Requirement: Lessons Learned Since Ariad v. Lilly Navigating Section 112 Disclosure Obligations and Withstanding Invalidity Challenges

Transcription

1 Presenting a live 90 minute webinar with interactive Q&A Patents and the Written Description Requirement: Lessons Learned Since Ariad v. Lilly Navigating Section 112 Disclosure Obligations and Withstanding Invalidity Challenges THURSDAY, SEPTEMBER 8, pm Eastern 12pm Central 11am Mountain 10am Pacific Td Today s faculty features: Michael R. Dzwonczyk, Partner, Sughrue Mion, PLLC, Washington, D.C. Thomas J. Scott, Jr., Partner, Goodwin Procter, Washington, D.C. Krishnan Padmanabhan, Attorney, Winston & Strawn, New York The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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5 Patents and the Written Description Requirement Lessons Learned Since Ariad v. Lilly Krishnan Padmanabhan Sept. 8, Winston & Strawn LLP

6 Written Description: Background 2011 Winston & Strawn LLP

7 35 U.S.C The specification shall contain: a written description of the invention, and of fthe manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention Winston & Strawn LLP 7

8 What is Required by 35 U.S.C Written description and enablement have often been lumped together The purposes of 35 U.S.C have long been agreed upon Describe: disclosing what exactly was patented Teach: Enable one of skill in the art to make and use the patented invention 2011 Winston & Strawn LLP 8

9 Purposes of the Written Description Requirement Prior to the introduction of a claims requirement (1836), was used to define the metes and bounds of the patented invention. Used to prevent inventor from pretending that his invention is more than what it really is Evans v. Eaton, 20 U.S (1822) Winston & Strawn LLP 9

10 Purposes of the Written Description Requirement Ensures that the inventor was in possession of the subject matter claimed by his or her patent; Defines the grant and what will become public property when the term of the monopoly expires; Part of the quid pro quo of a patent, and ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time. Ariad, 598 F.3d at Allows those in industry to know what can and cannot be practiced; 2011 Winston & Strawn LLP 10

11 Application of the Written Description Requirement Compliance with the written description requirement is a question of fact. Key question: would one of ordinary skill in the art have understood the inventor to have been in possession of the claimed invention at the time of filing? Analysis requires a comparison of the patent s claims with the patent s disclosure (specification). If the claimed invention is not described with sufficient specificity in the disclosure, the requirement is not met Winston & Strawn LLP 11

12 Application of the Written Description Requirement The level of detail required to satisfy the requirement is determined based on a number of factors: the nature and scope of the claims; the complexity and predictability of the relevant technology (e.g., predictable arts such as electrical-mechanical vs. unpredictable arts, such as chemistry/pharmaceuticals); the existing knowledge in the particular field; the extent and content of the prior art; the maturity of the science or technology; 2011 Winston & Strawn LLP 12

13 Patents and the Written Description Requirement Lessons Learned Since Ariad v. Lilly Thomas J. Scott, Jr September 8, Goodwin Procter LLP

14 II.A. Review of the Federal Circuit s Decision in Ariad v. Lilly

15 II. A. Overview of Ariad Decision Factual Background Ariad sued Eli Lilly for alleged infringement of U.S. Patent No. 6,410,516 B1 516 Patent: regulation of gene expression by the transcription factor Nuclear Factor kappa B (NFkB). Accused Products: Evista (i.e., Raloxifene, an estrogen inhibitor) Xigris (i.e., Drotrecogin alfa, used as treatment for sepsis) Ariad alleged that Eli Lilly s drugs induced or contributed to infringement of the 516 Patent t by patients. t Defenses raised by Lilly included invalidity under 35 U.S.C 101, 102, 112 (enablement and written description). Goodwin Procter LLP 15

16 II. A. Overview of Ariad Decision Inventors discovered artificially interfering with NFκB activity reduced harmful symptoms of certain diseases Claimed methods for regulating cellular responses to external stimuli by reducing NF-κB activity in a cell Genus claims encompassed the use of all substances that achieve the desired result of reducing the binding of NF-κB to NF-κB recognition sites Specification described three types of molecules with the potential to reduce NF-κB activity in cells: decoy, dominantly interfering, and specific inhibitor molecules Only one example provided of a specific inhibitor (IκB), a naturally occurring molecule, along with the sequence of DNA that encodes it 516 Patent, Table 2 Goodwin Procter LLP 16

17 II. A. Overview of Ariad Decision 516 Patent, Exemplary Figures 516 Patent, Figs. 36A, 39, 40A-40B Goodwin Procter LLP 17

18 II. A. Overview of Ariad Decision District Court and Federal Circuit Panel Decisions Claims found valid and infringed by jury District court ruled against Lilly s motion for JMOL that the claims were not infringed, invalid for anticipation, lack of enablement, or lack of written description Panel of the Federal Circuit affirmed-in-part, finding claims invalid for lack of written description because disclosure was insufficient to establish that the inventors were in possession of the claimed invention Goodwin Procter LLP 18

19 II. A. Overview of Ariad Decision The Federal Circuit Decision The Federal Circuit vacated the panel s decision agreed to a rehearing of the appeal en banc: 1. Does 35 U.S.C. 112, first paragraph contain a written description requirement separate from an enablement requirement? 2. If a separate written description is set forth in the statute, what is the scope and purpose of that requirement? En banc majority of the Federal Circuit ultimately found the claims invalid as lacking written description. Goodwin Procter LLP 19

20 II. A. Overview of Ariad Decision Majority held, even if the decoy-molecule hypothetical might enable a skilled artisan to make and use the claimed methods, the asserted claims [were] far broader and so were invalid for lack of written description. Reaffirmed the separate written description and enablement requirement of 35 U.S.C. 112, first paragraph: If Congress had intended enablement to be the sole description requirement of 112, first paragraph, the statute would have been written differently. Goodwin Procter LLP 20

21 II. A. Overview of Ariad Decision Federal Circuit: Written description doctrine requires an inventor to demonstrate conceptual possession of the claimed subject matter as of the filing date in the disclosure, i.e., to prove in the disclosure that the inventor invented what is claimed as of the filing date. Under the possession test[,] the inventor must disclose: knowledge of the structure of the claimed invention a functional description of what it does is insufficient (unless there is a known correlation between function and structure) Did not alter the state of the law with regards to the written description requirement. Goodwin Procter LLP 21

22 II. A. Overview of Ariad Decision Written description requirement is part of the quid pro quo of a patent and operates to allow: the USPTO to examine applications effectively; courts to understand the invention, determine compliance with the statute, and to construe the claims; and the public to understand and improve upon the invention and to avoid the claimed boundaries of the patentee s exclusive rights. Goodwin Procter LLP 22

23 II. A. Overview of Ariad Decision A few broad principles hold true across all cases. The written description does not require: actual reduction to practice; any particular form of disclosure; word for word disclosure; the same type of written description for every type of invention; or express disclosure of each and every species of a genus. Goodwin Procter LLP 23

24 II. A. Overview of Ariad Decision Detailed Reasoning of the Federal Circuit in Ariad v. Lilly Supreme Court precedent Schriber-Schroth Co. v. Cleveland Trust Co., 305 U.S. 47 (1938) Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002) Stare Decisis [T]his has been the law for over forty years, and to change course now would disrupt the settled expectations of the inventing community, which has relied on it in drafting and prosecuting patents, concluding license agreements, and rendering validity and infringement opinions. Invitation to Congress? Goodwin Procter LLP 24

25 II. A. Overview of Ariad Decision Excerpts from the Federal Circuit Decision [T]he overriding policy of patent systems requires both written description and enablement, and it is less critical to decide which statutory clause applies in a particular case, than to assure that both requirements are met. (Emphasis added). [T]he test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Based on that inquiry, the specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed. (Emphasis added). Although the content varies, the threshold in all cases requires a transition from theory to practice, from basic science to its application, from research plan to demonstrated utility. (Emphasis added). Goodwin Procter LLP 25

26 II. A. Overview of Ariad Decision Impact Of The Decision On The Claims-In-Suit [M]erely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. No bright-line rules governing the number of species that must be disclosed Asserted claims were invalid for lack of written description, because they were genus claims, encompassing the use of all substances that achieve the desired result of reducing the binding of NF-kB to NF-kB recognition sites[.] ] Concur/Dissent Concurrences by Newman, Gajarsa Dissent by Rader Goodwin Procter LLP 26

27 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott Krishnan Padmanabhan Sept. 8, Winston & Strawn LLP

28 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott Centocor sued Abbott in U.S. District Court for the E.D. Texas, asserting that Abbott's Humira antibody (used in combating arthritis) infringes claims 2, 3, 14, and 15 of U.S.P.N. 7,070, Jury found for Centocor (to the tune of $1.67 bn). Abbott filed a JMOL in part, based on failure to meet the written description requirement of 35 U.S.C Winston & Strawn LLP 28

29 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott Overproduction of TNF-αα has been implicated in a number of auto-immune diseases, including arthritis. This case involves antibodies that bind to TNF-α in order to regulate overproduction and reduce incidence of arthritis. Such antibodies have constant and variable regions Winston & Strawn LLP 29

30 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott Both Centocor and Abbott developed anti-tnf-α α antibodies, but pursued different strategies. Centocor made use of mouse based antibody to human TNF-α; such antibodies must be made useful for humans by reducing the antibody s immunogenicity. Centocor did so by exchanging the antibody s mouse constant region with a human constant region. The result is a chimeric antibody having a mouse variable region and a human constant region Winston & Strawn LLP 30

31 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott Abbott took an alternate approach, screening a phage library of human variable regions for variable regions that bind human TNF-α, and then used various techniques to improve the binding affinity of selected variable regions. The identified variable regions were then combined with human constant regions. The result was fully-human antibodies, from which the antibody Humira was identified and commercialized Winston & Strawn LLP 31

32 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott Centocor filed a patent application in 1991 claiming its chimeric antibody, and continuations-in-part in 1993 and In 2002, Centocor added claims reciting human variable regions in an application which resulted in the 775 patent. Abbott filed a patent application directed to fully-human antibodies to human TNF-α, of which Humira is one, in The patent was granted in Winston & Strawn LLP 32

33 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott Exemplary claims 1 and 2 of the 775 patent are as follows: 1. An isolated recombinant anti-tnf-α anti-body or antigenbinding fragment thereof, said antibody or antigen-binding fragment comprising i a human constant region, wherein said antibody or antigen binding fragment (i) competitively inhibits binding of A2 (ATCC Accession No. PTA-7045) to human TNF-α, and (ii) binds to a neutralizing epitope of human TNF-α in vivo with an affinity of at least 1x108 liter/mole, measured as an association constant (Ka), as determined by Scatchard analysis. 2. The antibody or antigen-binding fragment of claim 1, wherein the antibody or antigen binding fragment comprises a human constant region and a human variable region Winston & Strawn LLP 33

34 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott On appeal to the Fed. Cir., Abbott argued that the 775 patent did not provide adequate written description for the claimed human variable regions. Centocor relied on a priority date from its 1994 application. This was necessary because Abbott had patented claims with a 1996 priority date covering human antibodies. Thus, the 1994 application was required to have sufficient written description for an antibody to cover the human antibodies Winston & Strawn LLP 34

35 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott The application only provided amino acid sequence information for a single mouse variable region. The court determined that the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims Winston & Strawn LLP 35

36 Application of Ariad: Centocor Ortho Biotech, Inc. v. Abbott Centocor also argued the claims met the written description requirement under the antibody exception, by disclosing i the human TNF-α antigen (triggers production of antibody) Centocor cited PTO guidelines (Noelle v. Lederman, pg. 45 of Mar guidelines), which state an antibody which binds to a protein is sufficiently disclosed when the applicant fully discloses the novel protein and generating the claimed antibody is so routine that possessing the protein places the applicant in possession of an antibody The Federal Circuit rejected this argument finding the protein was not novel, and obtaining the human form of the TNF-α antibody would not have been routine to one of skill in the art in 1994, when the CIP application was filed 2011 Winston & Strawn LLP 36

37 Patents and the Written Description Requirement: Lessons Learned Since Ariad v. Lilly Michael Dzwonczyk Sughrue Mion PLLC com September 8, 2011

38 Impact of Ariad Predictable arts Nonpredictable arts On the written description requirement On patent litigation 38

39 Predictable arts Asserted claims directed metal cans and methods for seaming metal cans C =between 12 o and 20 o C o =between 30 o and 60 o anti-peaking bead or reinforcing bead Crown Packaging Tech., et al. v. Ball Metal Beverage Container Corp., 635 F.3d 1373 (Fed. Cir. 2011) 39

40 Predictable arts Parties agree that spec. describes increasing slope of chuck wall and limiting the with of the anti-peaking bead Parties disagree as to whether the WD supports an invention that improves metal usage by increasing the slope of the chuck wall without a modified chuck that does not drive deeply into the reinforcing bead. 40

41 Predictable arts D.Ct. granted SJ, invalidating asserted claims under 112 for lack of WD asserted claims cover driving a chuck either inside or outside of the reinforcing bead, but the specification only supports driving a chuck outside of the can end's reinforcing bead. 41

42 Predictable arts Fed. Cir. SJ invalidity reversed Spec. teaches two separate solutions: increasing the slope of the chuck wall of the can end and limiting the width of the reinforcing bead Nothing requires employment of both methods in all instances The specification supports the asserted claims that achieve metal savings by varying the slope of the chuck wall alone While the patents t teach two independent d ways to save metal, the advantages of limiting the chuck to driving outside the reinforcing bead only come into play when one narrows the reinforcing i bead 42

43 Chef America - type mistake Claim 4 recites a head member attached to the lower portion of the mandrel having a slot for catchably retaining the engaging portion of a superposed bridge plug Frazier v. Map Oil Tools, Inc., 725 F.Supp. 2d 597 (S.D.Tx. 2010) 43

44 Chef America - type mistake Parties agree that superposed is construed as "located above or over Defs. Seek SJ of noninfringement, invalidity for lack of WD, because: as superposed is defined, a bridge plug is simply not capable of using a slot at its bottom end to connect with another bridge plug positioned above it. Rather, this slot would be used to connect to another bridge plug located below it no WD support for superposed plaintiff/patentee tried to correct error by filing amended infringement contentions substituting "subjacent" for "superposed," and stating that a bridge plug connects to a "third, lower yet, plug. Frazier v. Map Oil Tools, Inc., 725 F.Supp. 2d 597 (S.D.Tx. 2010) 44

45 Chef America - type mistake D.Ct. superposed p appears nowhere in the specification With Claim 4 written as is, the specification would have to describe a bridge plug that has a lower end capable of engaging another bridge plug located above it. Instead, the specification describes what one would expect to find, namely a bridge plug with an engaging portion at an end that is capable of connecting with another bridge plug positioned adjacent to that end. (citation omitted) Because Claim 4 is not described anywhere in the specification (due to the use of "superposed" instead of "subjacent"), it necessarily fails the written description requirement of Section 112. Frazier v. Map Oil Tools, Inc., 725 F.Supp. 2d 597 (S.D.Tx. 2010) 45

46 New Trial After Jury Verdict! Whirlpool's '130 patent discloses a refrigerator design in which the ice storage bin is moved from its conventional location in the back of a freezer compartment to the compartment door. Whirlpool sued LG, and a jury awarded $1.8 MM after finding of infringement LG sought JMOL on invalidity of the 130 patent based on failure to meet the WD requirement of Sec. 112 LG Electronics v. Whirlpool l Corp., 2011 U.S. Dist. LEXIS (D. Del. July 1, 2011) 46

47 New Trial After Jury Verdict! Claims require mounting the ice maker on the freezer door. Whirlpool s sole proof of WD was Fig. 2, combined with expert statement that a POSA could recognize an ice maker mounted on the door as a possible arrangement of the claimed invention LG argued that mounting the ice maker in the door of the freezer compartment entails additional complications that would prevent one of ordinary skill in the art from readily visualizing such an arrangement based on the description of the ice maker mounted to the wall of the freezer compartment. Freezer door (20) Ice storage bin (28) Ice maker assembly (22) Ice dispensing system (26) Ice crushing system (30) 47

48 New Trial After Jury Verdict! New trial granted because jury verdict is against the weight of the evidence mounting the ice maker in the door of the freezer compartment entails additional complications that are apparent when the '130 patent t is compared with Whirlpool's l' '624 patent, which describes an ice maker on the door of the refrigerator in great detail in the specification. The evidence cited by Whirlpool fails to refute the evidence cited by LG because it does not indicate how one of ordinary skill in the art would recognize an ice maker mounted on the door based on his or her reading of the specification. LG Electronics v. Whirlpool Corp., 2011 U.S. Dist. LEXIS 70963, *38-*40 (D. Del. July 1, 2011) 48

49 What About Unpredictable Arts? The description needed to satisfy the requirements of 35 U.S.C. 112 "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005) For inventions characterized by factors not reasonably ypredictable which are known to one of ordinary skill in the art, more evidence is required to show possession MPEP

50 Unpredictable Arts Billups asserted against defendants its 681 patent, directed to methods of diagnosing hemochromatosis by providing from the individual a sample containing a gene encoding a nonclassical MHC class I heavy chain, and detecting a mutation in the gene that results in the reduced ability of the heavy chain to associate with ß2 microglobulin wherein the presence of the mutation identifies the individual as having or predisposed to having hemochromatosis The mutation referred to is known as the C282Y mutation Billups-Rothenberg, Inc. v. Assc. Regional and Univ. Pathologists, 2010 U.S. Dist. LEXIS (C.D. Cal. May 26, 2010) 50

51 Unpredictable Arts Defendants sought SJ of invalidity based on lack of WD support Defs. argued that Claim 2 is a genus claim, and the DNA sequence of the hemochromatosis gene and/or the sequence of the C282Y mutation were not expressly specified in the '681 patent Rather, the patent only discloses that the major histocompatibility complex gene, where the mutations linked to hemochromatosis were predicted to be located, is on the short arm of chromosome 6 51

52 Unpredictable Arts D. Ct. for genus claims, the disclosure must include "either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of ordinary skill in the art can 'visualize or recognize' the members of the genus." Defs urge invalidity under Sec. 112 because the 681 patent does not disclose any representative species of the genus or structural features common to the members of the genus. 52

53 Unpredictable Arts Plaintiffs urge: Claim 2 of the '681 patent is not a genus claim because there is only one known DNA mutation -- the C282Y mutation -- that satisfies the limitations of the claim Patentee has disclosed sufficient function and structure to meet the written description requirement 53

54 Unpredictable Arts Court: Claim 2 is a genus claim because its language includes yet undiscovered mutations First part of Ariad not satisfied where parties agreed that no species of the genus of DNA mutations were disclosed in the '681 patent specification Second part of Ai Ariad not satisfied where the patent t discloses the structure of the proteins produced by the mutated DNA, but not the structure of the DNA and its mutations Claims held invalid on SJ 54

55 Inadequate Support for Broad Genus Claims J&J patents directed to drug-eluting g stents using either rapamycin or a macrocyclic lactone analog of rapamycin as the therapeutic agent Boston Scientific sought DJ of invalidity under Sec. 112 as failing the WD requirement for inadequate disclosure of a reresentative number of species of the claimed genus The court construed "rapamycin or a macrocyclic lactone analog thereof" as meaning "sirolimus or a macrocyclic lactone molecule with a structure similar to sirolimus" Boston Scientific v. Johnson & Johnson, 2011 U.S. App. LEXIS (Fed. Cir. June 7, 2011) 55

56 Inadequate Support for Broad Genus Claims In the specification, no disclosure of any formulae or structures t of any specific analog or provide any "definitions, examples, or experimental models... for determining whether a compound is a structurally similar analog as contemplated by the patentees. " At the time of filing, numerous analogs of rapamycin were possible, but only a small number of macrocyclic lactone analogs of rapamycin were actually known Patentees expert stated that the structure t and the mechanism of action of rapamycin were known the correlation between the structural elements of rapamycin and its mechanism of action and biological activity was known, and that dozens of rapamycin analogs were known 56

57 SJ Invalidity for lack of WD Affirmed No reasonable jury could conclude that there is sufficient written description support for the asserted claims Only four experimental delivery methods using only rapamycin are detailed No experiments using macrocyclic lactone analogs nor does the specification even indicate performance of any such experiments No guidance on how to properly determine whether a compound is a macrocyclic lactone analog of rapamycin besides vaguely indicating they must be structurally similar to rapamycin. 57

58 SJ Invalidity for lack of WD Affirmed While a small number of such analogs were known in the prior art, the claims cover tens of thousands of possible macrocyclic lactone analogs. With no guidance at all in the specification as to how to properly p identify or choose the claimed analogs, and in light of the unpredictability and nascent state of using drug-eluting stents to treat restenosis, we agree with the district court that appellants have failed to create genuine issues of material fact. 58

59 Ariad s Effect on the WD Requirement Ariad confirmed WD as a free-standing requirement for patentability Since at least Lilly (1997), patentees in unpredictable arts (e.g., biotech, pharma, etc.) have understood that more disclosure is required to show possession than for claimed subject matter in predictable arts Lilly, Lockwood, Enzo (II), Univ. Rochester, etc. all confirm that written description must show patentees were in possession of the claimed subject matter, and that possession is shown by description in the disclosure Thus... 59

60 The Possession-Description Tautology Possession Description The hallmark of written description is disclosure. Thus, possession as shown in the disclosure is a more complete formulation. (Ariad at 1351). One shows that one is in possession" of the invention by describing the invention,, with all its claimed limitations, not that which makes it obvious (Lockwood v. American Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997) 60

61 Ariad s Effect on the WD Requirement Patentees in predictable arts face increased disclosure requiements Increase in post-filing declaration evidence? For global applications, a uniquely American description requirement presents increased challenges for global application preparation Heightened description standard in US separate from enablement Description and enablement are linked disclosure requirements under Paris Convention Treaty and in EPO Complicates preparation and examination of global applications 61

62 Ariad s Effect on Patent Litigation No empirical data yet But anecdotal increase in successful challenges to patents in classically unpredictable arts Surprisingly, i from , 2009 WD challenges succeeded d almost half of the time Success of Attack on Written Description Grounds in Litigation Year Average Challenger prevails 52% 35% 43% 25% 39% 37% 43% A.B. Rabinowitz, Ending the Invalidity Shell Game: Stabilizing the Application of the Written Description Requirement in Patent Litigation 12 Minn. J.L. Sci. & Tech. 127, 141 (2011) 62

63 II.B. Impact Of Ariad v. Lilly On Patent Prosecution Thomas J. Scott, Jr.

64 II. B. Impact of the Decision on Patent Prosecution How often does the separate written description requirement actually make a difference in patent prosecution? A 2010 study analyzed 2858 BPAI patent opinions from Study showed written description issues were decided in 123 (4.3%) of the decisions in the sample. None of the outcomes of the 123 decisions would have been impacted by a legal change that entirely eliminated the written description requirement of 112. New-matter style written description requirement rejections were outcome determinative in 20 of the 2858 cases about 1.0% of the cases in [the] sample. These results support Chief Judge Michel s statement during oral argument that it is indeed exceedingly rare that the patent office hangs its case on written description. Source: Crouch, Dennis D., An Empirical Study of the Role of the Written Description Requirement in Patent Prosecution (February 18, 2010). Northwestern University Law Review Colloquy, Vol. 104, 2010; University of Missouri School of Law Legal Studies Research Paper No Goodwin Procter LLP 64

65 II. B. Impact of the Decision on Patent Prosecution Although the law essentially remains unchanged, the Ariad decision may draw attention to the separate written description requirement as it applies to patent prosecution. Biotechnology patents in particular may come under increased scrutiny Possible decrease in the scope of protection afforded to pioneering-type inventions However, existing PTO guidelines remain unaffected. Goodwin Procter LLP 65

66 II. B. Impact of the Decision on Patent Prosecution Increased scrutiny of the written description may cause inventors to develop inventions further before filing Tension in a first-to-file system: fully developing invention versus possible loss of rights Anecdotal evidence shows increase in rejections of all claims by Examiners in the USPTO for lack of written description (both original and amended). Present claim chart with the claim language and written description support in a side-by-side comparison referencing specific portions in the specification (i.e., mapping the claims, which may be required by the Examiner under 37 CFR 1.105; see also MPEP (b)). Goodwin Procter LLP 66

67 III. Best Practices to Meet the Written Description Requirement

68 III. Best Practices to Meet the Written Description Requirement The Ariad opinion does not resolve the potential for confusion between the written description requirement and the enablement requirement as means to regulate the scope of the claims. develop the analysis of possession of the invention in terms of other patent law concepts regarding the invention. Remaining Questions after Ariad: Can a specification that expressly describes a genus and adequately discloses one or more species fail to satisfy the written description requirement because it does not show sufficient "possession" of the genus invention? Is a description inadequate when it defines a generic class in terms of a desired result and what species of the genus do instead of what they are? Goodwin Procter LLP 68

69 III. Best Practices to Meet the Written Description Requirement Written description problems typically appear in these circumstances: broad claim with little support in specification such as a genus claim or functionally described structure with few or no species described in specification; attempts to cherry pick the original disclosure to specifically claim narrow subject matter later discovered to be valuable; substantial claim amendments made during prosecution; and reliance on earliest priority date, often when priority application is a provisional. Goodwin Procter LLP 69

70 III. Best Practices to Meet the Written Description Requirement Presumption of sufficient written description: Examiner must have a reasonable basis for challenging g the adequacy of the description. Describe the structure of a genus and structures of as many species as necessary. Identify relationship between structure and function of useful materials. Avoid issues with written description upon amending the claims by drafting the specification with potential future claim amendments and fall back positions in mind. Goodwin Procter LLP 70

71 III. Best Practices to Meet the Written Description Requirement Be wary of adequacy of written description especially with regards to provisional applications Prior disclosure or offer for sale may be enough to render claimed invention obvious, but not satisfy written description Draft claims for provisional patent applications. Err on side of disclosing a lot of detail and alternative claim language in priority application invest more now for future value of valid patent, rather than less now for zero future value or worse. Consider trade secret protection Goodwin Procter LLP 71

72 III. Best Practices to Meet the Written Description Requirement Consider filing separate applications as structurally diverse means of attaining the desired result are discovered. This approach may be more suited to some technical areas than to others Means plus function claims Under this approach, it is also prudent to consider that 112, 6, presents its own unique set of requirements. Implications of Harari v. Lee, Case No (Fed. Cir. Sept. 1, 2011) (affirming decision of the Board judgment that Harari s claims lacked written description support). Goodwin Procter LLP 72

73 III. Best Practices to Meet the Written Description Requirement Strategy for responding to rejections of the written description: The Examiner has failed to establish by a preponderance of the evidence why a skilled person would not recognize in the disclosure a description of the invention defined in the claims. As necessary, map the claims. The claimed subject matter need not have literal support. No requirement that the specification support the claim word for word. Show identity of that which is described and that the applicant had possession of what is claimed within the four corners of the specification. Goodwin Procter LLP 73