Introduction
The legal battles between Novartis Pharmaceuticals Corporation and Natco Pharma Ltd. have been pivotal in shaping the landscape of patent law, particularly in the pharmaceutical sector. This article delves into the key aspects of these disputes, focusing on the recent and significant case involving Eltrombopag Olamine (ELT-O).
Background of the Dispute
Novartis initiated legal action against Natco Pharma Ltd. over the use of Eltrombopag Olamine (ELT-O), a compound marketed by Novartis under the brand names PROMACTA™ and REVOLADE™. Novartis alleged that Natco's product, TROMBOPAG™, infringed their patent IN 233161 (IN'161)[1].
Key Allegations and Demands
Novartis sought a permanent injunction to halt Natco’s activities related to ELT-O, along with an account of profits, damages, and the surrender of infringing product stocks. Natco, however, challenged these claims by arguing that their product was covered under an earlier patent, IN 213176 (IN’176), which had expired on May 24, 2021[1].
Natco’s Defense
Natco contended that ELT-O, being a salt of Eltrombopag free acid (ELT), constitutes a new form of a known substance. They argued that Novartis’s suit patent was invalid on several grounds, including prior claiming, lack of novelty and inventive step, non-patentability under Section 3(d) of the Indian Patents Act, 1970, lack of industrial applicability, and non-compliance with Section 8 of the Patents Act, 1970. Additionally, Natco accused Novartis of suppression and misrepresentation of information[1].
Initial Court Ruling
The Single Judge of the Delhi High Court dismissed Natco’s arguments, upholding the validity of Novartis’s patent and granting an interim relief that restrained Natco from various activities involving ELT-O. The Court emphasized that the onus to establish the suit patent’s vulnerability on the ground of invalidity lay heavily on Natco, and that Natco had failed to present a credible challenge to the validity of IN’161[1].
Appeal and Division Bench Ruling
Natco appealed against this decision before the Division Bench of the Delhi High Court. The Division Bench observed that the pivotal issue revolved around whether Natco had laid a credible challenge to the validity of the suit patent and whether Novartis was entitled to an interim injunction. The Court delved into Section 10 of the Patents Act, emphasizing the requirements for complete specifications and the importance of fully and particularly describing the invention. It noted that if the specifications were compliant and the claim was valid, a compound covered within the claim would also be included in the complete specifications. Thus, a second patent for such a compound would be vulnerable to challenge on grounds like prior claiming, lack of novelty, and lack of inventive step[1].
Conclusion of the Division Bench
The Division Bench concluded that Natco had raised a credible challenge to the validity of IN’161 and set aside the judgment of the Single Bench. The Court added that the observations made were prima facie views and that the parties were not precluded from raising further contentions[1].
Implications for the Pharmaceutical Sector
This decision has significant implications for the pharmaceutical sector, particularly in India. It highlights the importance of thorough patent specifications and the need for patent holders to ensure that their claims are novel and non-obvious. The case also underscores the evolving nature of Indian patent law, which is becoming more stringent in its requirements for patentability.
Comparison with Other Disputes
In another notable dispute, Novartis and Natco clashed over the cancer drug Ceritinib (Zykadia). Novartis claimed that Natco’s version, Noxalk, infringed their patent rights. The Delhi High Court initially granted a permanent injunction, which was later suspended due to the revocation of the patent for Ceritinib. This case also involved interpretations of the Indian Patents Act, 1970, and the exclusive rights granted to patent holders[5].
Expert Insights
Industry experts emphasize the critical role of patent law in the pharmaceutical industry. "The Novartis vs Natco cases demonstrate the complexities and challenges in enforcing patent rights, especially in jurisdictions with evolving patent laws," said a patent law expert. "Companies must ensure that their patent applications are meticulously drafted to withstand legal scrutiny"[1].
Statistical Impact
The outcome of such disputes can have significant financial implications. For instance, the market for generic drugs in India is substantial, and the ability of companies like Natco to produce generic versions of patented drugs can affect the revenue of patent holders like Novartis. According to industry reports, the Indian generic drug market is expected to grow significantly, making these legal battles crucial for market dominance[1].
Key Takeaways
- Patent Validity: The validity of a patent is crucial and can be challenged on multiple grounds, including prior claiming, lack of novelty, and lack of inventive step.
- Complete Specifications: The importance of fully and particularly describing the invention in patent specifications cannot be overstated.
- Legal Implications: Decisions in such cases have long-term implications for the pharmaceutical sector, influencing how companies approach patent law.
- Market Impact: The ability to produce generic drugs can significantly affect the market share and revenue of both generic and branded drug manufacturers.
- Evolving Law: Indian patent law is evolving, becoming more stringent in its requirements for patentability.
FAQs
What was the main issue in the Novartis vs Natco case over Eltrombopag Olamine?
The main issue was whether Natco’s product, TROMBOPAG™, infringed Novartis’s patent IN 233161 (IN'161) for Eltrombopag Olamine (ELT-O).
What were the grounds on which Natco challenged Novartis’s patent?
Natco challenged the patent on grounds including prior claiming, lack of novelty and inventive step, non-patentability under Section 3(d), lack of industrial applicability, and non-compliance with Section 8 of the Patents Act, 1970.
What was the decision of the Division Bench of the Delhi High Court?
The Division Bench set aside the judgment of the Single Bench, concluding that Natco had raised a credible challenge to the validity of IN’161.
How does this case impact the pharmaceutical sector?
This case highlights the importance of thorough patent specifications and the need for patent holders to ensure their claims are novel and non-obvious, influencing how companies approach patent law in the pharmaceutical sector.
What other notable dispute has Novartis had with Natco?
Novartis and Natco also disputed over the cancer drug Ceritinib (Zykadia), where Novartis claimed that Natco’s version, Noxalk, infringed their patent rights.
Sources
- BananaIP, "Cancerous Battle: Novartis and NATCO clash over Eltrombopag"[1].
- Casetext, "Villery v. Beard, Case No. 1:15-cv-00987-DAD-BAM (PC)"[2].
- Ediscovery Law, "Jared M. Villery v. Jeffrey Beard, et al., 1:15-cv-00987-DAD-BAM"[3].
- United States Court of Appeals for the Federal Circuit, "NOVARTIS PHARMACEUTICALS CORPORATION v. TORRENT PHARMA INC."[4].
- Patent Lawyer Magazine, "Novartis v Nacto : a testament to evolution of Indian Patent Law"[5].
