Introduction

The Delhi High Court, presided over by Hon'ble Justice Mukta Gupta, delivered a pivotal judgment on January 30, 2020, in the case of Bristol-Myers Squibb Holdings Ireland Unlimited Company Ors. vs. BDR Pharmaceuticals International Pvt. Ltd. Anr. This case centered around the alleged infringement of the Indian Patent No. 247381 (IN-381), which covers the pharmaceutical compound APIXABAN, a Factor Xa inhibitor used in the prevention and treatment of thromboembolic diseases. The plaintiffs, including Bristol-Myers Squibb, asserted that the defendant, BDR Pharmaceuticals, engaged in unauthorized manufacturing and tendering of APIXABAN, thereby infringing the patent. In response, the defendant sought revocation of the patent on grounds of obviousness. The court's decision to grant an ad-interim injunction underscored critical legal standards pertaining to patent obviousness and inventive steps.

Summary of the Judgment

The plaintiffs, owners of the IN-381 patent, claimed that the defendant's actions constituted patent infringement by violating the exclusive rights granted under the patent. The defendant countered by filing a petition for revocation, arguing that the patent lacked an inventive step and was obvious in light of prior art. After extensive hearings and consideration of numerous documents and prior art references, the Delhi High Court concluded that the plaintiff had established a prima facie case of patent infringement. The court found that the evidence presented by the defendant failed to convincingly demonstrate that the IN-381 patent was obvious or lacked an inventive step. Consequently, the court granted an ad-interim injunction in favor of the plaintiffs, restraining the defendant from further infringement activities until the final resolution of the case.

Analysis

Precedents Cited

The judgment extensively referenced seminal cases to delineate the boundaries of patent obviousness and inventive step. Notably:

• F. Hoffmann-La Roche Ltd. & Anr. vs. Cipla Ltd. (2015): Emphasized the necessity of avoiding hindsight bias when assessing obviousness.
• Eli Lilly vs. Zenith Goldline F.3d (2006): Highlighted that structural similarity alone does not suffice to establish obviousness without a motivational reason in the prior art.
• Strix Limited Vs. Maharaja Appliances Limited (2009): Asserted that revocation petitions must be substantiated with credible scientific evidence supported by expert testimony.
• Technograph Printed Circuits Limited vs. Mills & Rockley (1972): Clarified that obviousness must be assessed from the perspective of an "unimaginative man skilled in the art".

Legal Reasoning

The court adopted a meticulous approach to evaluate the defendant's claims of obviousness. The key aspects of the legal reasoning included:

• Inventive Step Requirement: The court reaffirmed that for a patent to be non-obvious, it must exhibit an inventive step that is not apparent to a person skilled in the field.
• Avoidance of Hindsight: Emphasizing the principle from F. Hoffmann-La Roche, the court stressed that prior art should not be retrofitted to make the invention seem obvious.
• Combination of Prior Art: Simply combining prior art references does not inherently prove obviousness. There must be a clear rationale or motivation within the prior art to make such combinations.
• Teaching Away: The court observed that several prior art documents actually teach away from the features claimed in the IN-381 patent, thereby negating claims of obviousness.
• Structural vs. Functional Similarity: The judgment distinguished between mere structural similarities and functional advancements introduced by the patented compound, emphasizing that functional enhancements contribute to inventive steps.

Impact

This judgment has significant implications for future patent litigation, particularly in the pharmaceutical sector:

• Strengthening Patent Protection: By upholding the injunction, the court reinforced the robustness of patent protections against generic manufacturers.
• Clarifying Obviousness Criteria: The detailed analysis provided clarity on how courts should assess obviousness, especially concerning the combination of prior art and the necessity of a motivational basis.
• Encouraging Innovation: By setting stringent standards for what constitutes an inventive step, the judgment encourages genuine innovation and discourages minor, non-innovative modifications from undermining patent protections.
• Guidance for Patent Applicants and Challengers: The principles elucidated serve as a guide for both patent holders in defending their rights and challengers in structuring their revocation petitions.

Complex Concepts Simplified

Obviousness and Inventive Step

Obviousness refers to the extent to which an invention is evident to a person skilled in the relevant field, based on existing knowledge and prior art. An invention lacks an inventive step if it can be easily deduced by such a person without requiring any inventive ingenuity.

Inventive Step is a criterion that assesses whether an invention is sufficiently innovative beyond what is already known. It ensures that patents are granted only for advancements that contribute meaningful progress in a field.

Ad-Interim Injunction

An ad-interim injunction is a temporary court order that prevents a party from engaging in a specific activity until a final decision is made in the case. In this context, it stops the defendant from continuing the alleged patent infringement while the lawsuit is ongoing.

Mosaicing of Prior Art

Mosaicing involves piecing together multiple prior art references to argue that an invention is obvious. However, courts require that there be a clear, logical motivation within the prior art to combine these references, rather than mere juxtaposition.

Conclusion

The Delhi High Court's judgment in Bristol-Myers Squibb Holdings Ireland Unlimited Company Ors. vs. BDR Pharmaceuticals International Pvt. Ltd. Anr. reinforces the stringent standards required to challenge patent validity on the grounds of obviousness. By meticulously evaluating prior art and emphasizing the necessity of a genuine inventive step, the court protects the integrity of patent rights while ensuring that only truly innovative advancements receive protection. This decision not only upholds the plaintiffs' rights but also sets a clear precedent for future patent litigations, thereby fostering an environment that encourages meaningful innovation and robust intellectual property protections in the pharmaceutical industry.