1. www.fitzpatrickcella.com Recent Developments In Patent Law: Update On Federal Circuit Cases FITZPATRICK, CELLA, HARPER & SCINTO 30 Rockefeller Plaza New York, NY Brian V. Slater, Esq. Partner

2. www.fitzpatrickcella.com 2 Standards for Patentability A valid patent must be: Useful Novel Nonobvious Fully and appropriately described

3. www.fitzpatrickcella.com 3 Overview Written description  Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (Fed. Cir. 2002)  Enzo Biochem, Inc. v. Gen-Probe Inc., 42 Fed. Appx. 439 (Fed. Cir. 2002)  U. of Rochester v. G.D. Searle & Co., 2003 U.S. Dist. LEXIS 3030 (W.D.N.Y. 2003) Best mode  Bayer AG v. Schein Pharmaceuticals, Inc., 301 F.3d 1306 (Fed. Cir. 2002)

4. www.fitzpatrickcella.com 4 Written Description Statute “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” 35 U.S.C. § 112, ¶ 1

5. www.fitzpatrickcella.com 5 Written Description Basics Fact question Meaningful disclosure is quid pro quo to public for being excluded from practicing the invention for limited period An “application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 1966 (Fed. Cir. 1997)

6. www.fitzpatrickcella.com 6 Written Description v. Enablement Written description means describing the invention in sufficient detail that one skilled in the art can conclude that the inventor invented the claimed invention Enablement means one skilled in the art is taught by the patent how to make and use the invention, without undue experimentation

7. www.fitzpatrickcella.com 7 Written Description Basics Most often applied to priority situation, e.g., new matter added Does WD requirement apply to original claims? YES: The Regents of the University of California v. Eli Lilly and Co., 119 F.3d 1559 (Fed. Cir. 1997)

8. www.fitzpatrickcella.com 8 Lilly Facts Patent specification disclosed: –rat insulin cDNA sequences –method for obtaining them –amino acid sequences of human insulin Claims in dispute were to vertebrate, mammalian and human insulin cDNA

9. www.fitzpatrickcella.com 9 Lilly Holdings I Human cDNA claims: patent describes only general method for obtaining human-insulin encoding cDNA, but not cDNA’s relevant structural or physical characteristics description of human insulin amino acid sequences does not describe cDNA that encodes them (because of redundancy of genetic code) Court affirmed judgment that both human cDNA and genus cDNA patent claims were invalid for lack of WD:

10. www.fitzpatrickcella.com 10 Lilly Holdings II Genus cDNA claims: disclosure of rat cDNA sequences does not describe structure of sufficient members of broad “functional” classes of “vertebrate” or “mammalian” insulin cDNA “A definition by function... does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is” Lilly, 119 F.3d at 1568

11. www.fitzpatrickcella.com 11 Lilly Consequences How should one properly describe cDNA genus? According to Lilly : One way is to recite the nucleotide sequences of a representative number of cDNAs (silent as to what is representative) Another way is to recite structural features common to genus members, which features constitute a substantial portion of genus Lilly, 119 F.3d at 1569

12. www.fitzpatrickcella.com 12 Enzo Facts I Detection of bacteria that causes gonorrhoeae difficult because of high degree of homology between N. gonorrhoeae and N. meningitidis Specification referred to ATCC deposit of three sequences that preferentially hybridize to six common strains of N. gonorrhoeae over six common strains of N. meningitidis (also deposited) Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (Fed. Cir. 2002)

13. www.fitzpatrickcella.com 13 Enzo Facts II Patent claimed nucleotide sequence that preferentially hybridizes to N. gonorrhoeae over N. meningitidis by a ratio of greater than 5:1 Dependent claims were drawn to the three deposited probe sequences and discrete subsequences, mutations, and mixtures

14. www.fitzpatrickcella.com 14 Enzo Procedural Background Original panel decision (Lourie; Prost; Dyk, dissenting) affirmed judgment claims were invalid for failure to meet WD requirement of 35 U.S.C. § 112 rejected argument that deposit inherently disclosed inventors were in possession of claimed sequences On rehearing, panel unanimously vacated that decision and reversed and remanded

15. www.fitzpatrickcella.com 15 Enzo Holdings I On rehearing, Court faced with two main questions: 1.Whether Enzo’s deposits of claimed sequences of dependent claims constituted an adequate WD? Issue of first impression Reference in specification to a deposit in a public depository, when it is not otherwise available in written form, constitutes an adequate WD Remanded fact issue of whether subsequences, mutations, and mixtures were described by reference to the deposited sequences Enzo, 296 F.3d at 1325

16. www.fitzpatrickcella.com 16 Enzo Holdings II 2.Whether WD requirement is met for all claims on basis of functional ability of three deposited probe sequences to hybridize to deposited strains of N. gonorrhoeae? Depends on whether three deposited sequences are representative of the genus under Lilly PTO WD Training Example 9 provide that nucleic acid genus claims may be adequately described if nucleic acids hybridize under highly stringent conditions to known sequences Remanded issue to be decided consistent with Lilly and PTO’s WD Guidelines Enzo, 296 F.3d at 1324, 1327-28

17. www.fitzpatrickcella.com 17 Enzo Additional Issues 1.Whether reference to deposit of six strains of N. gonorrhoeae inherently describes claimed sequences that hybridize to them (i.e., by showing function/structure correlation) is a fact issue 2.Ipsis verbis inclusion of claim words in specification does not necessarily satisfy the WD requirement, e.g., an “anti-inflammatory steroid” or an “antibiotic penicillin”

18. www.fitzpatrickcella.com 18 Enzo Additional Issues 3.Even if three deposited probe sequences indicated Enzo “possessed” invention, “possession” may not be sufficient to describe invention —compare Lockwood, “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.” 4.Reduction to practice without adequate description is insufficient to describe invention Lockwood 107 F.3d at 1572, emphasis omitted

19. www.fitzpatrickcella.com 19 Enzo En Banc Rehearing Denial Only Rader, Gajarsa and Linn voted for rehearing (PTO filed brief as amicus in favor of rehearing) Dyk, who voted against rehearing, nevertheless said Court would benefit from “further percolation” of the issues Enzo Biochem, Inc. v. Gen-Probe Inc., 42 Fed. Appx. 439 (Fed. Cir. 2002)

20. www.fitzpatrickcella.com 20 Enzo En Banc Rehearing Denial Those for en banc rehearing: based on statute, there is no separate WD requirement; only an enablement requirement separate WD requirement introduced by CCPA in 1967 only for determining priority Lilly was first CAFC case to apply WD outside of a priority context Lilly and Enzo result in heightened disclosure requirement making enablement irrelevant

21. www.fitzpatrickcella.com 21 Enzo En Banc Rehearing Denial Those against en banc rehearing: WD is separate requirement from enablement Statute says “and” between mentions of WD and enablement Supreme Court in Festo said “patent application must describe, enable and set forth the best mode of carrying out the invention” Fact that prior WD cases may have dealt only with priority is circumstantial

22. www.fitzpatrickcella.com 22 Post-Enzo WD Decisions Does Enzo and Lilly WD requirement apply to pharmaceutical method of treatment claims? YES: U. of Rochester v. G.D. Searle & Co., 2003 U.S. Dist. LEXIS (W.D.N.Y. 2003).

23. www.fitzpatrickcella.com 23 Searle Facts I Cox-1 enzyme helps protect stomach lining Cox-2 enzyme associated with inflammation stimuli Prior art drugs (NSAID’s) inhibited both Cox-1 and Cox-2 U. Rochester scientists discovered existence of Cox-2 and its separate function from Cox-1

24. www.fitzpatrickcella.com 24 Searle Facts II Patent describes screening assays useful for development of drugs that selectively inhibit inflammation without producing side effects due to inhibition of Cox-1 Patent says assays are for screening compounds including peptides, polynucleotides and small organic molecules Patent claims method of administering to humans a non-steroidal compound that selectively inhibits Cox-2 activity and has minimal effect on Cox-1 activity

25. www.fitzpatrickcella.com 25 Searle Holding Court held (Larimer, J.) patent failed to provide WD of claimed invention: patent only describes the function of compound called for but no showing of correlation between function and structure (relying on PTO WD Guidelines) inventors did not identify even one suitable compound patent is merely “research plan” that describes tests to run on wide spectrum of compounds in hope at least one will work

26. www.fitzpatrickcella.com 26 Searle Additional Issues Court rejected plaintiff’s contention that Enzo and Lilly limited to claims directed to nucleic acid sequences: Lilly ’s holding that the inventors must describe invention is not limited to genetic material Enzo gave specific non-DNA examples of descriptions that would not meet the WD requirement, i.e., “anti-inflammatory steroid” and “antibiotic penicillin”

27. www.fitzpatrickcella.com 27 Searle Additional Issues Court rejected plaintiff’s argument that WD requirement doesn’t apply to method of treatment claims: claimed method depends upon finding a compound that selectively inhibits Cox-2 “It means little to “invent” a method if one does not have possession of a substance that is essential to practicing that method” University of Rochester, 2003 U.S. Dist. LEXIS 3030 at *31

28. www.fitzpatrickcella.com 28 Status of WD Requirement Insufficient votes to overturn Lilly/Enzo application of WD to original claims Genus can be described by identifying sufficient number of species or structural features common to substantial portion of genus ( Lilly ) Functional descriptions not enough unless clear correlation between function and structure ( Enzo ) WD requirement applies to pharmaceuticals, nucleic acids, methods of treatment, and compositions ( Searle ) PTO WD Guidelines important reference for prosecutors, opinion givers and litigators ( Enzo/Searle )

29. www.fitzpatrickcella.com 29 Best Mode Statute “The specification... shall set forth the best mode contemplated by the inventor for carrying out his invention.” 35 U.S.C. § 112, ¶ 1

30. www.fitzpatrickcella.com 30 Best Mode Basics Fact question based on two part test: 1. Subjective test: Did inventor at time of filing application possess best mode for practicing invention? 2. Objective test: Is inventor's disclosure adequate to enable one of ordinary skill in art to practice the best mode? Best mode violation need not be intentional Bayer AG v. Schein Pharmaceuticals, Inc., 301 F.3d 1306, 1320 (Fed. Cir. 2002)

31. www.fitzpatrickcella.com 31 Best Mode Basics “The purpose of the best mode requirement is to ensure that the public, in exchange for the rights given the inventor under the patent laws, obtains from the inventor a full disclosure of the preferred embodiment of the invention.” Dana Corp. v. IPC Ltd. Partnership, 860 F.2d 415, 418 (Fed. Cir. 1988)

32. www.fitzpatrickcella.com 32 Best Mode v. Enablement Best mode is separate and distinct from enablement Enablement under § 112 requires specification to disclose an invention in such a manner as will teach one of skill in the art how to make and use it Because of subjective nature of best mode inquiry, unlike enablement, it cannot be met by “mute” reference to the knowledge of one of ordinary skill in the art and requires actual disclosure Bayer AG, 301 F.3d at 1314

33. www.fitzpatrickcella.com 33 Barr Case Claims to antidepressant drug Prozac Applicant did not disclose (a) cheaper/better method for making starting material or (b) preferred solvent for recrystallizing and purifying end product No best mode violation: –Neither starting material nor method to make it were claimed, and starting material commercially available, not “novel” –Recrystallization with a solvent disclosed and not claimed; selection of particular solvent routine to person of skill in the art Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955 (Fed. Cir. 2001)

34. www.fitzpatrickcella.com 34 Bayer Case Bayer AG v. Schein Pharmaceuticals, Inc., 301 F.3d 1306 (Fed. Cir. 2002) What is the proper legal test for meeting the best mode requirement? Is the best mode requirement limited to subject matter within the scope of the claims? Is best mode a trap only for “unwary” or for “wary” too?

35. www.fitzpatrickcella.com 35 Bayer Facts Patent directed to class of antibiotics including CIPRO Patent disclosed way to make CIPRO: 6-FQA + piperazine = CIPRO Patent did not disclose inventor’s preferred way of making 6-FQA, using “Klauke” compound

36. www.fitzpatrickcella.com 36 Bayer Discussion Of Law Focus is on carrying out the invention, i.e., as defined by the claims CAFC only ever invalidated claims for failure to satisfy best mode requirement seven times Two categories of best mode violation: 1.Failure to disclose a preferred embodiment 2.Failure to disclose aspects of making or using the claimed invention and the undisclosed matter materially affected the properties of the claimed invention Bayer AG, 301 F.3d at 1319

37. www.fitzpatrickcella.com 37 Bayer Holding CAFC affirmed district court’s finding of no best mode violation Must first construe claims Claims are to CIPRO end product, not the intermediate Schein conceded inventor’s preferred way of making intermediate had no material effect on properties of claimed CIPRO end product

38. www.fitzpatrickcella.com 38 Bayer Comments On “Novelty” Test Court rejected Schein’s argument (based on Barr ) that disclosure of preferred synthetic route to intermediate is mandatory because intermediate is “novel” According to Court, Barr “merely acknowledged that when a novel compound is necessary to practice the best mode, one of skill in the art must be able to obtain that compound,” i.e., the best mode must be enabled Bayer AG, 301 F.3d at 1322

39. www.fitzpatrickcella.com 39 Bayer – Rader Concurrence I Judge Rader issued concurring opinion: District Court correctly applied law in concluding best mode was an intermediate, not the claimed invention, and its disclosure was not compelled Majority should have halted its analysis there There is no support in statute or case law for widening best mode net to include “properties” of invention far less any “material effect or impact on those properties” Bayer AG, 301 F.3d at 1324

40. www.fitzpatrickcella.com 40 Bayer – Rader Concurrence II Applicants have commercial incentive to disclose best mode because otherwise “trade secret” status may be lost to competitor who obtains blocking patents Best mode historically was trap only for uninformed applicant because it was limited to a clear “scope of claimed invention” approach Extending best mode requirement to unclaimed “uses” and “properties” makes it also a trap for the wary: -what is a “property”? - what is a “material effect”? -how “material” is “material”?

41. www.fitzpatrickcella.com 41 Example Of Best Mode Affecting Invention’s Properties Patent on valve stem seal for use in engine Seal included portion of elastomeric material Inventor concluded fluoride surface treatment was necessary to satisfactory performance of seal; otherwise it leaked Specification did not disclose fluoride treatment Held: best mode violation Dana Corp. v. IPC Ltd. Partnership, 860 F.2d 415, 420 (Fed. Cir. 1988)

42. www.fitzpatrickcella.com 42 Example of Best Mode Affecting Invention’s Properties Bayer majority: “In Dana...the inventors failed to disclose subjective preferences that related to the use of the claimed inventions, and the undisclosed information materially affected the properties of the claimed inventions.” Rader concurrence: “Having invented a unique seal apparatus, the inventor could not have guessed that the best mode would reach out to encompass a process to increase the useful life of one component of the invention a process that was already well known in the prior art to boot.” Bayer AG, 301 F.3d at 1319, 1325

43. www.fitzpatrickcella.com 43 Status of Best Mode Requirement Lack of predictability in law “Materially affect” and “properties” are undefined Need for en banc clarification by CAFC In meantime, applicants need to carefully consider not only “claimed invention” but (1) way it is made and used; and (2) whether these affect its “properties” ( Bayer/Dana ) If in doubt -- disclose

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