Introduction:
Over the past three decades, the high-technology-based Indian pharmaceutical business has experienced sustained expansion. The contemporary industry participants are made up of a number of privately held Indian businesses that have gained a sizeable share of the domestic pharmaceutical market as a result of favourable government regulations and little competition from outside, among other things. However, as they start to emerge from domestic markets and prepare for global competition, Indian industries are changing as a result of the liberalisation of the Indian economy.
In order to successfully introduce a novel medicine from thousands of lead compounds, pharmaceutical companies lavishly invest money. Therefore, every business has the right to prevent unauthorised copying of its creative products. Without a doubt, “patents” are the only guardians of these medical intelligence products—the medications.
Meaning:
The Latin word “patere,” which means “to lay open,” or “to make available for public examination,” is where the word “patent” originates. a monopoly or exclusive right bestowed upon the patent holder over an innovation. A patent is a type of agreement between the inventor and the government of the nation in which the inventor promises to disclose the entirety of the innovation in exchange for the government agreeing to provide the inventor the only authority to prevent others from using or producing the creation.
Objective of Patent’s Law:
1.To inspire inventors, there should be a clause that prohibits others from plagiarising their work without their consent if they invest time and money in creating something that can be copyrighted. If it does, he would be inspired to do more investigation.
2.To safeguard the interests of inventors, laws that safeguard inventions also safeguard the goodwill and monetary rewards of the creator. For instance, if patents are not granted, anyone can reproduce the ingredients in medicines and sell them for less money. If the drug does not function, this will harm the inventor’s reputation, and he or she will also lose their market, which will cost them money.
3.Encourage Research and Development, an innovator may be inspired to conduct additional research if he receives credit for his efforts while simultaneously having them protected. This will encourage more people to enter the field of study. All of this will ultimately lead to the society’s growth in terms of technology and economy.
4.To ensure fair trading practises, the law indirectly encourages them by granting protection and monopoly rights. A businessman may not attempt to imitate another’s procedure or product if he is aware that doing so will subject him to legal action. This will support the management of unfair competition.
Patent Law in India:
The first patent rights were granted in India in 1856, and all earlier laws were repealed with the passage of the Patent Act 1970 (“the Patents Act”) in 1970. Additionally, India has ratified both the 1970 Patent Cooperation Treaty and the 1883 Paris Convention for the protection of Industrial Property. According to the Patents Act, any invention that meets the requirements of newness, non-obviousness, and utility may be the subject of a patent. The Indian pharmaceutical industry was significantly impacted by the lack of protection for product patents in the pharmaceutical and agrochemical industries, which led to the development of significant expertise in the reverse engineering of drugs that are patentable as products throughout the industrialised world but unprotectable in India.
As a result, the Indian pharmaceutical business quickly expanded by creating less expensive versions of certain medications that had domestic patents. Once those domestic patents had expired, the company then aggressively entered the global market with generic medications. The Patents Act also includes a number of measures to stop the infringement of patent rights and to improve medicine availability. Pharmaceutical companies have a 20-year exclusive right to possess the patent after the drug is registered under the Patent Act, and the drug’s marketing rights are also exclusive for the full 20-year period. The identical drug cannot be manufactured or produced by another pharmaceutical business. The patent expires at the end of the 20-year period. In such a case, other pharmaceutical companies are allowed to produce and market the identical medication.
Types of Pharmaceutical Patents:
1.Patents on goods
An exclusive right granted to the original inventor(s) of a tangible object that they have made is known as a product patent. No other manufacturer is permitted to invent, manufacture, develop, or provide the same product using the same or an alternative process after these rights have been granted. The breaking of this rule may result in patent infringement. The main advantage of a product patent system is that it offers the innovator more levels of protection. However, the drawback is that under such a rule there are fewer rivals.
2.Patents on methods
A process patent is a type of protection offered to inventors for a particular step in the design or production of a product. A specific manufacturing process is the subject of the protection granted under a process patent regime and not for the actual goods. The identical product can be made using a different process or by simply changing a few of the method’s parameters.
The main advantage of a process patent regime is that it gives the government authority over the monopolies of powerful multinational corporations and allows it to protect the interests of the underprivileged. The disadvantage still stands that such a system would deter pharmaceutical businesses from spending their hard-earned cash in an environment with low profit margins.
3. Product by Process Patents
Although product-by-process claims are constrained and defined by the process, the patentability of a product is predicated on the product itself, not the process used to make it.
Even if the prior product is produced using a different process, the claim will not be patentable if the product in the product-by-process claim is the same or obvious.
4. Patent on a formulation
The pharmaceutical dosage form of the medication, sometimes referred to as composition, is protected by formulation. The terms “composition” and “composition of matter” should not be confused, nevertheless. It’s feasible that it will take on a medication formulation or class of pharmaceuticals in some way. It may also be a generic formulation that can be used for a variety of medications with various effects. They consist of transdermal patches, slow-release technology, etc. Furthermore, it is crucial to examine the type of patent while doing a thorough patent search. It assists in focusing searches.Product By Process Patents
A product’s manufacturing process is detailed in a product-by-process patent or claim. When the product cannot be defined or distinguished from the prior art other than by reference to the technique by which the product is made, this patent is frequently issued.
World Trade Organization’s Effect on Pharmaceutical Patents:
A significant paradigm shift in international trade has resulted from the creation of the World Trade Organization (WTO). The pharmaceutical industry was “one of the main reasons for incorporating intellectual property issues into the GATT framework,” according to the agreement on Trade-Related (Aspects of) Intellectual Property Rights (TRIPS), which was negotiated during the Uruguay round trade negotiations of the General Agreement on Tariffs and Trade (GATT). India ratified the GATT on April 15, 1994, making it obligated to abide by its terms, including the TRIPS agreement.
As a result, ndia must adhere to the basic requirements set forth in the TRIPS Agreement with regard to patents and the pharmaceutical sector. The availability of patents for both pharmaceutical items and process inventions must now be addressed under India’s patent laws. Any discovery of a pharmaceutical product or technique that satisfies established requirements is entitled to a patent for a minimum of 20 years.
Granting the creator a patent:
The patent that is issued to an individual following the filing of a patent application is defined by Section 21 of the Indian Patent Act, 1970. To obtain a patent, also known as a patent application, the inventor must submit a written request to the government outlining the innovation. The patent will only be granted if there isn’t a pre-granted opposition to the patent application. The patent application may get a royalty from such inventions after being approved.
Assignment of patents:
An agreement between the parties concerned must be reduced to the form of a document that contains all the terms and circumstances controlling their rights and duties and is formally executed before it may be converted to writing and used to create a mortgage, licence, or other interest in a patent. There are three different types of assignments: mortgages, equitable assignments, and legal assignments.
Patents Licensees:
The person or persons registered as grantee or proprietor of a patent shall have the right to assign, grant licences under, or otherwise deal with the patent, and to give effectual receipts for any consideration for any such assignment, licence, or dealing, subject to the co-ownership provisions contained in this Act and subject, further, to any rights vested in any other person of which notice is entered in the register: With the caveat that any patent-related equity may be enforced in the same way as any other movable property.
There are various types of licences:
1.Voluntarily given licence.
2.An obligatory licence, often referred to as a statutory licence, is one that is mandated by the law.
3.Express or implied licences, whether exclusive or limited.
Important Case Laws:
Bayer Corporation v. Union of India & Ors.
The lawsuit has to do with the issue of mandatory licencing. A person may apply for a mandatory licence three years after the date of grant, according to Section 84 of the Act. Three factors must be met in order to receive a compulsory licence: the public’s reasonable needs have not been met; the patented invention is not accessible to the public for a reasonable price; and the invention is not produced in India. The petitioner was forced to pay a royalty to the patent holder under a compulsory licence, according to the court, who also ruled that medication must be made accessible to every patient at a reasonable cost.
Dimminaco A.G. v. Controller of Patents Design
A vaccine was created after being subjected to an examination under Section 12 of the Indian Patent Act of 1970 in the case of Dimminaco A.G. v. Controller of Patents Design. According to reports, the vaccine was not created under 2 (j). The court determined that the vaccine preparation procedure was fresh, original, and comprised creative processes. It is patentable if the finished output is a novel article.
Novartis Ag & Anr. v Natco Pharma Limited
In the case of Novartis Ag & Anr v Natco Pharma Limited, the court held that even though the patent rights may be crystallised once the opposition is decided, the rights of a patentee subsist while the post-grant opposition is pending. This is because the post-grant opposition was not decided by the Intellectual Property Appellate Board (IPAB). This demonstrates that rights granted to a patentee under Section 48 of the Patents Act are unaffected by the existence of a post-grant opposition.
Conclusion:
The Indian Patent Law is recognised as a key piece of patent legislation that tries to strike a balance between the interests of the consumer and the inventor. Currently, the owners of a variety of pharmaceutical goods and procedures are able to submit patent applications. Pharmaceutical patents come in a wide variety of forms based on the substance they are meant to protect. Due to drug development, marketing, and other factors, each patent’s exclusivity may be extended for different amounts of time. Researchers must first decide which patents best suit their pharmaceutical procedures or goods before deciding on the patentability requirements.
