/930, 443, Amendment filed May 24, 1995. After some additional prosecution, the examiner recommended that an interference be declared. Form 850, attachment to Paper 1.
During the interference, Yeda filed a . . . motion asserting that all of Abbott’s claims were unpatentable over certain prior art. Paper 21. Abbott opposed the motion arguing that its claimed subject matter was entitled to the benefit of the filing dates of two German applications under 35 U.S.C. § 119 – Applications P 39 22 089 (089) and P 39 15 072 (072). The filing dates of both applications preceded the date of [the prior art] reference. Abbott argued that because it was entitled to benefit [from the application dates for the ‘072 Application and the ’089 Application], the reference was not prior art to its claims.
On July 21, 2000, Abbott sought judicial review of the board’s decision under 35 U.S.C. § 146. Paper 107. Abbott reasserted entitlement to the filing date of the 089 application. Entitlement to the filing date of the 072 application was apparently not asserted in the district court.
On September 15, 2008, the district court held that Abbott’s claimed subject matter was described in the 089 application, vacated the panel’s decision of unpatentability, and remanded the interference to the board. Paper 110. Yeda’s appeal to the Court of Appeals for the Federal Circuit was dismissed for lack of jurisdiction on May 29, 2009. Paper 115.
See 5/26/10 Board Decision [Dkt. 89-4] AR at 5961-62. After remand in 2008, the Board granted Abbott the benefit of the May 9, 1989 filing date of German Application P 39 15 072 (’072 Application), giving it priority over Yeda. Id. at 5963.
This appeal followed. It has its own intricate history, which need not be detailed. During the course of the immediate proceedings, the parties have engaged in discovery, which has amplified the record from that before the Board. In the interim, the Federal Circuit determined that parties can introduce new evidence before the district court in a § 146 interference action, regardless of whether the issue or evidence was presented to the Board. See Troy v. Samson Mfg’g Corp., 758 F.3d 1322, 1325 (Fed. Cir. 2014) (reh’g denied) (“We conclude that the Supreme Court’s decision in [Kappos v. Hyatt, 132 S.Ct. 1690, 1694, 1700 (2012)] permits new evidence to be admitted without regard to whether the issue was raised before the Board. The Supreme Court held, without qualification, that ‘there are no evidentiary restrictions beyond those already imposed by the Federal Rules of Evidence and the Federal Rules of Civil Procedure.’”) Yeda seeks to introduce evidence produced from Abbott in discovery in this case and to obtain a claim construction on a new term. With some legitimacy, Abbott argues that the Federal Rules of Procedure bar Yeda’s late evidence. Nonetheless, to provide a complete record for appeal, this Court has considered all of the evidence and arguments submitted by both parties.
Under long-standing U.S. patent law, the “first person to conceive the invention is the first inventor, . . . provided that when the first to conceive the invention is the last to reduce it to practice, the person who was first to conceive must have exercised reasonable diligence to his own actual or constructive reduction to practice, ‘from a time prior to conception by the other.’” Hyatt v. Boone, 146 F.3d 1348, 1351 (Fed. Cir. 1998) (quoting 35 U.S.C. § 102(g) prior to 2011 amendment; other citations omitted) (emphasis added).
As a consequence of the principle that the first to invent is granted the patent, “there must be a mechanism for determining who among multiple patent applicants . . . was the first to invent the claimed subject matter.” Cytologic, Inc. v. Biopheresis GmbH, 682 F.Supp.2d 1, 4 (D.D.C. 2010). For this purpose, 35 U.S.C. § 135 specifically provided for “Interferences, ” a “proceeding [] principally declared to permit a determination of priority.” Minnesota Mining and Mfg. Co. v. Norton Co., 929 F.2d 670, 674 (Fed. Cir. 1991). As is the case here, a patent applicant may suggest an interference. See 37 C.F.R. § 41.203. If the Director of the United States Patent and Trademark Office (USPTO) decides that an interference is warranted, i.e., that “an application is made for a patent which . . . would interfere with any pending application, or with any unexpired patent, ” he may declare an interference. 35 U.S.C. § 135. The Board “determine[d] questions of priority of the inventions.” Id.
In 2013, the United States moved to a “first to file” system. See 35 U.S.C. § 102; see also Leahy-Smith America Invents Act (AIA), Pub. L. No. 112-29, 125 Stat. 284 (2011). While not applicable to this long-standing dispute, the critical change to the rules of priority must be noted. The AIA obviated patent interferences. See AIA § 3(i). Pursuant to AIA § 3(n)(2)(A), this interference remains governed by the laws in effect at the relevant time.
Plaintiff Yeda Research & Development Co., Ltd. (Yeda) is an Israeli company; Abbott GmbH & Co. KG (Abbott) is a German subsidiary of Abbott Laboratories, Inc., which is based in Illinois. Compl. [Dkt. 1] ¶¶ 3, 6–7.
A. Abbott’s German Patent Applications and the ’915 Patent
Abbott filed application P39 15 072 on May 9, 1989 (’072 Application) in Germany to cover a “novel protein found in certain biological fluids.” Abbott Mot. for Summ. J. [Dkt. 70] (Abbott Mot.) at 5; id., Ex. M [Dkt. 70-16] (’072 Application).[8] Abbott filed a second patent application in Germany, P39 22 089 (’089 Application) on July 15, 1989. See id., Ex. K [Dkt. 70-14] (’089 Application). On May 4, 1990, Abbott filed an International Patent Application, “claiming the benefit of the filing date of [the ’072 Application];” the International Patent Application was eventually designated as a U.S. Patent Application, and the USPTO issued U.S. Patent No. 5, 344, 915 (’915 Patent) to Abbott on September 6, 1994. Compl. ¶¶ 8– 10; see also Abbott Mot., Ex. A [Dkt. 70-4] (’915 Patent).
1. ’072 Application
The ’072 Application described a novel protein as having the following characteristics: (1) a molecular weight of about 42 kilodaltons (kDa); (2) the specific biological property of inhibiting the cytotoxicity of TNF[9] alpha; (3) found in the urine of febrile patients; and (4) not digestible by trypsin. See ’072 Application at 2. The ’072 Application identified the following partial amino acid sequence at the N-terminus of the claimed protein:
“XTX1YX2X3EX4GSX5X6RLR where X is oxygen, a phenylalanine radical (Phe) or the amino acid sequence X7X8PheQX9X10.” Id. Each of X1-X10 “denote[s] not yet determined amino acids.” Id. at 3. The ’072 Application identified three main sequences; Sequence 1: F T X1 Y X2 X3 E X4 G S X5 X6 R L R; Sequence 2: X7 X8 F Q W9 X1 0 F T X1 Y X2 X3 E X4 G S X5 X6 R L R; and Sequence 3: T X1 Y X2 X3 E X4 G S X5 X6 R L R. Id. at 8. The ’072 Application suggested probable identities for several of the amino acids that had not been definitely identified at the time of filing. Id.
Example 2 of the ’072 Application described a protocol for isolating the protein from the urine of patients with fever, which included the following elements: (1) collecting 40 liters of urine from patients with fever by (a) filtering the urine through a “Hemoflow F60” cartridge, and then (b) subjecting the “retentate” (what was retained on and then collected from the cartridge) to the following multi-step column-chromatography protocol: (i) “S-Sepharose” column chromatography; (ii) “TNF-affinity” column chromatography; and (iii) “Mono-Q” column chromatography. Id. at 4-5.
2. 915 Patent
The ’915 Patent described a novel protein having the following characteristics: (1) a molecular weight of about 42 kilodaltons (kDa); (2) the specific biological property of inhibiting the cytotoxicity of TNF alpha; (3) found in the urine of febrile patients; and (4) digestible by trypsin with difficulty or not at all. See ’915 Patent at 2. Example 2 of the ’915 Patent discloses the same protocol to isolate the protein as the ’072 Application. Compare ’915 Patent at 2-3 [Dkt. 70-4] with ’072 Application at 4-5 [Dkt. 70-16].
The ’915 Patent identified the following amino acid sequence at the N-terminus of the claimed protein:
Below is a comparison of Sequence 1 of the ’072 Application with Sequence 2 of the ’915 Patent:
'072
B. Yeda’s Patent Applications
On May 18, 1989, Yeda filed application No. 90, 339 (’339 Application) in Israel for a patent covering the TBP-II protein.[10] See Abbott Mot., Ex. AA [Dkt. 70-30] (’339 Application). Yeda disclosed an N-terminal sequence consisting of 13 amino acids in its longest sequence. See Abbott Mot. at 10. Below is a comparison of the longest sequence disclosed in Yeda’s ’339 Application with the nine amino acids disclosed in Abbott’s ’072 Application:
'D7I
Abbott Mot. at 10. Asserting the benefit of the ’339 Application, Yeda filed U.S. Patent Application No. 07/930, 443 (’443 Application) on August 19, 1992 to claim the TBP-II protein. Compl. ¶ 12; see also Abbott Mot., Ex. B [Dkt. 70-5] (’443 Application).
On January 16, 1990, the Journal of Biological Chemistry published a paper by Dr. Hartmut Engelmann et al. titled, “Two Tumor Necrosis Factor-Binding Proteins Purified from Human Urine.” See Abbott Mot., Ex. C [Dkt. 70-6] (Engelmann Reference). Dr. Engelmann is one of the named inventors on Yeda’s ’443 Application. The Engelmann Reference described the identification of the TBP-II protein, including the identification of an N-terminal sequence consisting of five amino acids. Id. at 1. The authors relied on that short amino acid sequence along with other characteristics and data to identify the TBP-II protein. Id. I, 4-6. There was agreement in the scientific community that the data cited in the Engelmann Reference showing that the scientists had identified a new TNFα-binding protein. See, e.g., Heller et al., Proc. Natl. Acad. Sci. USA 87, 6151-6155 (1990) (“The result is compatible with the sequence Val-Ala-Phe-Thr-Pro found in the recently published urinary TNF-binding protein II, which was also reported to be variable at the amino terminus.”); Loetscher et al., J. Bio. Chem. 265:33, 20131, 20137 (1990) (“. . . a short amino acid sequence of a second TNF inhibitory protein has recently been reported”); Lewis et al., Proc. Natl. Acad. Sci. USA. 88: 2830-2834 (April 1991) (“Recently two immunologically distinct cell-surface-associated TNF-binding proteins of 55-kDa and 75-kDa were identified.”).
Below is a comparison of the five amino acid sequence disclosed in the Engelmann Reference compared with the nine amino acid sequence disclosed in the ’072 Application and the fifteen amino acid sequence disclosed in the ’915 Patent:
Engelmann Val Ala Phe Thr Pro
072 Phe Thr x1 Tyr x2 x3 Glu x4 Gly Ser x5 x6 Arg Leu Arg
915 Phe Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu
Abbott Mot. at 11; see also id., Appendix III.
D. The 2003 Abbott Experiments
In response to Yeda’s claims, Abbott conducted a set of experiments in 2003 to demonstrate the validity of the protocol in the ’072 Application (2003 Experiments). See Abbott Mot., Ex. F [Dkt. 70-9] (Bradshaw Report) ¶¶ 40-52. There were two stages to the 2003 Experiments. The first took place in Ludwigshafen, Germany, and the second took place in Abbott Park, Illinois. During the 2003 Experiments, Abbott scientists repeated the protocol in Example 2 of the ’072 Application to demonstrate “that Abbott’s first patent application describes and enables the subject matter of the Count.” Abbott Mot. at 3. Yeda retained Dr. Engelmann to observe the first phase in Germany, and it retained Dr. Menachem Rubinstein (another of the inventors named on Yeda’s ’443 Application) to observe the second phase in the United States. Bradshaw Report ¶¶ 41, 45.
During the first stage, in a laboratory in Germany on February 3 through 7, 2003, Andreas Striebinger, one of Abbott’s scientists, performed the protocol from Example 2 in the ’072 Application. Id. ¶ 41. Present and observing the first phase were Dr. Bradshaw for Abbott and Dr. Engelmann for Yeda. Id. The first phase yielded two fractions of “essentially homogenous protein, ” which Abbott then sent to Abbott Park “for an analysis of the N-terminal amino acid sequence using automated Edman sequencing techniques.” Bradshaw Report. ¶¶ 42, 44. In lay terms, in Germany Abbott attempted to isolate the TBP-II protein; in the United States it sought to determine the composition of the sample.
The second stage of the 2003 Experiments took place on March 3 through 5, 2003, in Abbott Park, Illinois. Abbott scientist Dr. Thomas Holzman and his assistant, Sally Dorwin, performed the Edman degradation. Id. ¶ 45. Also present for the second phase were Dr. Bradshaw for Abbott and Dr. Rubinstein for Yeda. Id.
The parties characterize the results of the two phases differently. Abbott states that “the 2003 experiments resulted in a purified and isolated protein that could be definitively identified as the TBP-II protein based on (among other characteristics) its molecular weight, its method of purification, its biological activity, and its N-terminal sequence.” Abbott Mot. at 14. Yeda states that the 2003 Experiments “did not result in a purified and isolated TBP-II protein as defined by the Count . . . [because] the data does not permit the identification of anything close to one of the complete amino-acid sequences recited in the Count.” Yeda Response to Abbott Statement of Undisputed Facts [Dkt. 81-2] (Response to Abbott Facts) at 36.
A. Interference before the Board
On October 1, 1996, the Board declared Interference No. 103, 625 (’625 Interference) between Abbott’s ’915 Patent and Yeda’s ’443 Application. Compl. ¶ 14. The subject matter of the Interference was set forth in subsections (b) and (c) of the re-declared Count 2 (Count), which correspond to claims in the ’915 Patent:
(b) A purified and isolated TNFα-binding protein which has a molecular weight of about 42, 000 daltons and has at the N terminus the amino acid sequence
Xaa-Thr-Pro-Tyr-Ala-Pro-Glu-Pro-Gly-Ser-Thr-Cys-Arg-Leu-Arg-Glu
where Xaa is hydrogen, a phenylalanine residue (Phe) or the ...