Another Win for Novartis

28th June, 2023 - 8:28 am Categories: Legal Issues Patent Act 0 Comments

Introduction

It has been contended by the Pharma major that it is the patentee of the two tablets under the brand ‘Vymada’ in India. The plaintiff, Novartis was represented through advocate Mamta Jha and the primary bone of contention was to obtain a restraining order against the defendants. Moreover, the amount of time and efforts by Novartis in the research and development of an efficient and effective product cannot be neglected. The plaintiff obtained the patent in 2009 which was set to expire in 2023. It must also be noted that a scientific advisor was appointed to help the court decide on whether the drug of Natco is made through Novartis’ patent or not. The scientific adviser ruled in negative. However, the Delhi High Court dismissed the view stating that the opinion of a scientific advisor is not binding.

The plea by the plaintiff explicitly stated that the firm came to know about the launch of a pharmaceutical combination of Sacubitril and Valsartan tablet under the name VALSAC by the defendants through a press release of January 28, 2019.

Pharmaceutical Patents in India

The Pharma Industry is one of the most intense “knowledge-driven” sectors. The research is quite costly and unpredictable in nature. In this highly competitive and exhausting market, it is essential that the companies have a chance to protect their inventions from any unauthorized commercial use by acquiring patent rights over the invented product or process.

In case of drug compound patents, the claim is on the compound by its chemical structure per se. These patents have the ability to provide the broadest possible protection to the company’s product since other manufacturers and firms are completely excluded from preparing such drug by any route of synthesis.

Non-fulfilment of the Essentials of obtaining a patent

The patentable subject must pass the obstacles faced by other patent applications as well: novel, non-obvious, involvement of an inventive step and utility. A novel product simply means that it is new and has not yet been discovered. The question of non-obviousness is also connected to the former. It has always been a complex issue and left to the judicial interpretation. For instance: In the judicial pronouncement of Re Bell, the protein component was in question. It was stated that it is true that the genetic code of protein can be known and similarly, the basic principles of sciences are known but there can be multiple relations and combinations and therefore, the application of a patent should depict the first two prongs: novelty and non-obviousness. The third test that any patent application must pass is that of utility. The utility must be assessed with respect to any other natural substance and if that is capable of doing the same or not. The essence and basis of this parameter is that though the actual use of the product has not yet been found but it might be helpful in the future with respect to any economic activity. Utility simply means useful, and it should be useful to the immediate stakeholders or the public at large. The last prong of the concept is involvement of an inventive step. Inventive step acts as a crucial part of a patent application because it is that quality that makes a product distinct from others. The imagination and the thought process determine whether a product shall be innovative and differentiated. Thus, primarily, any product or application that passes the four-step test shall be allowed to be patented. Focusing on the issue, it is also essential to assess the judgment by the hon’ble apex court with regards to Novartis’ cancer drug ‘Gilvec’. In 2006, the Indian Patent Office refused Gilvec’s patent under Section 3(d) of the Indian Patent Act stating that it was only a modified version of an existing drug, Imatinib. Despite constant pleas to the Indian Courts, the Swiss giant could not obtain the patent. The Supreme Court stated that even if the bioavailability of the drug was improved, it did not demonstrate enhanced efficacy and that Gilvec was not patentable.

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Justice Jayant Nath, while pronouncing stated that the invention is nothing but a physical combination of Valsartan and Sacubitril and the defendant’s product is a “super molecular complex” comprising of the anions of the two substances with sodium cations and water molecules. Therefore, the question of novelty is scrapped in the beginning. The impugned invention cannot be within the scope of being patented.

Moreover, recently in 2020, in another battle between Novartis and Natco Pharma, the Delhi High Court passed an order restraining the latter from manufacturing and selling preparations comprising of the active pharmaceutical ingredient “Ceritnib”, which is a drug for the treatment of non-small cell lung cancer. Herein, also Natco aimed at combining ingredients including the Ceritnib compound and manufacturing a supposedly new product. It seems like there is a never-ending dispute between the two.

A generic drug is simply a pharmaceutical drug that contains the same chemical substance as the drug that was already patented. The manufacturing and selling of such copies of the branded drugs is allowed only after the patent expires. It has also been observed that the applications for generic drugs begin two to three years before a patent expires and not when the patent still holds valid. Herein, Novartis was still patentee of the impugned combination and substances. The patent was sought to expire in 2023 and therefore, the court’s judgment in upholding the true spirits of law seems appropriate.

Conclusion

Patents are to be used to enhance and encourage scientific and other inventions. The Indian Patent regime is an exemplary piece that is aimed to establish a balance between the interests of a common man and the inventors. Patenting in the Pharmaceutical sector has always been on the grey line as far as the legislature is concerned. However, the Judiciary has taken multiple steps through the pronouncements to provide a clear stance of the issues involved. Novartis, being a giant and an investor in research and development of medicines and drugs, has all the rights to protect its patent over the substances. The generic drugs may provide economic benefits but the same cannot be at the cost of one’s rights. A right always goes along with a duty. Therefore, it becomes the duty of such firms which manufacture generic drugs to respect the rights of a patentee. If the manufacturer wishes to carry on the processes, then it becomes necessary to seek the permission of the patent holder. Therefore, keeping in mind the black letters and intent of the law, the Delhi High Court has pronounced appropriately.

Author: Tanya Saraswat, in case of any queries please contact/write back to us via email to chhavi@khuranaandkhurana.com or at Khurana & Khurana, Advocates and IP Attorney.

References

• https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/delhi-hc-restrains-generic-pharma-firms-from-making-selling-patent-drug-of-novartis/articleshow/87483290.cms

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