Articles Posted in Drugs & Biotech

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Acorda’s patents claim the administration of a medication containing the active ingredient 4- aminopyridine (4-AP) to improve walking in individuals with multiple sclerosis. Acorda holds an FDA-approved New Drug Application and markets, under the name “Ampyra®,” 10 milligram 4-AP sustained-release tablets for twice-daily oral administration and holds an exclusive license to the earlier, broader “Elan patent,” which is listed in the FDA Orange Book for Ampyra with the Acorda patents, and claims methods of treating patients having certain conditions, including multiple sclerosis, by administering a drug containing a sustained-release formulation of any of certain agents, including 4-AP. Defendants sought FDA approval to market generic versions of Ampyra. In Acorda's infringement suit, the district court held that the asserted claims in the Acorda patents are invalid for obviousness but upheld the Elan patent and enjoined infringement of that patent until it expired in July 2018. The Federal Circuit affirmed that the asserted Acorda patent claims are invalid, discounting the weight of Acorda’s evidence of commercial success, failure of others, and long-felt but unmet need. The court noted the Elan patent issued in 1996 and was licensed exclusively to Acorda in 1997 for spinal cord injury and in 1998 for multiple sclerosis treatment, which blocked others from domestic marketing without risk of infringement and deterred other entities from investing in research whose reward depended on marketing a drug like Ampyra. View "Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc." on Justia Law

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Orexo’s 330 Patent, entitled “Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence,” claims a product having the brand name Zubsolv®, approved by the FDA for treatment of opioid dependence. Actavis filed an Abbreviated New Drug Application for a generic counterpart of Zubsolv, accompanied by a Paragraph IV certification, leading to Hatch-Waxman litigation under 21 U.S.C. 355(j) and 35 U.S.C. 271(e)(2)(A). The Federal Circuit reversed a finding of obviousness. The question is not whether the references separately taught components of the 330 Patent formulation, but whether the prior art suggested the selection and combination achieved by the 330 inventors. The district court erred in discounting the enhanced bioavailability in the 330 patent’s formulation as “a ‘difference in degree,’ not a difference in ‘kind.’” The clinical studies reported in the 330 Patent show 66% improved bioavailability. In the context of this invention, this is more than a trivial “degree.” View "Orexo AB v. Actavis Elizabeth, LLC" on Justia Law

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The Jazz patents relate to a drug distribution system for tracking prescriptions of a “sensitive drug.” “A sensitive drug is one which can be abused, or has addiction properties or other properties that render the drug sensitive.” One such sensitive drug is Xyrem®. Jazz exclusively markets Xyrem®, which the FDA has approved to treat symptoms associated with narcolepsy. The active ingredient in Xyrem®, gamma-hydroxybutyrate (GHB), may also be illicitly used as a “date-rape drug.” Under the Controlled Substances Act any approved drug product containing GHB is classified as a Schedule III depressant, so the FDA approved Xyrem® under “restricted distribution regulations contained in [21 C.F.R. 314.500] (Subpart H) to assure safe use of the product.” On inter partes review, the Patent Board found certain claims invalid as obvious. The Federal Circuit affirmed, upholding a conclusion that implementing prior art, consisting of background materials and the meeting minutes, transcript, and slides on the FDA website, on multiple computers “would have been a predictable use of a known distributed data system according to its established function.” View "Jazz Pharmaceuticals, Inc.. v. Amneal Pharmaceuticals, LLC" on Justia Law

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Endo holds the approved New Drug Application for Aveed®, a testosterone undecanoate intramuscular injection. Bayer owns the 640 and 395 patents listed in the Orange Book for Aveed®. Custopharm’s predecessor submitted an Abbreviated New Drug Application (ANDA) to the FDA for approval to produce and market a generic version of Aveed® and made a Paragraph IV certification and gave notice of the certification to Endo and Bayer in October 2014. Endo and Bayer brought an action alleging infringement of the 640 and 395 patents. Custopharm stipulated to infringement; Endo and Bayer limited their asserted claims to claim 2 of the 640 patent and claim 18 of the 395 patent. After a bench trial on invalidity, the district court concluded that Custopharm had not proven that the claims were invalid under 35 U.S.C. 103. The Federal Circuit affirmed. Custopharm failed to meet its burden of showing that a skilled artisan would combine a lowered dose with the injection schedule in the manner claimed. View "Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc." on Justia Law

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Triptans are selective serotonin receptor agonists, developed in the 1980s. When Zolmitriptan became available in the U.S. in oral tablet form in 1999 under the name Zomig® it was among several triptans on the market or under development. AstraZeneca owns the 237 and 767 patents, which relate to formulations of zolmitriptan for intranasal administration, and the New Drug Application for Zomig® (zolmitriptan) Nasal Spray, approved by the FDA for treatment of migraines. The patents are listed in connection with Zomig® Nasal Spray in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). In 2012, AstraZeneca and Impax entered into an agreement, granting Impax an exclusive license to AstraZeneca’s patents covering the Zomig® products, for the payment of $130 million and additional payments at varying royalty rates. In 2014, Lannett notified AstraZeneca that it had filed an Abbreviated New Drug Application, seeking approval for a generic version of Zomig® Nasal Spray, with a Paragraph IV certification (21 U.S.C. 355(j)(2)(A)(vii)(IV)), alleging noninfringement or invalidity of the 237 and 767 patents. In the subsequent infringement suit, 35 U.S.C. 271(e)(2)(A), the district court issued its claim construction opinion, the parties stipulated to infringement, and the court held that Lannett failed to prove by clear and convincing evidence that the asserted claims were invalid or would have been obvious over prior art. The Federal Circuit affirmed, upholding the entry of an injunction. View "Impax Laboratories Inc. v. Lannett Holdings Inc." on Justia Law

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The 551 patent discloses and claims lacosamide, the active ingredient in Vimpat®, a drug that treats epilepsy and other central nervous system disorders. UCB holds New Drug Applications that cover the FDA approval of Vimpat®. The 551 patent is listed in the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). Generic drug manufacturers filed Abbreviated New Drug Applications (ANDAs), seeking approval for generic versions of Vimpat®. Pursuant to the governing Hatch-Waxman Act provisions, they certified in their ANDAs that the 551 patent is invalid, unenforceable, or that their proposed generic lacosamide products will not infringe the patent. UCB sued and the generic manufacturers stipulated to infringement of claims 9, 10, and 13 but maintained that these claims are invalid for obviousness-type double patenting, 35 U.S.C. 101, obviousness, and anticipation. The district court concluded that the asserted claims are not invalid. The Federal Circuit affirmed, holding that the district court applied the correct legal standards and that there was no clear error in its underlying fact findings. The district court did not err by focusing its double patenting analysis on the claims’ differences, as well as the claims as a whole. View "UCB, Inc. v. Accord Healthcare, Inc." on Justia Law

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Mallinckrodt’s 112 patent is directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications. Inhaled nitric oxide is approved by the FDA for treating neonates with hypoxic respiratory failure, a condition where oxygen levels in the blood are too low. Nitric oxide functions to dilate blood vessels in the lungs and can thereby improve blood oxygenation. Mallinckrodt exclusively supplies inhaled nitric oxide in the United States for pharmaceutical use under the brand name INOmax®. On inter partes review, the Patent and Trademark Office Patent Trial and Appeal Board found claim 9 not unpatentable as obvious under 35 U.S.C. 103 but found claims1-8 and 10-11 unpatentable as obvious. The Federal Circuit reversed as to claim 9 but otherwise affirmed. The Board did not err in applying the printed matter doctrine to claims 1–8 and 10, but its findings regarding the differences between the prior art and claim 9 and its findings on secondary considerations depended on an incorrect interpretation of that claim, and are not supported by substantial evidence. The Board’s uncontested findings regarding prior art render claim 9 obvious under the proper reading of the claim. View "Praxair Distribution Inc. v. Mallinckrodt Hospital Products IP, Ltd." on Justia Law

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Anacor’s patent, entitled “Boron-containing Small Molecules,” is directed to the use of 1,3-dihydro-5- fluoro-1-hydroxy-2, 1-benzoxaborole, also known as tavaborole, to topically treat fungal infections that develop under fingernails and toenails. The patent teaches that tavaborole can be used to treat onychomycosis, a fungal infection that is responsible for approximately half of all nail disorders in humans. On inter partes review, the Patent Board found all of the claims of the patent unpatentable for obviousness. The Federal Circuit affirmed. Anacor was not denied its procedural rights with respect to the theory of obviousness the Board adopted or any evidence it relied on. The Board understood that the petitioner’s theory was “not based on structural similarities alone,” but was “based on the combination of structural similarity and functional similarity” and agreed with the petitioner that “a person of ordinary skill in the art would have expected that tavaborole, which shares functional activity with the compounds of Brehove, would have shared other activities as well, such as the inhibition of additional fungi responsible for onychomycosis.” View "Anacor Pharmaceuticals, Inc. v. Iancu" on Justia Law

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Defendants produce or sell patented drug products containing the antiviral agent tenofovir alafenamide fumarate (TAF), which is used in the treatment of AIDS. Healthcare provides medical care to persons afflicted with AIDS, including providing antiviral drugs, including the TAF products that Healthcare buys from Defendants. Healthcare sought declarations of invalidity for patents purportedly covering TAF and various combination products so that it could partner with generic makers and purchase generic TAF on the expiration of the five-year New Chemical Entity exclusivity s(21 U.S.C. 355(j)(5)(F)(ii)). Healthcare filed suit two months after the FDA approved Genvoya®—the first TAF-containing product to receive FDA approval; other TAF products were still undergoing clinical trials. No unlicensed source was offering a TAF product or preparing to do so. Healthcare told the court that “none of the generic makers wanted to enter the market because there was the fear of liability.” The court ruled that Healthcare’s actions in encouraging others to produce generic TAF products and interest in purchasing such products did not create an actual controversy under the Declaratory Judgment Act. The Federal Circuit affirmed. The declaratory requirement of immediacy and reality is not met by litigation delay. Healthcare has not otherwise shown that there is a controversy of sufficient immediacy and reality to create declaratory judgment jurisdiction. Liability for inducing infringement requires that there be direct infringement. An interest in buying infringing product is not an adverse legal interest for declaratory jurisdiction. View "AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc." on Justia Law

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Defendants produce or sell patented drug products containing the antiviral agent tenofovir alafenamide fumarate (TAF), which is used in the treatment of AIDS. Healthcare provides medical care to persons afflicted with AIDS, including providing antiviral drugs, including the TAF products that Healthcare buys from Defendants. Healthcare sought declarations of invalidity for patents purportedly covering TAF and various combination products so that it could partner with generic makers and purchase generic TAF on the expiration of the five-year New Chemical Entity exclusivity s(21 U.S.C. 355(j)(5)(F)(ii)). Healthcare filed suit two months after the FDA approved Genvoya®—the first TAF-containing product to receive FDA approval; other TAF products were still undergoing clinical trials. No unlicensed source was offering a TAF product or preparing to do so. Healthcare told the court that “none of the generic makers wanted to enter the market because there was the fear of liability.” The court ruled that Healthcare’s actions in encouraging others to produce generic TAF products and interest in purchasing such products did not create an actual controversy under the Declaratory Judgment Act. The Federal Circuit affirmed. The declaratory requirement of immediacy and reality is not met by litigation delay. Healthcare has not otherwise shown that there is a controversy of sufficient immediacy and reality to create declaratory judgment jurisdiction. Liability for inducing infringement requires that there be direct infringement. An interest in buying infringing product is not an adverse legal interest for declaratory jurisdiction. View "AIDS Healthcare Foundation, Inc. v. Gilead Sciences, Inc." on Justia Law