t expected to appear in this court are: SUGHRUE MION, PLLC Kenneth - - PDF document

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

June 16, 2009

.,

COUNSEL PRESS, LLC

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

(202) 783-7288 * (888) 277-3259 223450

t

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

• r 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 expected to appear in this court are:

SUGHRUE MION, PLLC

Kenneth J. Burchfiel John T. Callahan June 16, 2009 Kenneth J. Burchfiel

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

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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

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

• btaining 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

• btained 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,

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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

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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

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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

• f

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.

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Indeed, it is this absence of adequate generic claim scope which represents the greatest obstacle to adequate patent protection for bioinnovations. The USPTO's current practice in examination of protein and DNA claims flows directly and damagingly from the Eli Lilly doctrine, with the result that the disclosure of a single biomolecule in a patent is insufficient to support generic claim scope, even though the exact same disclosure of a single sequence provides a template which enables competitors to design variants using routine and simple

• methods. The panel decision only perpetuates this error. 560 F.3d at 1376.

The Eli Lilly doctrine places bioinnovators in an extremely difficult situation. On the one hand, an inventor is required outside the US to be the "first to file" for his or her invention, in jurisdictions which do not have the heightened Eli Lilly

• doctrine. The inventor could delay filing in order to generate myriad routine

variants of his protein as appears to be required by the Eli Lilly doctrine in the U.S., thereby risking the loss of all rights outside the U.S., or could immediately file worldwide including in the U.S., but risk losing patent rights of meaningful scope in the U.S. merely because he or she did not perform the routine experiments fully enabled by his or her specification. Variants of a disclosed protein species can be routinely generated by one of skill in the art using well-known techniques such as mutagenesis, recombination and cloning. The Eli Lilly doctrine ignores the

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advances in techniques in the biotechnology arts, in which highly skilled artisans can now produce thousands of variants through automation in a short period of time, once the sequence of a protein has been elucidated by a bioinnovator. In the absence of adequate generic claim scope that covers such routine variants, a United States patent containing claims restricted to a specific sequence

• r narrow range of

homologous compounds is little more than dedication of the invention to the public. Unless claims to a species or narrow genus encompassing the species are allowed without amendment or cancellation, or without having been defined in a specification as part of a broader genus, the greatly-restricted doctrine

• f

equivalents vitiates the value of narrow claims. The Eli Lilly doctrine has led to a disparate standard of patentability for biotechnology inventions in the United States. Amicus submits that it is unreasonable and unfair for an inventor to disclose and enable a genus in his specification and yet not be entitled to a patent on that genus under the Eli Lilly

• doctrine. Thus, the Court should take this occasion to restore the traditional

written description standard.

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CONCLUSION Rehearing en bane should be granted, and the Court should restore the written description requirement to its original and proper purpose, which is whether the claims find support in the specification, such as in the priority context

• r when a claim is added or amended during prosecution.

June 16, 2009 KENNETH J. BURCHFIEL SUGHRUE MION, PLLC 2100 Pennsylvania Ave., N.W. Suite 800 Washington, D.C. 20037 (202) 293-7060 JOHN T. CALLAHAN SUGHRUE MION, PLLC 2100 Pennsylvania Ave., N.W. Suite 800 Washington, D.C. 20037 (202) 293-7060

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Ariad Pharmaceutical v. Eli Lilly, 2008-1248 CERTIFICATE OF SERVICE I, John C. Kruesi, Jr., being duly sworn according to law and being over the age of 18, upon my oath depose and say that: Counsel Press was retained by SUGHRUE MION, PLLC, Attorneys for Amicus Curiae, to print this document. I am an employee of Counsel Press. On the 16th Day of June 2009, I served the within BRIEF OF AMICUS CURIAE NOVOZYMES AlS IN SUPPORT OF PETITION FOR REHEARING EN BANe upon: Leora Ben-Ami Kaye Scholer, LLP 425 Park Avenue New York, NY 10022 212-836-7203 Attorney for Plaintiffs-Appellees Charles E. Lipsey Finnegan, Henderao, Farabow 2 Freedom Square 1195 Freedom Drive Reston, VA 20190 571-203-2399 Attorney for Defendant-Appellant via Federal Express, overnight delivery by causing 2 true copies of each to be deposited, enclosed in a properly addressed wrapper, in an official depository of Federal Express. Unless otherwise noted, 19 copies have been hand-delivered to the Court on the same date as above. June 16, 2009

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