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A Publication of The New York Intellectual Property Law Association August/September 2009 Bulletin In This Issue When Your Case May Hang on a Single Comma: Article: Ariad Revives the Written Description Debate When Your Case under 35 U.S.C. §112, ¶1 May Hang on a Single Comma ......1, 3-5 By Dorothy R. Auth and John P. Halski President’s Corner .........2 or over four decades, patent prac- requirement is. The rehearing en banc titioners have struggled to cut is bound to be one of the most closely Report on F through a seemingly ever-growing watched proceedings this year, and the Annual Dinner .........6-7 thicket of not necessarily consistent validity of countless patents may hang jurisprudence concerning the meaning on the grammatical significance of a Leadership in the of the first paragraph of 35 U.S.C. §112. stray comma. Practice of Law ......8-10 Of particular concern is whether the first paragraph of Section 112 only requires Basis for the Written Description Honorable that the specification enable the skilled Requirement William C. Conner reader to make and use the invention, or Originally appearing in 1870, the Tribute ..................11-16 whether it also demands that the specifi- first counterpart of 35 U.S.C. §112, ¶1 cation convey that the inventor actually demands: Historian’s Corner .......16 possessed the claimed invention at the The specification shall contain time of the application. After years of a written description of the in- allowing the question to percolate, the vention, and of the manner and CLE Program Reports: Federal Circuit has at last decided to process of making and using • Patent/Trade tackle the controversy head on, having it, in such full, clear, concise Secret Comple- granted a petition for rehearing en banc and exact terms as to enable mentariness ..............17 by the plaintiffs in Ariad Pharmaceuti- any person skilled in the art to cals, Inc. v. Eli Lilly and Co., 560 F.3d which it pertains or with which •Hot Topics in 1366 (Fed. Cir. 2009). Specifically, the it is most nearly connected, to Trademark & Federal Circuit will address whether make and use the same, and Copyright Law ......18-21 Section 112 contains a separate writ- shall set forth the best mode ten description requirement and, if so, contemplated by the inventor •Issue of Future what the scope and purpose of that of carrying out his invention. Damages/Ongoing cont. on page 3 Royalties Post eBay ...22 NYIPLA’s NYIPLA Calendar ........23 Tribute to Judge William C. Conner on pages 11-15 New Members ........23-24 The views expressed in the Bulletin are the views of the authors except where Board of Directors approval is expressly indicated. © Copyright 2009 The New York Intellectual Property Law Association, Inc. NN Y Y I IP P L L A A PageAugust/September 1 www.NYIPLA.org 2009 September 2009 t is a privilege and an honor to write my first letter as President of our Association. The NYIPLAI is a growing and vibrant organization, and I thank each one of you for your continued support of the Association and its mission. My term follows a highly successful year, and I would like to thank immediate past president Anthony Giaccio for his vision, leadership and dedication. Having been involved in NYIPLA activities for 20 years, I greatly appreciate the professional and social benefits of the Association. Excellent and ethical representation is a hallmark of the As- sociation and the opportunity to interact with so many attorneys who exemplify these values has been a true pleasure. I am fortunate to count a great number of friends among the current and former the leadership of Committee Chairs Richard Er- leaders of the Association and its membership. wine and Richard Martinelli and Board Liaison These are exciting and challenging times for Tom Meloro, has hosted two luncheon meetings. the NYIPLA and our practice. Our membership is Judge Clark of the Eastern District of Texas spoke growing and participation in committees, activi- at one meeting and Chief Administrative Judge ties and events is increasing. During my term as Fleming of the Board of Patent Appeals and President, I intend to enhance opportunities for Interferences of the U.S. Patent and Trademark our members to become engaged in the activities Office spoke at the other. of the Association. Please join me in this effort. • The Membership Committee, under the lead- This year, in addition to the filing of amicus ership of Committee Chairs Joseph DeGirolamo briefs, presentation of Continuing Legal Educa- and Paul Bondor and Board Liaison Anthony tion programs, our Judgesʼ Dinner and our Annual LoCicero, has been active throughout the summer Dinner and Awards Ceremony, some of my key in promoting membership in the Association. objectives include fostering cooperation with the • The Corporate Practice Committee, under Conner Inn of Court and finding avenues for the the leadership of Committee Chairs Alexandra NYIPLA to participate in the AIPLA spring meet- Urban and Susan McHale McGahan and Board ing which will be held in New York City. Liaison Jeffrey Myers, has been working on a Following are some notable committee ac- number of initiatives to increase participation by tivities that are already underway. corporate attorneys. • The CLE Committee, under the leadership of Committee Chairs Dorothy Auth and Richard • The Young Lawyers Committee, under the Parke and Board Liaison Anthony Giaccio, has leadership of Committee Chairs Sonja Keenan and Andrew Stein and Board Liaison Alice Bren- PRESIDENT’S CORNER been working throughout the summer to plan the Fall one-day CLE program, which will be held nan, organized a happy hour event for associates on November 5, 2009. Publicity for this event and summer associates interested in intellectual has begun. property law in New York City. • The Amicus Committee, under the leadership Finally, I would like to extend my grati- of Committee Chairs Charles Weiss and John tude to Steve Quigley, Chair of the Publica- Hintz and Board Liaison David Ryan, has filed tions Committee, who was instrumental in amicus briefs at the Federal Circuit in Tafas v. overseeing this newsletter, including the trib- Doll, Princo v. ITC and Shire v. Sandoz. Chuck utes to Judge Conner. Miller, David Ryan and Charles Weiss wrote We are off to an excellent start of the Asso- the briefs in those cases, respectively, which are ciation year. I look forward to serving you during available on our website. my term as President and hope to see you soon at • The Meetings and Forums Committee, under an NYIPLA event. N Y I P L A Page 2 www.NYIPL A.org cont. from page 1 There is no disagreement that this section includes at (CCPA 1981) (“This court ha[s] said that a rejection of least two disclosure requirements, i.e. “enablement” an amended claim under §132 is equivalent to a rejec- and “best mode.” The divide amongst jurists centers tion under §112, first paragraph.”). on the first eleven words of the sentence. In a sense, the entire controversy may be summed up as a question Raising the Bar for the Chemical Arts? of grammar, specifically whether the comma between In 1997, when faced with a new challenge over “invention” and “and” separates out two distinct predi- patentability of DNA sequences, the Federal Circuit cate phrases (the “written description of the invention” again turned to the Ruschig holding, but now applied the on the one hand and the remaining language that con- holding outside the context of Section 132. In Regents of stitutes the “enablement” requirement on the other) or Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. simply divides two descriptive phrases. Compare In re 1997), the court held that originally submitted claims Barker, 559 F.2d 588, 594-95 (CCPA 1977) (Markey, may fail the written description requirement of §112 dissenting) (arguing that the comma merely separates when the specification does not convey to the skilled out descriptive phrases of a single requirement); Enzo person that the inventors had possession of the invention Biochem Inc. v. Gen-Probe Inc., et al., 323 F.3d 956, recited in the claims at the time of filing. The facts here 971 (Fed. Cir. 2002) (Lourie, concurring) (arguing that related to claims directed to mammalian, vertebrate and the comma clearly divides two distinguishable require- human insulin cDNA sequences, but a specification ments). However, despite the commentary about the that described (i.e., provided the nucleic acid sequence “errant” comma over the years, the story of the “written for) a rat single DNA sequence. The court held that “an description” requirement begins not with an elementary adequate written description of a DNA requires more school fixation on the proper rules of English grammar than a mere statement that it is part of the invention but in a classroom down the hall where the early pio- and reference to a potential method for isolating it; what neers in chemistry struggled to lay down the rules for is required is a description of the DNA itself.” Id. at identifying (and patenting) new chemical compounds. 1566, quoting Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Ironically, the modern “written description” require- Cir. 1993). Thus, Lilly extended the written description ment is widely recognized as originating in 1967 with the requirement to impose a higher standard of disclosure landmark In re Ruschig decision (379 F.2d 990 (CCPA on biotechnological inventions, i.e., one where long 1967)), where a claim directed to a chemical species accepted prophetic examples would no longer suffice. was invalidated because the specification provided no Post Lilly , the question remained as to whether clue that the claimed species was a preferred member this new standard was specific to the chemical arts.