PhRMA submits comments to USPTO highlighting important role of patent system in medicine development

PhRMA recently submitted comments in response to the USPTO's request for comments regarding initiatives to ensure the robustness and reliability of patent rights.

Megan Van Etten
Megan Van EttenFebruary 23, 2023

PhRMA submits comments to USPTO highlighting important role of patent system in medicine development.

PhRMA responded to the U.S. Patent and Trademark Office’s (USPTO) request for comments regarding USPTO initiatives to ensure the robustness and reliability of patent rights.

As outlined in our comments, PhRMA supports the goals of the USPTO in this process to “bolster the robustness and reliability of patents” and “ensure that the patent rights granted by the USPTO fulfill their intended purpose of furthering the common good, incentivizing innovation, and promoting economic prosperity.”

However, we are concerned with certain unfounded criticisms of continuation patents, including narratives about the quantity of patents and the families of patents comprising so-called “patent thickets” that are driven by questionable data and misunderstandings about patent coverage. Contrary to these narratives, continuation patents are essential to ongoing biopharmaceutical research and development  

The reality is that continuation patents provide critical incentives for biopharmaceutical companies to make the costly and high-risk investments necessary to develop new medicines for patients. Reduced intellectual property protections would lead to fewer options for patients — especially those battling our most complex and challenging diseases.  

As the USPTO reviews the comments and decides about any next steps, PhRMA encourages the USPTO to consider the three key points:

  • The U.S. patent system should continue to incentivize 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.

  • As the USPTO grapples with the important patent policy questions set forth in the Notice, it should recognize 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.

  • The U.S. 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.

We appreciate the USPTO’s efforts to address issues in the patent system. We remain committed to contributing to the dialogue between the USPTO and stakeholders on important patent issues moving forward, and we strongly encourage the USPTO to ensure that any policy changes made are based on factual evidence as well as reliable and transparent data.

Read the full comments submitted by PhRMA here.

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