What is a Patent?
Before diving into patent evergreening, let’s first understand what a patent is. A patent is a legal right granted by the government to an inventor. It gives the inventor the exclusive right to make, use, and sell their invention for a specific period, usually 20 years. This means that no one else can legally make, use, or sell the invention without the inventor’s permission. Patents are crucial because they protect inventors’ ideas and encourage innovation by providing a temporary monopoly as a reward for their creativity and investment.
What is Patent Evergreening?
Patent evergreening is a strategy used by some companies to extend the life of their patents beyond the standard 20-year period. By doing so, they can keep competitors from entering the market with similar products, allowing the original company to continue making money from their invention. This practice is common in the pharmaceutical industry, where extending a patent can mean billions of dollars in additional revenue.
How Does Patent Evergreening Work?
Patent evergreening involves various tactics to prolong the life of a patent. Here are some common methods:
1. Minor Modifications: Companies make small changes to their original invention and then file for new patents on these modifications. For example, a pharmaceutical company might make a slight change to the formulation of a drug or its method of delivery and then patent the new version.
2. New Uses: Another tactic is to discover new uses for an existing drug and patent those uses. For example, if a drug originally developed for treating heart disease is found to be effective for treating another condition, the company can file a new patent for this new use.
3. Combination Patents: Companies can combine two or more existing drugs into a single product and then patent the combination. This can extend the patent life because the combination is considered a new invention.
4.Secondary Patents: These are patents for additional features or improvements related to the original invention. For instance, a company might patent a new manufacturing process for an existing drug, thus extending the patent life.
Why is Patent Evergreening Controversial?
Patent evergreening is a controversial practice because it can have both positive and negative effects.
Pros of Patent Evergreening
1. Encourages Innovation: Proponents argue that evergreening encourages companies to continue investing in research and development. The potential for extended profits provides an incentive to improve existing products and discover new uses.
2. Quality Improvements: Through evergreening, companies can make genuine improvements to their products, which can benefit consumers. For example, a more effective drug delivery method can improve patient outcomes.
3.Economic Benefits: By maintaining exclusivity, companies can continue to profit from their inventions, leading to economic growth and job creation.
Cons of Patent Evergreening
1. Stifles Competition: Critics argue that evergreening stifles competition by preventing generic versions of drugs from entering the market. This keeps prices high and limits access to affordable medication for consumers.
2. Hampers Innovation: Instead of focusing on groundbreaking new inventions, companies might spend their resources on minor modifications to extend patents, which can slow down the overall pace of innovation.
3. Ethical Concerns: There are ethical concerns about prioritizing profits over public health. Extending patents on life-saving drugs can keep them out of reach for those who need them the most.
Examples of Patent Evergreening
One well-known example of patent evergreening is the case of the pharmaceutical company Pfizer and its blockbuster drug, Lipitor. Lipitor is a cholesterol-lowering medication that became one of the best-selling drugs of all time. As the original patent for Lipitor approached its expiration date, Pfizer made several strategic moves to extend its market exclusivity. These included obtaining patents for different formulations and combinations, as well as negotiating deals with generic manufacturers to delay the release of generic versions. These tactics allowed Pfizer to maintain its market dominance and continue profiting from Lipitor for several more years.
Legal and Regulatory Responses
Given the controversy surrounding patent evergreening, various legal and regulatory measures have been proposed or implemented to address the issue. These include:
1. Patent Term Extensions**: Some countries have introduced mechanisms to allow for patent term extensions under specific circumstances, such as delays in regulatory approval. However, these extensions are usually limited and come with strict conditions.
2. Bolar Exemption : This legal provision allows generic manufacturers to begin the process of developing and seeking approval for generic versions of a patented drug before the original patent expires. This can help ensure that generics are ready to enter the market as soon as the patent expires.
3. Patent Challenge Mechanisms: Some jurisdictions have established procedures for challenging the validity of evergreened patents. For example, the United States has a process called “inter partes review,” where third parties can challenge the validity of a patent at the U.S. Patent and Trademark Office.
The Future of Patent Evergreening
The future of patent evergreening will likely depend on ongoing legal, regulatory, and societal debates. As technology and innovation continue to evolve, so too will the strategies and policies surrounding patent protection. Balancing the need to reward innovation while ensuring access to affordable products remains a complex and dynamic challenge.
Conclusion
Patent evergreening is a strategy used by companies to extend the life of their patents and maintain market exclusivity. While it can encourage ongoing innovation and economic growth, it also raises concerns about competition, access to affordable products, and ethical implications. Understanding the nuances of patent evergreening helps us navigate the complex landscape of intellectual property and its impact on society. By finding a balance between rewarding innovation and promoting competition, we can ensure that the benefits of new inventions are shared widely and equitably.
Written by-Kaiser vashisht, 3 year (LLB),Guru Nanak dev university
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