1. www.fitzpatrickcella.com Claim Construction of U.S. Pharmaceutical Patents April 19, 2005 Brian V. Slater Partner

2. 2 www.fitzpatrickcella.com U.S. Claim Construction: An Overview Claim construction is exclusively a question of law for the judge* Frequently the subject of a special hearing prior to trial (so-called “Markman hearing) Court of Appeals for the Federal Circuit reviews claim construction decisions de novo on appeal** * Markman v. Westview Instr., 517 U.S. 370 (1996) ** Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998)

3. 3 www.fitzpatrickcella.com U.S. Claim Construction: An Overview Often dispositive issue in patent lawsuit: “[T]o decide what the claims mean is nearly always to decide the case.”* This is true of pharmaceutical patent suits: E.g., claim term “hydroxypropyl methylcellulose” (HPMC) not limited to particular grade of HPMC recited in examples (summary judgment of no infringement vacated)** * Markman v. Westview, 52 F.3d 967 (Fed. Cir. 1995)(Mayer J., dissenting) ** Glaxo Wellcome, Inc. v. Andrx Pharmaceuticals, 344 F.3d 1226 (Fed. Cir. 2003)

4. 4 www.fitzpatrickcella.com Claim Construction Facts & Figures Between 1/1/98 and 4/30/2000, Federal Circuit modified claim construction in 78 of 179 cases (44%)* In about 30% of Federal Circuit claim construction cases in 2004 there was either a concurrence or dissent** * Christian A. Chu, Empirical Analysis of the Federal Circuit’s Claim Construction Trends, 16 BERKTLJ 1075 (2001) ** Claim construction Project. See ClaimConstruction.com.

5. 5 www.fitzpatrickcella.com Recent Developments

6. 6 www.fitzpatrickcella.com En Banc Rehearing: Phillips v. AWH On July 21, 2004, the Federal Circuit agreed to rehear Phillips v. AWH en banc, asking: Which has primacy: dictionaries or specification? Should claims be construed to preserve validity? What is the role of the prosecution history? What is the role of expert testimony? What deference should Federal Circuit accord? Chief Judge Mayer dissented saying it is “futile” unless Court reconsiders its holdings that claim construction is question of law

7. 7 www.fitzpatrickcella.com Evolution of U.S. claim construction jurisprudence

8. 8 www.fitzpatrickcella.com Balancing Tensions Ensuring the notice function of a patent “[I]t is only fair (and statutorily required) that competitors be able to ascertain to a reasonable degree the scope of the patentee’s right to exclude.”* Versus Giving a patent owner a fair and reasonable scope of protection * Markman v. Westview, 523 F.3d 967 (Fed. Cir. 1995).

9. 9 www.fitzpatrickcella.com Balancing Tensions Relying on intrinsic record (claims, specification and prosecution history) Versus Relying on the “ordinary meaning” of claim terms (e.g., dictionaries) and refusing to import limiting features from the specification into the claims

10. 10 www.fitzpatrickcella.com Markman v. Westview Instruments, 52 F.3d 967 (Fed. Cir. 1995) (en banc) “Claims must be read in view of the specification of which they are a part.” BUT “The written description part of the specification itself does not delimit the right to exclude.”

11. 11 www.fitzpatrickcella.com Markman v. Westview Instruments, 52 F.3d 967 (Fed. Cir. 1995) (en banc) The Court should also consider the patent’s prosecution history, if it is in evidence BUT “... the prosecution history... cannot ‘enlarge, diminish or vary’ the limitations in the claims”

12. 12 www.fitzpatrickcella.com Markman v. Westview Instruments, 52 F.3d 967 (Fed. Cir. 1995) (en banc) Extrinsic evidence (including inventor testimony, dictionaries, and learned treatises) may be “helpful” to explain scientific principles/and the meaning of technical terms and terms of art BUT Cannot be used “for the purpose of varying or contradicting the terms of the claims”

13. 13 www.fitzpatrickcella.com Vitronics: The Door for Dictionaries Opens

14. 14 www.fitzpatrickcella.com Vitronics v. Conceptronic, 90 F.3d 1576 (Fed. Cir. 1996) Intrinsic evidence is “most significant source” in claim construction Only if “genuine ambiguity” exists after reviewing intrinsic evidence may extrinsic evidence be used Dictionaries and prior art are “more objective and reliable guides” than opinion testimony Footnote 6: dictionaries worthy of “special note”

15. 15 www.fitzpatrickcella.com Claim Construction After Vitronics

16. 16 www.fitzpatrickcella.com Wang Labs v. America Online, 197 F.3d 1377 (Fed. Cir. 1999) Issue: Construction of the term “information frame” Parties agreed that the term in its general usage could be applied to both bit-mapped and character based systems Court held claims limited to character-based systems because it was only system enabled

17. 17 www.fitzpatrickcella.com Dictionaries Gain Ground

18. 18 www.fitzpatrickcella.com Bell Atl. Network v. Covad Communications, 262 F.3d 1258 (Fed. Cir. 2001) Citing Vitronics footnote 6 (that dictionaries have a “special place”), does not list dictionaries as extrinsic evidence and almost treats dictionaries as intrinsic evidence CCS Fitness v. Brunswick, 288 F.3d 1359 (Fed. Cir. 2002) Held claim term “member” was to be construed in accordance with common and technical dictionaries where nothing in specification or prosecution history overcame that meaning

19. 19 www.fitzpatrickcella.com Dictionary is King

20. 20 www.fitzpatrickcella.com Texas Digital v. Telegenix, 308 F.3d 1193, (Fed. Cir. 2002) A “heavy presumption” in favor of ordinary meaning unless disavowed in intrinsic record “Dictionaries, encyclopedias and treatises, publicly available at the time the patent issued, are objective resources that serve as reliable sources of information on the established meanings that would have been attributed to the terms of the claims by those of skill in the art... Indeed, these materials may be the most meaningful sources of information to aid judges... “ “Categorizing dictionaries as ‘extrinsic evidence’... is misplaced.”

21. 21 www.fitzpatrickcella.com The Specification Pushes Back

22. 22 www.fitzpatrickcella.com Combined Sys. v. Defense Tech., 350 F.3d 1207 (Fed. Cir. 2003) Some recent opinions, when read in isolation, may have sent the message that the specification should be consulted “solely for the limited purpose of determining whether it contradicts the dictionary meaning of a claim term” Instead, intrinsic evidence must be reviewed not only to rebut the ordinary meaning, but also to aid in every case of claim construction Despite clarification, court heavily relied on dictionary definitions to determine ordinary meaning

23. 23 www.fitzpatrickcella.com Ferguson Beauregard/Logic v. Delaware Capital, 350 F.3d 1327 (Fed. Cir. 2003) “Dictionary definitions, while reflective of the ordinary meaning of words, do not always associate those meanings with context or reflect the customary usage of words by those skilled in a particular art.” “It is the use of the words in the context of the written description and customarily by those skilled in the relevant art that accurately reflects both the ‘ordinary’ and the ‘customary’ meaning of the terms in the claims of a patent.”

24. 24 www.fitzpatrickcella.com The Tension Resurfaces

25. 25 www.fitzpatrickcella.com Merck v. Teva Pharm. USA Inc., 347 F.3d 1367 (Fed. Cir. 2003) Majority (Newman, J.; Prost, J.): claimed method of treatment using alendronic “acid” encompasses administration of salt form because: specification describes active as encompassing both acid and salt forms experts testified pharmacologists would understand use of acid encompasses salt Dissent (Mayer, J.): both sides’ experts agreed acid is a different compound than its salt specification distinguishes between the two

26. 26 www.fitzpatrickcella.com Novartis v. Eon Labs., 363 F.3d 1306 (Fed. Cir. 2004) Invention: small solid particles of cyclosporin (a very poorly soluble drug) dispersed in an aqueous medium (called a “hydrosol”) Issue: Whether claim term “hydrosol” is limited to products made outside the body or includes products formed in vivo after ingestion Both parties’ experts agreed “hydrosol” means small solid particles of cyclosporin dispersed in an aqueous medium

27. 27 www.fitzpatrickcella.com Novartis v. Eon Labs. Majority (Dyk, J.; Prost, J.) Court first consulted general purpose dictionary not cited by parties that defined “hydrosol” as a “sol in which the liquid is water” Then looked up “sol”, which was defined as “a dispersion of solid particles in a liquid colloidal solution” Then looked up “solution”, which gave multiple meanings including “a liquid and usu. aqueous medicinal preparation with the solid ingredients soluble.”

28. 28 www.fitzpatrickcella.com Novartis v. Eon Labs. Majority (Dyk, J.; Prost, J.) Then looked up “medicinal preparation” in dictionary and found it to relate to “medicine”, which in turn was defined as a “preparation” And, finally, looked up “preparation” in three dictionaries that define it as “ready for use” Then stated that “medicinal preparation” is a “preexisting product that is administered to treat disease and therefore must necessarily be prepared outside the body”

29. 29 www.fitzpatrickcella.com Novartis v. Eon Labs. Majority (Dyk, J.; Prost, J.) Court found term “hydrosol” is ambiguous because it has two possible definitions: broad one unlimited to place of formation; and narrow one limited to products made outside body According to Court, intrinsic record supported adoption of narrower definition no examples to hydrosols formed in patient’s stomach specification says hydrosol “intravenously applicable”

30. 30 www.fitzpatrickcella.com Novartis v. Eon Labs. Dissent (Clevenger, J.) None of several dictionary definitions of “hydrosol” limits where hydrosol is made Term “hydrosol” is not ambiguous and deserves full scope Applicant made no explicit disclaimer or disavowal of hydrosols made inside the body Dictionary exercise went “too far” by pursuing definition of “medicinal preparation” which required ingredients be “soluble” (cyclosporin is poorly soluble)

31. 31 www.fitzpatrickcella.com Nystrom v. Trex Co., 374 F.3d 1105 (Fed. Cir. 2004) Majority (Linn, J.; Mayer, J.) held “board” has multiple dictionary meanings not all of which are limited to sawn lumber so term was not so limited Dissent (Gajarsa, J.) claimed majority’s approach was inconsistent with Novartis v. Eon where court determined which dictionary definition was most consistent with intrinsic Majority counters that, under prior precedent, claim terms are construed to encompass all dictionary definitions not inconsistent with intrinsic record

32. 32 www.fitzpatrickcella.com Phillips v. AWH Corp., 363 F.3d 1207 (Fed. Cir. 2004) Invention: vandalism-resistant building modules consisting of modular wall panels Issue: Whether claim term “baffles” limited to those at other than at 90º Ordinary meaning of “baffle” from dictionary: “something for deflecting, checking, or otherwise regulating flow”

33. 33 www.fitzpatrickcella.com Phillips v. AWH Corp. (Majority (Lourie, J.; Newman, J.) Specification is rife with references to impact resistance against projectiles, and baffles directed at 90º cannot deflect projectiles None of the figures shows any baffle that is not at an angle other than 90º “Inspection of the patent shows that baffles angled at other than 90º is the only embodiment disclosed in the patent; it is the invention.”

34. 34 www.fitzpatrickcella.com Phillips v. AWH Corp. (Dissent (Dyk, J.) Majority improperly limited claim to preferred embodiment “We however have ‘expressly rejected the contention that if a patent describes only a single embodiment, the claims of the patent must be construed as being limited to that embodiment.’” Projectile resistance is only one of several objectives of the invention (including load bearing and thermal-acoustical isolation)

35. 35 www.fitzpatrickcella.com Phillips Petition for Rehearing En Banc: Positions in Amicus Briefs

36. 36 www.fitzpatrickcella.com Which has Primacy: the Specification or Dictionaries? NYIPLA/U.S/IPO: The primary source of claim construction should be the intrinsic evidence FCBA/ABA: “middle ground”: neither has primacy IPO: No other evidence should be considered if the claims can be construed from intrinsic sources Boston PLA: The primary audience for a patent includes the workers in the field, not “the tweed- jacketed editorial staff of the OED”

37. 37 www.fitzpatrickcella.com Should Claims be Construed to Preserve their Validity? NYIPLA/U.S.: Where there are two plausible constructions of a claim term, courts should adopt the one that preserves validity. FCBA/ABA: Claims should be construed without regard to their validity. IPO: “Claims should be construed to preserve their definiteness but IPO has serious reservations regarding interpreting claims to preserve validity on other grounds.”

38. 38 www.fitzpatrickcella.com What is the Role of Expert Testimony? NYIPLA: “Expert testimony by a credible witness, particularly when supported by documentary evidence, may be highly persuasive.” FCBA: “Expert testimony should also be permitted to the extent the trial court believes it may be useful.” ABA: “Secondary sources, such as expert testimony, may always be considered.”

39. 39 www.fitzpatrickcella.com What Deference should the Federal Circuit Accord Claim Construction Determinations? NYIPLA/ABA/FCBA: Subsidiary findings of fact should be accorded deference under a clearly erroneous standard but the ultimate construction should be subject to de novo review United States: Court should give “due consideration to a persuasive claim construction by the district court and accord due weight to its evaluation of any live testimony on this issue”

40. 40 www.fitzpatrickcella.com Phillips En Banc Oral Argument Phillips (appellant): You should read the specification, then the claims. If the claims are broader, you should rely on the claims. The purpose of the specification is to provide written description and enablement, not to narrow the claims. If you are construing an ordinary term, you can rely on a dictionary to see if there is a definition that fits with the specification. Ordinary person would know main purpose of baffle is load bearing (not bullet deflection).

41. 41 www.fitzpatrickcella.com Phillips En Banc Oral Argument AWH: You should read the specification to determine the invention. If an element is described as essential to the invention, and there are no other examples given, then it is implicitly narrowed. Load supporting function is not part of the term baffle; the only function of the baffles is bullet deflection.

42. 42 www.fitzpatrickcella.com Phillips En Banc Oral Argument U.S.: As a practical matter, patent examiners do not use dictionaries. Specification has primacy over dictionaries.

43. 43 www.fitzpatrickcella.com THANK YOU

44. 44 www.fitzpatrickcella.com ADDENDUM

45. 45 www.fitzpatrickcella.com Phillips En Banc Rehearing: Seven Questions Question #1 WHICH HAS PRIMACY, DICTIONARIES OR THE SPECIFICATION? –“Is the public notice function of patent claims better served by referencing primarily to technical and general purpose dictionaries and similar sources to interpret a claim or by looking primarily to the patentee’s use of the term in the specification? If both sources are to be consulted, in what order?”

46. 46 www.fitzpatrickcella.com Phillips Rehearing: Seven Questions Question #2 IF IT’S THE DICTIONARY, WHAT IS THE ROLE OF THE SPECIFICATION? –“If dictionaries should serve as the primary source for claim interpretation, should the specification limit the full scope of claim language (as defined by the dictionaries) only when the patentee has acted as his own lexicographer or when the specification reflects a clear disclaimer of claim scope? If so, what language in the specification will satisfy those conditions? What use should be made of general as opposed to technical dictionaries? How does the concept of ordinary meaning apply if there are multiple dictionary definitions of the same term? If the dictionary provides multiple potentially applicable definitions for a term, is it appropriate to look to the specification to determine what definition or definitions should apply?”

47. 47 www.fitzpatrickcella.com Phillips Rehearing: Seven Questions Question #3 IF IT’S THE SPECIFICATION, WHAT IS THE ROLE OF THE DICTIONARY? –“If the primary source for claim construction should be the specification, what use should be made of dictionaries? Should the range of the ordinary meaning of claim language be limited to the scope of the invention disclosed in the specification, for example, when only a single embodiment is disclosed an no other indications of breadth are disclosed?”

48. 48 www.fitzpatrickcella.com Phillips Rehearing: Seven Questions Question #4 SHOULD THERE BE A DUAL RESTRICTION? –“Instead of viewing the claim construction methodologies in the majority and dissent of the now-vacated panel decision as alternative, conflicting approaches, should the two approaches be treated as complementary methodologies such that there is a dual restriction on claim scope, and a patentee must satisfy both limiting methodologies in order to establish the claim coverage it seeks?”

49. 49 www.fitzpatrickcella.com Phillips Rehearing: Seven Questions Question #5 SHOULD CLAIMS BE CONSTRUED TO PRESERVE THEIR VALIDITY? –“When, if ever, should claim language be narrowly construed for the sole purpose of avoiding invalidity under, e.g., 35 U.S.C. §§ 102, 103 and 112?”

50. 50 www.fitzpatrickcella.com Phillips Rehearing: Seven Questions Question #6 WHAT IS THE ROLE OF PROSECUTION HISTORY? WHAT IS THE ROLE OF EXPERT TESTIMONY? –“What role should prosecution history and expert testimony by one of ordinary skill in the art play in determining the meaning of the disputed claim terms?”

51. 51 www.fitzpatrickcella.com Phillips Rehearing: Seven Questions Question #7 WHAT DEFERENCE SHOULD THE FEDERAL CIRCUIT ACCORD? –“Consistent with the Supreme Court’s decision in Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), and our en banc decision in Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998), is it appropriate for this court to accord any deference to any aspect of trial court claim construction rulings? If so, on what aspects, in what circumstances, and to what extent?”