Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

Filing 1310

BRIEF by Amgen Inc. Bench Memorandum Regarding No Obviousness-type Double Patenting. (Rich, Patricia)

Amgen Inc. v. F. Hoffmann-LaRoche LTD et al

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UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ) ) ) Plaintiff, ) ) v. ) ) ) F. HOFFMANN-LA ROCHE ) LTD., a Swiss Company, ROCHE ) DIAGNOSTICS GmbH, a German ) Company and HOFFMANN-LA ROCHE ) INC., a New Jersey Corporation, ) ) Defendants. ) __________________________________________) AMGEN INC.,

Civil Action No.: 05-12237 WGY

AMGEN'S BENCH MEMORANDUM REGARDING NO OBVIOUSNESS-TYPE DOUBLE PATENTING

808415

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TABLE OF CONTENTS I. II.

PAGE NO.

INTRODUCTION ....................................................................................................... 1 STATEMENT OF FACTS .......................................................................................... 4 A. B. Roche's ODP Allegations................................................................................ 4 Relevant Prosecution History .......................................................................... 8 1. The PTO's 1986 Restriction Requirement Required Amgen To Prosecute Dr. Lin's EPO Inventions In Multiple Applications .......................................................................... 8 Amgen Complied with the PTO's 1986 Restriction Requirement....................................................................................... 10 The PTO Repeatedly Determined That Dr. Lin's Process Inventions Are Patentably Distinct from Lin's DNA and Host Cell Inventions .......................................................................... 14

2. 3.

C. III.

The Court's ODP Summary Judgment Order................................................ 19

ARGUMENT............................................................................................................. 20 A. Governing Legal Standards ........................................................................... 20 1. 2. B. The ODP Safe Harbor Statute: 35 U.S.C. § 121................................ 20 Obviousness-Type Double Patenting................................................. 25

The Court Should Strike Roche's Allegations That the `933, `422 and `349 Claims Are Invalid For ODP Over the `868 and `698 Claims (Roche's "Theory No. 4") Because These Defenses Were Not Disclosed During Discovery or In Roche's § 282 Pretrial Notice............................................................................................................. 32 Under 35 U.S.C. § 121, the `933, `422 and `349 Claims Are Exempt from ODP Over the `868 and `698 Claims....................................... 34 The `868 and `698 Claims Are Not Invalid for ODP Over the `008 Claims (Roche's "Theory No. 3") ......................................................... 38 1. 2. The `868 and `698 Asserted Claims Are Significantly Different from the `008 Patent Claims .............................................. 38 The Significant Differences in Claimed Subject Matter Render Each `868 and `698 Asserted Claim Non-Obvious and Patentably Distinct from Each `008 Patent Claim ...................... 44

C. D.

IV.

CONCLUSION.......................................................................................................... 59 ii

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TABLE OF AUTHORITIES PAGE NO. Cases Amgen Inc. v. Chugai Pharm. Co. Ltd., 13 U.S.P.Q.2d 1737 (D. Mass. 1989) ............................................................................. 8, 28, 42 Amgen Inc. v. Chugai Pharm. Co. Ltd., 927 F.2d 1200 (Fed. Cir. 1991)................................................................................................. 42 Amgen Inc. v. Hoechst Marion Roussel, Inc., 126 F. Supp. 2d 69 (D. Mass. 2001) ................................................................................... 25, 38 Applera Corp. v. MJ Research Inc., 363 F. Supp. 2d 261 (D. Conn. 2005)....................................................................................... 27 Applied Materials, Inc. v. Adv. Semiconductor Materials Am., Inc., 98 F.3d 1563 (Fed. Cir. 1996)............................................................................................ passim Applied Materials, Inc. v. Adv. Semiconductor Materials Am., Inc., 1994 U.S. Dist. LEXIS 7810 (N.D. Cal. Apr. 26, 1994) .......................................................... 24 Astellas Pharma, Inc. v. Ranbaxy Inc., 2007 U.S. Dist. LEXIS 11870 (D.N.J. Feb. 21, 2007) ............................................................. 30 Bristol-Myers Sqibb Co. v. Pharmachemie B.V., 2002 U.S. Dist. LEXIS 27230 (D.N.J. July 25, 2002)........................................................ 24, 25 Carman Industries, Inc. v. Wahl, 724 F.2d 932 (Fed. Cir. 1983)................................................................................................... 29 Cytyc Corp. v. TriPath Imaging, Inc., 2007 U.S. Dist. LEXIS (D. Mass. Aug. 22, 2007).................................................................... 34 Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2001)................................................................................................... 27 Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 364 F. Supp. 2d 820 (S.D. Ind. 2005) ....................................................................................... 30 Engineered Prods. Co. v. Donaldson Co, Inc., 313 F. Supp. 2d 951 (N.D. Iowa 2004)..................................................................................... 26 Ferguson Beauregard/Logic Controls v. Mega Sys., LLC, 350 F.3d 1327 (Fed. Cir. 2003)................................................................................................. 33

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Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359 (Fed. Cir. 2003)................................................................................................. 26 Gen. Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, (Fed. Cir. 1992)......................................................................................... passim Geneva Pharms., Inc. v. GlaxoSmithKline, PLC, 349 F.3d 1373 (Fed. Cir. 2003)........................................................................................... 24, 30 Georgia-Pacific Corp. v. U.S. Gypsum Co., 195 F.3d 1322 (Fed. Cir. 1999) .................................................................................... 26, 27, 38 Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683 (Fed. Cir. 1990)............................................................................................ passim In re Braithwaite, 379 F.2d 594 (C.C.P.A. 1967) .................................................................................................. 32 In re Durden, 763 F.2d 1406 (Fed. Cir. 1985)........................................................................................... 10, 48 In re Emert, 124 F.3d 1458 (Fed. Cir. 1997)................................................................................................. 30 In re Gladrow, 406 F.2d 1376 (C.C.P.A. 1969) ................................................................................................ 30 In re Glaxo `845 Patent Litig., 450 F. Supp. 2d 435 (S.D.N.Y. 2006)....................................................................................... 30 In re Kaplan, 789 F.2d 1574 (Fed. Cir. 1986)........................................................................................... 30, 32 In re Longi, 759 F.2d 887 (Fed. Cir. 1985)....................................................................................... 28, 29, 30 In re Metoprolol Succinate Patent Litig., 494 F.3d 1011 (Fed. Cir. 2007).......................................................................................... passim In re Sarett, 327 F.2d 1005 (C.C.P.A. 1964) .......................................................................................... 31, 32 Klonoski v. Mahlab, 156 F.3d 255 (1st Cir. 1998)..................................................................................................... 34 KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007)........................................................................................................ 28, 29 Lucent Techs. Inc. v. Gateway, Inc., 470 F. Supp. 2d 1163 (S.D. Cal. 2007)..................................................................................... 31 iv

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Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).................................................................................................................. 26 Ortho Pharm. Corp. v. Smith, 959 F.2d 936 (Fed. Cir. 1992) ............................................................................................ 26, 30 Pfizer Inc. v. Synthon Holdings BV, 2006 U.S. Dist. LEXIS 63063 (M.D.N.C. Aug. 31, 2006)....................................................... 30 Pfizer Inc. v. Teva Pharms. USA, Inc., 2007 U.S. Dist. LEXIS 20190 (D.N.J. Mar. 20, 2007)....................................................... 23, 25 PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007)..................................................................................... 25, 29, 38 Primos, Inc. v. Hunter's Specialties, Inc., 451 F.3d 841 (Fed. Cir. 2006)................................................................................................... 33 Studiengesellschaft Kohle mbH v. N. Petrochemical Co., 784 F.2d 351 (Fed. Cir. 1986)............................................................................................. 21, 23 Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569 (Fed. Cir. 1991).......................................................................................... passim Takeda Chem. Indus., Ltd. v. Alphapharm, Pty., 492 F.3d 1350 (Fed. Cir. 2007)........................................................................................... 28, 29 Texas Instruments Inc. v. ITC, 988 F.2d 1165 (Fed. Cir. 1993)................................................................................................. 24 Thermo King Corp. v. White's Trucking Serv., Inc., 292 F.2d 668 (5th Cir. 1961) .................................................................................................... 33 Transco Prods. Inc. v. Performance Contracting, Inc., 38 F.3d 551 (Fed. Cir. 1994)..................................................................................................... 23 Union Carbide Corp. v. Dow Chem. Co., 619 F. Supp. 1036 (D. Del. 1985)....................................................................................... 24, 25 Statutes 35 U.S.C. § 102............................................................................................................................. 32 35 U.S.C. § 121...................................................................................................................... passim 35 U.S.C. § 282...................................................................................................................... passim Rules 21 C.F.R. § 601.51(c).................................................................................................................... 56 v

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37 C.F.R. § 1.60 ...................................................................................................................... 11, 12 37 C.F.R. § 1.601(f) ................................................................................................................ 16, 46 37 C.F.R. § 1.603 .................................................................................................................... 16, 46 M.P.E.P. § 201.6 ........................................................................................................................... 11 M.P.E.P. § 2303 ...................................................................................................................... 15, 46 M.P.E.P. § 804.01 ......................................................................................................................... 37 Other DONALD S. CHISUM ET AL., PRINCIPLES OF PATENT LAW, 105 (2d ed. 2001) ............................... 41 S. Rep. No. 1979, 82nd Cong., 2nd Sess. 20, 1952 U.S.C.C.A.N. 2394 ...................................... 21

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I.

INTRODUCTION On August 27, 2007, this Court granted Amgen's motion for summary judgment that all

of the claims-in-suit are not invalid for obviousness-type double patenting ("ODP") over the Lai/Strickland `016 patent claims. The Court also held that the asserted claims of the `933, `422 and `349 patents are exempt from ODP over the `008 patent claims under 35 U.S.C. § 121 -- the ODP "safe harbor" statute. In response to the Court's summary judgment ruling, Roche presses its allegations that the `868 and `698 claims are invalid for ODP over the `008 patent claims. Roche refers to these ODP defenses as Roche's ODP "Theory No. 3." In addition, Roche seeks to add several new ODP defenses that Roche neither disclosed nor developed during discovery. Roche refers to these new allegations, that the `933, `422 and `349 claims are invalid for ODP over the `868 and `698 claims, as Roche's ODP "Theory No. 4." Theory No. 4 is not properly in the case. The Court has requested additional briefing from the parties concerning these unresolved ODP defenses. For the reasons explained below and in Amgen's summary judgment briefing, the Court should dispose of Roche's remaining ODP defenses as a matter of law. Roche's new ODP defenses based on the `868 and `698 patent claims ("Theory No. 4") should be dismissed on procedural grounds, not only because Roche concealed these ODP defenses during discovery to the detriment of Amgen, but also because Roche is barred by 35 U.S.C. § 282 from asserting claims of Lin's `868 and `698 patents as prior art against any other claims-in-suit. Pursuant to § 282, Roche was required to disclose to Amgen thirty days before trial every prior art reference on which it relied in support of any defense or claim that the patents-in-suit are invalid. Roche's § 282 Notice lists the Lin `008 and Lai/Strickland `016 patents (Roche's other ODP references), but does not list the `868 and `698 patents as invalidity references. (See Docket Item ("D.I.") 799, at 4.) Even now -- three weeks into trial -- Roche 1

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has not provided any detailed explanation of how and why Roche contends that claims of the `868 and `698 patents render the other claims-in-suit invalid for ODP.1 ODP is an affirmative defense for which Roche bears the burden of proof. It is entirely improper for Roche to seek a tactical advantage by ambushing Amgen with these new defenses in the middle of trial. Roche's Theory No. 4 should also be dismissed on substantive grounds, because these defenses are precluded by 35 U.S.C. § 121 for the same reasons that the statutory safe harbor exempts the `933, `422 and `349 claims from ODP over the claims in the `008 patent. As already established on summary judgment, the `933, `422 and `349 patent claims arise from applications filed as a result of the PTO's 1986 restriction requirement and are consonant with the nonelected invention groups of that restriction requirement. None of the `933, `422 or `349 claims belong to the same restriction group as the `868 and `698 patent claims (which belong to the same restriction group as the `008 claims), and for that reason 35 U.S.C. § 121 prevents Roche from asserting Lin's `868 and `698 claims as ODP references against Lin's `933, `422 or `349 claims. The admissions in Roche's briefing make clear that its latest ODP defenses are nothing more than a transparent attempt to circumvent the Court's summary judgment ruling that the `933, `422 and `349 claims are exempt from ODP over the `008 claims. Assuming, arguendo, that Roche's latest ODP defenses were not precluded by § 121, and that these claims were not patentably distinct from the `868 and `698 claims, the terms of the `933, `422 and `349 patents would be co-terminus with the `868 and `698 patents (which are terminally disclaimed to each other). But that is not Roche's end-game, because the `868 and `698 patents do not expire until 2012, a full five years from now. Rather, by combining its Theory No. 4 (the `933, `349 and
1

Should the Court require any additional information to dispose of Roche's new ODP defenses, Amgen respectfully requests the opportunity to submit additional information once Amgen has

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`422 claims are obvious over and coterminous with the `868 and `698 claims) with its Theory No. 3 (the `868 and `698 claims are obvious over and coterminous with the `008 claims), Roche hopes to achieve the very result that this Court rejected in its summary judgment ruling, namely, a ruling that the `933, `422 and `349 claims were obvious over, and therefore coterminous with, Lin's `008 patent. This result is precluded by the Court's summary judgment Order, and the Court should reject Roche's latest gambit for what it is: a contrived end-run around the Court's summary judgment ruling. Roche's Theory No. 3 defenses should be dismissed because the process inventions claimed in Lin's `868 and `698 patents are patentably distinct from the DNA and host cell inventions claimed in Lin's `008 patent. The Patent Office determined on several occasions that Lin's process claims were patentably distinct from the claims of the `008 patent, including an express determination signed by the Acting Commissioner of the PTO that the DNA and host cells claimed in Lin's `008 patent were "deemed to be patentably distinct" from the processes claimed in the `868 and `698 patents. Indeed, during the prosecution of the `868 claims, the examiners expressly considered many of the very same arguments and the very same prior art that Roche now presents. They did so in the context of a rejection of the pending `868 claims for ODP over the `008 claims. After review of the evidence, the PTO decided to withdraw the rejection and allow the claims to issue precisely because it concluded that the inventions claimed in the `868 patent were in fact patentably distinct from the `008 claimed inventions. Consequently, the burden now falls on Roche to prove by clear and convincing evidence that Dr. Lin's process claims were not patentably distinct from Lin's DNA and host cell claims. For all of the reasons previously made manifest in the prosecution of Lin's process claims, as well as the reasons explained in the supporting declaration of Dr. Lodish, the PTO's had an opportunity to review the details of Roche's not-yet-disclosed ODP arguments. 3

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determination that Lin's process inventions are patentably distinct from Lin's DNA and host cell inventions should be affirmed. The Court should hold as a matter of law that the `868 and `698 asserted claims are not invalid for ODP over the `008 patent claims. II. STATEMENT OF FACTS A. ROCHE'S ODP ALLEGATIONS Based on the information disclosed in Roche's August 31, 2007 Pre-Trial Brief (D.I. 919) and September 7, 2007 Offer of Proof (D.I. 1035), Amgen understands Roche's current allegations of obviousness-type double patenting to consist of the following: Theory No. 3: · · `868 claims 1 and 2 invalid for ODP over `008 claims 2, 4, 6, 7, 25, and/or 27; `698 claims 6-9 invalid for ODP over `008 claims 2, 4, 6, 7, 25, and/or 27;

Theory No. 4: · · · · · `933 claims 3, 7-9, 11-12, and 14 invalid for ODP over `868 claims 1, 2, 4, and/or 5; `422 claim 1 invalid for ODP over `868 claims 1, 2, 4, and/or 5; `422 claim 1 invalid for ODP over `698 claims 6, 7, 8 and/or 9; `349 claim 7 invalid for ODP over `868 claims 1, 2, 4, and/or 5; `349 claim 7 invalid for ODP over `698 claims 6, 7, 8 and/or 9.2

Roche's Theory No. 4 defenses are not properly in this case. Roche's ODP allegations have morphed repeatedly and substantially over the course of this action, including after the close of discovery, and even during trial. Roche's original

Roche's September 7, 2007 Offer of Proof (D.I. 1035) -- filed in response to this Court's order that Roche specify which `868 and `698 claims it seeks to assert as ODP references -- does not identify claim 4 of the `698 patent as a basis for any ODP defense. Thus, Roche's arguments and evidence at the October 1, 2007 ODP hearing purporting to show that claim 7 of the `349 patent is invalid for ODP over `698 claim 4 should be disregarded. 4

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Answer and Counterclaims, filed November 6, 2006, provided nothing more than bare notice of Roche's intent to allege that certain undisclosed claims of the patents-in-suit are invalid for ODP over certain undisclosed claims of Amgen's `008 patent: "The claims of the `868, `933, `698, `080, `349 and `422 patents are invalid for double patenting over claims of Amgen's earlier issued and now expired U.S. Patent No. 4,703,008 (`the `008 patent')." (D.I. 140, at 4, ¶ 37.) No other theories of ODP were mentioned in Roche's original Answer and Counterclaims. During pretrial discovery, Amgen pressed Roche to disclose the factual bases for its general ODP allegation, but Roche repeatedly declined to do so. Roche provided only incomplete disclosure of its ODP defenses in its interrogatory responses served before the close of fact discovery on April 2, 2007. None of these interrogatory responses identified or discussed ODP based on the `868 or `698 patent claims (i.e., Roche's Theory No. 4). On December 11, 2006, Amgen served two interrogatories, Nos. 9 and 11, requesting detailed, claim-by-claim information regarding Roche's double patenting allegations. In its first response to Amgen's ODP interrogatories, served January 11, 2007, Roche merely alleged that Amgen's asserted claims were invalid for ODP over certain undisclosed claims of Amgen's `008 patent. (Declaration of Geoffrey M. Godfrey In Support of Amgen's Bench Memorandum and Offer of Proof Regarding No Obviousness-Type Double Patenting (D.I. 1165), Ex. A, at 48.) On February 9, 2007, Roche supplemented its response to Amgen's interrogatories, listing the specific claims of the `008 patent that Roche contended invalidated the claims-in-suit for ODP. Roche identified as ODP references `008 claims 1, 2, 4-8, and 23-27. (D.I. 1165, Ex. B, at 69.) On February 26, 2007, in its second supplemental response to Amgen's interrogatories, Roche did not identify any further allegations of ODP. On March 2, 2007, Roche sought leave to amend its sixth affirmative defense (double patenting) to plead the Lai/Strickland `016 patent as a basis for ODP and to plead that "the

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claims of the `349, `933, `080, and `422 patents are invalid for double patenting over the claims of the `868 and `698 patents." (D.I. 304.) Amgen opposed Roche's motion and requested that the Court preclude Roche from seeking any additional time for discovery. (D.I. 321.) On March 20, 2007, the Court granted Roche's motion, but specifically ordered that "The Time For Discovery and Other Pre-Trial Scheduled Dates Are Not Extended." (3/20/07 Electronic Order.) Two weeks later, on April 2, 2007 -- the close of fact discovery -- Roche served its third supplemental response to Amgen's ODP interrogatories. As in its prior interrogatory responses, Roche did not explain its ODP allegations based on any patent other than the `008 patent. Roche made absolutely no mention of ODP based on the `868 or `698 patent claims in these interrogatory responses. (D.I. 1165, Ex. C.) On April 6, 2007, Roche filed its initial expert reports addressing Roche's ODP and other invalidity defenses. Five different Roche experts submitted reports concerning Roche's ODP defenses: Dr. Lowe, Dr. Harlow, Dr. Kellems, Dr. Blobel, and Mr. Sofocleous. All of these expert reports focused on Roche's ODP defenses based on the `008 or `016 patent claims. None of these expert reports mentioned ODP based on the `868 or `698 patent claims.3 Nor did any of the numerous "corrected" and supplemental reports submitted by Roche's experts address Roche's current ODP defenses based on the `868 and `698 patent claims.4 Relying on Roche's

Roche has conceded that Dr. Lowe, Roche's only expert witness at trial regarding ODP issues, never provided any opinions regarding Theory No. 4 (ODP over the `868 and `698 claims) in his expert report. (See D.I. 1022, at 2 (quoting 9/6/07 Trial Tr. at 306-307).) In a supplemental report concerning § 112 validity issues, one of Roche's experts, Dr. Kadesch, recited a conclusory, two-sentence opinion that `349 claim 7 is invalid for double patenting over `698 claim 4: "there is no significant difference between claim 7 of the `349 patent and claim 4 of the `698 patent. Therefore, claim 7 of the `349 patent is invalid for double patenting." (5/1/07 Supp. Expert Rpt. of Dr. Thomas Kadesch, at ¶ 8.) This opinion does not address any of the `868 or `698 claims that Roche now asserts as bases for ODP. (See Roche's 9/7/07 Offer of Proof, D.I. 1020, at 1.) Moreover, this unsupported opinion is not the type of clear and convincing evidence required to justify a holding of obviousness-type double patenting. 6
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failure to describe any ODP defenses based on the `868 and `698 claims either in its interrogatory responses or its expert reports, Amgen's experts did not address ODP based on the `868 and `698 claims in their rebuttal expert reports. On May 1, 2007, a month after the close of fact discovery and weeks after Roche's ODP expert reports were submitted, Roche served a fifth supplemental response to Amgen's ODP interrogatories. In these untimely interrogatory responses, Roche made cursory mention of its new theory that the asserted claims of the `933, `422 and `349 patents are invalid for ODP over certain unspecified claims of the `868 and `698 patents. Like Roche's amended affirmative defense, however, these interrogatory responses lacked any detail or any claim-by-claim comparison and failed to state any of the specifics required to establish a defense of ODP over the `868 and `698 patent claims. (D.I. 1165, Ex. D, at 60-61.) In June and July 2007, Roche's summary judgment briefs expressly referenced Roche's `008- and `016-based ODP defenses but made no mention whatsoever of any ODP defenses based on the `868 or `698 claims.5 On August 2, 2007, Roche filed its 35 U.S.C. § 282 Notice regarding its invalidity contentions. Although Roche listed the Lin `008 and Lai/Strickland `016 patents (Roche's other ODP references) in this statutorily-mandated disclosure, Roche failed to disclose the `868 and `698 patents as invalidity references. (See D.I. 799, at 4.) This again signaled Roche's intent not to pursue ODP defenses based on claims in the `868 and `698 patents. The following week, in response to this Court's Order that the parties meet prior to the final pretrial conference "to narrow the issues to be tried," (D.I. 536, at 1), Roche disclosed in the
5

See, e.g., Mem. In Supp. of Defendants' Mot. for Sum. Judgment That the Claims of PatentsIn-Suit Are Invalid for Double Patenting Over Amgen `016 Patent (D.I. 491), at 1 n.2 (noting that, in addition to Roche's ODP defense based on the `016 claims, Roche also had an additional ODP defense based on the `008 patent claims). 7

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parties' August 10, 2007 Joint Pretrial Memorandum one claim from the `868 and `698 patents as a basis for ODP: 72. Whether subject matter covered by the Asserted Claims is obvious in view of claim 1 of the `868 patent. (D.I. 807, Ex. B, at 8 (emphasis added).) Roche did not disclose any other details regarding this new ODP defense in the Joint Pretrial memorandum. On August 27, 2007, the Court granted Amgen's Motion for Summary Judgment of No Obviousness-Type Double Patenting, which disposed of most of Roche's ODP defenses based on the `008 and `016 patent claims.6 In light of this ruling, Roche filed a Pre-Trial Brief on August 31, 2007 -- the last business day before trial -- stating Roche's new desire to pursue at trial several additional ODP defenses based on claims in the `868 and `698 patents. But even that untimely disclosure failed to identify which claims of the `868 and `698 patents Roche sought to assert as a basis for ODP. Roche's pre-trial brief merely contended that the `933, `422 and `349 claims are invalid for ODP over "the claims of the `868 or `698 patents." (D.I. 919, at 34, 41, 50.) It was not until September 7, 2007 -- after the first week of trial -- that Roche first identified which claims of the `868 and `698 patents Roche now contends invalidate the other claims-in-suit for ODP. (See D.I. 1035, at 1.) These untimely disclosures do not provide any explanation of how or why Roche contends that these claims of the `868 and `698 patents render the `933, `422 and `349 claims-in-suit invalid for ODP. B. RELEVANT PROSECUTION HISTORY 1. The PTO's 1986 Restriction Requirement Required Amgen To Prosecute Dr. Lin's EPO Inventions In Multiple Applications See Electronic Order, dated Aug. 27, 2007, granting Amgen's Motion for Summary Judgment of No Obviousness-Type Double Patenting (D.I. 498). 8
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Beginning in December 1983, Amgen filed a succession of four applications to patent the path-breaking inventions of Dr. Fu-Kuen Lin relating to erythropoietin ("EPO").7 The last and most comprehensive of Dr. Lin's four initial and continuation-in-part applications, No. 06/675,298 ("the `298 application"), was filed on November 30, 1984.8 As originally filed, the `298 application was well over 100 pages, and included 60 claims and multiple tables and figures. (TX 2013.6-142 (AM-ITC 00952292-428).) The `298 application disclosed a breadth of information and teaching regarding Dr. Lin's pioneering inventions, including, among many other things, purified and isolated DNA sequences encoding human and monkey EPO, vertebrate and other cells capable of producing recombinant human EPO in abundance when grown in culture, processes for producing in vivo biologically active glycosylated recombinant EPO polypeptides as well as the polypeptides themselves, and the first pharmaceutical compositions effective for the therapeutic treatment of severely anemic patients. At the time of Dr. Lin's `298 application, none of these important inventions were in the prior art, and none of Lin's teachings were publicly available to persons of ordinary skill in the art.9 On July 3, 1986, after an initial assessment of Dr. Lin's `298 application, the PTO determined that the `298 application included claims to six different categories or "groups" of patentably distinct inventions. For the convenience of the PTO and its examination, the examiner imposed a "restriction requirement" that required Amgen to select one of the six See generally Amgen Inc. v. Chugai Pharm. Co. Ltd., 13 U.S.P.Q.2d 1737, 1746-49 (D. Mass. 1989) (summarizing events leading up to the filing of these applications). See generally D.I. 501, Ex. A (providing a visual overview of the prosecution history of Dr. Lin's patents). The patents-in-suit are filed in the record as Trial Exhibits ("TX") 1-5.
9 8 7

A "person of ordinary skill" or "ordinarily skilled artisan" in the field relevant to Dr. Lin's claimed inventions would have been a research scientist with a Ph.D. or M.D. and at least two years of postdoctoral research experience in the field of molecular biology, cellular biology, or protein expression. (Declaration of Harvey F. Lodish, Ph.D. In Support of Amgen's Bench Memorandum and Offer of Proof Regarding Obviousness-Type Double Patenting (D.I. 1164),

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invention groups for further examination in the `298 application, and to file separate applications for examination of the remaining, "non-elected" inventions: Restriction to one of the following inventions is required under 35 U.S.C. § 121: I. Claims 1-13, 16, 39-41, 47-54 and 59, drawn to polypeptide, classified in Class 260, subclass 112. II. Claims 14, 15, 17-36, 58 and 61-72, drawn to DNA, classified in Class 536, subclass 27. III. Claims 37-38, drawn to plasmid, classified in Class 435, subclass 240. IV. Claims 42-46, drawn to cells, classified in Class 435, subclass 240. V. Claims 55-57, drawn to pharmaceutical composition, classified in Class 435, subclass 177. VI. Claim 60, drawn to assay, classified in Class 435, subclass 6. .... Because these inventions are distinct for the reasons given above and have acquired a separate status in the art because of their recognized divergent subject matter, restriction for examination purposes as indicated is proper. (TX 2013.232-33 (AM-ITC 00952501-02).) The specific claims assigned to each of these restriction groups are set forth at TX 2013.103-111 (AM-ITC 00952389-97) and TX 2013.188190 (AM-ITC 00952457-58). A table organizing these original claims according to the various restriction groups to which they were assigned by the examiner is provided in the 9/26/07 Godfrey Decl. (D.I. 1165), at Ex. E. 2. Amgen Complied with the PTO's 1986 Restriction Requirement Amgen complied with the PTO's restriction requirement by selecting the claims of Group II for continued examination in the `298 application. (TX 2013.233 (AM-ITC 00952502).) The other, non-elected claims were cancelled from the `298 application so that they could be ¶ 17.) 10

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prosecuted in separate applications. (Id.) Although Amgen initially elected all of the Group II claims, which included DNA, host cell and process claims, for further prosecution in the `298 application, Amgen later cancelled the process claims after it became apparent that the PTO would not allow issuance of those claims based on In re Durden, 763 F.2d 1406 (Fed. Cir. 1985), which the PTO at the time mistakenly interpreted as prohibiting the allowance of any claim to a process that applied known process steps to a novel starting material. (See TX 2013.365 (AMITC 00952592); TX 2013.369 (AM-ITC 00952596); TX 2013.372 (AM-ITC 00952599).) On October 27, 1987, Dr. Lin's `298 application issued as the `008 patent. (TX 7.) Consistent with Amgen's election to have Group II claims examined in the `298 application, all of the `008 patent claims fall within the scope of restriction Group II. (Declaration of Harvey F. Lodish, Ph.D. In Support of Amgen Inc.'s Motion for Summary Judgment of No Obviousness-Type Double Patenting ("6/14/07 Lodish Decl.") (D.I. 502), at ¶ 25.) Prior to the issuance of the `008 patent, on October 23, 1987, Amgen filed two new applications -- Nos. 07/113,178 ("the `178 application")10 and 07/113,179 ("the `179 application")11 -- that contained claims to non-elected inventions that the PTO had required be examined separately from the `298 application. The `178 and `179 applications were filed under 37 C.F.R. § 1.60. That provision, and the associated PTO procedures, permitted Amgen to file the `178 and `179 applications by submitting a copy of the prior `298 application (as originally filed) and canceling certain of the original `298 claims that were pending in the `298 application, so that only previously non-elected claims were included in the `178 and `179 applications as filed. See M.P.E.P. § 201.06(a) (D.I. 501, Ex. P-1).12 In keeping with the 1986 restriction

10 11 12

TX 2011.3-143 (AM-ITC 000862-1002). TX 2012.3-123 (AM-ITC 000003-123). The filing fee for applications filed under 37 C.F.R. § 1.60 was calculated based on the 11

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requirement and the election of Group II in the `298 application, Amgen canceled all claims belonging to Group II, and selected only claims belonging to the non-elected restriction groups for filing in the `178 and `179 applications. The `178 application as filed contained original claims 1-13, 16, 39-41, 47-49, and 55-57, which the PTO had assigned to restriction Groups I and V. (Compare TX 2011.4-8 (AM-ITC 000863-67) with TX 2013.232 (AM-ITC 00952501).) The `179 application as filed contained original claim 1, which the PTO had assigned to restriction Group I. (Compare TX 2012.113-116 (AM-ITC 000972-75) with TX 2013.232 (AMITC 00952501).) The `178 and `179 applications are both "divisional" applications under the PTO's definition because they are "later application[s]" (than the `298 application), "carved out of a pending application" (the `298 application), containing claims to "a distinct and independent invention" (Groups I and V, not Group II), and "disclosing and claiming only subject matter disclosed in the earlier or parent application" (as 37 C.F.R. § 1.60 applications, the disclosure and claim language is identical to that in the parent `298 application). See M.P.E.P. § 201.6 (D.I. 501, Exs. P-1 and P-2). As summarized in the following diagram, the `178 and `179 applications were the first applications giving rise to the patents-in-suit filed after the PTO's 1986 restriction requirement, and all of Dr. Lin's patents-in-suit arise from one of these two applications:

number of claims in the new application (i.e., the non-canceled claims), and not on the number of claims originally filed in the parent application. M.P.E.P. § 201.06 (a) (D.I. 501, Ex. P-1). The filing fee calculation in the `178 and `179 applications makes clear that the canceled claims were not part of the `178 and `179 applications as filed. (See TX 2011.5-6 (AM-ITC 000864-65); TX 2012.117-18 (AM-ITC 000117-18).) 12

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Patent
`298 App. I: I I: 1986 Restriction Requirement Polypeptide DNA `179 App.

`008

II

Patent

`868

II

Patent

`698

II `349

III: Plasmid IV: Cells V: Pharm. Comp. VI: Assay

Patent

IV
Patent
`178 App.

`933

Patent

`422

V

I/V

During prosecution of the `178, `179, and subsequent applications leading to the patentsin-suit, Amgen canceled claims, amended claims, and added new claims. As a result, the issued claims in the patents-in-suit are not identical to the original claims filed in the `178 and `179 applications. But, importantly, all claims of the `933, `349, and `422 patents fall within the scope of the non-elected restriction groups, and none of these claims fall within the scope of restriction Group II, which was prosecuted to issuance in the `008 patent. (6/14/07 Lodish Decl. (D.I. 502), ¶¶ 26-34.) As shown in the diagram above, the `933 patent claims fall within the scope of restriction Groups I and V, the `422 patent claims fall within restriction Group V, and the `349 patent claims fall within restriction Group IV. (Id.) By contrast, the issued claims of the `868 and `698 patents fall within the scope of restriction Group II. (D.I. 568, at 2, 5.) Where appropriate, Amgen filed terminal disclaimers during prosecution to ensure that the term of any patent which contained claims that were not patentably distinct from claims in an earlier-issued patent would expire on the same date as the earlier-issued patent. The `008 patent (TX 7) issued in October 1987 and expired in October 2004. The `868 patent (TX 2) issued in 13

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August of 1995 and will expire in August of 2012. The `698 patent (TX 3) issued in April of 1997 and, because of a terminal disclaimer over the `868 patent (TX 2007.161-63 (AM-ITC 001782-84)), will also expire in August of 2012. The `933 patent (TX 1) issued in August of 1996 and will expire in August of 2013. The `422 patent (TX 5) issued in September of 1999 and, because of a terminal disclaimer over the `933 patent (TX 2009.766-67 (AM-ITC 00326768)), will also expire in August of 2013. The `349 patent (TX 4) issued in May of 1998 and will expire in May of 2015. The terms of Amgen's patents are summarized in the following diagram:

3. The PTO Repeatedly Determined That Dr. Lin's Process Inventions Are Patentably Distinct from Lin's DNA and Host Cell Inventions On multiple occasions during prosecution of Dr. Lin's `868 and `698 patents, the PTO determined that, notwithstanding the fact that they all originated from Group II in the 1986 restriction requirement, the process claims of the `868 and `698 patents are patentably distinct 14

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from (and not obvious over) Dr. Lin's DNA and host cell claims in the `008 patent. For example, at the urging of Amgen's competitor Genetics Institute, Inc. ("GI"), the PTO declared interference proceedings to determine priority as between Lin/Amgen and Fritsch/GI to various EPO-related inventions. Interference No. 102,096 ("the `096 Interference," declared on May 9, 1989) involved "[a] purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin." (TX 2013.576-78 (AM-ITC 00952797-99).)13 Interference No. 102,097 ("the `097 Interference," declared on May 9, 1989) involved a multi-step process for preparing a glycosylated polypeptide having "the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells . . . ." (TX 2012.742-44 (AM-ITC 000297-99).)14 Interference No. 102,334 ("the `334 Interference," declared on February 9, 1990) involved "[a] non-naturally occurring glycoprotein product . . . possessing the in vivo biological property of causing bone marrow cells to increase production of reticulocytes and red blood cells . . . ." (TX 2011.306-08 (AM-ITC 001140-42).)15 The fact that the PTO declared three separate interferences with three separate counts indicates that the PTO considered the DNA, process, and product inventions corresponding to those counts to be patentably distinct. By rule, each interference count must define a separate patentable invention. M.P.E.P. § 2303 (5th ed., Rev. 9, Sept. 1988) (D.I. 868, Ex. A) ("Each

13

This "DNA Count" of the `096 Interference is identical to claim 2 in Amgen's `008 patent. The PTO also designated host cell claims of Lin's `008 patent as corresponding to the `096 Interference Count. (TX 2013.578 (AM-ITC 00952799).) This "Process Count" of the `097 Interference was identical to then-pending claim 65 in Amgen's `179 application which later gave rise to Amgen's `868 and `698 patents. The full text of the `097 Process Count is set forth at TX 2012.744 (AM-ITC 000299).

14

This "Product Count" of the `334 Interference was identical to then-pending claim 76 in Amgen's `178 application which later gave rise to Amgen's `933 patent. The full text of the `334 Product Count is set forth at TX 2011.308 (AM-ITC 001142). 15

15

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count shall define a separate patentable invention.") (quoting 37 C.F.R. § 1.603); see also 37 C.F.R. § 1.601(f) (1988) (D.I. 868, Ex. B) (same). Importantly, with respect to the subject matter of these three interferences, a determination was signed by Acting Commissioner Jeffrey Samuels, as well as Group Director John Kittle and Examiner Howard Schain, stating that, while related, "the subject matter of the three interferences is deemed to be patentably distinct . . . ." (TX 2011.300 (AM-ITC 001134) (emphasis added).) Once the `097 Interference was resolved, examination of the `179 application resumed. In a 1994 Office Action, the examiner rejected the pending process claims as obvious over (and not patentably distinct from) the DNA claims of Lin's `008 patent. (TX 2012.1019 (AM-ITC 000422).) In response, Amgen demonstrated that the `008 claims and the pending process claims were patentably distinct inventions. Amgen explained to the axaminer: (1) the expression of a glycosylated EPO product having in vivo biological activity was unexpected given the state of the art at the time;16 (2) a prior ITC decision had determined that Lin's `008 claims did not extend to the process of producing EPO glycoproteins;17 and (3) the PTO's declaration of separate interference proceedings for the DNA and process counts reflected its determination that Lin's `008 claims and process claims were patentably distinct inventions. (TX 2012.1023-80 (AM-ITC 000426-36, AM-ITC 00455484-530).) The examiner likely was bound by the PTO

Indeed, Amgen had already overcome an obviousness rejection by demonstrating that the in vivo biological activity of the erythropoietin polypeptide resulting from the claimed processes was not reasonably expected by the person of ordinary skill in the art at the time. (See TX 2012.214-443 (AM-ITC 000191-211, AM-ITC 00454366-574); TX 2012.494-501 (AM-ITC 000262-69); TX 2012.526 (AM-ITC 000294).) As Amgen explained to the Patent Office during earlier prosecution of the `179 application, the ITC had determined that "the `008 patent covers articles, i.e. host cells, but not processes." (TX 2012.533 (AM-ITC 00953316).) The ITC decision made clear that, unlike Amgen's later `868 and `698 process claims, Amgen's `008 DNA and host cell claims did not provide legal protection against foreign competitors that produced recombinant erythropoietin abroad for importation into the United States. (TX 2012.533-34 (AM-ITC 00953316-17).) 16
17

16

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Board's and Acting Commissioner's prior determinations of patentable distinctiveness, but instead of relying solely on those determinations, Amgen also argued the merits that based on the uncertain and highly unpredictable state of the art in 1983-84, there was no reasonable expectation of successfully producing an in vivo biologically active EPO product according to the claimed processes. What is especially significant about Amgen's response to this ODP rejection over the `008 claims is that Amgen disclosed and directed the examiner's attention to a declaration by Dr. Arthur Sytkowski that had been submitted in European Opposition proceedings against Dr. Lin's European EPO patent. (TX 2012.1031 (AM-ITC 000434).) One of the Opponents in this proceeding was Boehringer Mannheim, Roche's predecessor-in-interest. The Sytkowski declaration set forth, in detail, various arguments as to why Dr. Lin's inventions were not patentable,18 including many of the same arguments Roche now makes in support of its allegations that the process inventions claimed in Lin's `868 and `698 patents were obvious over Lin's `008 claims. For example, the Sytkowski declaration asserts: · "It was reasonable to expect that the expression of the EPO DNA in COS and CHO cells would yield biologically active rEPO." (TX 2012.1070 (AM-ITC 00455520).) "As of 1983, what was the probability of success for the expression of biologically active recombinant EPO? That is, could one introduce exogenous DNA, such as the EPO gene, into a eukaryotic host cell and have a reasonable expectation that this gene would be expressed and that biologically active protein would be produced? The answer is unquestionably `yes'." (TX 2012.1071 (AM-ITC 00455521).) "The successful examples in the prior art pointed the way for Lin: [Genentech's patent], for example, describes the

·

·
18

For example, like Roche and GI before him, Dr. Sytkowski argued that Dr. Goldwasser's supply of purified urinary EPO to Amgen was the reason Lin succeeded and others failed to isolate EPO DNA. (See TX 2012.1060-61 (AM-ITC 00455510-11); TX 2012.1068 (AM-ITC 00455518).) 17

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production of human tissue plasminogen activator which `comprises expressing a DNA sequence from a transformed host cell . . . . Preferred host cell is a transformed E. coli strain or a mammalian cell line, especially CHO cell line'. . . . Additional examples of production of recombinant proteins in CHO cells using the methods subscribed in [Lin's] patent exist as well. Therefore, it was not only reasonable to try stable transfection and expression in CHO cells, it was the most likely way to succeed, especially if transient expression in COS cells had already yielded a biologically active compound." (TX 2012.877-78 (AM-ITC 00455527-28).) · "Amgen's inventor Dr. Lin merely followed prior art teachings and, in view of the successful experiments reported on in the prior art, must have had a reasonable expectation of success when he introduced the human EPO gene into COS cells and CHO cells in Example 7 and 10 of the contested patent, respectively, and obtained biologically active glycosylated human erythropoietin protein." (TX 2012.1078 (AM-ITC 00455528).)

After considering Amgen's detailed response to the PTO's rejection of Dr. Lin's process claims for ODP over Lin's `008 DNA and host cell claims, including the invalidity arguments made by Amgen's competitors in the Sytkowski declaration, the PTO withdrew its ODP rejection, indicating yet again that it viewed the subject matter of the process claims to be patentably distinct from the claims of the `008 patent, and issued a notice of allowability for the `868 patent. (TX 2012.1101 (AM-ITC 000455).) The PTO did not require Amgen to file a terminal disclaimer for the `868 patent over the `008 patent. After further examination, the PTO also determined that the `698 claims were allowable. (TX 2007.208-210 (AM-ITC 001829-31).) The same senior level examiner, Dr. Martinell, made the determination to allow both the `868 and `698 patents. (TX 2012.1101 (AM-ITC 000455); TX 2007.208 (AM-ITC 001829).) As with the `868 patent, the PTO did not require Amgen to file a terminal disclaimer for the `698 patent over the `008 patent.19 The `008 patent is listed as a

19

Amgen did file a terminal disclaimer of the `698 patent over the `868 patent. (TX 2007.16118

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cited reference on the face of each of the patents-in-suit, including the `868 and `698 patents. (TX 1-5.) C. THE COURT'S ODP SUMMARY JUDGMENT ORDER On August 27, 2007, this Court granted Amgen's motion for summary judgment of no obviousness-type double patenting. (See 8/27/07 Electronic Order, granting D.I. 498.) Amgen's summary judgment briefing addressed the two ODP theories that were the focus of Roche's discovery responses and expert reports, namely, ODP over the Lai/Strickland `016 patent claims (Roche's ODP "Theory No. 1") and ODP over the `008 patent claims (Roche's ODP "Theory No. 2"). Amgen did not move for summary judgment on Roche's allegations of ODP over the `868 and `698 patent claims (Roche's ODP "Theory No. 4") because those defenses had not been disclosed or developed by Roche during discovery.20 With respect to Roche's ODP defenses based on the Lai/Strickland `016 patent claims, Amgen proved in its summary judgment briefing, under both the two-way and one-way ODP tests, that the claims-in-suit are not invalid for ODP over the `016 claims. (See D.I. 499, at 1320; D.I. 676, at 12-20; D.I. 576, at 1-20.) As to Roche's ODP defenses based on the `008 claims, Amgen proved that 35 U.S.C. § 121 exempts the inventions claimed in Lin's `933, `422 and `349 patents from ODP over the DNA and host cell inventions claimed in the `008 patent. (See D.I. 499, at 8-13; D.I. 676, at 2-12.) In particular, Amgen demonstrated that: (1) the `178 and `179 applications that gave rise to the patents-in-suit were "divisional" applications "filed as a result of" the 1986 restriction requirement in the earlier `298 application; and (2) the issued claims in the `933, `422 and `349 patents maintained consonance with the non-elected invention groups in

63 (AM-ITC 001782-84).)
20

Also, Amgen did not move for summary judgment on Roche's allegations that the `868 and `698 claims are invalid for ODP over the `008 claims (Roche's ODP "Theory No. 3"). 19

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the 1986 restriction requirement. To prove consonance, Amgen demonstrated that the issued claims of the `933, `422 and `349 patents fall within non-elected invention groups of the 1986 restriction requirement (Groups I, IV and V), and do not fall within Group II -- the invention group that was elected in the `298 application and prosecuted to issuance in the `008 patent. Although the Court has not yet issued its written opinion addressing these ODP issues, the Court indicated that it agreed with the positions set forth in Amgen's summary judgment briefing.21 Roche has filed a motion for partial reconsideration of the Court's summary judgment Order, contending that the Court committed a "clear error of law" by granting summary judgment that Amgen's `349 patent claims are exempt under § 121 from ODP over the `008 patent claims. (D.I. 908.) Amgen maintains that the Court was correct to reject Roche's flawed ODP analysis on summary judgment, and Amgen has filed an opposition to Roche's motion for reconsideration. (D.I. 1000.) III. ARGUMENT A. GOVERNING LEGAL STANDARDS 1. The ODP Safe Harbor Statute: 35 U.S.C. § 121

A preliminary step in any obviousness-type double patenting analysis is to determine whether the defense is precluded under 35 U.S.C. § 121, the ODP safe harbor statute. Section 121 routinely protects patentees against ODP attacks where the Patent Office has imposed a "restriction requirement" that required the applicant to prosecute its inventions in separate applications. See Applied Materials, Inc. v. Adv. Semiconductor Materials Am., Inc., 98 F.3d 1563, 1568-69 (Fed. Cir. 1996).22 Section 121 states in pertinent part:

21

"I've ruled what I've ruled. She's [Ms. Ben-Ami] correct to assume that, to the extent you [Amgen] have argued, the restriction; I have bought that argument. She's correct to assume that." (9/4/07 Trial Tr. 35:8-11.) "A restriction requirement is made during the prosecution of a patent application at the 20

22

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If two or more independent and distinct inventions are claimed in one application, the Director may require the application to be restricted to one of the inventions. If the other invention is made the subject of a divisional application which complies with the requirements of section 120 of this title it shall be entitled to the benefit of the filing date of the original application. A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application. . . . The validity of a patent shall not be questioned for failure of the Director to require the application to be restricted to one invention. Section 121 "effects a form of estoppel that shields the [patentee] from having to prove the correctness of the restriction requirement in order to preserve the validity of the second patent." Studiengesellschaft Kohle mbH v. N. Petrochemical Co., 784 F.2d 351, 361 (Fed. Cir. 1986) (Newman, J., concurring). In so doing, § 121 "assures that the technicalities of restriction practice are not elevated from their purpose of examination convenience to a potential taint on the validity of the ensuing patents." Applied Materials, 98 F.3d at 1568.23 The final sentence of § 121 provides that the absence of a restriction requirement separating two groups of claims may not be used to argue that the claims are patentably indistinct and therefore invalid: "The validity of a patent shall not be questioned for failure of the Director to require the application to be restricted to one invention." 35 U.S.C. § 121. Section 121 immunizes a later-issued patent from an obviousness-type double patenting attack if two fundamental requirements are met: (1) the patent arises from an application that was discretion of the Commissioner to avoid granting a patent for more than one invention. . . . The restriction requirement also preserves revenue to the PTO and ensures the integrity of the PTO's classification system." Applied Materials, 98 F.3d at 1576 (Archer, J., dissenting).
23

The effect of the § 121 ODP safe harbor is summarized in the legislative history as follows: "neither of the resulting patents can be held invalid over the other merely because of their being divided in several patents." S. Rep. No. 1979, 82nd Cong., 2nd Sess. 20, 1952 U.S.C.C.A.N. 2394, 2413. 21

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filed as a result of a restriction requirement; and (2) the claims in the patent are consonant with that restriction requirement. See, e.g., Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 687-88 (Fed. Cir. 1990).24 Additionally, the patent containing the "reference" claim (i.e., the earlier-issued claim asserted as the basis for ODP) must either have issued from the application in which the restriction requirement was made, or arisen from an application filed as a result of the restriction requirement, and must not contain claims belonging to the same restriction group as the later-issued patent. As applied in the case law, Element (1) -- "filed as a result of a restriction requirement" -- is satisfied if the first application filed after the restriction requirement that gave rise to the later-issued patent contained claims drawn only to the non-elected inventions, and contained no claims to the invention elected in response to the restriction requirement. See, e.g., Gerber, 916 F.2d at 687-88. The Federal Circuit has applied § 121 to patents that issued from continuations of earlier applications filed as a result of a restriction requirement. See, e.g., Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1579-80 (Fed. Cir. 1991) (affirming § 121 protection for patent that issued from an application filed approximately three years after a restriction requirement where the application was a continuation of an earlier application filed as a result of the restriction requirement); Applied Materials, 98 F.3d at 1567-69 (affirming § 121 protection for patent that issued from an application filed approximately ten years after a restriction requirement where the application was one in a series of continuations of an earlier application filed as a result of the restriction requirement).25 Additionally, several cases have indicated that

24

The requirements for § 121 protection are discussed in detail in Amgen's summary judgment briefing. (See D.I. 499, at 10-13; D.I. 676, at 3-12.) In Applied Materials, the Federal Circuit even noted that "the history of these patents shows several refilings, amendments, and continuations-in-part," and nonetheless held that § 121 applied to preclude ODP. Id. at 1567. 22

25

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§ 121 applies to applications that are not formally designated as "divisional" applications.26 Element (2) -- "consonance" -- is satisfied if all claims in the later-issued patent fall within the scope of the non-elected restriction groups and not within the scope of the restriction group elected for prosecution in the original application. That is, the later-issued claims must not "cross the line of demarcation drawn around the invention elected in the restriction requirement." Symbol, 935 F.2d at 1579.27 New or amended claims in the later-issued patent (i.e., claims not originally present in the application filed as a result of the restriction requirement) also are entitled to the protection of § 121, provided all claims in the patent satisfy the consonance requirement. Id.28 One reason for this rule is that "[i]t is almost inevitable that some refinement of the claims will occur after restriction is ordered, since restriction often comes as a preliminary step before the examiner reaches the merits of the patent claims." Union Carbide Corp. v. Dow

See, e.g., Gerber, 916 F.2d at 684, 686-89 (applying § 121 to continuation-in-part application and finding lack of consonance); Studiengesellschaft Kohle, 784 F.2d at 353, 355-56 (stating in dicta that § 121 would have applied to application, which was a continuation-in-part); id. at 35761 (Newman, J., concurring) (agreeing that § 121 applied to application, which was a continuation-in-part, and arguing that case should be decided on § 121 grounds); Pfizer Inc. v. Teva Pharms. USA, Inc., 2007 U.S. Dist. LEXIS 20190 at *234 n.58 (D.N.J. Mar. 20, 2007) (stating in dicta that "[t]he Federal Circuit has applied § 121 to continuation-in-part applications on several occasions"); cf. Transco Prods. Inc. v. Performance Contracting, Inc., 38 F.3d 551, 556 (Fed. Cir. 1994) ("[T]he expressions `continuation,' `divisional,' and `continuation-in-part' are merely terms used for administrative convenience."). Consonance is not violated if a patent contains claims from multiple, non-elected restriction groups. Consonance is maintained so long as the claims are drawn to the non-elected inventions, and "do not cross the line of demarcation drawn around the invention elected in the restriction requirement." Symbol, 935 F.2d at 1579 (emphasis added); see also Gerber, 916 F.2d at 688 ("To gain the benefits of Section 121 . . . Gerber must have brought its case within the purview of the statute, i.e., it must have limited the claims in its divisional application to the non-elected invention or inventions.") (emphasis added). This makes sense because a patent that contains claims drawn only to the non-elected inventions, and not to the inventions elected for examination in the earlier patent, does not extend the term of patent protection for the previously elected inventions. Broadening amendments are permitted, provided consonance is maintained. See Applied Materials, 98 F.3d at 1567-69 (affirming § 121 protection notwithstanding amendments that enlarged the claims beyond their scope at the time of imposition of the restriction requirement). 23
28 27

26

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Chem. Co., 619 F. Supp. 1036, 1060 (D. Del. 1985). Testimony from technical experts may be relevant to the consonance determination. See, e.g., Symbol, 935 F.2d at 1580 (affirming determination of consonance and § 121 protection based on declaration of technical expert). During prosecution, "[n]oncompliance with the consonance requirement is normally detected by the PTO examiner." Gerber, 916 F.2d at 685. When assessing whether claims are consonant with the non-elected invention groups in a restriction requirement, the proper point of reference is the actual restriction groupings imposed by the examiner (i.e., the substance of the claims in each restriction group), and not the examiner's written descriptions thereof. Texas Instruments Inc. v. ITC, 988 F.2d 1165, 1179 (Fed. Cir. 1993); see also Applied Materials, Inc. v. Adv. Semiconductor Materials Am., Inc., 1994 U.S. Dist. LEXIS 7810, at *28-34 (N.D. Cal. Apr. 26, 1994) ("[T]he line of demarcation and its attendant consonance requirement are controlled by the actual claim groupings made by the Examiner, [not] by the Examiner's subsequent explanatory comments."), aff'd, 98 F.3d 1563 (Fed. Cir. 1996). Where there are multiple restriction requirements, the relevant restriction requirement for purposes of assessing § 121 protection is the one that first required the applicant to prosecute the later-issued claim separately from the claim asserted as the basis for ODP. Cf. Geneva Pharms., Inc. v. GlaxoSmithKline, PLC, 349 F.3d 1373, 1378 (Fed. Cir. 2003) ("Thus, if the [later] patents and the [earlier] patent trace their lineage back to a common parent which was subject to a restriction requirement, then § 121 intervenes to prevent a non-statutory double patenting rejection."). The applicability of § 121 is a question of law. Bristol-Myers Squibb Co. v. Pharmachemie B.V., 361 F.3d 1343, 1348 n.1 (Fed. Cir. 2004); Applied Materials, 98 F.3d at 1567. As such, the § 121 issue is frequently decided on summary judgment. See, e.g., Gerber, 916 F.2d at 685; Bristol-Myers Squibb Co. v. Pharmachemie B.V., No. 01-cv-3751, 2002 U.S.

24

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Dist. LEXIS 27230 (D.N.J. July 25, 2002); Union Carbide, 619 F. Supp. at 1055-60. Although the heavy burden of proving obviousness-type double patenting remains with the party challenging the validity of the patent at all times (i.e., it never