Your IPR petition argues that a patent is obvious—but will those arguments even be fully considered? A recent decision in Affordable Drugs VII v. Pozen Inc. emphasizes the importance of providing evidence-based arguments within the appropriate documents that inform the Board’s investigation.

Kyle Bass’ Coalition for Affordable Drugs filed several IPR requests for review of patents related to Pozen Inc.’s arthritis and ulcer drug, Vimovo®, in 2015. Three of the requests were denied and the only instituted IPR (IPR2015-01718) was recently decided in favor of patent holder Pozen—the Board upheld all of the issued claims of US Patent No. 8,945,621.

Pozen contended that a unit dose form comprising immediate-release esomeprazole and delayed-release naproxen is more effective at reducing ulcers in patients taking low-dose aspirin (LDA) than in patients not taking LDA, despite the expectation that patients taking LDA would be at an increased risk for ulcers. Pozen argued that the unexpected effects found in its studies were substantial and reflected in its claims. The Board agreed, noting that the results represented a difference in kind, rather than degree.

The petitioner’s challenge, supported by a declaration from expert witness, Dr. Shargel, was based on an assertion that all of the limitations claimed in the ’621 patent had been previously disclosed. However, these arguments were not considered because the underlying data was excluded from the petition. Although the petitioner argued that the relevant facts and arguments were presented in an appendix, the Board declined to consider them, noting that this type of evidence must be included in the petition itself and cannot be incorporated by reference.

This result is reminiscent of an earlier IPR (IPR2015-01680) against U.S. Patent 8,852,636, which involved the same parties, expert witness and drug. In denying institution of this IPR, the Board noted several times that the petitioner had not properly presented evidence-based arguments, but rather proffered its expert witness’s conclusory and unsupported statement.

Whether or not the petitioner’s arguments in either case would have won the day is a matter of speculation—but at a minimum they could have been considered by the Board if properly presented in the petition.

Takeaways

Those seeking to challenge issued US patent claims must remember to carefully formulate petitions to include all of the relevant factual underpinnings of their arguments and not to simply rely on conclusory or unsupported assertions—even those made by an expert. However, patent owners (and those seeking patents) can remain confident that unexpected effects are still considered by the Board to move claims beyond an initial showing of obviousness, especially if the evidence shows differences in kind rather than differences in degree.