ROSEMARY M. COLLYER, United States District Judge.
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
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,
As stated by the Board of Patent Appeals and Interferences (Board)
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.
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, ___ U.S. ___, 132 S.Ct. 1690, 1694, 1700, 182 L.Ed.2d 704 (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.,
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.
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).
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
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)
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:
'915 PATENT (COUNT 2) Seq. 1 Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu Seq. 2 Phe Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu Seq. 3 Ala Phe Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu Seq. 4 Val Ala Phe Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu Seq. 5 Gln Val Ala Phe Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu Seq. 6 Ala Gln Val Ala Phe Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu Seq. 7 Pro Ala Gln Val Ala Phe Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu Seq. 8 Leu Pro Ala Gln Val Ala Phe Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr Cys Arg Leu Arg Glu
Abbott Mot., Appendix I.
Below is a comparison of Sequence 1 of the '072 Application with Sequence 2 of the '915 Patent:
7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
'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 18; see also id., Appendix I.
On May 18, 1989, Yeda filed application No. 90,339 ('339 Application) in Israel for a patent covering the TBP-II protein.
5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 '339 Val Ala Phe Thr Pro Tyr Ala Pro Glu Pro Gly Ser Thr '072 Phe Thr X 1 Tyr X2 X3 Glu X4 Gly Ser X5 X6 Arg Leu Arg
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. 1, 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:
5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
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.
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
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.
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:
AR at 6007-08 (Board Redeclaration).
Id.
Yeda prevailed in the '625 Interference, arguing that the Engelmann Reference was a prior art publication that invalidated the claims of the '915 Patent because Abbott had not established entitlement to the filing dates of the '072 and '089 Applications. The Board invalidated Abbott's '915 Patent and found that Abbott was not entitled to priority. See Abbott III, 576 F.Supp.2d at 47. The Board reasoned that the '072 and '089 Applications did not, "as originally filed," sufficiently describe the TBP-II protein, id., and that Abbott "failed to effectively remove Engelmann as prior art," Abbott Mot., Ex. D [Dkt. 70-7] (First '625 Interference Decision) at 19. Abbott sought review of the Board's decision in this Court under 35 U.S.C. § 146, in case Civil No. 00-1720.
The case was assigned to the Honorable Ricardo Urbina. In 2005, Judge Urbina denied Yeda's motion for summary judgment, rejecting its argument that Abbott's '089 Application did not adequately describe the '915 Patent as a matter of law.
On remand, the primary issue was whether Abbott's '072 Application was a constructive reduction to practice of the Count, which required Abbott to prove by a preponderance of the evidence that the '072 Application "describes and enables at least an embodiment meeting all the limitations of the [C]ount." 5/26/10 Board Decision at 5968-89, 5971 (citing Frazer v. Schlegel, 498 F.3d 1283 (Fed.Cir.2007)). Before the Board, Abbott argued that the "N-terminal sequences are inherent in the proteins obtained as described in the '072" Application so that it did not need to identify a full sequence to recognize the TBP-II protein. Id. at 5965. Yeda maintained that Abbott did not submit sufficient evidence of discovery. The Board noted that Abbott's burden was to "show that it is more likely true than not that the necessary and only reasonable construction of the 072 application is that the proteins are the same." Id. at 5970. The Board compared the disclosures contained in the '072 Application with the '915 Patent and found that
Id. In light of these similarities, the Board concluded that the '072 Application and
The Board evaluated Yeda's central argument that the '072 Application did not meet the written description or enablement requirements of 35 U.S.C. § 112. Id. at 5971. Yeda argued that "a correct sequence, at least at the N-terminal, is critical in order to adequately identify and fingerprint the [TBP-II] protein as being something different from other proteins of about the same molecular weight and activity, and obtained from the same source." Id. at 5973. The Board rejected Yeda's argument because "Abbott's motion [was] not based on the disclosure of 072 [Application] alone. Abbott relies upon a comparison of the 072 and 915 disclosures to show that the proteins are the same." Id. The Board reiterated its prior finding that the protein described in both applications is the same. Id. at 5973-74.
Yeda filed a Complaint in the Northern District of Illinois on September 8, 2010 to obtain review of the May 26, 2010 Board Decision. That Court granted Abbott's motion to transfer the case to this District, where it was docketed as Civil No. 10-1836, before Judge Urbina. While discovery was under way, Judge Urbina retired and the case was reassigned to the undersigned.
A district court has authority to review a decision by the Board under 35 U.S.C. § 146. Questions of law are reviewed de novo and the Board's underlying factual determinations are reviewed for clear error. See Winner Int'l Royalty Corp. v. Wang, 202 F.3d 1340, 1348 (Fed. Cir.2000). If a district court accepts new evidence not previously before the Board, the proceedings become "a hybrid of an appeal and a trial de novo." Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d 588, 592
"The filing of a patent application serves as conception and constructive reduction to practice of the subject matter described in the application." Hyatt v. Boone, 146 F.3d 1348, 1352 (Fed.Cir.1998). As is argued here, "when the priority claim is based on subject matter disclosed in a foreign patent application whose filing date is properly claimed, ... the foreign application has the same effect as if filed in the United States." Frazer v. Schlegel, 498 F.3d 1283, 1287 (Fed.Cir.2007) (citing 35 U.S.C. § 119(a), (e)(1)). Therefore, the invention disclosed in a foreign patent application "must be disclosed in the manner provided by the first paragraph of [35 U.S.C.] section 112." Id.
35 U.S.C. § 112 codifies the written description, enablement, and best mode requirements of a patent:
A written description of the invention "is separate and distinct from the enablement requirement." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir.1991). To satisfy the written description requirement, "the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Id. (emphasis in the original).
Enablement requires that "the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation.'" ALZA Corp. v. Andrx Pharm. LLC, 603 F.3d 935, 946 (Fed.Cir.2010) (citing Genentech Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1365 (Fed.Cir.1997)) (emphasis added). "Enablement is not precluded where a `reasonable' amount of routine experimentation is required to practice a claimed invention, however, such experimentation must not be `undue.'" Id. at 940 (citations omitted). "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." In re Wands, 858 F.2d 731, 737 (Fed.Cir. 1988). In Wands, the Federal Circuit set forth the factors that a district court may consider when determining if a disclosure requires undue experimentation:
Id. at 737.
The test for best mode is whether the "invention possessed a better mode than was described in the patent and ... such better mode was intentionally concealed." Ateliers de la Haute-Garonne v. Broetje Automation USA, Inc., 717 F.3d 1351, 1356-57 (Fed.Cir.2013). In the context of a priority claim, "one looks to the
Under Rule 56 of the Federal Rules of Civil Procedure, summary judgment shall be granted "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a); accord Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). Moreover, summary judgment is properly granted against a party who "after adequate time for discovery and upon motion ... fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
The moving party bears the initial burden of "identifying those portions of `the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any,' which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp., 477 U.S. at 323, 106 S.Ct. 2548. In ruling on a motion for summary judgment, the court must draw all justifiable inferences in the nonmoving party's favor. Anderson, 477 U.S. at 255, 106 S.Ct. 2505. A nonmoving party, however, must establish more than "the mere existence of a scintilla of evidence" in support of its position. Id. at 252, 106 S.Ct. 2505. In addition, the nonmoving party may not rely solely on allegations or conclusory statements. Greene v. Dalton, 164 F.3d 671, 675 (D.C.Cir. 1999). If the evidence "is merely colorable, or is not significantly probative, summary judgment may be granted." Anderson, 477 U.S. at 249-50, 106 S.Ct. 2505 (citations omitted). Summary judgment is properly granted against a party who "after adequate time for discovery and upon motion ... fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex, 477 U.S. at 322, 106 S.Ct. 2548.
Abbott filed for summary judgment, Dkt. 70, on the grounds that the Board of Patent Appeals and Interferences correctly determined that the '072 Application met the written description and enablement requirements in 35 U.S.C. § 112. Yeda filed three separate motions for summary judgment, contending that the '072 Application did not contain an adequate written description, Dkt. 71; that the '072 Application did not enable the invention defined by the Count in the '915 Patent, Dkt 73; and that the '072 Application did not disclose Abbott's best mode of carrying out the invention, Dkt. 72.
Although somewhat reframed to support each of its motions for summary judgment, Yeda rests on the same alleged frailties of the '072 Application: (1) the '072 Application failed to disclose a complete amino acid sequence identified in the Count; (2) just before the '072 Application was filed, Abbott scientists used different processes that were not disclosed in the '072 Application to discover some of the TBP-II amino acids claimed in the '072 Application; and (3) the '072 Application failed to describe a process that would result in a "purified and isolated" TBP-II protein, as required by the Count. These arguments challenge
Yeda has repeatedly argued that Abbott's '072 Application is infirm because it did not disclose any of the "complete N terminal amino acid sequences recited in the [C]ount." See, e.g., Yeda Mot. for Summ. J. on Written Description [Dkt. 71] (Yeda Mot. re: Description) at 10; see also 5/26/10 Board Decision at 5972-73 ("Yeda argues that the 072 application neither provides a written description nor enables the subject matter of the count. Yeda's argument focuses on the failure of 072 [Application] to disclose the complete N-terminal sequences of the count."). The facts are not in contention: the '072 Application correctly identified nine
Yeda advances three arguments concerning the amino acid sequences disclosed in the '072 Application: first, that the '072 Application does not satisfy the express limitations of the Count because it does not explicitly include at least one of the complete N-terminal amino acid sequences recited in the Count; second, that Abbott cannot rely on the doctrine of inherent disclosure because all of the amino-acid-sequence limitations in the Count are material to the patentability of Abbott's claims; and third, that a person of ordinary skill would not have understood, at the time the '072 Application was filed, that the specification disclosed any complete amino acid sequence disclosed in the Count.
Yeda quotes Hyatt v. Boone, 146 F.3d 1348, 1354-55 (Fed.Cir.1998), as its basic support: "the written description must include all of the limitations of the interference count, or the applicant must show that any absent text is necessarily comprehended in the description provided and would have been so understood at the time
Yeda's "first step" in furtherance of the Hyatt analysis is its contention that "you can't really define the invention properly without [identifying] all 22 [amino acids.]" Oral Arg. Tr. I [Dkt. 94] at 18-19. In the alternative, Yeda argues that the '072 Application is fatally flawed because it failed to identify, at the least, "the shortest [sequence] at the top, which I believe is 15 amino acids." Id. at 19.
Despite Yeda's adherence to its argument, it is clear that the identification of every amino acid in a sequence is not always necessary before it can be determined that a new protein has been identified. The Federal Circuit most recently made this point clear when it adopted the Board's findings in Sanofi-Aventis v. Pfizer Inc., 733 F.3d 1364 (Fed.Cir.2013). Sanofi-Aventis was an interference in which Pfizer claimed priority of invention of a "DNA polynucleotide that encodes the protein binding chain of the IL-13 receptor." Id. at 1366. The Circuit noted the unremarkable fact that, under "applicable law [pre-AIA], the patent is awarded to the first party to conceive and reduce to practice the invention represented by the interference count." Id. The Board awarded priority to Pfizer because Pfizer "had established conception of the subject matter of the count when it selected, isolated, and obtained the desired IL-13bc full-length polynucleotide and verified that it was the desired product, regardless of whether the fully correct sequencing of the polynucleotide was complete." Id. On appeal, Sanofi continued to argue that "conception of the claimed cDNA could not be established for priority purposes until the fully correct nucleotide sequence was determined, because the interference count was directed to the isolated polynucleotide." Id. In sharp contrast, the Board had concluded that, "`[f]or proteins and polynucleotide species, a sequence is the gold standard for identifying a species with precision.... It does not, however, thereby follow that a sequence is the only way to identify the composition precisely.'" Id. at 1369. Because the Board's findings were based on substantial evidence and it had "applied the correct law," the Circuit sustained the award of priority to Pfizer, even though Pfizer had not identified all of the polynucleotides. Id.
This should come as no surprise to Yeda. Indeed, Yeda's own '339 Application disclosed an N-terminal sequence consisting of 13 amino acids in the longest sequence, and therefore did not disclose any of the complete amino acid sequences identified in the Count. The Engelmann Reference, written by Yeda's chief scientist, reported that an N-terminal sequence of five amino acids, together with other biological data, was sufficient to identify a novel TNFα-binding protein. See Engelmann Reference at 1, 4-6. When prosecuting its U.S. Patent Application No. 08/485,129 (claiming priority for Yeda's '339 Application), Yeda assured the U.S. Patent Examiner that a novel protein can be "adequately defined and fingerprinted by a partial amino acid sequence with disclosures of certain biological properties." Abbott Mot., Ex. E [Dkt. 70-8] (Amendment to Yeda Application) at 16 (emphasis added). The Examiner agreed
Yeda attempts to avoid this evidence and its concessions by challenging Abbott's reliance on the doctrine of inherent disclosure. That doctrine holds that the requirement of Section 112 for a written description can be satisfied by showing that the first-filed application inherently discloses a property of the later-claimed subject matter. Kennecott Corp. v. Kyocera Int'l Inc., 835 F.2d 1419, 1422-23 (Fed. Cir.1987). The doctrine stands on the recognition that a "compound and all of its properties are inseparable; they are one and the same thing." Regents of the Univ. of New Mexico v. Knight, 321 F.3d 1111, 1122 (Fed.Cir.2003). Thus, "the disclosure in a subsequent patent application of an inherent property does not deprive the product of the benefit of an earlier filing date. Nor does the inclusion of a description of that property in later-filed claims change this reasonable result." Kennecott, 835 F.2d at 1423; see also Therma-Tru Corp. v. Peachtree Doors, Inc., 44 F.3d 988, 993 (Fed.Cir.1995). It is not necessary for skilled artisans to possess actual knowledge of an inherent property so long as the initial filing provides an adequate description of the claimed invention. See Hitzeman v. Rutter, 243 F.3d 1345, 1354 (Fed.Cir.2001) ("Where the balance of the claim fully identifies the compound ... and the property is inherent, we fail to see that such statements add anything to the claim definition of the named compound."); Silvestri v. Grant, 496 F.2d 593, 599 (CCPA 1974).
Yeda stresses that "in the context of priority determination, the allegedly inherent limitation cannot be material to the patentability of the invention." Hitzeman, 243 F.3d at 1355 (rejecting "conception" of invention based on later-discovered inherent property). Yeda contends that Abbott relied exclusively on amino acid sequences to distinguish prior art, i.e., the Engelmann Reference, and to persuade the Patent Office to issue the '915 Patent. Yeda therefore urges the Court to disregard Abbott's reliance on inherency to prove Abbott's invention of the TBP-II protein based only on nine amino acids at the N-terminal.
Yeda, however, has misread the prosecution record. Reviewing the '915 Patent, the Patent Examiner first concluded that prior art relating to the TBP-I protein invalidated the claimed TBP-II
Next, Yeda maintains that one of ordinary skill in the art must have been able to deduce each of the additional amino acids identified in the Count based on those disclosed in the '072 Application. See Yeda Mot. re: Description at 23 (citing Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed.Cir.2009) ("The very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.")). Yeda argues that "there is no dispute here by Abbott that one of ordinary skill, back in 1989, looking at the 072 Application could not have discerned... that the missing amino acids... are inherent, inherently disclosed or inherently described." Oral Arg. Tr. I at 31. Without doubt, the '072 Application did not disclose any of the complete amino acid sequences set forth in the Count; it erred in one identified amino acid, inserted an X in the sequence for amino acids not yet identified, and suggested probable amino acids (not always correctly) when uncertain. Abbott's experts acknowledge that the unknown amino acids could not have been predicted or otherwise identified as of the date of filing of the '072 Application. See Yeda Exhibits, Ex. G [Dkt. 74-3] (Dep. Of Dr. Heinz Hillen) at 63-64.
Nonetheless, the Court is persuaded that Yeda's test for inherent disclosure is not scientifically or legally required when
This Court has no difficulty concluding that the Board's findings here are supported by substantial evidence. The '072 Application correctly identified nine of 15 amino acids in the top line of the full N-terminal sequences recited in the Count. The '072 Application also identified certain biological characteristics of the novel protein: (1) a molecular weight of about 42 kilodaltons (kDa); (2) the specific biological property of inhibiting the cytotoxicity of TNFα; (3) found in the urine of febrile patients; and (4) not (usually) digestible trypsin. See '072 Application. Yeda's argument that "those other limitations ... did not distinguish what Abbott had in its test tube" fails to read the Board's decisions or Abbott's argument correctly.
Oral Arg. Tr. I at 24. As the Board held and Abbott argues, a partial amino acid sequence and the other biologic characteristics distinguished the TBP-II protein in the '072 Application. Yeda argued:
Id. Yeda is incorrect that the entire sequence for TBP-II is necessary to distinguish it from TBP-I. Yeda's own reliance in multiple fora on fewer than 15 amino acids to identify the TBP-II protein imposes judicial estoppel against its contrary position here. See, e.g., Comcast Corp. v. FCC, 600 F.3d 642, 647 (D.C.Cir. 2010). Even if judicial estoppel did not bar Yeda's argument, it is without merit. With identification of other biologic characteristics, a partial amino acid sequence for a protein may be sufficient to distinguish the novel protein from a known protein. The Engelmann Reference relied on biologic characteristics, in addition to only five identified amino acids. See Engelmann Reference at 1, 4-6 ("TBPII can be clearly differentiated from TBPI by its lack of immunological cross-reactivity, different NH2-terminal amino sequences, and a difference in chromatographic properties...."). Yeda itself argued to the
Having found that the '072 Application adequately described the invention of the TBP-II protein, the Court agrees with Abbott that the additional amino acids of the TBP-II protein disclosed in the '915 Patent are inherent properties of the TBP-II protein. Abbott cites Wallach for the proposition that "a protein's amino acid sequence is an inherent property of that protein." Wallach, 378 F.3d at 1334. Yeda objects, pointing out that the Federal Circuit adds that "the fact that Appellants may have isolated and thus physically possessed TBP-II does not amount to knowledge of that protein's sequence or possession of any of its other descriptive properties." Id. at 1334-35. The Federal Circuit, however, has previously said that an applicant need not demonstrate knowledge of an inherent property at the time of filing. See Hitzeman, 243 F.3d at 1354. The additional amino acids "add[] nothing to the count beyond the other recited limitations and [are] redundant to the count." Id.
Yeda's argument that the '072 Application was required to identify all 22 amino acids, or alternatively, the 15 amino acids in the first sequence, contradicts its own application, its own admissions and Federal Circuit law. The full record demonstrates that the '072 Application satisfies the written description requirements of 35 U.S.C. § 112. A complete sequence of 15 amino acids in the first sequence is not needed to identify and distinguish the TBP-II protein. Yeda's argument that one of ordinary skill would not have understood the '072 Application to disclose a full sequence of amino acids is merely a variant of the argument that the '072 Application was infirm because it did not identify a full sequence of amino acids. It fares no better on the second try. For the foregoing reasons, the Court will grant summary judgment to Abbott on the issue of written description.
Yeda's argument on enablement has two parts: First, Yeda argues that Abbott "failed to successfully practice its 072 Application protocol in 1989" because the procedure that is reported in the '072 Application did not yield a sample that was "purified and isolated" when practiced just before the '072 Application was submitted. Oral Arg. Tr. I. at 32, 35. Second, Yeda argues that to obtain the sample reported in the '072 Application, Abbott "worked out a materially different protocol that involved different column chromatography methods," which "they didn't disclose in the 072 Application." Oral arg. Tr. I. at 35. Yeda asks this Court, years after
The Court begins with Yeda's request that the Court construe "purified and isolated" to mean "sufficiently purified and isolated to permit identification of one of the complete amino-acid sequences in the Count." Yeda Mot. for Summ. J. on Enablement [Dkt. 73] (Yeda Mot. re: Enablement) at 13. Yeda argues that the need for a purified and isolated sample is the
Oral Arg. Tr. II [Dkt. 96] at 9. Abbott opposes on the grounds that Yeda's proposed construction is the product of attorney argument and that a person of ordinary skill in the art in 1989 would not know that "purified and isolated" required the specification of either 22 or 15 amino acids in sequence. See id. at 39-40. Abbott proposes that a protein is "purified and isolated" when "you're able to make a definitive identification of the protein." Oral Arg. Tr. II at 40.
The words of a patent claim "are generally given their ordinary and customary meaning." Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005) (en banc) (citation omitted). "[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at 1313. "Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." Id. "[I]n interpreting an asserted claim, the court should look first to the intrinsic evidence of record, i.e., the patent itself, including the claims, the specification and, if in evidence, the prosecution history. Such intrinsic evidence is the most significant source of the legally operative meaning of disputed claim language." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996) (internal citation omitted). "In most situations, an analysis of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term." Id. at 1583. "In some cases, however, the district court will need to look beyond the patent's intrinsic evidence
In arguing that it proposed a construction of "purified and isolated" to the Board, Yeda adopts and re-argues points made on enablement in its earlier brief. See Yeda Reply [Dkt. 85] at 21-21. As now, Yeda argued:
Abbott Opp'n, Ex. PP [Dkt. 82-5] (Wallach Opp. to LeMaire Preliminary Mot. No. 1) at 21-23 (emphasis added). Before this Court, Yeda asks that "purified and isolated" be defined as "sufficiently purified and isolated to permit identification of one of the complete amino-acid sequences in the Count." Yeda Mot. re: Enablement at 13. Yeda claims that the language of the Count, the specification of the '915 Patent, and the prosecution history of the '915 Patent support this construction. Id. at 13-16.
Yeda's proposed definition of "purified and isolated" is merely a lawyer's repeat of the failed argument that a full sequence of the TBP-II amino acids must have been "unambiguous[ly]" revealed. Given the long history of this litigation and Yeda's own repeated admissions, the argument is a non-starter. In other fora, as well as before this Court, Yeda has admitted that it is not necessary to identify a complete amino acid sequence, and the Court has rejected this argument as unsound. See Sanofi-Aventis, 733 F.3d at 1369 (a protein can be adequately described based on a partial amino acid sequence and other biological data). It is now clear, as a matter of law, that identification of a full amino acid sequence is not required when a patent applicant has additionally disclosed sufficient biological characteristics of a protein to "distinguish it from other materials, and to define how to obtain it." Id. (quoting Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206 (Fed.Cir.1991)).
Furthermore, the intrinsic evidence does not support Yeda's proposed construction. First, Yeda admits that the '915 specification "does not define or indicate that any special meaning was meant for `purified and isolated.'" Yeda Mot. re: Enablement at 15. The specification of the '915 Patent identifies characteristics of the TBP-II protein in addition to amino acid sequences, i.e., the protein's molecular weight, its ability to inhibit the cytotoxicity of TNFα, its source, and its digestibility by trypsin. The specification uses "purified" and isolated" in reference to sources and techniques used to obtain the protein. For example, the specification states that "[t]he novel proteins can be isolated ... from the urine of patients with fever," "[t]he proteins can be purified by conventional methods such as affinity or ion exchange chromatography" and "the protein obtained [by the protocol in Example 2] had a purity of
Part (b) of the Count describes the "purified and isolated TNFα-binding protein" as having one of eight amino acid sequences. See supra p. 14. Yet, defining "purified and isolated" to mean "sufficiently purified and isolated to permit identification of one of the complete amino-acid sequences in the Count" would conflate these limitations. Yeda has advanced the most stringent restriction from the Count and specification to form a narrow construction of the term in furtherance of its legal position here.
Yeda's reliance on the prosecution history of the '915 Patent fares no better. Yeda points to Abbott's attempts to distinguish TBP-II from prior art based on amino acid sequences as evidence that identification of a complete amino acid sequence is key to the definition of "purified and isolated." See Yeda Mot. re: Enablement at 16. Granted, explanation of the unique amino acid sequences of the TBP-II and TBP-I proteins was necessary for Abbott to convince the Patent Examiner that they are separate proteins: Abbott distinguished the TBP-II protein from the TBP-I protein based, in part, on Dr. Engelmann's description of a new protein after he had identified only five amino acids. The five amino acids identified by Dr. Engelmann were critical because they were sufficient — along with other biologic characteristics — to differentiate the novel protein from the known protein. Here, as before, Yeda ignores the significant role the other characteristics of the TBP-II protein played in the prosecution history of the '915 Patent. The intrinsic evidence reveals that the term "purified and isolated" does not have the narrow meaning that Yeda's lawyers now ascribe to it. The Court therefore rejects Yeda's proposed definition of the term "purified and isolated."
Because the intrinsic evidence alone could arguably render several variations of the definition of "purified and isolated," the Court finds the intrinsic evidence insufficient to define the term. Therefore, the Court turns to the parties' experts to identify "the meaning of a term in the relevant art during the relevant time period." Teva Pharmaceuticals, 135 S.Ct. at 841. First, the Court notes that Yeda's proposed construction is unaccepted by its own experts. Both Dr. Shively and Dr. Capra acknowledged that different meanings could be imputed to the term:
Yeda Exhibits, Expert Statement of John E. Shively, PH.D [Dkt. 74-10] (Shively Report) ¶ 68; id., Expert Statement of J. Donald Capra, M.D. [Dkt. 74-8] (Capra Report) ¶ 70. Abbott's experts, Drs. Bradshaw and Baldwin, provided opinions directly on the question of how one skilled in the art at the time of invention would have understand the term "purified and isolated:"
Abbott Mot., Ex. J [Dkt. 70-13] (Bradshaw Rebuttal) ¶ 19; id., Ex. W [Dkt. 70-26] (Baldwin Rebuttal) ¶ 19. Yeda does not point to evidence to contradict or undermine the position of Abbott's experts. See Yeda Reply at 22. The Court therefore adopts the statements of Drs. Bradshaw and Baldwin for purposes of construing the term "purified and isolated."
The Court is persuaded by the experts. The Court finds that Abbott's proposed construction — that a protein is "purified and isolated" within the meaning of the Count if it results in a definitive identification of the protein — more accurately reflects the intrinsic evidence and the expert opinions. It therefore adopts Abbott's proposed construction and construes "purified and isolated," as used in the '072 Application (and therefore in the '915 Patent) to mean "purified and isolated enough to definitely identify the TBP-II protein."
Yeda discovered Abbott's 1989 lab notebooks after this § 146 suit was filed in September 2010.
The Patent Act requires a specification to "contain a written description ... of the manner and process of making and using [the claimed invention] in such full, concise, and exact terms as to enable any person skilled in the art ... to make and use the same...." 35 U.S.C. § 112, ¶ 1. "To be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation.'" ALZA Corp. v. Andrx Pharmaceuticals, LLC, 603 F.3d 935, 940 (Fed. Cir.2010) (internal citation omitted). "That some experimentation is necessary" to practice the invention does not constitute a lack of enablement. Atlas Powder Co. v. E.I. DuPont De Nemours & Co., 750 F.2d 1569, 1576 (Fed.Cir.1984). "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." In re Wands, 858 F.2d 731, 737 (Fed.Cir.1988). A court need not consider all of the Wands factors, but only those that pertain to the facts of the case. Amgen, Inc. v. Chugai Pharm. Co., Ltd., 927 F.2d 1200, 1213 (Fed.Cir.1991).
The protocol in Example 2 of the '915 Patent repeats the protocol from Example 2 of the '072 Application in relevant part. Compare '915 Patent at 2-3 with '072 Application at 45. Yeda claims, and Abbott does not effectively dispute, that the Abbott scientists attempted to duplicate the '072 protocol just before the '072 Application was filed and got weak results. Yeda's new evidence shows that "[t]he sample that Abbott actually obtained when they practiced the 072 protocol — the protocol reported in the application — [] resulted in a sample that was more contaminated and less purified and isolated than the sample they actually reported." Oral Arg. Tr. I at 34-35. Therefore, Abbott scientists "worked out a materially different protocol that involved different column chromatography methods. That's the procedure, that's the protocol which they didn't disclose in the 072 Application, and they actually used that to obtain the sample reported in the 072 Application." Id. at 35. More precisely Dr. Capra, one of Yeda's experts, states:
Yeda Exhibits, Expert Statement of J. Donald Capra, M.D. [Dkt. 74-8] (Capra Report) ¶¶ 291, 292, 297. Yeda asserts that this history reveals that the '072 Application did not specify a protocol that would enable a person of ordinary skill in the art to duplicate the invention.
Abbott responds that it is "[u]ndisputed that Abbott used sources and methods in addition to the protocol in the '072 Application, but disputed that the '072 protocol did not yield a protein containing the sequences recited in the Count." Response to Yeda Facts re: Enablement [Dkt. 82-2] at 6. Abbott does not dispute that its lab notebooks show use of different chromatographic procedures and equipment prior to submission of the '072 Application, but disputes that these differences were material. Id. at 4-5. Abbott also acknowledges that, after the '072 Application was filed, it continued its research and used additional sources and methods to identify the complete 22 amino acids identified in the '915 Patent. Id. at 6-7; see '089 Application [Dkt. 70-14]. Abbott points to the 2003 Experiments to prove that the '072 protocol successfully resulted in sufficient biological evidence and amino acids of the TBP-II protein to prove its discovery.
The Court finds that Abbott's pre-filing modifications to the '072 protocol do not bear on the question of enablement, which concerns the specification of a patent. The real inquiry, then, is whether the '072 protocol, as written and disclosed in the '072 Application, "teach[es] those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation.'" ALZA Corp., 603 F.3d at 940. The legitimacy and outcome of the 2003 Experiments are the proper focus of this inquiry.
Abbott cites to the 2003 Experiments,
Yeda does not argue about the chromatography techniques performed during the 2003 Experiments. See Oral Arg. Tr. II at 10 (Yeda: "[A]s far as the count chromatography that's reported in the '072 Application, we're not taking the position that they didn't do what the '072 Application said to do" in the 2003 Experiments.). Instead, Yeda objects that during the 2003 Experiments Abbott scientists "actually put a lot less protein on the gel" compared to the '072 protocol. Oral Arg. Tr. II at 16-17. Yeda asserts that less protein would produce stronger evidence of the TBP-II protein. Id. at 17 (Yeda: "Why does that matter? When you're putting less protein on the gel, ... the contaminants are less likely to be visible."). Although Dr. Bradshaw stated that 2 micrograms is the "normal amount that's used in experiments of that type" and noted that smaller amounts of protein were loaded onto certain lanes of the gel in the 2003 Experiments, he was not asked about the significance of using less gel. See Abbott Mot., Ex. KK (Bradshaw Dep.) at 80-84; 170-174. Yeda's experts, Dr. Shively and Dr. Capra, do not cite this alleged deficiency in their review of the 2003 Experiments. See Shively Report ¶¶ 302-314; Capra Report ¶¶ 304-316. The Court does not accept or rely on a lawyer's late invention of a scientific argument.
Yeda also argues that Abbott did not perform an amino assay in 2003 as it did in 1989, which, Yeda contends, would have shown evidence of contamination with TBP-1. Oral Arg. Tr. II at 19; see also Shively Report ¶ 308 ("Abbott's 2003 experiments did not include any immunoassay with antibodies to TBP-I to rule out the existence of TBP-I in Abbott's protein fractions ...."). Abbott does not address the point, and the Court deems it conceded. Whether it matters is a different question. Yeda's attack on the 2003 Experiments is ultimately dependent on its proffered definition of "purified and isolated" which the Court has already rejected.
Yeda does not otherwise dispute that Abbott followed the '072 protocol during the 2003 Experiments. On the record as a whole, the Court concludes that the 2003 Experiments materially followed the '072 protocol.
Yeda neatly describes its central objection to Abbott's 2003 Experiments:
Oral Arg. Tr. II at 9 (emphasis added). The presence of contaminants in the samples
Abbott concedes that contaminants may have been present in the samples, but insists that "it cannot be denied that whatever contaminants may have been present, the Abbott scientists were able to identify a protein that has each of the amino acids specified in the count." Oral Arg. Tr. II (Abbott) at 43. Based on their review of the sequencing results, both of Abbott's experts conclude that a person skilled in the art who followed the '072 protocol would have obtained a protein with one of the amino acid sequences identified in the Count. See Bradshaw Rebuttal ¶¶ 47-52; Baldwin Rebuttal ¶¶ 69-71.
Yeda asserts that the Board failed to apprehend that the "gemish"
Yeda contends that one of ordinary skill in the art in 1989 would not have used Coomassie Blue, a dye used by Abbott scientists in 1989 and 2003 to provide evidence of purification. Id. At oral argument, Yeda asserted that "[i]t hasn't been rebutted that one of ordinary skill in the art typically does not rely on Coomassie Blue ... [instead of] silver stain." Id. Yeda's expert, Dr. Shively, stated that "Coomassie Blue stain ... was well-known to be not nearly as sensitive as other stains (such as silver stain) for detecting small amounts of protein. One of ordinary skill in the art would have expected Abbott
Yeda challenges the identification of amino acids from the contaminated samples produced from the 2003 Experiments. Oral Arg. Tr. II at 13-14 (Yeda) ("[I]f you already know the sequences to look for, which Abbott's experts did, then you can see the sequences, but you can also see other sequences in the data. That's not a genuine demonstration of entitlement.... [W]e submit that it biased their opinions in this case."). However, a later scientist, seeking to reproduce the protocol taught by the '072 Application, would inevitably "know the sequences to look for:" the results specified in the patent. And, as Abbott points out, this is the central question of an enablement case: whether a skilled person, using all of the information in the challenged specification, could practice the claimed invention. See Abbott Opp'n [Dkt. 82] at 36-37. Yeda responds that the sufficiency of an application must be judged as of the filing date, see Vas-Cath Inc., 935 F.2d at 1566, and one skilled in the art would not have had the benefit of the complete sequences disclosed in the '915 Patent. However, this objection again rests on the rejected premise that one skilled in the art must have been able to identify a full sequence of 15 or 22 amino acids of the TBP-II protein disclosed in the Count. Yeda cannot escape the fact that the amino acids identified by the '072 Application are found only in the TBP-II protein and that the amino acids of the TPB-II protein were found in the contaminated sample produced by the 2003 Experiments after adhering to the '072 protocol.
Lastly, Yeda questions how it could be that the '072 protocol failed when attempted in late May 1989 and "just magically work[ed] in 2003." Oral Arg. Tr. II at 10. This is a purely speculative question and is rejected as neither factual nor legal argument.
Nonetheless, the Court recognizes that Yeda's argument on enablement rests on the alleged "failure" of Abbott scientists to duplicate the '072 protocol in 1989 when it discovered TBP-II and some of its amino acids. Abbott's defense rests on its initial success in 1989 (uncontested by Yeda), albeit in a "contaminated" sample, and the success of the same protocol in 2003 to produce a "contaminated" sample following the '072 protocol from which TBI-II amino acids were discerned. Inasmuch as Yeda's scientists were immediately present and observant at the 2003 Experiments, while an unobserved scientist reproducing the '072 protocol in 1989 may have erred in some unknown way, the
Finally, Yeda argues that the '072 Application does not comply with 35 U.S.C. § 112 because it does not set forth the best mode practiced by Abbott for obtaining the TBP-II protein. Specifically, the '072 Application does not disclose the modified protocol that Abbott relied upon to obtain the protein and an unspecified number of amino acids immediately before filing the '072 Application. See Yeda Mot. for Summ. J. on Best Mode [Dkt. 72] (Yeda Mot. re: Best Mode) at 9-11.
Section 112 requires that the specification of a patent "set forth the best mode contemplated by the inventor or joint inventory of carrying out his invention." 35 U.S.C. § 112. Courts engage in a two-pronged inquiry to determine compliance with the best-mode requirement. "First, the court must determine whether the inventor possessed a best mode of practicing the claimed invention at the time of filing the patent application. This first step is subjective and focuses on the inventor's preference for a best mode of practicing the invention at the time of the
Yeda concedes that it has presented no evidence showing that Abbott intentionally concealed its best mode. Yeda argued only that Abbott did not disclose its preferred mode in the '072 Application. See Yeda Mot. re: Best Mode at 11-12. In response to Abbott's defense that Yeda had presented no evidence of intentional concealment, Yeda only suggests that "if the Court does not grant one of Yeda's other motions for summary judgment, Yeda may seek leave to take additional discovery regarding Abbott's failure to disclose its best mode." Yeda Reply at 30.
The Court finds that there are no true disagreements of fact between the parties. While the experts disagree, in part, those disagreements that are relevant are resolved on the record. Thus, as both parties' motions for summary judgment suggest, the Court agrees that this matter can be decided without an evidentiary hearing.
Having so concluded, the Court affirms the May 26, 2010 decision of the Board of Patent Appeals and Interferences and finds that Abbott is entitled to the benefit of the May 9, 1989 application date of the '072 Application in Germany. The Court will grant Abbott's motion for summary judgment, Dkt. 70, and will deny Yeda's motions for summary judgment, Dkts. 71, 72, and 73. Judgment will be entered in favor of Abbott. A memorializing Order accompanies this Opinion.
5/26/10 Board Decision at 5973-74 (internal citations omitted).
Id. at 3.
In re Gosteli, 872 F.2d 1008, 1011 (Fed.Cir. 1989); see also Bigham v. Godtfredsen, 857 F.2d 1415, 1418 (Fed.Cir.1988) (noting that for priority claim under 35 U.S.C. § 119, disclosure of subject matter of the count must meet the requirements of 35 U.S.C. § 112, first paragraph); Frazer, 498 F.3d at 1287 ("Constructive reduction to practice does not invoke different standards whether the priority document is foreign or domestic."). When Congress amended 35 U.S.C. § 120 in 2011, it repealed the best mode requirement so that an earlier filed application need only comply with the written description and enablement requirements of Section 112. See 35 U.S.C. § 120 (2011). The amendment does not have retroactive effect, however. Best mode was plainly a requirement of 35 U.S.C. § 112, paragraph 1, and, therefore, the Court entertains Yeda's best mode argument.
