Sk Bioscience Co Ltd v. Assistant Controller Of Patents And Designs

In the high-stakes world of biotechnology, a patent isn't just a piece of paper — it's the foundation of a company's competitive edge, investor confidence, and future growth. So when a patent examiner slams the door shut on an application, calling the innovation either not an invention or merely a combination of known substances, the consequences ripple far beyond the courtroom. This is the story of SK Bioscience Co Ltd, a company that found itself battling not just a rejection, but a fundamental challenge to whether its work qualifies for protection at all.

SK Bioscience Co Ltd, a biotechnology company, filed a patent application numbered 77/DELNP/2015 seeking protection for what it believed to be a novel and patentable innovation. The application went through the standard examination process at the Indian Patent Office. However, on October 31, 2023, the Assistant Controller of Patents and Designs issued an Impugned Order rejecting the application. The rejection was grounded in two specific provisions of the Patents Act, 1970: Section 2(1)(j), which defines what constitutes an "invention," and Section 3(e), which excludes certain categories from patentability. Determined to challenge this rejection, SK Bioscience filed an appeal before the court, seeking to overturn the decision and secure the patent protection it believed it deserved.

At the heart of this dispute lies a fundamental legal friction: what does it take for a biotech innovation to cross the threshold from a mere combination of components to a true, patentable invention? The Assistant Controller of Patents and Designs, in the Impugned Order, essentially argued that SK Bioscience's application failed to meet the criteria under Section 2(1)(j) — meaning the subject matter did not qualify as an "invention" as defined by law — and also fell foul of Section 3(e), which specifically excludes substances obtained by mere admixture resulting only in the aggregation of the properties of the components, or processes for producing such substances. SK Bioscience, as the Appellant, contested this rejection, arguing that its innovation deserved patent protection. The legal battle thus centered on whether the application met the statutory requirements for novelty, inventive step, and proper subject matter under Indian patent law.

On February 28, 2024, the court addressed the procedural aspects of the appeal. The court disposed of applications related to condonation of delay — meaning it ruled on SK Bioscience's request to excuse any delays in filing — as well as applications seeking exemption from filing certain documents. Importantly, the court allowed the respondent (the patent authorities) to file a reply, signaling that the substantive merits of the case are still under consideration. As of this stage, the case remains pending, with the full legal reasoning and final outcome yet to be determined. The court's decision to permit the respondent's reply indicates that the appellate process is actively moving forward, but the ultimate question of whether SK Bioscience's innovation qualifies as a patentable invention remains unresolved.

[TAKEAWAY