Understanding of Patent Law and its applicability gets better with knowing the recent case developments.
RAVI KAMAL BALI VS. KALA TECH AND ORS. 2008(110)BOM LR 2167,
Here both the plaintiff and the defendant were manufacturers of tamper-proof locks and seals that had industrial applications. The plaintiff, apart from claiming an infringement of his patent under Patent Law, also claimed that Defendant No. 3, who used to work for the plaintiff, conspired with Defendant No. 1 in the manufacturing of the locks and seals. Both products used near identical material, i.e., Spring Steel, with a slight difference in the quality of the material used in the two. A difference between the two products also existed concerning the shape of the product. While the plaintiff’s product was in the shape of a “V,” that of the defendant was rectangular with four walls. The last difference between the two products was also in the number of “vanes” used in the two products.
In this case it was held that:
1. Material and Quality: Both products used spring steel, with the court noting that slight differences in material quality were insignificant for distinguishing between the inventions.
2. Shape Analysis: The defendant’s product was rectangular, whereas the plaintiff’s was V-shaped. The court found that the rectangular shape did not contribute to functional novelty or improve the product’s functionality.
3. Additional Features: Even with additional vanes in the defendant’s product, the court concluded that the construction and function remained essentially unchanged from the plaintiff’s invention.
4. Infringement Decision: The court determined that the defendant’s product infringed on the plaintiff’s patent because the differences were minor and did not constitute a new product. This decision aimed to prevent trivial modifications from being claimed as new inventions, which could lead to misuse of patent rights.
In essence, the court applied rigorous scrutiny under Patent Law and the Doctrine of Equivalence, focusing on functional aspects and structural similarities to conclude infringement based on substantial similarity between the products.
NOVARTIS V. UNION OF INDIA (SC CIVIL APPEAL NO. 2706-2761 OF 2013)
Novartis sought a patent in India for the “Beta Crystalline” form of “Imatinib Mesylate” in 1998 under WTO’s TRIPS agreement. However, the application faced challenges: it was initially rejected in 2006 due to issues of novelty and non-obviousness under the amended Indian Patent Law. Novartis appealed this decision to the Madras High Court, which referred the case to the IP Appellate Board. The Board upheld the rejection, ruling that the claimed invention was not significantly different from a known substance and failed to demonstrate enhanced efficacy as required by section 3(d) of the Indian Patent Law.
Novartis contested section 3(d) before the Madras High Court, arguing it violated Article 14 of the Constitution as it deemed the requirement of ‘enhanced efficacy’ vague and gave broad discretion to patent examiners. The High Court dismissed this appeal, affirming that section 3(d) of Patent Law aimed to prevent patent monopolies and the extension of patent terms through minor modifications.
Subsequently, Novartis appealed to the Supreme Court
The Supreme Court’s decision in the Novartis case on Section 3(d) of the Indian Patent Act can be summarized as follows:
1. Definition of Known Substance: The Court determined that “Imatinib Mesylate” was the known substance as it existed before Novartis’ claimed invention, despite Novartis arguing for “Imatinib Free Base” to be considered the known substance.
2. Interpretation of Efficacy: The Court clarified that under Section 3(d), efficacy refers specifically to therapeutic efficacy. Other beneficial properties like increased stability were deemed irrelevant unless they directly enhanced therapeutic efficacy.
3. Bioavailability: The Court acknowledged that a 30% increase in bioavailability could qualify as enhancing therapeutic efficacy under Section 3(d), provided sufficient evidence was presented.
4. Comparison of Properties: Properties such as flow properties, thermodynamic stability, and hygroscopicity of the claimed invention were considered by the Court but were not deemed relevant to increased therapeutic efficacy under Section 3(d).
5. Conclusion: Novartis’ appeal was rejected because it failed to substantiate with conclusive evidence that the beta crystalline form of Imatinib Mesylate would provide enhanced therapeutic efficacy compared to the known substance (Imatinib Mesylate).
In essence, the Supreme Court’s decision upheld a strict interpretation of Patent Law, emphasizing that to obtain a patent, a pharmaceutical must demonstrate significantly enhanced therapeutic efficacy over existing known substances.
BAYER CORPORATION VS. UNION OF INDIA 2013 INDLAW IP AB 20
Bayer, a corporation incorporated under the laws of the United States of America (U.S.A.), developed and patented a drug used for treating Kidney Cancer (Renal Cell Carcinoma, RCC) and liver cancer (Hepatocellular Carcinoma, HCC). This drug, known as Nexavar, acts primarily as a palliative treatment, alleviating pain and slowing cancer progression by inhibiting the growth rate of cancer cells. Under Patent Law, Bayer acquired the patent for the compound Sorafenib Tosylate in India in 2008.
Natco, an Indian pharmaceutical company, approached Bayer to obtain a voluntary license to manufacture and sell the patented drug in India at a significantly lower price of less than Rs. 10,000 per month of therapy, compared to Bayer’s price of Rs. 2,80,428 per month. Natco’s goal was to make the drug more affordable and accessible to the public. In their application, Natco highlighted that Bayer had not adequately met the public’s needs, offered a reasonably priced product, or made the drug available in India. However, Bayer rejected Natco’s request for a voluntary license under Patent Law.
Subsequently, on July 29, 2011, after three years from March 3, 2008, Natco applied to the Controller for a Compulsory License under Section 84 (1) of the Indian Patents Act. Natco argued that the conditions for granting a Compulsory License under Patent Law were met and proposed selling the drug under the brand name Nexavar at Rs. 8,800 per month of therapy. On March 9, 2012, the Controller granted Natco a Compulsory License, authorizing them to manufacture and sell the drug. Natco was directed to pay Bayer a royalty of 6% of its net sales. The license was non-exclusive, non-assignable, and valid for the remaining term of the patent, allowing the drug to be sold at Rs. 8,800 for 120 tablets for a month’s treatment.
In this case, the Court upheld the Controller’s decision denying adjournment of the compulsory license application. It also declined to interfere with previous rulings by the Controller and Tribunal on March 9, 2012, and March 4, 2013, respectively, which had granted Natco a compulsory license under Section 84 of Patent Law. Consequently, the petition was dismissed. As part of its decision, the Court ordered the petitioner to increase the royalty paid to Natco from 6% to 7% of Natco’s net sales as compensation for the compulsory license granted. This adjustment reflected the petitioner’s failure to provide evidence of the expenses incurred in developing the patented drug.