Ariad v. Eli Lilly 560 F.3d 1366 (Fed. Cir. 2009) Written Description as a Function of Enablement N. Scott Pierce, Esq. Suffolk University Law School November 4, 2009

2 Claim A method of modifying effects of external influences on an eukaryotic cell, which external influences induce NF- kB-mediated intracellular signaling, the method comprising [reducing] NF-kB activity in cells such that NF-kB-mediated effects of external influences are modified. Extracellular NF-kB Expression of + Some Harmful Influence Activation Protective Proteins Effects

3 Candidates Specific Inhibitors Dominantly Interfering Molecules –Hypothesized examples only Decoy Molecules –Examples

4 Holding by CAFC Issue: "[W]hether there is substantial evidence to support the jury's verdict that the written description evidenced that the inventor possessed the claimed invention." Holding: "[T]he jury lacked substantial evidence for its verdict that the asserted claims were supported by adequate written description, and thus hold the asserted claims invalid."

5 Statute 35 U.S.C. §112 – first paragraph –The specification shall contain a written description of the invention, and of the 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

6 Ariad v. Eli Lilly En Banc Questions on Rehearing Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement? If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

Statute [T]he grantee or grantees of each patent shall, at the time of granting the same, deliver to the Secretary of State a specification in writing, containing a description, accompanied with drafts or models, and explanations and models... of the thing or things, by him or them invented or discovered.... [The] specification shall be so particular, and said models so exact, as not only to distinguish the invention or discovery from other things before known and used, but also to enable a workman or other person skilled in the art or manufacture, whereof it is a branch, or wherewith it may be nearest connected, to make, construct, or use the same, to the end that the public may have the full benefit thereof, after the expiration of the patent term....

Statute Sec. 3 [E]very inventor... shall deliver a written description of his invention, and of the manner of using, or process of compounding the same, in such full, clear and exact terms, as to distinguish the same from all other things before known, and to enable any person skilled in the art or science, of which it is a branch, or with which it is most nearly connected, to make, compound, and use the same.

9 Statute of 1793 Sec. 2 "[A]ny person, who shall have discovered an improvement in the principle of any machine, or in the process of any composition of matter which shall, have been patented,…he shall not be at liberty to make use or read the original discovery…: And it is hereby enacted and declared, that simply changing the form or proportion of any machine, or composition of matter, in any degree, shall not be deemed a discovery." Sec. 3 "And in the case of any machine, he shall fully explain the principle, and the several modes in which he has contemplated the application of that principle or character, by which it may be distinguished from other inventions…"

10 Odiorne v. Winkley 18 F. Cas. 581 (C.C.D. Mass.1814) Infringement/Patentability Infringement –"Mere colorable alterations of a machine are not sufficient to protect the defendant." Patentability –"Mere colorable differences, or slight improvements, cannot shake the right of the original inventor."

11 Evans v. Eaton 20 U.S. (7 Wheat.) 356 (1822) Two Objects – Linked to Statute "to enable artisans to make and use it, and this give to the public the full benefit of the discovery." "to put the public in possession of what the party claims as his own invention, so as to ascertain if he claim anything that is in common use."

12 [H]e shall deliver a written description of his invention or discovery, and of the manner and process of making, constructing, using, and compounding the same, in such full, clear, and exact terms, avoiding unnecessary prolixity, as to enable any person skilled in the art or science to which it appertains, or with which it is most nearly connected, to make, construct, compound and use the same.... [He] shall particularly specify and point out the part, improvement, or combination, which he claims as his own invention or discovery Statute

13 "[H]e shall fully explain the principle and the several modes in which he has contemplated the application of that principle or character by which it may be distinguished from other inventions." 1836 Statute (cont.)

14 Winans v. Adams, 56 U.S. (15 How.) 330 (1853) Infringement/Patentability Whether defendants had "constructed cars which, substantially, on the same principle and on the same mode of operation, accomplished the same result." Court: "Under our law a patent cannot be granted merely for a change of form….[T]o employ other mechanical principles or natural powers, such is the basis on which the plaintiff's patent rests." Thereby equating tests for patentability and infringement.

Statute That before any inventor or discoverer shall receive a patent for his invention or discovery, he shall...file in the patent office a written description of the same, and of the manner and process of making, constructing, compounding, and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art or science to which it appertains, or with which it is most nearly connected, to make, construct, compound, and use the same...." [S]aid specification and claims shall be signed by the inventor and attested by two witnesses.

16 White v. Dunbar, 119 U.S. 47 (1886) Patentability/Infringement "Textile fabric" vs. "enveloping material" "We see nothing [to imply] that the patentees were the inventors…." "[W]hen their claim is confined to a lining of textile fabric, it is tantamount to a declaration that they claimed nothing else. "

17 Graver Tank v. Linde Air Products, Co. 339 U.S. 605 (1950) "A patentee may invoke this doctrine to proceed against the producer of a device 'if it performs substantially the same function in substantially the same way to obtain the same result.'" "Thus, where a device is so far changed in principle…the doctrine may be used to restrict the claim…."

18 Eng. Dev. Labs v. Radio Corp. of America, 153 F.2d 523 (2d Cir.1946) "[S]ame result in substantially the same way;…any patent is entitled to some range of equivalents." "The doctrine [of intervening rights]...certainly does not prevent amendments which go no further than to make express what would have been regarded as an equivalent of an original."

19 Summary: Pre-1952 Patent Act Partition of meaning of possession by public** –Particularity: claim language and equivalents –Scope: specification and equivalents ** as a function of enablement

Patent Act The specification shall contain a written description of the invention, and of the 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.

21 Early Interpretation In re Gay, 309 F.2d 769 (CCPA 1962) Enablement: "[A] The specification shall contain a written description of the invention…as to enable." Best Mode: "[B] set forth the best mode…."

22 In re Ruschig, 379 F.2d 990 (CCPA 1967) "Appellants are pointing to trees. We are looking for blaze marks which single out particular trees. We see none." "Does the specification convey clearly to those skilled in the art, to whom it is addressed, in any way the information that appellants invented the specific compound."

23 In re DiLeone, 436 F.2d 1404 (CCPA 1971) A B C D Enablement Description "The first paragraph of § 112 requires both description and enablement."

24 In re Wertheim, 541 F.2d 257 (CCPA 1976) [T]he function of the description requirement is to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him….

25 35 U.S.C. §112 – first paragraph –The specification shall contain a written description –of the invention, –and of the 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. In re Barker, 559 F.2d 588 (CCPA 1977) –Dissent What How and for who m

26 35 U.S.C. §112 – first paragraph –The specification shall contain a [1] written description –of the invention, –and of the 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. In re Barker, 559 F.2d 588 (CCPA 1977) –Dissent –Majority [1] What How and for who m

27 35 U.S.C. §112 – first paragraph –The specification shall contain a [1] written description –of the invention, –[2] and of the 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. In re Barker, 559 F.2d 588 (CCPA 1977) –Dissent –Majority [1] [2] What How and for who m

28 Summary: Post-1952 Patent Act Change in judicial interpretation of 35 U.S.C. § 112, 1 st ¶ Shift in emphasis by caselaw from possession by public to possession by inventor.

29 Biotechnology

30 Fiers v. Revel 984 F.2d 1164 (Fed. Cir. 1993) "The issue here, however, is conception of the DNA of the count, not enablement." "To paraphrase the Board, one cannot describe what one has not conceived." "Because the count…purports to cover all DNAs that code for [ß]-IF, it is analogous to a single means claim….[I]t is an attempt to pre-empt the future before it has arrived. Fiers Revel

31 The Regents of the Univ. of Cal. v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997) Enabling method and sequence for rat only Example 6 – prophetic method for obtaining human sequence was insufficient. "Whether or not it provides an enabling disclosure, it does not provide a written description…." " A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs,….This is analogous to enablement of the genus under § 112, ¶1…."

32 Enzo Biochem, Inc. v. Gen-Probe, 323 F.3d 956 (Fed. Cir. 2002) Deposit of sequences that selectively hybridize "[W]e hold that reference in the specification to a deposit in a public depository, …. sufficient to comply with the written description requirement of § 112, ¶ 1."

33 "In any event, the WD [Written Description] doctrine, at its inception, had a very clear function--preventing new matter from creeping into claim amendments." Judge Rader Introduces "Priority Policeman" Idea

34 Moba v. Diamond Automation Inc., 325 F.3d 1306 (Fed. Cir. 2003) "[T]he Lilly disclosure rule does not require a particular form of disclosure because one of skill could determine from the specification that the inventor possessed the invention at the time of filing."

35 Rader's Concurrence "In 1997, this court inexplicably wrote a new disclosure requirement, found nowhere in title 35…." "After all, to enable is to show possession, and to show possession is to enable."

36 Bryson "[T]he real question raised by Judge Rader's statutory analysis is not whether Lilly was an unwarranted departure from the Ruschig line of cases, but whether that entire line of cases is based on a fundamentally flawed construction of 35 U.S.C. § 112, paragraph 1."

37 University of Rochester v. G.D. Searle, 358 F.3d 916 (Fed. Cir. 2004) Method claimed selective inhibition of "PGHS-2" or "COX-2" No compounds actually disclosed in specification

38 Majority Opinion (Lourie) Written Description and Enablement Distinct Relied on DiLeone (CCPA 1971)

39 Rader - Theory Critical of DiLeone hypothetical: –"In the first place, the hypothetical rarely, if ever, happens."

40 Described: radio Claimed: receiver Scope of claim: TV? Rader: No According to Rader, Lilly court would invalidate "Lack of disclosure is a dead give-away for enablement problems." Rader's Analogy

41 Two Problems with Rader's Theory Pre-Ruschig Prutton v. Fuller, 230 F.2d 459 (CCPA 1956) –The determining factor is whether the application would fairly suggest to the skilled worker in the art the particular composition claimed…. In re Gay, 309 F.2d 769 (CCPA 1962) –"[A]ppellants' specification would have indicated to one skilled in the art that all suggested container materials were to be substantially nonporous…." In re Rainer, 347 F.2d 574 (CCPA 1965) –"the specification discloses nothing to guide such a person in making the selection of such specific materials from the rather extensive catalog of materials recited…."

42 Post-Ruschig In re Robins, 429 F.2d 452 (CCPA 1970) –"mention of representative compounds may provide an implicit description upon which to base generic claim language...." In re Smythe, 480 F.2d 1376 (CCPA 1973) –"The question which must be answered is whether the application originally filed…conveyed…the information that appellants invented the analysis system with an inert fluid as the segmentizing medium." Amgen v. Hoechst (Fed. Cir. 2003) –"Moreover, the specification can fairly be read to, if not expressly, disclose the use of human DNA in human host cells in culture…."

43 Chiron Corp. v. Genetech, 363 F.3d 1247 (Fed. Cir. 2004) –Monoclonal antibodies that bind to human breast cancer antigen (c-erb-2, or HER2) –Original claim language in CIP at issue –No description of later-developed chimeric and humanized technology.

44 Summary Pre-1952 Patent Act –Bifurcation of requirement to put public in possession. Particularity: claim language and equivalents Scope: specification and equivalents Post-1952 Patent Act –Change in judicial interpretation of 35 U.S.C. § 112, 1 st ¶ Left no standard for description of the invention. –Shift in focus of "possession" from public to inventor. –Result: Requirement of more than literal description of invention as claimed.

45 A written description…

46 A written description… Literal Description (or "fair reading") Time of filing of the invention…

47 A written description… Literal Description (or "fair reading") Time of filing of the manner and process of making and using it of the invention… Description of Enablement

48 A written description… Literal Description (or "fair reading") Time of filing of the manner and process of making and using it of the invention… Description of Enablement

49 A written description… Literal Description (or "fair reading") Time of filing of the manner and process of making and using it of the invention… Possession by inventor (e.g., demonstration) Description of Enablement

50 A written description… Literal Description (or "fair reading") Time of filing of the manner and process of making and using it of the invention… Possession by inventor (e.g., demonstration) Possession by inventor (e.g., embodiment) Description of Enablement

51 A written description… Literal Description (or "fair reading") Time of filing of the manner and process of making and using it of the invention… Possession by inventor (e.g., demonstration) Possession by inventor (e.g., embodiment) Description of Enablement Future Point

52 A written description… Literal Description (or "fair reading") Time of filing of the manner and process of making and using it of the invention… Possession by inventor (e.g., demonstration) Possession by inventor (e.g., embodiment) Description of Enablement Future Point

53 A written description… Literal Description (or "fair reading") Time of filing of the manner and process of making and using it of the invention… Possession by inventor (e.g., demonstration) Possession by inventor (e.g., embodiment) Description of Enablement Future Point

54 A written description… Literal Description (or "fair reading") Time of filing of the manner and process of making and using it of the invention… Possession by inventor (e.g., demonstration) Possession by inventor (e.g., embodiment) Description of Enablement Future Point

55 A written description… Literal Description (or "fair reading") Time of filing of the manner and process of making and using it of the invention… Possession by inventor (e.g., demonstration) Possession by inventor (e.g., embodiment) Description of Enablement Future Point Ariad Literal Description Inhibitor Jointly interfering Decoy