INDIA Trends and Developments Contributed by: Pravin Anand, Vaishali R Mittal and Gursimran Singh Narula, Anand and Anand Advocates
Maintainability of an infringement suit The High Court of Delhi in AstraZeneca Ab & Anr v Westcoast Pharmaceutical Limited held that nothing in the Patents Act, 1970 precludes a patentee’s right to institute an infringement suit even if a post-grant opposition proceed - ing is pending. The Court rejected Westcoast’s argument that the patentee was required to wait for one year to have their patent rights crystal - lised. It was held that such an interpretation of an orbiter dicta from an earlier decision of the Supreme Court in Alloys Wobben was incorrect. Ad interim injunctions for pharmaceutical patents The High Court of Delhi has passed a series of ad-interim restraining orders in lawsuits filed by AstraZeneca AB for infringement of patent - ed compound “Osimertinib”. The orders were passed against several entities, including West - coast Pharmaceuticals, BDR Pharmaceuticals, Azista Industries, Everest Pharmaceuticals, Beacon Pharmaceuticals, Zee Laboratories and MSN Laboratories. Notably, AstraZeneca was also successful in post-grant oppositions filed by Natco Pharma Ltd and Sunshine Organics Pvt Ltd against the grant of a patent for Osimertinib. The claimed compound is an oral, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) approved for the treatment of non- small cell lung cancer (NSCLC). The drug is being marketed under the brand Tagrisso in India and several other countries across the world. The Delhi High Court also passed an ad inter - im injunction in Helsinn Healthcare SA v Het- ero Healthcare Limited, restraining Hetero from infringing a formulation patent for an oral dosage of “Netupitant” and “Palonosetron hydrochlo -
ride”. The infringing drug was being sold in an integrated combination of both salts. Imposition of cost for causing delay in determining infringement The Delhi High Court in Bristol Myers Squibb Holdings v KM Swarnlatha imposed a cost on one of the defendants who had launched the infringing drug but failed to appear before the Court, causing a delay in suit proceedings. Ear - lier, the Court issued an ex parte restraining order as the defendant launched a generic version of Dasatinib before the expiry of the patent. Relevance of Opposition Board Recommendations The Madras High Court in Ashok Leyland Lim- ited vs. The Controller of Patents has ruled that while dealing with post-grant opposition, the Controller is duty-bound to decide on the quali - tative merit of the Opposition Board Recom - mendations (OBR). The Court held that OBR is a foundational document during the post-grant stage, and the patent applicant shall be given an opportunity to illustrate the inadequacies of the OBR during the hearing. Writ proceedings against pre-grant opposition decisions A Division bench of the Delhi High Court in Rich Products Corporation v The Controller of Patents & Anr examined the issue of maintainability of a writ petition against the Controller’s dismissal of a pre-grant opposition. The Court held that remedy under Article 226 of the Constitution is discretionary and shall not be used if there is an efficacious, alternate and statutory recourse available. The Court upheld the single judge’s refusal to entertain a writ petition in view of the post-grant opposition remedy available for the opponent.
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