Source: http://ny.findacase.com/research/wfrmDocViewer.aspx/xq/fac.19960626_0000419.SNY.htm/qx
Timestamp: 2017-04-24 17:26:51
Document Index: 36315759

Matched Legal Cases: ['§ 112', '§ 112', '§ 112', '§ 112', '§ 112', '§ 112', '§ 112', '§ 112', '§ 112', '§ 282', '§ 102', '§ 112', '§ 112', '§ 112']

| GENENTECH, INC. v. NOVO NORDISK A/S
GENENTECH, INC. v. NOVO NORDISK A/S
GENENTECH, INC., Plaintiff, against NOVO NORDISK A/S, NOVO NORDISK OF NORTH AMERICA, INC., AND NOVO NORDISK PHARMACEUTICALS, INC., Defendants.
FINDINGS OF FACT AND CONCLUSIONS OF LAW I. PRIOR PROCEEDINGS 1. This consolidated action began on November 30, 1994. On May 12, 1995, Genentech Inc. ("Genentech") moved for a temporary restraining order and a preliminary injunction to enjoin Novo Nordisk A/S, Novo Nordisk of North America, Inc., and Novo Nordisk Pharmaceuticals Inc.'s (collectively, "Novo's") importation, marketing and sale of Norditropin (R) in the United States based on Genentech's U.S. Patent No. 4,601,980 ("the '980 patent"). An evidentiary hearing was held before this court from May 22, 1995 until June 14, 1995. 2. On June 14, 1995, this court issued a temporary restraining order to preserve the status quo pending the Court's ruling on Genentech's motion for a preliminary injunction. On June 28, 1995, this motion was granted.
3. Then, on February 26, 1996, the Federal Circuit issued its decision vacating the preliminary injunction and remanding the action to this court. See Novo Nordisk of North America, Inc. v. Genentech, Inc., 77 F.3d 1364 (Fed. Cir. 1996). The Federal Circuit found that this court had applied an erroneous claim construction in determining that Genentech had established a likelihood of success on the merits of its patent infringement claim. Specifically, the Federal Circuit held that Claim 2 of the '980 patent, read in light of the specification, covers "only a method of directly expressing human growth hormone and does not encompass a cleavable fusion expression process." Id. at 1369. 4. The Federal Circuit did not analyze this court's findings and conclusions on the issues of validity, irreparable harm, balancing of equities, and public interest. Rather, the Federal Circuit set these conclusions aside because all were premised on an erroneous finding of infringement. Id. at 1371. 5. On March 21, 1996, Genentech again moved for a preliminary injunction prohibiting Novo from marketing and selling Norditropin (R) in the United States -- this time based on Novo's alleged infringement of U.S. Patent No. 5,424,199 ("the '199 patent"). A hearing on this motion was held from May 8, 1996 through May 23, 1996, and included concurrent testimony and evidence on Novo's motion to dismiss in Genentech, Inc. v. Novo Nordisk A/S, et al., 96 Civ. 1755 (CBM), Genentech's separate action relating to the '199 patent. The court now addresses this motion.
II. THE ISSUANCE AND HISTORY OF THE '199 Patent 6. The '199 patent was not before this court at the time of Genentech's original motion for a preliminary injunction because it did not issue until June 13, 1995 (GNE 200), the day the evidentiary hearing concluded, and the day before the temporary restraining order was issued.
7. The '199 patent arises out of the same pioneering invention as, and shares the specification of the '980 patent and the other patents which issued on the basis of the original Goeddel-Heyneker application filed July 5, 1979 (FF 58; 96 Tr. 515-516, Peet). The sole '199 patent claim, however, explicitly covers a cleavable fusion expression process. Novo has conceded this. (96 Tr. 1283, Villa-Komaroff). This claim reads as follows: 1. A method of producing a protein consisting essentially of amino acids 1-191 of human growth hormone comprising: (a) expressing in a transformant bacterium, DNA coding for a human growth hormone conjugate protein, which conjugate protein consists essentially of amino acids 1-191 of human growth hormone as set forth in combined FIGS. 1 and 3 unaccompanied by the leader sequence of human growth hormone or other extraneous protein bound thereto and an additional amino acid sequence which is specifically cleavable by enzymatic action, and (b) cleaving extracellularly said conjugate protein by enzymatic action to produce said protein consisting essentially of amino acids 1-191 of human growth hormone. 8. A patent applicant may apply for and obtain a series of patents based on the same application (96 Tr. 392, Peet). It is common practice for the applicant to obtain a series of different claims in separate patents covering different specific embodiments until satisfied that the issued claims provide coverage for the full scope of the invention disclosed in the specification (96 Tr. 392, Peet). This is what Genentech did with the '199 patent (96 Tr. 392-93, Peet). III. LIKELIHOOD OF SUCCESS ON THE MERITS A. Claim Interpretation--The Scope Of Claim 1 Of The '199 Patent 9. The interpretation and construction of a patent claim, which define the scope of the patentee's rights under the patent, is a matter of law to be determined exclusively by the court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 970-971, (Fed. Cir. 1995) (en banc), aff'd, U.S. , 134 L. Ed. 2d 577, 116 S. Ct. 1384 (1996). To determine the meaning of claims, courts look to the claim language, the specification, and the prosecution history. See, e.g., Minnesota Mining and Manufacturing Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1576-77 (Fed. Cir. 1992). The prosecution history "is of primary significance in understanding the claims" because it provides an "undisputed public record" of the proceedings in the Patent and Trademark Office. Markman, 52 F.3d at 980. Additionally, claims should be interpreted as "those skilled in the art would interpret the claims." Id. 10. The parties agree that Claim 1 of the '199 patent covers a cleavable fusion expression process. However, Novo raised two issues regarding claim interpretation: (1) whether the term "DNA" and the reference to Figures 1 and 3 in the claim exclude the of genomic DNA from the claim, and (2) whether the claim is a "means plus function" claim, therefore covering only the use of trypsin and the amino acid extensions recognized by trypsin and their "equivalents." For the reasons set forth below, the court finds that (1) the claim does not exclude genomic DNA and (2) enzymatic action is a generic term not limited to trypsin and its "equivalents" and the amino add sequence is simply one which is specifically cleavable by the enzyme of choice. 1. Claim 1 Of The '199 Patent Contains No Limitation For The Source Of DNA Coding For Human Growth Hormone 11. The court rejects Novo's argument that Claim 1 of the '199 patent should be construed to contain a limitation on the source of the DNA utilized in the claimed process. No such limitation appears in the language of the claim (96 Tr. 396-397, Peet). Moreover, it is clear from the '199 patent prosecution history that both the Examiner and Genentech stated that the source of the DNA coding for human growth hormone was irrelevant and could include chemically synthesized DNA, cDNA or genomic DNA (GNE 201, pp. 83, 91). Indeed, this issue arose during prosecution of the '199 patent. The Examiner stated specifically his understanding that the DNA was generic and would include genomic DNA (GNE 201, p. 83). In response to a specific inquiry from the Examiner, Genentech stated that the source of the DNA was not critical and "need not be recited in the claims." (GNE 201, p. 91). Thus, the file history explicitly states that the claim of the '199 patent contained no limitation as to the source of the DNA, and can include genomic DNA (96 Tr. 396, Peet). 12. Novo also argues that the claim language "which conjugate protein consists essentially of amino acids 1-191 of human growth hormone as set forth in combined FIGS. 1 and 3" requires the use of semi-synthetic DNA, i.e., a combination of synthetic DNA and cDNA, because the Figures show the preferred semi-synthetic DNA. Novo's argument, however, fails as a matter of simple grammatical construction. First, the phrase is set off by a comma from the DNA portion of the claim, indicating that the phrase modifies the conjugate protein, not the DNA. Second, Figures 1 and 3 show both a DNA sequence and an amino acid sequence. The claim language requires only that the hGH component of the conjugate protein be the amino acid sequence 1-191 disclosed in the referenced Figures. It does not require the particular example of the DNA for amino acids 1-191. Thus, the reference to the Figures has no bearing on the source of the DNA. The phrase relates only to the amino acid sequence. 13. Novo also argues that because the specification does not explicitly mention it, genomic DNA cannot be within the claim's scope (96 Tr. 1139, Villa-Komaroff). This argument is without merit. First, the claim language clearly does not require a particular source of DNA, as compared, for example, to the '832 patent, which does require a particular source, namely a combination of synthetic DNA and cDNA (NN 200). Second, although the specification refers to synthetic DNA and cDNA, Novo has conceded previously that everything in the specification is not necessarily in a claim (95 Tr. 1561, 1667-1668 Rzucidlo). The restriction requirement early in the prosecution of the parent '832 patent case distinguished as classes of inventions the use of semi-synthetic DNA to code for a protein (i.e., the '832 patent) and the methods of making hGH (Pl. Ex. 56; 95 Tr. 1322-1324, 1667-1668, Rzucidlo)). Third, the prosecution history is clear that the claim is generic as to the source of DNA (GNE 201; pp. 83, 91; 96 Tr. 394-96, Peet). 14. Finally, the court has considered Novo's argument that because it was not known whether the genomic DNA coding for amino acids 1-23 was without introns and, therefore, useful,
the claim cannot include genomic DNA. The court finds this argument irrelevant. Methods to determine whether a genomic DNA sequence contained introns were known by 1979 (96 Tr. 1308-1311, Villa-Komaroff). Moreover, generic language in a claim can cover future improvements. Bio-Technology General Corp. v. Genentech, Inc., 80 F.3d 1553, 1559 (Fed. Cir. 1996). 15. Therefore, the term "DNA coding for human growth hormone" in Claim 1 may include chemically synthesized DNA, cDNA, genomic DNA or any combination thereof. Furthermore, the claim's reference to "FIGS. 1 and 3" describes the amino acid sequence of the hGH component of the conjugate protein and, therefore, does not limit the source of the DNA. 2. Claim 1 Of The '199 Patent Is Not A "Means Plus Function" Claim 16. Novo next argues that because the DNA coding for the conjugate protein is described in part by what it does (encodes the conjugate), the claim is a "means plus function" claim under 35 U.S.C. § 112(6). Novo then argues that because its process uses a different (and allegedly nonequivalent) amino extension and enzyme, it does not infringe. The court finds this claim characterization to be inconsistent with the claim, the specification and the prosecution history. 17. A "means plus function" claim is one in which a critical element is drafted so generally (as a "means for" or a "step for" performing a function) that the words alone cover all the means or methods for performing that function. Jonsson v. Stanley Works, 903 F.2d 812, 819 (Fed. Cir. 1990). However, not every claim including functional language is subject to § 112(6) analysis. See, AMP, Inc. v. Fujitsu Microelectronics, Inc., 853 F. Supp. 808 (M.D.Pa. 1994) (the specific means language in the claim "'bus solder tail means' rather than just any means to accomplish the function" found not to trigger the application of § 112(6)). Even when one of the elements is recited in a claim using "means plus function" language, 35 U.S.C. § 112(6) applies only to that element, and not to the entire claim. Johnston v. IVAC Corp., 885 F.2d 1574, 1580 (Fed. Cir. 1989). Claim 1 of the '199 patent is not a "means plus function" claim (96 Tr. 428-429, Peet). First, it does not contain the language that traditionally has been used in such claims. Second, the claim does not cover all means of encoding hGH but rather recites the required material--DNA. As the file history explains, the source of the material is not critical and is not limited, just as the source of the other starting materials are not limited (GNE 201, p. 91). Third, the claim covers only one of several possible processes for expressing human growth hormone--cleavable fusion. 18. The specification generally discloses the enzymes for performing extracellular cleavage. The '199 patent (col. 7, 1. 57-59) identifies trypsin by example (GNE 200). Similarly, the file history makes clear that both Genentech and the Examiner stated that Claim 1 covered enzymes generally (GNE 201, pp. 181, 194). In an office action dated July 9, 1993, the Examiner proposed to allow a claim limiting the enzyme to trypsin (Id. at 181). In response, Genentech stated that "trypsin must be regarded as a mere example of various enzymes that would be available in order to cleave the additional amino acids in the conjugate so as to give the 191 human growth hormone product after such cleavage" (Id. at 194). Genentech provided the Examiner with evidence showing not only the existence of many such enzymes, but also that those skilled in the art knew how to use them to effect specific cleavage (Id. at 156-162). Following Genentech's submission, the Examiner allowed the claim without the proposed limitation (Id. at 210-211). Thus, the claim cannot be reasonably construed as a "means plus function" claim as Novo suggests. 19. The cases relied upon by Novo to establish that Claim 1 of the '199 patent should be construed as a "means plus function" claim are distinguishable. Ex parte Maizel, 27 U.S.P.Q.2D (BNA) 1662 (Bd. Pat. App. 1993), the Board analogized the language "biologically functional equivalent thereof" to "means plus function" language. Unlike the instant case, neither the DNA nor the protein was defined. In the '199 patent, the end product, 1-191 hGH, is a specific amino acid sequence. Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993) did not involve 35 U.S.C. § 112(6); rather, the Court held that the patent claim at issue failed to meet the written description requirement of 35 U.S.C. § 112(1). Moreover, Fiers is clearly distinguishable because the patent claimed DNA whereas in the present case, the claim is to a method of making the protein. Likewise, Genentech, Inc. v. Wellcome Found. Ltd., 29 F.3d 1555 (Fed. Cir. 1994) is inapposite. Genentech also involved 33 U.S.C. § 112(1), not 33 U.S.C. § 112(6). 20. Moreover, even if Novo is correct, the designation of Claim 1 of the '199 patent as a "means plus function" claim would be of little help to Novo. 35 U.S.C. § 112(6) provides that a "means plus function" claim "shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof." As shown in more detail below, Novo's process for manufacturing hGH clearly uses equivalents to the enzymes and amino acid cleavage sites disclosed in the specification. B. Novo's Infringement Of The '199 Patent 21. The determination of infringement is a two-step process. First, the language of the claims must be interpreted; second, the accused process must be compared to the interpreted claim language. Read Corp. v. Portec, Inc., 970 F.2d 816, 821 (Fed. Cir. 1992) (citation omitted). In light of the language of Claim 1 of the '199 patent and Novo's Norditropin (R)'s process explained below, the court concludes that Genentech has shown a substantial likelihood of success on its infringement claim. 22. First, Novo's expert agreed that if the claim included genomic DNA and was not limited to particular enzymes, then Novo infringes (96 Tr. 1270-71, Villa-Komaroff). Thus, the issues to be decided at this juncture are narrow. Since Genentech has made a substantial showing that "DNA" may include genomic DNA and the enzyme for cleavage is not limited, it follows that Genentech has made a substantial showing of infringement. 23. In making the accused product Norditropin (R), Novo utilizes cDNA encoding amino acids 24-191 of hGH (96 Tr. 96-97, 106-107, Falkinham, 95 Tr. 581, Dalboge). Novo utilizes a genomic DNA fragment encoding amino acids 1-23 of human growth hormone which does not contain introns (96 Tr. 98-100, Falkinham; 95 Tr. 621-622, Dalboge). The genomic DNA is interchangeable with synthetic DNA (96 Tr. 172-174, Falkinham; 96 Tr. 395-397, Peet; 96 Tr. 1312, Villa-Komaroff). In addition, Novo chemically synthesizes nucleotides coding for an additional amino acid sequence [TEXT REDACTED BY THE COURT] which is specifically cleavable by enzymatic action (96 Tr. 95-104, Falkinham). The three pieces--cDNA, genomic DNA, and chemically synthesized DNA--code for a conjugate protein (96 Tr. 133-137, Falkinham; 95 Tr. 1353-1356, 1360 Rzucidlo; GNE 210). This DNA is introduced into a plasmid (Def. Ex. 72, 126, 95 Tr. 128-146, Falkinham; 95 Tr. 617-23, Dalboge). 24. Novo next places the recombinant plasmid in a bacterial host, E. coli, to express DNA coding for the conjugate protein [TEXT REDACTED BY THE COURT] hGH (95 Tr. 135-36, Falkinham). 25. Following the expression of DNA coding for conjugate protein [TEXT REDACTED BY THE COURT] -hGH, the bacterial host has within it the conjugate protein [TEXT REDACTED BY THE COURT] -hGH (95 Tr. 137-138, 96 Tr. 104, Falkinham). Novo then conducts an isolation and purification process, during which Novo utilizes enzymatic action to cleave, outside of the cell, the [TEXT REDACTED BY THE COURT] extension, using an enzyme called [TEXT REDACTED BY THE COURT] (95 Tr. 139-140, 96 Tr. 137, 139-145, Falkinham; GNE 211). After cleaving the [TEXT REDACTED BY THE COURT], Novo is left with amino adds 1-191 of human growth hormone (Id.) 26. Based on its proposed claim construction, Novo argues that its process for manufacturing Norditropin (R) does not infringe Claim 1 of the '199 patent because it uses genomic DNA, rather than synthetic DNA, for a certain portion of its DNA sequence, and because it uses a different cleavage site and [TEXT REDACTED BY THE COURT], rather than trypsin, for cleavage. However, as shown above, Claim 1 of the '199 patent contains no limitations with respect to either the source of the DNA or the enzymes utilized in the cleavage process and Novo's [TEXT REDACTED BY THE COURT] is specifically cleavable. Therefore, Novo's argument fails. 27. Moreover, even if Novo is correct in characterizing Claim 1 of the '199 patent as a "means plus function" claim, Genentech has made a substantial showing that Novo nonetheless literally infringes each and every element of the claim. Novo in its brief states that the alleged "means plus function" nature of the claim only limits the type of enzyme and amino extension which can be used. Novo did not argue that section 112(6) limited the source of the DNA--thus, this issue is not before the court. In any event, the genomic and synthetic DNA encoding amino acids 1-23 of hGH are interchangeable (see, supra). The enzyme [TEXT REDACTED BY THE COURT] is equivalent to trypsin for purposes of the process of Claim 1 of the '199 patent (GNE 201, p. 158; 96 Tr. 167-170, Falkinham; 96 Tr. 347-349, Ravetch). The [TEXT REDACTED BY THE COURT] extension of Novo's conjugate is similarly equivalent to the disclosed arg-arg or lys-lys cleavage sites taught in the '199 patent. In both cases, the sequences were chosen because the enzyme would specifically cleave them and, in fact, both sequences contain [TEXT REDACTED BY THE COURT], a choice [TEXT REDACTED BY THE COURT] (see, infra at p. 23). Therefore, even if Claim 1 is construed as a "means plus function" claim, Novo does not avoid a finding of literal infringement. See Texas Instruments, Inc. v. United States Trade Commission, 805 F.2d 1558, 1571 (Fed. Cir. 1986). 28. Novo contends that its process involves various purported improvements over the process of the '199 patent, such as how to tailor genomic DNA and the specific amino extension and cleavage enzyme (96 Tr. 1127, 1149, 1201, Villa-Komaroff). Assuming that the Novo process may employ improvements, Genentech still enjoys a likelihood of success on the merits of its claim that Novo's improved process nonetheless infringes. It is hornbook law that the development of patentable improvements to a process does not avoid infringing a dominant patent. See Bio-Technology, 80 F.3d at 1559-60; Atlas Powder Co. v. E. I. Du Pont de Nemours & Co., 750 F.2d 1569, 1580 (Fed. Cir. 1984). Furthermore, as the Federal Circuit has held "'an embellishment' made possible by technological advances may not permit an accused device to escape 'the web of infringement.'" Datascope Corp. v. SMEC, Inc., 776 F.2d 320, 326 (Fed. Cir. 1985), cert. denied, 493 U.S. 1024, 107 L. Ed. 2d 747, 110 S. Ct. 729 (1990). 29. Based on the foregoing, Genentech has satisfied the requirements necessary to entitle it to a preliminary injunction. Genentech's evidence strongly supports its claim that Novo's process for making hGH literally infringes Claim 1 of the '199 patent. Novo's cultured bacterial transformants will express DNA coding for a hGH conjugate protein as specified in Claim 1 because its DNA sequence codes for amino adds 1-191 of hGH and an additional amino acid sequence which is specifically cleavable by enzymatic action (95 Tr. 608-609, Dalboge). Following expression, Novo cleaves, outside of the cell, the hGH conjugate protein to produce amino acids 1-191 of hGH (95 Tr. 141-143, 96 Tr. 137, Falkinham; 95 Tr. 610, Dalboge; GNE 210). C. Genentech Did Not Disclaim Cleavable Fusion Expression 30. Finally, Novo raises the issue of "prosecution history estoppel" -- i.e., whether by limiting Claim 2 of the '980 patent claim to direct expression, Genentech forever surrendered its right to claim cleavable fusion expression in the '199 patent. Novo's argument is specious. It is routine practice to accept certain claims which the Patent Office indicates are allowable and to continue the examination process with continuation applications to seek further claims (96 Tr. 412-413, Peet). No argument or amendment was made which forever precluded Genentech from seeking coverage of the cleavable fusion expression embodiment taught in the patent (96 Tr. 392-393, Peet). 31. The Federal Circuit decision, which held that the language used in Genentech's '980 patent claimed only direct expression, does not prevent Genentech from prevailing on the instant claim. Novo, 77 F.3d at 1369-70. In fact, the Court's statement that the patent teaches cleavable fusion expression, but did not claim it, suggests that a further application to this alternative embodiment is proper. Id. at 1369. 32. Finally, Novo's cited cases do not suggest another result. This is not a case where applicant narrowed his claim during prosecution and then sought broader coverage under the doctrine of equivalents. See, Mark I Marketing Corp. v. R.R. Donnelley & Sons Co., 66 F.3d 285, 291 (Fed. Cir. 1995), cert. denied, U.S. , 133 L. Ed. 2d 847, 116 S. Ct. 917 (1996). Nor is this a case where applicants declared that certain subject matter did not work in order to achieve allowance of claims and later sought to cover the supposedly unworkable subject matter. Texas Instruments Inc. v. United States International Trade Commission, 988 F.2d 1165, 1173-75 (Fed. Cir. 1993). Genentech only argued that uncleavable hGH conjugates did not work (95 Tr. 1907-1908, Falkinham; 96 Tr. 406-407; 415-416, Peet). Nor is this a case where the inventor defined a term as limited to a single embodiment and was later held to that definition. Abtox, Inc. v. Exitron Corp., 899 F. Supp. 775, 780 (D. Mass. 1995). 33. Thus, the prosecution history of the '980 patent, as interpreted by the Federal Circuit, did not preclude Genentech from seeking claims to cleavable fusion expression in the '199 patent. As explained above, the court finds that there is a strong likelihood that Genentech win prevail on the merits of its infringement claim. D. Validity Of The '199 Patent 34. The '199 patent is presumed valid under 35 U.S.C. § 282. Genentech's likelihood of success must be determined in the context of Novo's ultimate burden to establish invalidity by clear and convincing proof Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1570 (Fed. Cir. 1986). That is, to be entitled to injunctive relief, Genentech must show that it is likely that Novo will not prove invalidity by clear and convincing evidence. Genentech has met this burden. 35. The burden is on Novo to come forward with an affirmative defense to the "validity of the patent. Roper Corp., v. Litton Systems, Inc., 757 F.2d 1266, 1270 (Fed Cir. 1985); New England Braiding Co., Inc. v. A.W. Chesterton Co., 970 F.2d 878, 882 (Fed. Cir. 1992). Novo did not challenge the validity of the '199 patent under 35 U.S.C. § 102 and/or 103. Novo's sole challenge to validity is based on 35 U.S.C. § 112(1)--purported lack of enablement and lack of written description or support. 36. In Novo, the Federal Circuit held that the '980 patent specification contains support for the production of hGH by "cleavable fusion" expression: The specification teaches, for example, that the invention allows the "expression of either the intended product absent extraneous conjugated protein [i.e., by direct expression], or intended product conjugated to but specifically cleavable from extraneous protein [i.e., by cleavable fusion expression]." Col. 7, 11, 48-51. 77 F.3d at 1369. The Federal Circuit never determined that the specification of the '980 patent did not contain sufficient teachings to enable one skilled in the art to utilize a cleavable fusion expression process to make hGH. Rather, the Federal Circuit acknowledged the teachings of the patent specification, and found it unnecessary to determine whether these teachings were sufficient to satisfy the requirements of 35 U.S.C. § 112. 37. Moreover, the Federal Circuit noted that a patentee may claim something narrower than the full scope of the invention taught by the specification: While claims are to be interpreted in light of the specification, all that appears in the specification is not necessarily within the scope of the claims and thus entitled to protection. What is not claimed, even though disclosed as part of the "invention," cannot be enjoined. Id. at 1369 38. Novo's 35 U.S.C. § 112(1) challenge raises several related arguments on invalidity. First, Novo contends that Novo is the "law of the case" and establishes lack of "support." Second, Novo argues that the '199 patent does not contain enough information for one skilled in the art to practice cleavable fusion hGH expression without "undue experimentation." Finally, Novo contends that the '199 patent lacks an adequate written description to show that the inventors were in possession of the invention of cleavable fusion hGH expression at the time of filing; thus, Novo argues that the '199 patent represents an "incomplete conception." These arguments are legally and factually incorrect. 1. Novo's Law Of The Case Argument Is Without Merit 39. The "law of the case" doctrine applies to legal questions determined on appeal in the same case. Arizona v. California, 460 U.S. 605, 75 L. Ed. 2d 318, 103 S. Ct. 1382 (1983). Here, the only legal question decided by the Federal Circuit in the prior appeal concerned the interpretation of Claim 2 of the '980 patent. Whether a patent specification contains "support" for claim language (i.e., whether the specification provides a sufficient written description or enablement) includes questions of fact. In re Alton, 76 F.3d 1168, 1171-72 (Fed. Cir. 1996) ("the issue of whether a patent specification adequately describes the subject matter claimed is a question of fact") (citation omitted); Novo, 77 F.3d at 1371 (the Federal Circuit stated that determining whether a patent specification was enabling would require "resolution of factual questions"). 40. Moreover, the "law of the case" is not to be applied in draconian fashion from an appeal in a preliminary injunction setting.
Generally, rulings on tentative and extraordinary relief (such as preliminary injunctions) do not trigger "law of the case" consequences. This is because such rulings represent, by definition, a preliminary rather than final adjudication on the merits. See University of Texas v. Camenisch, 451 U.S. 390, 395, 68 L. Ed. 2d 175, 101 S. Ct. 1830 (1981); Goodheart Clothing Co., Inc. v. Laura Goodman Enters., Inc., 962 F.2d 268, 274 (2d Cir. 1992); Consumers Union of United States, Inc. v. New Regina Corp., 664 F. Supp. 753, 760 (S.D.N.Y. 1987). 41. Novo's argument is premised on the statement by the Federal Circuit that the "broad reading of Claim 2" of the '980 patent was not supported by the specification and prosecution history. Novo overreaches when it attempts to transform the Court's statement into one conclusively determining whether there is support for a new and different claim in another patent. The Court did not conclusively address the written description or enablement for enzymatic cleavable fusion expression. Novo, 77 F.3d at 1364. A close and fair reading of the Federal Circuit's decision shows that the Court relied upon the specification only for the determination that the phrase "unaccompanied by ...bound thereto" was defined by the specification as direct expression. Id. at 1369. The Court, on the issue of whether the specification otherwise described cleavable fusion expression, stated that the '980 (and thus the '199) patent ...