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Obviousness of Drug Compounds And Formulations

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Overview of patent cases directed to the obviousness of drug compounds and formulations

Overview of patent cases directed to the obviousness of drug compounds and formulations

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  • 1. 1 Obviousness for Drug Compounds and Formulations Kevin B. Laurence Samuel E. Webb Danish Patent Office November 11, 2009
  • 2. 2 Disclaimer • This presentation is for information purposes only and does not constitute legal advice. Patent issues are fact-dependent and require the assistance of counsel experienced with such issues. This presentation does not establish any form of attorney-client relationship. • The views expressed in this presentation are solely those of the presenter and do not represent the views of Stoel Rives LLP or clients of Stoel Rives LLP. • Note that while every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.
  • 3. Overcoming the Presumption based on3 Structural Similarity • In re Papesch, 315 F.2d 381 (C.C.P.A. 1963). • The claimed compound had three ethyl groups where the prior art had three methyl groups.” • Specification disclosed that the claimed trialkyl compounds had unexpectedly potent anti-inflammatory activity compared with the trimethyl compound.
  • 4. 4 In re Papesch • The Board of Appeals held that a newly discovered advantageous property may be useful for establishing nonobviousness “where some doubt of unobviouness exists,” but is “insufficient alone to override the holding of unpatentability in a clear case of obviousness.” • The CCPA held that the Board of Appeals erred in failing to consider the pharmacologically advantageous property of the compounds on the basis that to chemists the structure of the claimed compounds would be so apparent that a finding of obviousness was not questionable.
  • 5. 5 In re Papesch • “If that which appears, at first blush, to be obvious though new is shown by evidence not to be obvious, then the evidence prevails over surmise or unsupported contention and a rejection based on obviousness must fall.” • “Patentability has not been determined on the basis of the obviousness of structure alone.”
  • 6. 6 In re Papesch • “From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing. The graphic formulae, and the chemical nomenclature, systems of classification and study such as the concepts of homology, isomerism, etc., are mere symbols by which compounds can be identified, classified, and compared. But a formula is not a compound and while it may serve in a claim to identify what is being patented…the thing that is patented is not the formula but the compound identified by it.”
  • 7. 7 Patentability of structurally obvious compounds based on new property • Under Papesch there is a two step inquiry: – First, is there a structurally similar compound, which would suggest that the claimed compound and the prior art compound have similar properties? If there is no such compound then the analysis is complete. – Second, does the claimed compound have new, nonobvious properties?
  • 8. 8 Patentability of structurally obvious compounds based on new property • Examples, under Papesch, of the patentability of a structurally obvious variant of a prior art compound with a new, nonobvious property: – In re de Montmollin, 344 F.2d 976 (C.C.P.A. 1965) (The compound able to dye cotton was obvious in light of a structurally similar compound able to dye wool. – In re Hoch, 4289 F. 2d 1341 (C.C. P.A. 1970). (Herbicide was obvious in light of a structurally similar compound used for “treatment of plant disease.”
  • 9. In re Dillon, 919 F.2d 688 9 (Fed. Cir. 1990)(en banc) • Dillon originally claimed a hydrocarbon fuel in combination with tri- or tetra-orthoesters. Dillon’s patent application indicated that tri- and tetra-orthoesters had equivalent activity in reducing particulate emissions. • Prior art taught that tri-orthoesters were known to be useful as additives for dewatering hydrocarbon fuels. • Dillon amended the claims to recite the fuel with only tetra-orthoesters. • Based on the structural similarity of the tri-orthoesters and tetra-orthoesters, it was expected that tetra- orthoesters would also be useful as a fuel additive for a purpose such as dewatering fuels.
  • 10. 10 In re Dillon • Dillon’s broadest composition claim: – 2) A composition comprising: a hydrocarbon fuel; and a sufficient amount of at least one orthoester so as to reduce the particulate emissions from the combustion of the hydrocarbon fuel, wherein the orthoester is of the formula: wherein R5, R6, R7, and R8 are the same or different monovalent organic radical comprising 1 to about 20 carbon atoms
  • 11. 11 In re Dillon • The Issue: “[W]hether the Board erred in rejecting as obvious under 35 U.S.C. § 103 claims to Dillon’s new composition and to the new method of reducing particulate emissions, when the additives in the new composition are structurally similar to additives in known compositions, having a different use, but the new method of reducing particulate emissions is neither taught nor suggested by the prior art?”
  • 12. 12 In re Dillon • FC: “This court, in reconsidering this case in banc, reaffirms that structural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions, creates a prima facie case of obviousness, and that the burden (and opportunity) then falls on an applicant to rebut that prima facie case. Such rebuttal or argument can consist of a comparison of test data showing that the claimed compositions possess unexpectedly improved properties or properties that the prior art does not have[.]”
  • 13. 13 In re Dillon • FC: Dillon’s invention was obvious despite the new use of the claimed compound. – “We believe that the PTO has established, through its combination of references, that there is a sufficiently close relationship between the tri- orthoesters and tetra-orthoesters in the fuel oil art to create an expectation that hydrocarbon fuel compositions containing the tetra-orthoesters would have similar properties, including water scavenging, to like compositions containing the tri-orthoesters, and to provide the motivation to make such new compositions.
  • 14. 14 In re Dillon • Data not presented to rebut prima facie obviousness: – “The art provided the motivation to make the claimed composition in the expectation that they would have similar properties. Appellant had the opportunity to rebut the prima facie case. She did not present any showing of data to the effect that her compositions had properties not possessed by the prior art compositions or that they possessed them to an unexpectedly greater degree.”
  • 15. Prima facie obviousness: 15 In re Dillon • “[I]t is not necessary in order to establish a prima facie case of obviousness that both a structural similarity between a claimed and prior art compound be shown and that there be a suggestion in or expectation from the prior art that the claimed compound or composition will have the same or similar utility as one newly discovered by applicant.”
  • 16. 16 Eli Lilly and Co. v. Zenith Goldline Pharmaceuticals, Inc. (Fed. Cir. 2006) (RADER, Schall, Gajarsa) • DC in Indiana: Patent valid and infringed • FC: affirmed • Claimed compound:
  • 17. Eli Lilly and Co. v. Zenith Goldline 17 Pharmaceuticals, Inc. (Fed. Cir. 2006) Prior Art Compounds
  • 18. Eli Lilly and Co. v. Zenith Goldline 18 Pharmaceuticals, Inc. (Fed. Cir. 2006) • “Until discovery of olanzapine, researchers attributed the efficacy of clozapine and typical antipsychotics to their “neuroleptic substituent”—an electron-withdrawing group considered important to the antipsychotic activity of the compounds. Id. Halogen – a fluorine (F) or chlorine (Cl) atom – is such an electron withdrawing group.” • “Olanzapine does not have a halogen atom, i.e. a fluorine (F) or chlorine (Cl) atom. Instead, it has a hydrogen atom (H), which is not an electron withdrawing (or electronegative) group. Id. at 48.”
  • 19. Eli Lilly and Co. v. Zenith Goldline 19 Pharmaceuticals, Inc. (Fed. Cir. 2006) • “For a chemical compound, a prima facie case of obviousness requires “structural similarity between claimed and prior art subject matter . . . where the prior art gives reason or motivation to make the claimed compositions.” In re Dillon, 919 F.2d 688, 692 (Fed. Cir. 1990) (en banc). “[A] reasonable expectation of success, not absolute predictability” supports a conclusion of obviousness. In re Longi, 759 F.2d 887, 896 (Fed. Cir. 1985).”
  • 20. Eli Lilly and Co. v. Zenith Goldline 20 Pharmaceuticals, Inc. (Fed. Cir. 2006) • “Prior art taught that the addition of a fluorine or chlorine enhanced antipsychotic activity. It also taught that the unfluorinated Compound ‘222 was less active than the benchmark compound, clozapine. Thus, rather than providing the requisite motivation, the prior art taught away from selecting Compound ‘222 as a lead compound for further development.”
  • 21. Eli Lilly and Co. v. Zenith Goldline 21 Pharmaceuticals, Inc. (Fed. Cir. 2006) • Prior art compounds “had significant detrimental side effects.” • Nothing in prior art taught that the detrimental side effects could be avoided by making structural changes.
  • 22. Eli Lilly and Co. v. Zenith Goldline 22 Pharmaceuticals, Inc. (Fed. Cir. 2006) • “Mere identification in the prior art of each component of a composition does not show that the combination as a whole . . . is obvious.” • Rather, to establish a prima facie case of obviousness based on a combination of elements in the prior art, the law requires a motivation to select the references and to combine them in the particular claimed manner to reach the claimed invention.
  • 23. Eli Lilly and Co. v. Zenith Goldline 23 Pharmaceuticals, Inc. (Fed. Cir. 2006) • Furthermore, Lilly overcame any prima facie case of obviousness by extensive evidence regarding secondary considerations. • “Lilly established: (1) a long-felt and unmet need; (2) failure of others; (3) industry acclaim; and (4) unexpected results”
  • 24. Eli Lilly and Co. v. Zenith Goldline 24 Pharmaceuticals, Inc. (Fed. Cir. 2006) The record showed: • a long-felt need for a safer, less toxic, and more effective clozapine-like drug; • a decade (or more) of failure to find a replacement for clozapine; • a reasonable amount of commercial success for olanzapine; • a number of awards for olanzapine as indicators of industry acclaim; • unexpected differences between olanzapine and the closest analog, Compound ‘222, as well as other similar drugs.
  • 25. 25 Federal Circuit – Post KSR • On April 30, 2007, in KSR v. Teleflex, t U.S. Supreme the Court held that the Federal Circuit applied the TSM test in a narrow, rigid manner that is inconsistent with § 103 and Graham v. John Deere and provided a variety of rationales for finding obviousness. • The Federal Circuit already began adjusting its obviousness jurisprudence before the KSR decision. However, it was still surprising in May 2007 that the Federal Circuit denied a petition for panel rehearing of Pfizer v. Apotex which involved a finding of obviousness based on an “obvious to try” rationale which seemed to.
  • 26. U.S. PTO – Post KSR 26 A. Combining prior art elements according to known methods to yield predictable results. B. Simple substitution of one known element for another to obtain predictable results. C. Use of known technique to improve similar devices in same way to achieve a result that would have been predictable to one of ordinary skill in the art. D. Applying a known technique to a known device ready for improvement to yield predictable results. E. “Obvious to try”—choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. F. Known work in one field may prompt variations of it for use in same or different field based on design incentives or market forces if the variations would have been predictable. G. The teaching-suggestion-motivation (TSM) test. H. Anything else that can be used to prove obviousness.
  • 27. Pfizer v. Apotex 27 480 F.3d 1348 (Fed. Cir. March 22, 2007) reh’g and reh’g en banc denied, (Fed. Cir. May 21, 2007), cert denied, (U.S. Oct 01, 2007) (MICHEL, Meyer, Linn) • “Even if the patentee showed that the claimed compound “exhibits unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion.” • This contradicts In re Papesch as pointed out by Judge Lourie in his dissent. “Any useful and unexpected property should be eligible to overcome a prima facie obviousness determination.”
  • 28. 28 Pfizer v. Apotex • Judge Lourie’s dissent criticized the emphasis on therapeutic properties instead of manufacturing properties and quoted In re Papesch, 315 F.2d 381 (CCPA 1963): • “From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.... There is no basis in law for ignoring any property in making such a comparison.”
  • 29. 29 Takeda Chem v. Alphapharm 492 F.3d 1350 (Fed. Cir. June 28, 2007) (LOURIE, Bryson, Dyk) • Claim 1 recites: • The ethyl-substituted pyridyl ring encompasses four possible compounds as the ethyl substituent (C2H5) is located at one of four available positions on the pyridyl ring.
  • 30. 30 Takeda Chem v. Alphapharm • Claim 2 covers pioglitazone (the 5-ethyl compound) which has the ethyl substituent attached at the 5-position of the pyridyl ring
  • 31. 31 Takeda Chem v. Alphapharm • Alphapharm asserted that the claimed compounds were obvious based on a prior art compound known as "compound b." Compound b possesses a pyridyl ring in which a methyl (CH3) group is attached to the 6-position. O O C 2H 5 NH NH S S N O CH 3 N O O O Pioglitazone "Compound b"
  • 32. 32 Takeda Chem v. Alphapharm • DC concluded that “there was no motivation in the prior art to select compound b as a lead compound for antidiabetic research, and that the prior art actually taught away from its use.” • DC also concluded that even if Alphapharm had succeeded in making a prima facie case of obviousness, such a showing would be rebutted by the unexpected results of pioglitazone's nontoxicity.
  • 33. 33 Takeda Chem v. Alphapharm • DC and FC: nonobvious • FC’s analysis: – Alphapharm failed to shows that Compound b would have been selected as the lead compound – Alphapharm failed to show a reason to modify Compound b to achieve the claimed compounds.
  • 34. Aventis v. Lupin 34 (Fed. Circ. September 11, 2007) (LINN, Mayer, Robertson by designation) • ramipril (Altace), for blood pressure • contains 5 stereocenters, all “S” configuration • prior art = enalapril (3 stereocenters, all “S”) ramipril enalapril
  • 35. 35 Aventis v. Lupin • prior art (Schering) synthesized a mixture of 5S isomer with SSSSR isomer of ramipril • prior art (Merck, etc) disclosed previous ACE inhibitors with all “S” stereochemistry, including enalapril, with SSS having stronger activity than SSR isomer • prior art (Schering) disclosed separation of ramipril isomers by chromatography or crystallization • since KSR, no need for an explicit teaching in the prior art to purify the 5S isomer from a mixture: obvious • Aventis failed to show unexpected results to rebut
  • 36. 36 Ortho- Ortho-McNeil v. Mylan Laboratories (Fed. Cir. March 31, 2008) (RADER, Michel, Linn) • topiramate (Topomax); epilepsy drug • lower court permanently enjoined Mylan from infringing Ortho’s product, and the FC affirmed • Ortho was searching for new diabetes drugs, but found that a synthetic intermediate (itself derived from DPF) for an anti- diabetic compound was a potent anticonvulsant O OH O OSO2NH2 O O O O O O O O DPF (di-isopropylidine fructose) topiramate
  • 37. 37 Ortho v. Mylan • CAFC: a skilled artisan “would not even be likely” to start with DPF as a lead compound to design a diabetes drug • hindsight analysis is inappropriate • the subject matter as a whole must be examined at the time the invention was made; not obvious • secondary considerations also support nonobviousness – powerful unexpected results – skepticism of experts and copying – commercial success
  • 38. 38 Eisai v. Dr. Reddy’s/Teva (Fed. Circ. July 21, 2008) (RADER, Linn, Prost) • rabeprazole (Aciphex); PPI for ulcers, GERD • prior art = lansoprazole, omeprezole, Brändström
  • 39. 39 Eisai v. Dr. Reddy’s/Teva • Teva claimed rabeprazole was obvious because of lansoprazole, omeprazole and Brändström’s core • prior art (lansoprazole) contained a CF3 group in order to increase lipophilicity, but rabeprazole has no F’s • omeprazole not structurally similar enough • no “reasoned identification of a lead compound” since the F’s were removed, so lansoprazole not a valid lead because no motivation to select it • no other support to select leads other than lansoprazole • thus, not obvious to make rabeprazole
  • 40. 40 Sanofi v. Apotex (Fed. Circ. December 12, 2008) (NEWMAN, Lourie, Bryson) • clopidogrel bisulfate (Plavix); blood thinner • single enantiomer • prior art = racemic mixture
  • 41. 41 Sanofi v. Apotex • CAFC: the separation of the mixture was not routine or simple (salt with (+)-camphorsulfonic acid/acetone) • Apotex cited no reference that showed or suggested a reliable method of separation for analogous compounds • success in the separation was unpredictable • unknown before the separation which isomer desirable • KSR recognized hindsight bias as inappropriate • not obvious to separate the enantiomers
  • 42. 42 P&G v. Teva (Fed. Circ. May 13, 2009) (Mayer, Dyk, Huff by designation) • risedronate (Actonel); osteoporosis • 3-pyridyl EHDP risedronate prior art
  • 43. 43 P&G v. Teva • prior art = 2-pyridyl EHDP • bisphosphonate art at the time was very unpredictable • 3-pyr EHDP much less toxic, 4-pyr EHDP not active • CAFC: no evidence that the structural modification was routine in the art, so no prima facie case of obviousness • even if a prima facie case had been shown, the unexpected results would successfully rebut • secondary considerations (commercial success and meeting a long-felt need) supported nonobviousness
  • 44. Altana v. Teva 44 (Fed. Circ. May 14, 2009) Newman (concur), Gajarsa, WARD by designation) • pantoprazole (Protonix); PPI for ulcers, GERD • 3-methoxy pyridine group; prior art = 3-methyl pantoprazole prior art
  • 45. 45 Altana v. Teva • review of a denied preliminary injunction requested by Altana in the lower court decision • CAFC can only reverse if lower court abused discretion and their decision was clearly erroneous • lower standard for determining obviousness – must only establish a likelihood of success on the merits – burden then shifts to patentee to show lack of merit – not the “clear and convincing” evidence standard for trials
  • 46. 46 Altana v. Teva • prior art compound was identified as one of the “more potent” of 18 compounds for which data was given • additional prior art (Sachs) taught that the optimum pKa for PPI = 4 • additional prior art (Bryson) taught that the pKa of 3-methoxy pyridine is closer to 4 than the pKa of 3-methyl pyridine • CAFC: prior art compound was a reasonable lead compound from which to pursue further development • lower court’s decision for sufficient case of obviousness on merits was affirmed (i.e., likelihood of success) • Newman concurrence: evidence doesn’t establish obviousness, but deference to lower court given in a preliminary injunction phase
  • 47. 47 Summary of Recent Drug Structural Obviousness Cases case date holding comments Aventis v. Lupin Sept 2007 obvious Ortho v. Mylan March 2008 not obvious Eisai v. Dr. Reddy July 2008 not obvious strategic error by Defense? Sanofi v. Apotex Dec 2008 not obvious P&G v. Teva May 2009 not obvious weak experts by Defense? Altana v. Teva May 2009 obvious preliminary injunction
  • 48. 48 Recent CAFC Decisions on Obvious Drug Formulation Claims • 6 cases post-KSR discuss obviousness as applied to drug formulations • much “closer” cases; half (3/6) were 2:1 – dissent by Gajarsa in Abbott v. Sandoz – dissent by Newman in Bayer v. Barr – dissent by Mayer in Ortho v. Teva
  • 49. McNeil v. Perrigo 49 (Fed. Circ. April 14, 2008) Lourie, Rader, Bryson (per curiam) • CAFC affirmed lower court decision without opinion • famotidine (Pepsid Complete) • oral histamine H2 receptor NH 2 antagonist drug + antacid N NH 2 • bitter-tasting • McNeil added a coating to S N S N the drug granules to SO NH 2 2 mask the bitterness NH 2
  • 50. McNeil v. Perrigo 50 • prior art A = uncoated famotidine + antacid for solid oral dosing, with or without a flavoring agent • prior art B = coating oral drugs to mask taste • prior art C = cimetidine + antacid + coating to mask bitter drug taste (cimetidine = Tagamet, also H2 blocker) • CAFC = predictable results from A + predictable results from B or C, together with motivation to coat the drug to mask a bitter taste, make McNeil’s patent obvious • secondary considerations not enough to overcome the strong showing of obviousness
  • 51. Novartis v. Teva 51 (Fed. Circ. June 9, 2008) Mayer, Schall, Linn (per curiam) • affirmed denial of preliminary injunction, no opinion • famciclovir (Famvir); antiviral • a prodrug of penciclovir, an acyclic nucleoside N N N N H2N N N H2N N N penciclovir O famciclovir O OH O OH O
  • 52. 52 Novartis v. Teva • prior art = taught how to make acetyl ester prodrugs of other acyclic nucleosides to increase oral bioavailability • prior art = penciclovir had high antiviral activity and low toxicity, but poor oral bioavailability • prior art = penciclovir was one of only 5 known acyclic nucleosides with high activity/low toxicity (finite number) • CAFC; penciclovir was an obvious lead compound, there was motivation to make an orally active drug, and it was obvious to make the acetyl ester prodrugs • no unexpected results
  • 53. In re Omeprezole 53 [AstraZeneca v. Apotex] (Fed. Circ. August 20, 2008) (Lourie, BRYSON, Gajarsa) • omeprezole (Prilosec); PPI for ulcers, GERD N O H3C OCH3 S H3CO N CH3 H N omeprazole
  • 54. 54 In re Omeprazole • AstraZeneca found that alkaline reacting compound (ARC) addition to drug core helped stabilize drug in storage, and that an enteric coating was needed to keep drug from decomposing in the stomach, but normal enteric coatings were known to dissolve the ARC • AZ determined that a water-soluble subcoating would keep ARC intact but allow drug release in small intestine • no prior art showed a negative interaction between ARC and enteric coatings or discussed subcoatings, thus no motivation to introduce a subcoating; not obvious • even if there were motivation, a water-soluble subcoating would not be obvious to try
  • 55. Abbott v. Sandoz 55 (Fed. Circ. October 21, 2008) NEWMAN, Archer, Gajarsa (dissent by Gajarsa) • affirmed preliminary injunction • clarithromycin (Biaxin XL) • extended release formulation of a macrolide antibiotic
  • 56. 56 Abbott v. Sandoz • prior art taught dissolution control with polymer addition or alginate salt + azithromycin • prior art also taught extended release formulations of erythromycin derivatives in general • CAFC; physical properties (PK) of azithromycin very different than clarithromycin, so skilled artisan could not predict how clarithromycin would act using the extended release formulation for azithromycin • dissent; only routine experimentation needed here
  • 57. Bayer v. Barr 57 (Fed. Circ. August 5, 2009) (MAYER, Newman, Friedman) (dissent by Newman) • drospirenone (Yasmin); oral contraceptive • poorly soluble in water • isomerizes in acid to a compound with undesired properties
  • 58. 58 Bayer v. Barr • prior art taught micronization to improve solubility in water, but it also increased acid sensitivity • enteric coatings known to protect oral drugs from stomach acid, but also decreased bioavailability • Bayer found that the micronized drug with an enteric coating had same bioavailability as without the coating • CAFC; prior art narrowed options to a finite number of identifiable predictable solutions, so obvious • Newman dissent; no reasonable expectation of success here
  • 59. Ortho v. Teva 59 (Fed. Circ. August 26, 2009) (PROST, Moore, dissent by Mayer) • combination of acetaminophen + tramadol (Ultracet) O H N tramadol OH O HO N acetaminophen
  • 60. 60 Ortho v. Teva • prior art = tramadol + para-acetaminophenol in a combination drug, at 1:10 ratio • 2 kinds of Ortho formulation claims – one set with ratio “consisting of about 1:5 – 1:19” – one claim with ratio “comprising about 1:5” • Ortho got narrowing reissue to avoid prior art (discovered that para-acetaminophenol = acetaminophen) • CAFC construed “about 1:5” to mean 1:1.36 – 1:1.71 (Ortho v. Caraco)
  • 61. 61 Ortho v. Teva • CAFC: the difference between 1:7.1 and 1:10 is slight, so a prima facie case of obviousness regarding the “comprising about 1:5” claim • Ortho’s unexpected result rebuttal (synergy) failed, as there was no difference in the synergistic effect between these ratios • claims with ratio “consisting of about 1:5 – about 1:19” raise an issue of material fact (remand) • “dissent” (Mayer); all claims are obvious
  • 62. Summary of Recent Drug 62 Formulation Obviousness Cases case date holding comments McNeil v. Perrigo April 2008 obvious per curiam Novartis v. Teva June 2008 obvious prelim. injunction; per curiam In re Omeprezole August 2008 not obvious Abbott v. Sandoz October 2009 not obvious Gajarsa dissent Bayer v. Barr August 2009 obvious Newman dissent Ortho v. Teva August 2009 some obvious Mayer dissent some not
  • 63. 63 For More Information Kevin B. Laurence Partner Salt Lake City, UT (801) 578-6932 Direct (801) 578-6999 Fax 200 S Main Street, Suite 1100 Salt Lake City, UT 84111 kblaurence@stoel.com Samuel E. Webb Partner Seattle, WA (206) 386-7683 Direct (206) 386-7500 Fax 600 University Street, Suite 3600 Seattle, WA 98101 sewebb@stoel.com