Case Name: Ferring Pharms. Inc. v. Fresenius Kabi USA, LLC, No. 20-431 (MN) (D. Del. Dec. 12, 2022) (Noreika, J.)
Drug Product and Patent(s)-in-Suit: Firmagon® (degarelix acetate); U.S. Patents Nos. 9,579,359 (“the ’359 patent”), 10,729,739 (“the ’739 patent”), 10,973,870 (“the ’870 patent”), 9,415,085 (“the ’085 patent”), 10,695,398 (“the ’398 patent”), and 8,828,938 (“the ’938 patent”)
Nature of the Case and Issue(s) Presented: Firmagon® is a GnRH receptor antagonist indicated for the treatment of patients with advanced prostate cancer. Fresenius argued that it did not infringe the patents-in-suit and that they were invalid. The Side-Effect Patents include the ʼ359, ʼ739, and ʼ870 patents. The CV Patents include the ʼ085 and ʼ398 patents. After a four-day bench trial and post-trial briefing, the court issued an opinion finding Fresenius’s ANDA product would induce infringement of the ’359 patent and the ’739 patent, but that those patents were invalid as obvious. The court further found that Ferring had not proven that Fresenius would infringe the ’870 patent, the ’085 patent, or the ’398 patent.
Why Fresenius Prevailed: Although healthcare providers would directly infringe the ’359 and ’739 patents when following Fresenius’s ANDA label, Fresenius argued that it did not have the requisite intent to induce infringement. The court disagreed and concluded that Fresenius’s internal documents demonstrated that it knew that performing the steps in the manner directed by the proposed label would cause the claimed reduction in side effects. As a result, Fresenius induced infringement.
For the ’870 patent, Fresenius only contested infringement of the claim element “choosing a dosing regimen of degarelix over gonadotrophin releasing hormone (GnRH) agonist treatment to decrease the likelihood of developing a musculoskeletal disorder or a connective tissue disorder compared to GnRH agonist treatment when treating prostate cancer in the subject.” As a result, the relevant infringement question was whether Fresenius had the specific intent to induce healthcare providers to choose degarelix over a GnRH agonist to decrease the likelihood that a patient develops a musculoskeletal disorder. Ferring failed to introduce evidence that Fresenius’s proposed label instructs, teaches, or encourages users to perform the patented method by choosing to administer degarelix to decrease the likelihood of the claimed side effect. Although Fresenius knew that degarelix offered “better clinical outcomes” than alternatives, there was no evidence that Fresenius knew that administration of degarelix would decrease the likelihood of developing a musculoskeletal disorder or a connective tissue disorder compared to a GnRH agonist treatment.
As to the CV Patents, Ferring argued that healthcare providers would use the ANDA product in a manner that directly infringed the asserted claims of the CV Patents and that Fresenius would induce this infringement because the ANDA label does not contain a warning addressing cardiovascular risk whereas GnRH agonists do contain such a warning. In response, Fresenius argued that it performed no action instructing healthcare providers to “select” a patient based on their CV history or to reduce CV events. The court agreed with Fresenius and found no infringement of the CV patents.
Next, Fresenius argued that certain prior art rendered the ’359 and ’739 patents obvious. In response, Ferring argued that it would not have been obvious to administer the initiation dose of degarelix in two subcutaneous injections because injections are uncomfortable, meaning that clinicians would prefer one injection. But the court found that the prior art teaches splitting the initiation dose and that there was ample evidence that a skilled artisan would have an expectation of success in doing so. As for secondary considerations, the court found that Ferring’s indicia related to inherent properties of degarelix when used to treat prostate cancer (which was known) and not to the claimed inventions. The ’359 and ’739 patents were thus invalid as obvious.
As for the ’870 patent, Fresenius argued that the prior art discloses the “choosing” limitation because treating prostate cancer with degarelix avoids testosterone flare, which, in turn, would reduce bone pain. The court found, however, that the evidence did not support Fresenius’s argument.
For the CV Patents, the court concluded that Fresenius’s argument was based on improper hindsight. In particular, a skilled artisan reading the prior art would not believe that prostate cancer patients with at least one prior cardiovascular event should avoid a GnRH agonist in order to reduce the likelihood of a future event.
Finally, Fresenius argued that the Side-Effect Patents lacked enablement support because the specification includes only two examples of degarelix trials. But the court explained that Fresenius’s expert never addressed the other In re Wands factors, including quantity of experimentation, the disclosures in the prior art, and the predictability (or lack thereof) of the art. For that reason, Fresenius’s enablement argument failed.
