Patents Act 1970 is a key law that governs how inventions, including medicines, are protected through patents. It has had a big impact on the pharmaceutical industry, which makes and sells drugs. The law tries to encourage companies to create new medicines (innovation) while ensuring that people, especially in developing countries, can afford them. This article explains the pharmaceutical in Patent Law, its history, key rules, and how it affects the pharmaceutical industry in a simple and clear way.
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Overview of Pharmaceutical Patents Law
The Patents Act 1970 is a major law in India that controls how inventions, including medicines, are patented. It was passed on September 19, 1970, and started being used on April 1, 1978. Over the years, the law has been updated to meet global standards while keeping public health needs in mind, especially for affordable medicines. Given below breakdown of how this law works for the pharmaceutical industry:
Historical Background
Before 2005, the Patents Act only allowed process patents for medicines, which meant that companies could patent the method of making a drug, but not the drug itself. This rule helped India become a world leader in producing generic drugs, cheaper versions of brand-name medicines. The companies could make these drugs using different methods and keeping the costs low. This was especially important for medicines treating serious diseases like HIV/AIDS and making India the “pharmacy of the developing world” by supplying affordable drugs globally.
In 1995, India joined the World Trade Organization (WTO) and signed the TRIPS agreement (Trade-Related Aspects of Intellectual Property Rights). This agreement required India to change its patent laws to allow product patents for medicines, meaning the drug itself could be patented, not just the way it’s made. These changes were made through updates to the Patents Act in 1999, 2002, and 2005, which we’ll explain below.
Key Amendments to the Patents Act
India’s Patents Act has evolved significantly to align with global standards, particularly under the TRIPS agreement. These amendments transformed India’s patent system, balancing innovation with public interest. Below are the key changes introduced in 1999, 2002 and 2005.
1999 Amendment
This was the first step toward meeting TRIPS requirements. It introduced pipeline protection, which allowed companies to file patent applications for new drugs (called mailbox applications) starting January 1, 1995. These applications would be reviewed later when product patents were fully allowed. The amendment also introduced Exclusive Marketing Rights (EMRs), letting companies sell their drugs in India while waiting for their patent to be approved. This was a stepping stone to the full product-patent system.
2002 Amendment
This amendment continued preparing India for product patents by updating the legal system to meet TRIPS requirements. It focused on procedural changes, setting the stage for the big shift in 2005.
2005 Amendment
This was the most important change. It allowed product patents for medicines, chemicals, and biotechnology. Now, companies could patent a new drug itself, not just the process of making it. This gave patent holders exclusive rights to make, sell, and import the drug for 20 years from the filing date (whether it’s a local or international application). This change encouraged big companies to invest in research in India but also raised fears about higher drug prices. To address this, the amendment included rules like Section 3(d) and compulsory licensing to protect public health.
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Key Rules Related to Pharmaceuticals
India’s patent regime for pharmaceuticals, shaped by the Patents Act and its 2005 amendment, balances innovation with public health. These rules govern what can be patented, how patents are enforced, and mechanisms to ensure affordable access to medicines. Below are the key provisions relevant to pharmaceuticals.
Product Patents: Since 2005, companies can patent a new drug itself, not just the way it’s made. This gives the patent holder exclusive rights for 20 years to produce, sell, or import the drug. This rule, found in Chapter VIII of the Act, encourages companies to invent new medicines because they can profit from their work for a long time.
Section 3(d) ‘The Anti-Evergreening Rule’: Section 3(d), added in 2005, stops companies from getting new patents for minor changes to existing drugs unless those changes make the drug work much better. For example, if a company tweaks an old drug to create a new version (like a different form or salt), they can’t patent it unless it’s significantly more effective. This rule prevents evergreening, where companies extend patents to keep generics off the market. The Novartis case in 2013, where the Supreme Court rejected a patent for Glivec, showed how seriously India takes this rule.
Compulsory Licensing: Under Section 84, the government can allow other companies to make a patented drug if the drug is too expensive for most people, the drug isn’t available enough in India and there’s a public health emergency, like a disease outbreak. This rule, called compulsory licensing, lets generic companies produce the drug at a lower cost. For example, India used this rule to allow generic versions of an anti-cancer drug, making it more affordable.
Patent Term: All patents, including those for medicines, last for 20 years from the filing date. This applies to both local and international patent applications (filed under the Patent Cooperation Treaty). This rule, found in Chapter VIII, ensures that inventors have a set time to benefit from their invention before generics can enter the market.
Non-Patentable Inventions: Section 3 lists things that can’t be patented. For medicines, this includes -
Section 3(d): As explained, minor changes to existing drugs aren’t patentable unless they significantly improve efficacy.
Section 3(e): Mixtures of known substances (like drug formulations) can’t be patented unless they have a new and inventive effect. These rules ensure that only truly new and innovative drugs get patents.
Pre-Grant Opposition: The 2005 amendment allows anyone to challenge a patent application before it’s approved (under Chapter V). For example, generic drug companies or public health groups can argue that a patent shouldn’t be granted because the drug isn’t new or inventive. This process helps ensure that only valid patents are approved, protecting access to affordable medicines.
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Impact on the Pharmaceutical Industry
The Patents Act 1970 has had a huge impact on the pharmaceutical industry, which is a global leader in generic drugs. Here’s how it has shaped the industry:
Before 2005 (Process Patents Era)
Without product patents, Indian companies could make generics by finding new ways to produce patented drugs. This kept costs low, especially for life-saving medicines like HIV/AIDS drugs. India became known as the “pharmacy of the developing world” because it supplied affordable drugs to poorer countries.After 2005 (Product Patents Era)
Allowing product patents encouraged big international companies to invest in research in India, leading to more innovation and new drugs. However, it also meant that new drugs could be expensive because only the patent holder can sell them for 20 years. This has made it harder for generic companies to produce affordable versions of new drugs right away.Balancing Innovation and Access
Rules like Section 3(d) and compulsory licensing help keep medicines affordable. Section 3(d) ensures that generics can enter the market after the original patent expires, while compulsory licensing helps in cases where patented drugs are too expensive or unavailable. The Novartis case is a key example of how India prioritizes public health.Recent Trends
There’s been an increase in pre-grant and post-grant oppositions, where generic companies and public interest groups challenge patent applications. They often argue that a drug isn’t new or inventive enough to deserve a patent use of TRIPS flexibilities, like compulsory licensing, has also caused debates in international trade talks, with some countries pushing for stronger patent protections.
Summary
The Patents Act 1970, with its updates, has shaped how medicines are patented in India. It balances the need to encourage new drug development with the goal of keeping medicines affordable for everyone. The introduction of product patents in 2005, along with rules like Section 3(d) and compulsory licensing, has helped India stay a leader in generic drugs while supporting research. However, the debate between innovation and access continues, with court cases and international trade discussions shaping how the law is applied.
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Pharmaceutical in Patent Law: FAQs
Q1. What is patent law in pharmacy?
Patent law in pharmacy is a set of rules that protects new medicines and their manufacturing processes through patents. It balances encouraging companies to create new drugs with ensuring people can access affordable medicines.
Q2. What is a patent on pharmaceuticals?
A pharmaceutical patent gives a company exclusive rights to make, use, or sell a new drug or its production process for a limited time, usually 20 years.
Q3. What is the patent act in pharmaceutical chemistry?
The Patents Act 1970 in India governs patents for pharmaceutical chemistry, allowing both product and process patents for medicines while using rules like Section 3(d) to prevent minor changes from being patented.
Q4. What is the patent act for drugs?
The Patents Act 1970, updated in 2005, regulates drug patents in India. It allows product patents, includes compulsory licensing for affordability, and has measures to ensure access to medicines.
Q5. What is meant by patent law?
Patent law is a legal system that gives inventors exclusive rights to their inventions for a set time, encouraging innovation while controlling how the invention is used.
