USPTO told to avoid negative focus on patent thickets

Pharma trade body highlighted negative narratives involving continuation patents | Such IP “essential for ongoing research and development” | USPTO requested comments following criticism of patent thickets.

A US trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), has urged the US Patent and Trademark Offic e’s (USPTO) to ignore “unfounded concerns” about continuation patents.

In the US, a continuing patent application follows, and claims priority to, an earlier-filed patent application.

According to critics, such patents can lead to patent thickets, an overlapping set of patent rights. For example, in the pharmaceutical industry, companies may file many patents on nearly the same invention with minor tweaks to delivery mechanisms, dosages and formulations.

The organisation made the comments in a letter sent earlier this month in response to the office’s request for feedback on its proposed initiatives to “bolster the robustness and reliability of patents, which can then “promote economic prosperity”.

The letter’s contents were later publicised in a statement published on its website on February 23.

The USPTO’s plans stem from a September 2021 letter sent by the US Food and Drug Administration (FDA) that drew attention to the issue of continuation patents and their impact on the marketplace.

In June 2022, a bipartisan group of six US senators also asked the USPTO to address patent thickets, arguing that they were used to stifle competition.

While PhRMA backed the USPTO’s bid to improve the patent system, it drew attention to the prevalence of negative narratives about “the quantity of patents and the families of patents comprising so-called patent thickets”.

Such narratives were driven by questionable data and misunderstandings about patent coverage, said PhRMA.

“Contrary to these narratives, continuation patents are essential to ongoing biopharmaceutical research and development,” the group warned.

It went on to argue that, in reality, continuation patents provide “critical incentives” to biopharmaceutical companies to make the costly and high-risk investments necessary to develop new medicines for patients.

“Reduced IP protections would lead to fewer options for patients— especially those battling our most complex and challenging diseases,” added PhRMA.

As the USPTO reviews the comments and decides about any next steps, the trade group has encouraged the the agency to consider the three key points below:

1. The US patent system should continue to incentivise innovation that can change lives, and encourage disclosure of inventive subject matters in patent applications that can be claimed over time, rather than restricting protection for inventions.
2. It should recognise that biopharmaceutical innovation occurs incrementally and is often unpredictable, which makes flexibility in the patent application process critical to the invention of new and improved treatments and cures.
3. The US03 Patent Act encourages broad disclosure of inventive subject matter precisely because it permits a patent applicant to secure the full scope of patent protection supported by a patent application over time rather than in one moment. Continuation applications, divisional applications, and terminal disclaimers all ensure important flexibility and efficiency in the patent prosecution process and should be supported, rather than restricted. Protecting the common good requires preservation of these practices.

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