INDIA Trends and Developments Contributed by: Pravin Anand, Vaishali R Mittal and Gursimran Singh Narula, Anand and Anand Advocates
empirical evidence may not be readily available to the applicant at the time of filing a patent application. Therefore, the clinical trial data can be filed later only to support the stand taken by the applicant in the complete specification dem - onstrating enhancement of therapeutic efficacy. Biochemical patents A Single of the Madras High Court in Novozymes v Assistant Controller of Patents clarified the effi - cacy test for a biochemical patent application titled “Phytase Variants with Improved Thermo - stability”. The Court observed that biochemical derivative forms are distinguishable from the derivatives of synthesised chemicals. It was held that the explanation clause of Section 3(d) is only applicable to synthesised chemicals and not to variants of phytase, ie, an enzyme/biochemical. The Court ruled that the efficacy of biochemicals is to be assessed based on the product’s func - tion, purpose or utility. The Court agreed with the appellant, noting that increased thermostability is a relevant factor that enhances the known effi - cacy of the enzyme for phytase. Biosimilar litigations Indian courts have currently witnessed an expo - nential rise in biosimilar litigation proceedings. A Single Judge of the Delhi High Court in F Hoffman-La Roche Ltd & Ors v Drugs Controller General of India & Others rejected applications filed by Cadilla Healthcare and Hetero Drugs against Roche’s suit for restraining the said companies to manufacture a biosimilar version of “Trastuzumab” and “Bevacizumab”, respec - tively. Roche has challenged the validity of mar - keting approval secured by the said companies and has a restraining order from representing those versions of drugs as biosimilars. Roche had alleged several irregularities in clinical tri - als carried out by Hetero and Cadilla, which is a mandatory requirement as per Biosimilar
Guidelines. The Court held that a substantial part of the cause of action pleaded relates to non-compliance/violation of the Drugs and Cos - metics Act, 1940, Drugs and Cosmetics Rules, 1945 and Guidelines on Similar Biologics: Regu - latory Requirements for Marketing Authorization in India, 2012, and in any manner, these statutes do not exclude the jurisdiction of the civil courts. Roche has also filed biosimilar infringement liti - gation against Zydus Lifesciences Limited for its patented drug Pertuzumab, a monoclonal anti - body (MAb) biologic and first in a line of agents called “HER Dimerisation Inhibitors”. In another suit, E.R Squibb and Sons have filed an infringe - ment proceeding against Zydus for infringement of their patent pertaining to the pharmaceutical product “Nivolumab”. These cases are pending adjudication before the Delhi High Court. Directions for treatment of rare diseases The High Court of Delhi decided a batch of writ petitions in Master Arnesh Shaw v Union of India & Anr pertaining to the treatment of patients suffering from rare diseases in India. The Court issued a slew of directions for all stakeholders, including the constitution of a National Fund for Rare Diseases (NFRD) with a budgetary alloca - tion of at least INR 974 crores. The Court also directed pharmaceutical companies to ensure a proper distribution network to make available therapies and medicines for rare diseases in India. The companies involved in the import of rare disease therapies were also directed to pre - pare detailed plans for establishing local manu - facturing or distribution facilities. Furthermore, the companies were directed to make the thera - pies available after reaching a price agreement with the National Rare Diseases Committee.
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