Soon after the Connecticut General Assembly finished the 2015 session in June, the focus of biopharma policy advocacy shifted to Washington, D.C., and federal patent reform legislation.

After many significant changes were made to U.S. patent law in the 2011 America Invents Act (AIA), several issues have surfaced in the wake of that landmark legislation that need attention.

Soon after the Connecticut General Assembly finished the 2015 session in June, the focus of biopharma policy advocacy shifted to Washington, D.C., and federal patent reform legislation.

Topping the issues is how to rein in “patent trolls”–that is, individuals and groups who make vague and dubious claims of patent infringement in order to force a monetary settlement.

Even when patent trolls’ allegations have no merit, companies often choose to settle with (read: “pay off”) trolls in order to avoid delaying product development or product launches.

As federal patent troll legislation (H.R. 9, also known as the Innovation Act)  took shape, however, many biopharma companies and research universities cautioned that the reform could go too far and endanger very legitimate efforts to enforce patents related to their inventions.

The act’s tools for dealing with patent trolls appear to be most effective for companies with products built on a great number of patents. A tablet computer, for example, is based on thousands of patents.

But the proposal is potentially harmful to companies with products that depend on the validity of just a few key patents, such as a new medicine.

The Innovation Act also aims to correct an unintended consequence of the comprehensive AIA that established a new administrative procedure for challenging patents after they are issued.

This “inter partes review” in the U.S. Patent and Trademark Office was meant to streamline the patent system, but has turned out to have the opposite effect.

Because the proposed cures for patent policy ills might be worse than current law, advocates, including the CBIA Bioscience Growth Council, successfully argued that the House should set aside the bill to allow for more research and analysis, and a revised bill.

The council continues to promote:

  • Innovation is key. Protecting and nurturing biopharma new medicine innovation should be the overarching goal of any revisions to patent law.
  • Reining in/addressing authentic abuses of patent “trolls” is very important, but shouldn’t be done in a way that makes it more difficult and costly for legitimate patent holders to protect their inventions against infringement. The patent enforcement process should be made more, not less, certain.
  • The unintended consequences of “inter partes review” should be addressed as part of any reform legislation. The patent-related rules and procedures established for new and generic medicines under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act should not be encumbered.

For more information, contact CBIA Bioscience Growth Council chair Paul Pescatello at 860.244.1938 | paul.pescatello@cbia.com | @CTBio