Patent Evergreening involves the practice of patent extension where minor modifications or new filings are made in order to extend the exclusivity period of a patent and, by extension, market control. This is usually done in respect of incremental innovations or variations of an existing product. This practice delays the onset of generic competition, keeps prices high, and extends the period during which a patent holder can dominate the market. Evergreening can be achieved in any sector, though it is more common in pharmaceuticals, technology, and biotechnology.
Context in the Key Industries
Pharmaceuticals: This industry is the most common problem area, as drug companies achieve extended patent life through minor active ingredient modifications, new drug formulations, or extended-release types of drugs. It increases the price of drugs and removes cheaper generic options.
Technology: Software companies may patent incremental updates to existing products or methods to prevent competition and maintain a technological monopoly.
Biotechnology: Involving genetic modifications, new diagnostic techniques, or updated versions of biologics, patent evergreening in biotech may prolong the exclusivity of high-cost innovations.
Step into the future of legal expertise! Join our Advanced Certification Program in Intellectual Property Law, created by The Legal School in collaboration with Khaitan & Co. Designed for fresh law graduates and professionals, this unique course boosts your legal career. Don’t miss this opportunity—enquire today to secure your spot
What is Patent Evergreening?
Explanation of Evergreening Practices
Secondary Patents: Companies can file patents for new versions of an already patented product, like reformulations, new delivery systems, or combinations of previously patented ingredients.
Minor Modifications: Among the modifications that may be patented are changes in dosage of drugs, formulation- from tablet to injectible, or delivery systems such as from liquid form to slow release.
Patent Thicket Strategies: Obtaining patents that relate to the same product or technology and thereby blocking generic or competitive products from entry into the market for a longer time are strategies employed by companies through patent evergreening.
Also, Check out What is Patent Novelty
Case Examples of Patent Evergreening
Pharmaceutical: A well-known case study is that of GlaxoSmithKline's asthma drug Advair. The secondary patents it garnered included combinations with other drugs, delivery mechanisms, and new forms.
Technology: Here, firms can file for patents on incremental features or algorithms that prolong the useful life of a main product—for example, software upgrades of mobile phones.
Biotechnology: In biologics, minor changes to an active ingredient or a new use for the drug could be patented.
Rationale Behind Evergreening
Economic Incentives for Patent Holders
Extended Monopoly: The most economic logic behind evergreening is extended monopoly for a firm about its period of exclusivity. Patents provide an invented thing as a legal right in which the owner charges comparatively higher prices.
Holds Higher Profits: Generally, the patent holders limit the entry of generics and competitors in the market where they hold higher price scales and profit margins for quite a long time.
Investment in R&D: Patent holders point out that evergreening provides justification for the significant expense of R&D, hence they are able to recover some investment and finance further invention.
Effects on Competition and Innovation
Competition: Evergreening may prevent new entrants into the market and thus result in high prices. That can be particularly problematic within the pharmaceutical industry, whereby competition leads to a vast decrease in the price of drugs.
Innovation: Some people argue that evergreening promotes further innovation because the patent holders may continue to innovate on existing technologies. However, critics argue that such practices often lead to "me-too" innovations that are not really significant contributors to the overall progress of the industry. Instead, they may stifle real innovation by preventing cheaper alternatives from entering the market.
Know What are the Grounds for Patent Revocation In India
Public Health Concerns (in Pharmaceuticals)
The practice of evergreening is often criticized in the pharmaceutical sector because it leads to delayed access to generic drugs or biosimilars, which could substantially reduce the cost of healthcare. This is particularly worrisome for developing countries where access to affordable medicine is essential.
Example: Gleevec (Imatinib), where Novartis used multiple secondary patents to delay generic versions, and it hit access to cancer treatment immediately.
How Evergreening Questions Patentability
Incremental Innovation vs. Innovative Invention: Evergreening often consists of winning patents for incremental changes (say, a slightly different form of a drug or a mere change in chemical structure) and thus raises questions on whether such changes are novel and not obvious.
Non-Obviousness and Patent Thickets: Courts often struggle with questions of whether secondary patents – especially those covering minor twists – are indeed nonobvious, or if these are just attempts to extend monopoly markets.
Patent "Trolling": Evergreening can sometimes be associated with patent trolling, where companies engage in strategic litigation or create patent thickets not to innovate but to extract settlements or delay competition.
Also, Check out the Patentability Criteria in India
Practical Example of Patent Evergreening
Abacavir in HIV Treatment
Overview: Abacavir is an antiretroviral drug used in the treatment of HIV/AIDS. It was originally patented in the 1990s by the pharmaceutical company GlaxoSmithKline (GSK).
Evergreening Tactics:
Combination Patents: After the expiration of the original patent, GSK applied for secondary patents on new combinations of Abacavir with other antiretroviral drugs, effectively evergreening the drug's market exclusivity.
New Formulations: GSK also sought patents for the oral solution of Abacavir, which provided another layer of exclusivity, even though it was a minor modification to the original formulation.
Patent Thickets: GSK built a patent thicket around Abacavir, filing for patents not just on the active ingredient but on its formulation, combinations, and methods of use.
Impact:
The result was a delay in the entry of generic versions of Abacavir, thus keeping the drug's price high and restricting affordable access to life-saving HIV medication for many patients, especially in low-income countries.
These evergreening practices drew criticism from healthcare advocates, who argued that the strategy prevented access to cheaper generic versions and contributed to the high cost of HIV treatment.
Also, Get to Know the Global & Landmark Patent Cases
In Summary,
Patent Evergreening is perhaps the most controversial practice to extend the exclusivity term of a patent by developing minor modifications or filing the concept of secondary patents on pre-existing products. This allows economic incentives for further development but often leads to much higher prices and restricted availability of essential medicines, an industry that is heavily included in pharmaceuticals, biotechnology, and technology-related industries.
Frequently Asked Questions (FAQs) on Patent Evergreening
Q1. What is the difference between a secondary patent and evergreening?
Secondary patent: A new patent granted for a modification or improvement of an existing product, such as a new formulation or delivery method.
Evergreening: The practice of filing secondary patents to extend exclusivity and delay generic competition, often without substantial innovation.
Q2. Can patent evergreening be challenged in court?
Yes, it can be challenged through patent invalidity claims, where the patent is argued to be invalid due to lack of novelty or non-obviousness, or through antitrust lawsuits if it harms competition.
Q3. Are there specific industries more affected by patent evergreening?
Pharmaceuticals: Most often used to delay generic drug entry.
Biotechnology: Used to extend biologic patents or genetic innovations.
Technology: In software and electronics, used to extend product exclusivity through minor feature updates.
Q4. What are penalties for patent evergreening?
Indirect penalties like court decrees invalidating patents as well as possible antitrust penalties in the event of the determination that evergreening restricts competition.
Q5. Does patent evergreening have adverse effects on access to medicines in low-income countries?
Evergreening delays generic drug arrival, which keeps prices high and reduces access to cheap medications, which is a bad effect to public health in poor settings.
Q6. Is evergreening a threat but not innovation stifling innovation?
Yes, by stricter patent criteria, encouraging competition through generic and biosimilar entry, and using antitrust law to prevent abuse, yet supporting genuine innovation.
