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  • Litigating Infringement of Different Types of Pharmaceutical ClaimsWorkshop on litigation strategies in Pharmaceutical Patents by Linda Liu & Partners , Beijing China.18- 20 May, 2012.Pravin Shejul, M.Sc., Ph.D. (LL.B.)

  • Types of ClaimsCompoundCompositionMethod of TreatmentProcess of ManufactureMethod of [mediating a biological pathway]Kit claims

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  • Types of InfringementStatutory 271(e)(2)(a) Filing of an ANDADirect 271(a)Make, use, sell, offer to sell, importInducement 271(b) Aid and abet direct infringement, requiringKnowledgeintentContributory 271(c)offer to sell, sell, or import a material component of a patented machine, manufacture, combination, or composition knowing the same to be especially made for use in an infringement of such patent, andnot a staple article of commerce Having no substantial noninfringing use

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  • Types of InfringersAPI manufacturersFinished drug product manufacturersimporterswholesalersPharmaciesDoctorsPatients

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  • Compound ClaimsA compound of Formula I, wherein . . . Typically the broadest of the claims, but usually the earliest filed the earliest to expirethe subject of PTE the most difficult to invalidate or avoidthe basis of a product LCM strategy

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  • Compound ClaimsFrequent challenges under 102, 103, 112Although 2006 KSR case relaxed standards for obviousness, still difficult to invalidate compound claims as obviousBUT challenging compound claims under Section 112 increasingly successful

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  • Structural Obviousness of Compound Claims post-KSRConsider the following case studies:Aciphex (rabeprazole sodium)Actos (pioglitazone)Protonix (pantoprazole)Famvir (famciclovir)

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  • Aciphex (rabeprazole sodium)Patented compound is rabeprazole sodium, a proton pump inhibitor that suppresses gastric acid production by inhibiting action of the enzyme H[+]K[+]ATPase

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  • Aciphex (rabeprazole sodium) Teva selected lansoprazole as the lead compound for an obviousness-based invalidity argument Lower court rejected lansoprazole as lead compound even though it was structurally the closest

    Eisai v. Dr. Reddys Labs, Inc.,2008 U.S. App.LEXIS 15399 (Fed. Cir. July 21, 2008)

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  • Aciphex (rabeprazole sodium)Lansoprazole is an ulcer-treating compoundBecause of the differences between anti-ulcer activity and gastric acid inhibiting activity, the closest structural compound was not the starting point for an obviousness analysis

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  • Actos (pioglitazone)

    thiazolidinedione used for treating diabetes

    Closest prior art contained a methyl group at an adjacent ring positionActosCompound b

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  • Actos (pioglitazone)No motivation to start with compound b even though an adjacent homologueTwo other prior art references taught away from the use of compound b

    Takeda v. Alphapharm, et al., 492 F.3d 1350 (Fed. Cir. 2007)

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  • Protonix (pantoprazole) Pantoprazole is a proton pump inhibitor:

    Teva alleged the claimed pantoprazole would have been obvious

    based on the prior art disclosure of Compound 12 in USP 4,555,518:

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  • Protonix (pantoprazole)At-risk launch, Altana seeks PIDistrict Court, following KSR, finds no likelihood of success, denies PI motionCompound 12 was a natural choice for a lead compoundOther prior art references taught:The desirability of lowering the pKa of the pyridine ring to a pKa of 4 (the Sachs reference)a compound with a methoxy group at the 3-position of the pyridine ring would have a lower pKa value (namely, a pKa of 4) that a compound with a methyl group at that position (the Bryson reference)

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  • Protonix (pantoprazole)KSR appliedDefendants have provided sufficiently persuasive evidence that pantoprazole was a predictable variation of compound 12 and thus, is evidence of obviousness, at this stage of the litigation. See KSR, 127 S. Ct. at 1740 ("If a person of ordinary skill in the art can implement a predictable variation, and would see the benefit of doing so, section 103 likely bars its patentability.").

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  • Famvir (famciclovir )

    Novartis sought a preliminary injunction against Tevas at-risk launch of famciclovir

    Famciclovir is a prodrug of penciclovir, an in-vivo active compound with anti-viral activity

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  • Famvir (famciclovir )Applying KSR and Takeda (Actos), court determined that penciclovir would have been an obvious lead compoundthe 6-deoxy modification was shown in the prior art to be several times more effective than any other substitutions, therefore skilled artisan [would] have a reasonable expectation of success based on the prior art. citing KSR

    Novartis v. Teva (D.N.J. Sept. 6, 2007)

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  • Nexium (magnesium esomeprazole trihydrate)'504 Patent claims alkaline salts of esomeprazole. Salt scope is in question.Patent describes and exemplifies only six salts characterized throughout the specification as "the invention" No description or enablement of other salts. What other salts are legitimately covered?broad alkaline salt scope construction 112 challenges

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  • Claims are facially generic to hydrated forms of esomeprazole salts. No claim recitation of hydrate forms, no express disclosure in the specificationNo disclosure for making a hydrated formExamples to not result in production of hydrated or even solvated formLater patents obtained on trihydrate form with characterization that hydrated form could not have earlier been made

    Yet claims purportedly cover specific hydrate formsChallenges under 112, lack of enablement and written description

    Plant Genetic Systems v. DeKalb Genetic Corp, 315 F.3d. 1335 (Fed. Cir. 2003) (claims to transformed plant cell invalid, enabling for monocots not accused dicots); compare In re Hogan (cannot use later existing technology to invalidate patent that is enabled for what it claimed at the time of filing)Nexium (magnesium esomeprazole trihydrate)

  • Composition ClaimsA pharmaceutical composition comprising a compound of formula X or a pharmaceutically acceptable salt thereofAn HPMC polymer matrix, andA pharmaceutically carrier

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  • BiaxinPharmaceutical composition for extended release of erythromycin comprising erythromycin and from about 5-50% of hydrophilic water-soluble pharmaceutically acceptable polymer Combination of references showing:

    1. controlled release formulation of azithromycin with most preferred HPMC polymer 2. controlled release formulation of clarithromycin with water soluble alginate salt release agent

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  • Biaxinsecond reference also disclosed:particular pharmacokinetic release characteristics of composition that meet the involved claims, and composition containing azithromycin

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  • BiaxinHeld:Clarithromycin is sufficiently similar to azithromycin to provide a reasonable expectation of success in substituting clarithromycin for azithromycin in a controlled release formulation Obvious to administer any macrolide antibiotic in sustained release matrix to reduce adverse gastrointestinal effects

    Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331 (Fed. Cir. 2006)

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  • Ditropan XLSustained release oxybutynin obvious over reference disclosing sustained release composition for API highly soluble in water, including oxybutynin, disclosing release of morphine at claimed rates, where reference provided motivation to use oxybutynin

    Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1286 (Fed. Cir. 2006)

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  • Combination of drug with drug coatingPatents directed to APIs with drug coatings that impart certain properties to the drug productYasmin Pepcid Complete (a combination of famotidine and aluminum hydroxide)

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  • Yasmin (oral contraceptive)combination of drospirenone and ethinylestradioldrospirenone is acid sensitive and degrades in patients stomachBayer micronizes the combination and markets Yasmin as an

    immediate release tablet

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  • Yasmin - post KSR analysis The prior art taught 2-4 mg drospirenone; in combination with 0.01 to 0.05 mg 17 [alpha]-ethinylestradiol; along with pharmaceutically acceptable carriers; used as an effective oral contraceptive in human females

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  • Yasmin - post KSR analysis Issue was whether it was obvious to a person of ordinary skill in the art to:

    (1) micronize drospirenone so as to increase its bioavailability, and (2) not protect the drospirenone from the gastric environment with an enteric coating

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  • Yasmin - post KSR analysis Held: 531 patent invalid as obvious

    micronization was a conventional formulation technique to increase absorption and bioavailability at the time of inventioncertain prior art references showed that a closely related drug, spirorenone, absorbed rather than isomerizedother prior art references which note that poorly water soluble sex steroids benefit from micronization

    Bayer Schering Pharma AG v. Barr Labs., Inc., (D.N.J . March 3, 2008)

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  • Pepcid CompletePatent covers a solid oral dosage of aluminum hydroxide or magnesium hydroxide (the "antacids") and famotidine Famotidine is a bitter-tasting guanidinothiazole compound that inhibits acid secretion in the stomach by interfering with histamine receptors in the stomach liningThe famotidine is separated from the antacids by an impermeable coating because the antacids would degrade the famotidine

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  • Pepcid CompleteThe prior art showed the combination of uncoated famotidine and magnesium or aluminum hydroxide in a solid oral dosage The Wolfe reference provided that compositions combining antacids and H[2] blockers

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