Facts
The Appellant, a Chinese medical device company, filed an Indian Patent Application (No. 201917030431) on July 27, 2019, for an "Absorbable Stent".
Source reference: p. 1-2The invention claims a specific structural arrangement of a metal-alloy matrix (magnesium/iron/zinc) designed to balance a short corrosion cycle with high radial strength.
Source reference: p. 6, 7On April 4, 2024, the Respondent (Assistant Controller) refused the application under Section 15 of the Patents Act, 1970, citing a lack of inventive step under Section 2(1)(ja) in view of prior arts D1 (US 9427344 B2) and D2 (US 2015/265438 A1).
Source reference: p. 2-5The Respondent concluded that combining the cylindrical shape of D1 with the matrix design of D2 would be obvious to a person skilled in the art.
Source reference: p. 5The Appellant challenged this refusal, arguing that the Respondent failed to address their technical submissions and relied on hindsight analysis.
Source reference: p. 8-12Issues
1. Whether the Respondent’s order refusing the patent application complied with the principles of natural justice by providing a reasoned and speaking decision.
Source reference: p. 18, 202. Whether the claimed invention involves an 'inventive step' under Section 2(1)(ja) or if it is rendered obvious by the mosaicking of prior arts D1 and D2.
Source reference: p. 5, 83. Whether the Respondent’s reliance on a hypothetical "frustum-to-cylindrical" structural conversion in D2 constitutes impermissible hindsight analysis.
Source reference: p. 12, 28Law Applied
The Court applied Section 2(1)(ja) of the Patents Act, 1970, which defines "inventive step" as a feature involving technical advance or economic significance that makes the invention non-obvious to a person skilled in the art.
Source reference: p. 2, 21It relied on the Windsurfing/Pozzoli test and the Division Bench ruling in F. Hoffmann-La Roche Ltd. v. Cipla Ltd. to establish the five-step framework for determining obviousness, specifically emphasizing the need to "rule out a hindsight approach".
Source reference: p. 23-25The court applied principles from Agriboard International LLC v. Deputy Controller of Patents and Designs, which mandates that the Controller must analyze existing knowledge, the subject invention, and the specific path a skilled person would take between them to satisfy the requirements of a "reasoned order" under natural justice.
Source reference: p. 20-21Reasoning
The Court found that the Respondent failed to conduct a proper three-element analysis (prior art, subject invention, and manner of obviousness) as required by law.
Source reference: p. 21, 27Specifically, the Respondent noted the Appellant's arguments regarding D1’s polymer-based nature but failed to address them in the actual "Reasons for decision," constituting a violation of natural justice.
Source reference: p. 18Regarding D2, the Court observed that the Respondent ignored the material differences—notably that D2 is primarily polymer-based while the subject invention is metal-based—and improperly relied on a generic disclosure in a single paragraph of D2 to bypass the essential limitations of D2’s claims.
Source reference: p. 19The Court further criticized the Respondent's conclusion that the structural dimensions were "fairly known," noting that the Respondent identified no teaching in prior art suggesting a relationship between matrix volume and strut length to balance corrosion and strength.
Source reference: p. 21-22Finally, the Court held that the Respondent’s logic (assuming D2 would have the same properties if it were cylindrical instead of frustum-shaped) was purely conjectural and based on impermissible hindsight.
Source reference: p. 28-29Holding
The Court set aside the impugned order dated April 4, 2024, holding that the refusal was based on an improper hindsight analysis and a failure to consider material submissions.
The Court remanded the matter back to the Respondent for a fresh consideration of Application No. 201917030431 regarding the lack of inventive step.
Source reference: p. 29The Respondent is directed to provide the Appellant an opportunity for a hearing and pass a reasoned decision within four months, without being influenced by previous findings.
Source reference: p. 30Original Court PDF
Biotyx Medical Shenzhen Co., LtdvsAssistant Controller Of Patents And Design
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