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2008-1248 lanitell ~ates arourt of ,Appeals for the 1I1elleral arirruit ARlAD PHARMACEUTICALS, INC., MASSACHUSETTS INSTITUTE OF TECHNOLOGY, THE WHITEHEAD INSTITUTE FOR BIOMEDICAL RESEARCH, AND THE PRESIDENT AND FELLOWS OF HARVARD COLLEGE, .

  1. 2008-1248 lanitell ~ates arourt of ,Appeals for the 1I1elleral arirruit • ARlAD PHARMACEUTICALS, INC., MASSACHUSETTS INSTITUTE OF TECHNOLOGY, THE WHITEHEAD INSTITUTE FOR BIOMEDICAL RESEARCH, AND THE PRESIDENT AND FELLOWS OF HARVARD COLLEGE, . Plaintiffs-Appellees, v. ELI LILL Y & COMPANY, Defendant-Appellant. Appeal from the United States District Court for the District of Massachusetts in Case No. 02-CV-11280, Judge Rya W Zobel BRIEF OF AMICUS CURIAE NOVOZYMES AlS IN SUPPORT OF PETITION FOR REHEARING EN BANe KENNETH 1. BURCHFIEL SUGHRUE MION, PLLC 2100 Pennsylvania Ave., N.W, Suite 800 Washington, D.C. 20037 (202) 293-7060 -and- JOHN T. CALLAHAN SUGHRUE MION, PLLC 2100 Pennsylvania Ave., N.W. Suite 800 Washington, D.C. 20037 (202) 293-7060 June 16, 2009 (202) 783-7288 * (888) 277-3259 223450 ., COUNSEL PRESS, LLC

  2. CERTIFICATE OF INTEREST Counsel for amicus Novozymes A/S certifies the following: 1. The full name of every party or amicus represented by me is: Novozymes A/S 2. The name of the real party in interest (if the party named in the caption is not the real party in interest) represented by me is: Novozymes A/S 3. All parent corporations and any publicly held companies that own 10 percent or more of the stock of the party or amicus curiae represented by me are: None 4. [X] There is no such corporation as listed in paragraph 3. 5. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are t expected to appear in this court are: SUGHRUE MION, PLLC Kenneth J. Burchfiel John T. Callahan Kenneth J. Burchfiel June 16, 2009

  3. TABLE OF CONTENTS .i CERTIFICATE OF INTEREST ................................................................................ TABLE OF AUTHORITIES ................................................................................... iii INTEREST OF THE AMICUS CURIAE ................................................................. 1 ARGUMENT ............................................................................................................. 2 CONCLUSION .......................................................................................................... 7 11

  4. TABLE OF AUTHORITIES CASES Page(s) Carnegie Mellon Univ. v. Hoffman-La Roche, Inc., 541 F.3d 1115 (Fed. Cir. 2008) ............................................................ 3 Enzo Biochem, Inc v. Gen-Probe, Inc., 296 F.3d 1316, reh 'g en banc denied, 42 Fed. Appx. 439 (Fed. Cir. 2002) ................................................. 2, 3 Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993) .............................................. 3 In reKoller, 613 F.2d 819,823 (C.C.P.A. 1980) ........................................... 2 In re Lukach, 442 F.2d 967 (C.C.P.A. 1971) .................................................. 4 In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967) ................................................. 3 University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) ................................................... passim Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991) ......................... 2 In re Wright, 866 F.2d 422 (Fed. Cir. 1989) ................................................... 2 iii

  5. INTEREST OF THE AMICUS CURIAE Novozymes A/S is a world leader in bioinnovation, specializing in the discovery and production of enzymes used in industrial processes, in areas as diverse as removing trans-fats in food and advancing biofue1s. With over 700 products used in 130 countries, and over 6,000 patents in the United States and abroad, Novozymes recognizes the critical role of patents in fostering and rewarding bioinnovation. Broad patent coverage is essential to provide adequate protection against "designing around" by competitors who are easily able to make insubstantial changes in patented biomolecules, avoiding the scope of narrow claims while obtaining the benefit of valuable biotechnology inventions. The written description doctrine developed under University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) imposes a severe burden on biotechnology innovators such as Novozymes, because it frequently limits claim scope that can be obtained in the United States and affords little protection against design around by competitors. For these reasons, Novozymes supports the petition for rehearing en bane, and urges the Court to restore the written description requirement to its original and proper purpose, which is whether the claims find support in the specification, 1

  6. such as in the priority context or when a claim is added or amended during prosecution. ARGUMENT Novozymes agrees with Petitioners that the Court should grant en banc review of the panel decision, and eliminate the confusion of enablement with written description engendered by University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997). Amicus agrees that there is a "separate" requirement for written description of an invention in § 112, first paragraph, but submits that written description only requires that the claims find support in the specification, such as in the priority context or when a claim is added or amended during prosecution. Importantly, "original claims constitute their own description. Later added claims of similar scope and wording are described thereby." In re Koller, 613 F.2d 819, 823 (C.C.P.A. 1980). "The question raised by these situations is most often phrased as whether the application provides 'adequate support' for the claim(s) at issue; it has also been analyzed in terms of 'new matter' under 35 U.S.C. §132." Enzo Biochem, Inc. v. Gen-Probe, Inc., 42 Fed. Appx. 439, 448 (Fed. Cir. 2002), reh 'g en banc denied (Rader, J. dissenting) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1560 (Fed. Cir. 1991)); In re Wright, 866 F.2d 422,424 (Fed. Cir. 1989) ("When the scope of a claim has been changed by amendment in 2

  7. such a way as to justify an assertion that it is directed to a different invention than was the original claim, it is proper to inquire whether the newly claimed subject matter was described in the patent application when filed as the invention of the applicant. That is the essence of the so-called 'description requirement' of § 112, first paragraph."); Enzo Biochem, supra, 42 Fed. Appx. at 448 (Fed. Cir. 2002) (Rader, J. dissenting). Accordingly, amicus considers that this Court should restore the law of written description to the principles applied in In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967) and eliminate the "super-enablement" standard imposed under Eli Lilly and subsequent decisions. Under the bright-line test of Eli Lilly, as interpreted and applied by the United States Patent and Trademark Office, biotechnology companies are uniquely disadvantaged by the requirement of "a precise definition, such as by structure, formula, chemical name, or physical properties" and of a disclosure of "representative" number of species to obtain generic claim scope. Eli Lilly, 119 F.3d at 1566 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993)); Carnegie Mellon Univ. v. Hoffman-La Roche, Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008). The Eli Lilly holding that a definition by function is insufficient to support a genus ignores the reality and state of the art in biotechnology inventions. Eli Lilly, 119 F.3d at 1568. A person of skill in the biotechnology arts frequently 3

  8. describes established classes of compounds, such as proteins and enzymes, by their functionality. Furthermore, although it is correct that the naming of a species does not in itself support a genus, the naming of a genus is an adequate written description for that genus. See, e.g., In re Lukach, 442 F.2d 967, 968-69 (C.C.P.A. 1971) ("[W]here an applicant claims, as here, a class of compositions, he must describe that class in order to meet the description requirement of the statute. "). Generic claim scope is essential to protect biotechnology innovation, because of the ease with which competitors can now design around specific biomolecules, to attain bioequivalent but noninfringing variants once the identity of the biomolecule has been elucidated, often at great cost, by a bioinnovator. Enzymes are complex proteins, often consisting of hundreds of linked amino acids which are folded into precise shapes which permit other molecules to "dock" in the enzymes, and undergo chemical transformation. All proteins are encoded by genes, and because of the redundancy of the genetic code, an almost limitless number of genes can encode the same protein. Competitors are easily able to analyze and replicate new proteins and genes, and to substitute amino acids and DNA nucleotides that do not affect their chemical properties, based on automated techniques which are now routine and well known. 4

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