PhRMA shames Brazil and Thailand over patent backlogs

Pharmaceutical Research and Manufacturers of America (PhRMA) has identified Brazil and Thailand as two of the worst countries for patent delays, in a submission made to a US government report.

At the end of October, the industry group sent comments to the Office of the US Trade Representative for its “2019 National Trade Estimate (NTE) Report on Foreign Trade Barriers”.

The annual report documents foreign trade and investment barriers facing US exports globally.

PhRMA covered a wide range of challenges facing pharmaceutical innovators, including patent enforcement, compulsory licences (CLs) and patentability.

On the backlog issue, the group said that while delays are a challenge around the world, a few countries stand out for persistently long pendencies.

“In Brazil and Thailand, for example, it can take ten years or more to secure a patent on a new medicine. Thailand approved a patent application filed by one PhRMA member six weeks before the patent expired,” it said.

The situation is only “somewhat better” in markets like India, where it takes an average of six years to secure a patent and, in 2015, the IP office granted one patent based on an application filed 19 years earlier, PhRMA added.

PhRMA also noted that some governments, including in India, Indonesia and Malaysia, have approved and/or issued CLs, while other countries, such as Chile, Colombia, Peru, Russia, Turkey and Vietnam, have adopted or are considering measures that promote or provide broad discretion to issue such licences.

“PhRMA believes that governments should grant CLs in accordance with international rules, only in exceptional circumstances, and only as a last resort,” the group said in its submission.

The association also took aim at patentability and patent enforcement.

On the first issue, PhRMA said a number of countries maintain laws and regulations that prevent the patenting of a wide range of specific improvements to existing medicines.

For example, Argentina issued regulations in 2012 that prevent patents for certain types of inventions, including new dosage forms and combinations, while Indonesia adopted a new patent law in 2016 that similarly prohibits patents for new forms and uses of existing medicines, the group said.

On enforcement, it said that, in Australia, US innovators do not receive any notice of a third party’s intention to enter the market; in Mexico, they are unable to quickly secure effective preliminary injunctions, PhRMA added.

In response to its concerns, the association suggested that the US government pursues five actions: first, enforce and defend international rules, and second, secure strong commitments in trade negotiations.

Third, the authorities should ensure that government pricing and reimbursement policies and decisions are fair and transparent, while they should combat the worldwide proliferation of counterfeit medicines.

Finally, the US government should build and strengthen global cooperation.

The 2019 NTE Report will be published next year.

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