What are the primary legal mechanisms to protect drug formulations from generic competition?
India follows a pro-access and anti-evergreening patent regime, therefore, pharmaceutical companies must adopt a robust protection strategy to protect drug formulations from generic competition.
The primary legal mechanism to protect drug formulations from generic competition is patent protection. The Indian Patents Act, 1970, provides patent protection for products and processes, provided they meet the criteria of novelty, inventive step and industrial applicability. Specifically, formulation patents which protect the specific pharmaceutical formulation instead of the active pharmaceutical ingredient (API) itself are a useful tool when the patent term for the API has expired. Further, process patents protect a novel and inventive method of manufacturing the drug formulation and are of relevance in the Indian context where generic companies routinely reverse-engineer drug formulations.
Additionally, polymorphs, crystalline and salt forms of active pharmaceutical ingredients (APIs) can also be protected under the Indian Patents Act, 1970 subject to compliance with the requirement of “enhanced therapeutic efficacy” as stipulated u/s 3(d) of the Act.
Additional criteria related to drug formulations such as process parameters, scale up conditions, stability optimization data, etc can also be protected by adopting secondary legal mechanisms such a trade secret protection through confidentiality agreements, employment agreements, and non-disclosure agreements. Since India is a strong generics market, trademark protection could also be a useful secondary tool to ensure brand loyalty even after the term for the formulation/process patent has expired.
A combined strategy of patent, trade secret and trade mark protection will allow pharmaceutical companies to protect drug formulations from generic competition.
What is the difference between patent protection and regulatory exclusivity in pharma?
Patent protection gives the patentee the right to exclude other parties from commercially exploiting the claimed invention while regulatory exclusivity prevents competitors from using or relying on the innovator’s submitted regulatory data (clinical trial/safety/efficacy data) to obtain marketing approval. However, Indian does not have a statutory regulatory exclusivity programme like EU or USA. In the Indian context, patent protection is of primary relevance due to the absence of statutory regulatory exclusivity.
Can pharmaceutical companies patent modified or improved formulations?
Pharmaceutical companies can patent modified or improved formulations provided the provisions of Section 3(d) of the Patents Act are complied with. As per Section 3(d) of the Patents Act, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. To overcome the exclusion u/s 3(d), it is important to demonstrate that the modified or improved formulation demonstrates “enhanced efficacy”. While the term “efficacy” as used in Section 3(d) is not particularly defined by the Act, it is understood to mean “therapeutic efficacy” in the context of the pharmaceutical industry. Of particular importance is the law crystallized in Novartis v. Union of India, wherein the Supreme Court of India held that “enhanced efficacy” for pharmaceutical derivatives means specific enhancement in the therapeutic efficacy and not mere improvement in the physicochemical properties such as bioavailability.
This strict interpretation aligns with the anti-evergreening paten regime in India.
How long does patent protection last for pharmaceutical drugs and what strategies are used to extend patent life in pharma?
In India, the term of patent protection is twenty (20) years and thereafter, it is not possible to extend the life of the patent. Since the Indian pharmaceutical regime does not permit evergreening of patents, derivatives (polymorphs/salts/metabolites, etc) can only be protected if the bar under Section 3(d) of the Patents Act is overcome.
How do regulatory approvals enable generic drugs to enter the market?
Even if patent barrier does not exist, a generic drug cannot lawfully enter the Indian market without regulatory authorization. Before generic drugs can enter the market, the generic manufacturer must obtain the necessary regulatory approvals as provided by the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The necessary approvals are to be obtained from the Central Drugs Standard Control Organization (CDSCO) under the Drugs Controller General of India (DCGI) along with State Licensing Authorities.
What is an ANDA (Abbreviated New Drug Application) and how does it affect innovators?
The term Abbreviated New Drug Application (ANDA) refers to an abbreviated application submitted before the US Food and Drug Administration (FDA) by generic manufacturer for approval to market a generic version of an already approved innovator drug. It is termed as an “abbreviated” drug application since the generic manufacturer is not required to repeat full clinical trials for safety and efficacy and can instead rely on the drug’s prior approval, provided bioequivalence is established.
An ANDA triggers generic competition, thereby affecting the price and market share of the innovator drug. An ANDA could also trigger patent litigation as well as undermine the monopoly of the innovator drug.
In the Indian context, ANDA filings are of utmost importance since India is primarily a generic drug market.
Does India provide data exclusivity protection for drug formulations?
India does not provide statutory data exclusivity protection for drug formulations like USA or EU, thereby, pharmaceutical companies operating in India primarily rely on patent protection to protect drug formulations from generic competition.
Can drug formulations be protected as trade secrets instead of patents?
Yes, drug formulations can be protected as trade secrets instead of patents. Specifically, the manufacturing know-how (scale up parameters, stability optimization data, sequence of events in the manufacturing process, etc.) can be protected through confidentiality agreements, employment agreements, and non-disclosure agreements.
How can pharmaceutical companies prevent generic manufacturers from copying their drugs?
While pharmaceutical companies cannot stop generic manufacturers indefinitely, they can lawfully delay generic manufacturers from copying their drugs through protection of intellectual property in India. Building strong patent protection is the core effective strategy for pharmaceutical companies to prevent generic manufacturers from copying their drugs, however, this can be additionally fortified through trade secret as well as trade mark protection since the Indian Patent regime is balanced against evergreening of pharmaceutical patents.
Why are incremental innovations harder to patent in India?
Incremental innovations refer to improvements made to an existing product instead of creation of an entirely new molecule. India has established strict standards to prevent evergreening of pharmaceutical patents. As per the provisions of Section 3(d) of the Patents Act, patent monopoly rights cannot be extended by claiming minor modifications in known drugs and enhanced therapeutic efficacy must be established while claiming patent protection for derivatives of a known product.
