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Pharmaceutical Patents: Patentability in India Pharmaceutical Patents • The number of patents for new chemical entities is decreasing annually. • The number of patents for new forms, uses, dosages, etc of known substances are increasing annually. • How will these applications be treated in India? Clear legislative intent to curb increased granting of patents on existing pharmaceutical patents. Types of Pharmaceutical Patents • New chemical entities • Compositions/Formulations • Combinations · Methods and processes · Salts and polymorphs · Prodrugs and active metabolites Primary Legal Doctrines Applicable to Pharmaceutical Patents • Novelty - Narrow or Broad? Identical disclosure vs selection inventions. • Inventive Step - Strict or Lenient? • Industrial Application - Level Required? Also… • Efficacy - Level Required? • Sufficiency - Grounds for refusal, Importance for licensing Formulations and Compositions • Formulations include tablets, solutions, dosages. • API + excipient is considered a composition. • New uses are unpatentable in India formulations/compositions claiming new use will be denied. • In India, s3e prohibits the patenting of mere admixtures. • Formulations/compositions will have to meet 3d test: depends on how efficacy is defined. If defined as dose-receptor complex leading to therapeutic benefit, very rarely will you see differences. Formulations and Compositions • Formulations/compositions will often fail to meet inventiveness standard due to obviousness, unless unexpected or surprising effect is demonstrated demonstrated. • Processes for formulations/compositions are obvious to someone skilled in the art. The exception is if there is an unexpected or surprising advantage. • Although API may be off-patent, formulation patents can be used to sue for infringement and injunctions may be granted in the interim period. Combinations • Combination drugs are unpatentable in India under s3d of the patent law. • Combination drugs may be patentable if they demonstrate a significant increase in efficacy. • The issue will turn on how the patent office defines efficacy, e.g. pharmacologically, patient compliance, decreased pill burden. • Even if the applicant meets the test for efficacy, they will still have to demonstrate nonobviousness. Methods and Processes • Exclusion from patentability: – Section 3(i): any process for the medicinal, surgical, curative, prophylactic [diagnostic, therapeutic] or other treatment of human beings • Determining whether to oppose processes: can we “process around” it? Is there sufficiency of disclosure? Salts and Polymorphs • These patents are often used to extend patent life. • India’s s3d prohibits the patenting of salts and polymorphs unless there is a significant difference in efficacy. • Polymorphs and salts are usually designed and investigated to control purity, yield and streamlining the manufacturing process, i.e for regulatory reasons and for strategic reasons to keep competitors out. Rarely are these forms specifically designed to enhance therapeutic advantage. Polymorphs and Salts • Processes for developing salts are generally obvious to someone skilled in the art. • Selection patents - require unique advantage not shared by others in group. • The basic process to result in one polymorphic form often inevitably results in another polymorphic form - rendering the second form unpatentable. Prodrugs and Metabolites • Prodrugs, when metabolised in the human body, result in an active ingredient. India may opt to deny patents for prodrugs based on PGOs advancing the arguments. – Scope for India to deny patents on prodrugs • Metabolites are often patented along with the compounds containing the metabolite. Section 3(d) • Section 3(d), and the intention/meaning of the term “efficacy” within the provision. – – – – Legislative intent Exclusion from patentability Defining and arguing efficacy Requiring in vitro, in vivo or clinical trial test data resources, R&D landscape, ethical issues, TRIPS issues, mailbox issues