RECENT BIOTECH CASE LAW

1. RECENT BIOTECH CASE LAW Stephen Walsh, Ph.D., J.D. Associate Solicitor Prepared for Biotech/Chem/Pharm Customer Partnership Meeting, November 10, 2005

2. Today’s topics • WRITTEN DESCRIPTION • UTILITY • DISCLOSING INFORMATION TO THE PTO • OBVIOUSNESS • CLAIM CONSTRUCTION

3. WRITTEN DESCRIPTION Case law includes several tests for written description, including possession, but two themes are re-emerging in recent decisions. Is the Federal Circuit’s written description jurisprudence converging?

4. Possession Tests Variety of ways disclosure could show possession such as: • Described an actual reduction to practice • Showed the invention was ready for patenting such as by the disclosure of drawings or structural chemical formulas showing the invention was complete • Described distinguishing identifying characteristics sufficient to show possession • Other….

5. What Are Distinguishing Identifying Characteristics? • Complete or partial structure • Other physical and/or chemical properties • Functional characteristics when coupled with a known or disclosed correlation between function and structure • Some combination of such characteristics

6. Themes Re-emerging In Recent Written Description Cases • MPEP 2163 II.A.2: Inverse correlation between level of skill and knowledge in the art and the amount of description needed – what is already known does not have to be repeated in the specification • MPEP 2163 II.A.3.ii: Predictability in genus/species cases – representative number inverse function of level of skill and knowledge in the art

7. First re-emergent theme: credit for what is already known • Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) • old DNAs fused to make chimeric genes • Amgen v. Hoecsht Marion Rousell, 314 F.3d 1313 (Fed. Cir. 2003) • mammalian and vertebrate cells • Union Oil Co. of Cal. v. Atlantic Richfield, 208 F.3d 989 (Fed. Cir. 2000) • gasoline formulations • Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570 (Fed. Cir. 1985) • food product

8. Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) Claims directed to chimeric genes to be made from known DNA sequences of known function using known procedures The Board found that “persons having ordinary skill would not have been able to visualize and recognize the identity of the claimed genetic material without considering additional knowledge in the art, performing additional experimentation, and testing to confirm results”

9. Capon (cont.) The Court explained: • “descriptive text needed . . . varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence” • “as each field evolves, the balance also evolves between what is known and what is added by each inventive contribution” • “Board’s rule . . . is an inappropriate generalization”

10. A very old theme Loom Co. v. Higgins, 105 U.S. 580, 586 (1881) The inventor “may begin at the point where his invention begins, and describe what he has made that is new, and what it replaces of the old. That which is common and well known is as if it were written out in the patent and delineated in the drawings.”

11. Second re-emergent theme: predictability in genus claims In re Lukach, 442 F.2d 967, 968 (CCPA 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.”

12. Really an old theme: predictability in the art Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245, 256 (1928) “an inventor may not describe a particular starch glue which will perform the function of animal glue and then claim all starch glues which have those functions”

13. Univ. Of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004) Paraphrased claim: A method of selectively inhibiting an enzyme comprising administering a selective inhibitor. • District court found no disclosure of selective inhibitor structure or physical properties, and selective inhibitor structure could not be deduced from any known structure. • The claimed method was not adequately described. • A “reach through” claim?

14. In re Curtis,354 F.3d 1347 (Fed. Cir. 2004) Claim: Dental floss “having a coating of at least one material capable of increasing the coefficient of friction.” • Generic claim was not supported by parent application disclosing one microcrystalline wax coating. • “[A] patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when . . . the evidence indicates ordinary artisans could not predict the operability . . . of any other species.”

15. In re Wallach,378 F.3d 1330 (Fed. Cir. 2004) Claim: Isolated DNA encoding TBP-II. • Inventor described the purified protein TBP-II by its molecular weight, biological activity, and a partial amino acid sequence listing ten amino acids. • Credited with possession of the genus of DNA molecules encoding the partial protein structure, but not DNA encoding the entire protein. • No evidence that there is any known or disclosed correlation between the combination of a partial structure of a protein, the protein’s biological activity, and the structure of the DNA encoding the protein.

16. Bilstad v. Wakalopulos,386 F.3d 1116 (Fed. Cir. 2004) • sterilizing apparatus • “if the art is unpredictable, then disclosure of more species is necessary to adequately show possession of the entire genus” • Remanded for further fact finding on the understanding of predictability in this art

17. LizardTech v. Earth Resources Mapping,___ F.3d ___, 2005 WL 2429824 (Fed. Cir. Oct. 4, 2005) • digital image transform process (DWT) • Specification described a particular seamless DWT algorithm, but claim also covered a nonseamless algorithm • Person of skill in the art would not have understood LizardTech to have invented a method for DWT except by the particular disclosed method

18. Time out for a tip about a process described in a provisional application • Provisional applications don’t have claims • A spec that describes only one order of steps might not cover another order • Process claims are construed to cover any order, but specs are not • Be alert to unintended process limitations • In re Holcomb, No. 04-1550 (Fed. Cir. April 14, 2004)

19. UTILITY Section 101: “any new and useful . . . .” “Useful” means that a specific and substantial utility is currently available.

20. In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005) • Nucleic acid comprising any of SEQ ID NO:1 to 5 • SEQ ID NO:1 to 5 are ESTs characterized as being from corn leaves • Proposed uses: chromosome marker, measure mRNA levels, primers, find polymorphisms, isolate promoters, control expression, locate other organism molecules

21. Fisher (cont.) • Board found no specific and substantial utility, CAFC affirmed • Board’s reasoning tracked guidelines • CAFC agreed that Brenner v. Manson, 383 U.S. 519 (1966), is controlling precedent • CAFC agreed that Fisher’s proposed uses were the sort of “use-testing” that fails under the Manson standard

22. DISCLOSING INFORMATION TO THE PTO • Star Fruits v. USA, 293 F.3d 1277 (Fed. Cir. 2005) • Rule 105: Applicant must disclose nonfrivolous information if examiner asks for it • Purdue Pharma L.P. v. Endo Pharmaceuticals Inc., 410 F.3d 690 (Fed. Cir. 2005) • Rule 56: Applicant must disclose material information without being asked for it • past tense for prophetic example violated duty of candor • Novo Nordisk v. BioTechnology Gen., ___ F.3d ____, 2005 WL 2443857 (Fed. Cir. Oct. 5, 2005) • past tense for prophetic example violated duty of candor

23. Star Fruits v. USA,393 F.3d 1277 (Fed. Cir. 2005) • 37 C.F.R. § 1.105 (Rule 105): Office may require applicant to submit information reasonably necessary to examine or treat a matter

24. Star Fruits (cont.) Rule 105 authorizes PTO to require applicants to provide: • information relevant to examination procedurally or substantively • information that supports a rejection • information that might not support a rejection (materiality is not the standard) • information relevant to patentability under any nonfrivolous legal theory

25. Purdue Pharma v. Endo Pharms.,410 F.3d 690 (Fed. Cir. 2005) • District court’s inequitable conduct finding affirmed • Purdue repeatedly told the examiner what it had “discovered,” and its surprising “result” • Statements were made to overcome obviousness rejection • Failure to disclose that the discovery was an insight, not a result, was material • Purdue intentionally misled the PTO

26. Novo Nordisk Pharms. v. Bio-Technology Gen., ___ F.3d ____, 2005 WL 2443857 (Fed. Cir. Oct. 5, 2005) • District court found inequitable conduct based on: • Examiner relied on Example 1 to support enablement • Board relied on Novo’s expert testimony about Example 1 to support enablement in an interference proceeding • Novo failed to disclose that Example 1 had never been performed • Novo failed to disclose that it had not been able to perform Example 1 successfully • Novo argued that district court erred because: • It did not make a finding that anyone had actual knowledge that Example 1 was prophetic • It did not make a finding that anyone had actual knowledge that Example 1 never worked • It did not make a finding that the author of Example 1 had actual knowledge that a prophetic example in the past tense is not good procedure • Federal Circuit rejected Novo’s “circular logic”

27. OBVIOUSNESS • Range overlapping prior art range prima facie obvious • In re Harris, 409 F.3d 1339 (Fed. Cir. 2005) • Harris sharply distinguishes, and may limit, dictum in In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003) • Case to watch: Teleflex, Inc. v. KSR Int’l Co., 119 Fed. Appx. 282 (Fed. Cir. 2005) (non-precedential), cert. petition pending at the Supreme Court

28. In re Harris,,409 F.3d 1339 (Fed. Cir. 2005) (nickel-base superalloy comprising nickel plus percentages of 12 other elements) • Reaffirms prima facie obviousness if prior art discloses overlapping ranges • Distinguishes dictum in earlier opinion about “broad” ranges in prior art

29. CLAIM CONSTRUCTION • PTO applies the broadest reasonable interpretation in light of the specification • Do dictionaries trump the specification?

30. Phillips v. AWHCorp., 415 F.3d 1303 (Fed. Cir. 2005) Issue: extent to which specification is used for finding proper scope of claims • person of ordinary skill reads the claim in context of entire patent • specification: the single best guide to the meaning of a disputed term, note 37 CFR 1.75(d)(1) • prosecution history: created by patentee in attempting to explain the invention • extrinsic evidence less reliable than patent and prosecution history

31. Phillips (cont.) Why extrinsic evidence is less reliable than intrinsic evidence: • Not part of the patent • Extrinsic pubs may not be written by or for skilled artisans • Bias not present in intrinsic evidence • Unbounded universe of marginally relevant extrinsic evidence • Undue reliance on extrinsic evidence risks changing the meaning of claims

32. Phillips (cont.) Problems arise if a dictionary is given more weight than the specification: • focus on the abstract meaning of words rather than on the meaning of claim terms within the context of the patent • collection of multiple definitions from common to obscure may extend patent protection beyond what should properly be afforded

33. Nystrom v. Trex, ___ F.3d ___, 2005 WL 2218631 (Fed. Cir. Sept. 14, 2005) Pre-Phillips decision (dictionary meaning + no scope disclaimer) withdrawn ! • “board” not limited to boards of wood • “manufactured” not limited to processes of woodworking techniques • finding of non-infringement reversed Post-Phillips decision turns on context of written description and prosecution history • “board” is limited to boards of wood • “manufactured” is limited to processes of woodworking techniques • finding of non-infringement affirmed

34. THANK YOU stephen.walsh@uspto.gov (571) 272-9035