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Experts stress on need to combat patent thickets & product hopping in US market through policy interventions

Shardul Nautiyal, Mumbai
Thursday, July 27, 2023, 08:00 Hrs  [IST]

Since a majority of the drugs exported by India to the US are generics, intellectual property (IP) experts have advocated the need to combat patent thickets and product hopping in the US through legislation and policy interventions to facilitate pharma trade and exports.

Trade experts further caution that pharmaceutical companies should not be allowed to apply for patents over minor variations of a patented drug. These duplicative patents allow pharmaceutical companies to extend their exclusivity rights on drugs for decades, and therefore delaying the timeline for when generics and biosimilars can legally enter the market.

“This significantly limits the competition in the US market, which also allows for pharmaceutical companies to charge exorbitant prices for drugs which are protected by a patent,” experts said, further informing that certain pharmaceutical companies apply for an excessive number of duplicative patents that represent no significant innovation. There exist a large number of patents that cover a single product or minor variations on a single product.

Studies reveal that 78% of all pharmaceutical patents between 2005 and 2015 were issued on old, previously patented medicines, and not on new drugs or biologics. According to a study by I-MAK, there are 125 patent applications filed and 71 granted patents per drug.

Since these duplicative patents are not “new and useful” as required by the Patent Act, many of these patents are ruled to be invalid. However, in order to achieve the ruling of invalidity, generic and biosimilar companies are required to engage in time-intensive and expensive patent litigation.

Another method to block competition from generics through patents is called “product hopping.” Drugs can be categorized as “extended release” and “immediate release” medications, depending on the period of relief granted by the drugs. Immediate release medications relieve pain immediately but are required to be consumed every few hours.

On the other hand, extended-release medications are required to be consumed only once or twice a day, since they are designed to provide a pre-designated amount of medication throughout the day. Therefore, upon nearing the expiration of the patent of an immediate release drug, the company obtains a new patent covering an extended-release version of the drug and starts advertising the new product aggressively.

“In certain cases, it may also disparage the immediate release version of the drug and take it off the market, thereby forcing a switch in consumer preferences. Therefore, a product hopping strategy can render the original drug and its generic forms obsolete,” experts reveal.


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