Evergreening of patents

Topic: International Trade Policy, WTO and Intellectual Property · NCERT: Beyond NCERT

Meaning

Evergreening of patents is when a company makes a small change to a drug it already has a patent on and files a fresh patent on that change. The change is usually made close to the end of the first patent. It might be a new salt, a new crystal form, a new dosage or a combination with another drug. The change gives patients no real extra medical benefit.

Evergreening matters because it keeps the monopoly going past the normal patent term. Cheap generic copies stay off the market, and patients keep paying high prices.

Explanation

How it works

• The normal patent bargain:
• A patent gives the holder the sole right to make, use, sell or import an invention for 20 years from the filing date.
• In return, the holder must disclose (publish) how the invention works.

• When the 20 years end, anyone can make the product. For medicines, this is when cheap generics arrive. A generic is a copy of a drug, sold under its chemical name, that works the same way as the brand.

• Evergreening breaks this bargain:

• The main molecule's patent is about to expire.
• The company files a new patent on a slightly changed form of the same molecule.
• The new patent gets its own fresh 20 years, counted from its own filing date.

• Generic makers now risk being sued if they copy the new form. They may also struggle to compete if the brand moves patients over to it.

• Worked example (made-up numbers, to show the 20-year rule):

• Original patent filed 1 January 2010. It expires 31 December 2029.
• A new crystal form of the same drug is patented, filed 1 January 2027. It expires 31 December 2046.
• The monopoly on the product now effectively lasts about 17 more years. Nothing has been gained medically.

Common forms of "minor change"

• Salts, esters, ethers: the same active molecule joined to a different chemical partner.
• Polymorphs: the same molecule in a different crystal shape. Glivec (imatinib) was one of these.
• Isomers, metabolites, pure forms, particle sizes: mirror-image versions, forms the body breaks the drug into, purer versions, or finer powder.
• New dosages and combinations: a new dose, a slow-release tablet, or two known drugs combined in one pill.

Why it happens, and what makes it worse or better

• It happens more when:
• the old drug earns a lot of money and its patent is about to expire;
• the law allows patents on small changes with only a low "inventive step" (the change does not have to be something an expert would find non-obvious);

• TRIPS-plus rules exist, meaning obligations in trade agreements that go beyond the WTO's IP rules, such as patent-term extension.

• It happens less when:

• the law says a changed form of a known substance counts as the same substance unless it clearly works better, as India's Section 3(d) does;
• any person can challenge a patent application before it is granted (pre-grant opposition);
• courts judge whether the new form actually helps patients more, not just whether it is chemically different.

In India

• The law behind it: the Patents Act 1970 allowed only process patents (patents on one method of making a product) for food, drugs and chemicals. Product patents came in with the 2005 amendment, meeting the TRIPS deadline of 1 January 2005. India added anti-evergreening safeguards in the same amendment.
• Section 3(d), the anti-evergreening rule:
• Salts, esters, ethers, polymorphs, metabolites, pure forms, particle sizes, isomers, mixtures of isomers, complexes, combinations and other derivatives of a known substance count as the same substance. The exception is when they differ significantly in properties with regard to efficacy [3].

• Courts read "efficacy" as therapeutic efficacy. The patient must actually benefit more. Being more stable or easier to store is not enough.

• Novartis v Union of India (Supreme Court, 1 April 2013):

• The case was about Glivec, the beta-crystalline form of imatinib mesylate, a cancer drug.
• The patent was refused because the new form did not show enhanced therapeutic efficacy. This upheld s. 3(d).

• Result: cheap generic imatinib stayed on the market.

• Patent opposition backs up s. 3(d):

• Pre-grant opposition (s. 25(1)): any person can object before a patent is granted. Patient groups and generic firms use it to block evergreening patents early.

• Post-grant opposition (s. 25(2)): only an "interested person" can use it, and only within 1 year of grant.

• Stakes for India: India is the largest provider of generic drugs in the world. Indian generics make up about 20% of global generic exports by volume [4]. Evergreening patents would directly shrink this generic space.

• Outside pressure: the US USTR Special 301 report (an annual US review of other countries' IP laws) placed India on the "Priority Watch List" in 2014. Section 3(d) was among the concerns it flagged [3]. India's position is that its law is TRIPS-compliant and that disputes belong in the WTO.

Don't confuse with

• Patent thicket: a dense web of many overlapping patents around one product, as with biologics like Humira (adalimumab). Evergreening is about extending the monopoly in time through follow-on patents. A thicket is about crowding many patents together so a rival cannot launch without risking infringement. They often overlap, but the exam point is time vs density.
• Compulsory licensing: the government lets a third party make a patented product without the holder's consent, and the holder is paid a royalty. It does not stop a patent being granted. Section 3(d) acts at the grant stage and stops a weak patent from existing at all.
• Data exclusivity: a fixed period during which the drug regulator cannot use the originator's clinical-trial data to approve a generic. It delays generics even without any patent. Evergreening works through the patent system. India rejects data exclusivity. TRIPS Art. 39.3 only asks for protection against "unfair commercial use".
• Genuine incremental innovation: a real improvement that gives patients a significant gain in therapeutic efficacy. Section 3(d) still allows a patent for this. So s. 3(d) does not ban patents on new forms. It bans new forms that bring no added efficacy.

Prelims Hooks

• Section 3(d) of the Patents Act is India's anti-evergreening provision. It came in with the 2005 amendment.
• Under s. 3(d), derivatives of a known substance count as the same substance unless they differ significantly in properties with regard to efficacy [3]. Courts read this as therapeutic efficacy.
• Novartis v Union of India (SC, 1 April 2013): the Glivec patent (beta-crystalline form of imatinib mesylate) was refused and s. 3(d) was upheld.
• A patent lasts 20 years from the date of filing, not from grant. Each follow-on patent starts its own 20-year clock, and this is why evergreening pays.
• Pre-grant opposition (s. 25(1)) is open to any person. Post-grant opposition (s. 25(2)) is open only to an "interested person", within 1 year of grant.
• Trap: s. 3(d) is a TRIPS flexibility, not a violation. TRIPS sets minimum standards, and the Doha Declaration (November 2001) confirmed that TRIPS "can and should" be read in support of public health [1].

Mains Points

• Innovation vs access.
• Patents reward research with a fixed monopoly. Evergreening stretches that monopoly with no new benefit to society, so it breaks the patent bargain.
• Section 3(d) sets the bar at therapeutic efficacy. Real improvements are rewarded, and trivial changes are not.

• Novartis (2013) shows how this kept affordable cancer medicine available. This can be read with the Doha Declaration on flexibilities [1][2].

• Protecting the "pharmacy of the world".

• About 20% of global generic exports by volume come from India [4]. Much of this rests on a strict patentability standard.
• TRIPS-plus demands in FTAs, such as patent-term extension, data exclusivity and weakening s. 3(d), would let evergreening in through the back door.

• India has resisted these in the EFTA, UK and EU FTA negotiations. The current status of these talks should be checked.

• Unilateral pressure vs rules-based order (GS-II link).

• USTR Special 301 flagged s. 3(d) and put India on the Priority Watch List in 2014 [3].
• India's answer is that its law is TRIPS-compliant and that disputes belong in the WTO.
• This is a clear case study for India-US relations, global health governance and the North-South split over IP.

Related concepts

• Intellectual property rights
• TRIPS
• Patent
• Pre-grant opposition
• Compulsory licensing
• Parallel import
• Data exclusivity
• TRIPS-plus provisions
• Patent pool
• Patent thicket

Read more

• TRIPS and patents: innovation vs access to medicines