Opinion ID: 809417
Heading Depth: 4
Heading Rank: 2

Heading: The Saadah Reference

Text: The Saadah reference is a 1992 report entitled “Abortive Migraine Therapy With Oral Naproxen Sodium Plus Metoclopramide Plus Ergotamine Tartrate With Caffeine.” It discloses the simultaneous delivery of several components: ergotamine, which is a 5-HT agonist that at the time was a widely used anti-migraine agent; metoclopramide and caffeine to reduce nausea and improve “gastric emptying” which in turn leads to better absorption of anti-migraine agents; and naproxen for its pain and inflammation reduction effects. Par argues that another article, N.H. Raskin’s “Acute and Prophylactic Treatment of Migraine: Practical Approaches and Pharmacologic Rationale,” (“Raskin”) shows 7 Although the properties of the two agents were known independently, Parma does not give any indication that the combination of the two produced any benefit beyond those experienced when each agent is taken alone. 17 POZEN INC v. PAR PHARMA sumatriptan has beneficial effects on nausea, and can be used instead of ergotamine to treat migraines eliminating the need for a concurrent antiemetic. 8 Therefore, Appellants contend, a person of ordinary skill in the art would reasonably expect to successfully substitute sumatriptan for ergotamine, both 5-HT agonists, in the treatment plan disclosed by Saadah. Furthermore, Appellants contend that in substituting sumatriptan for ergotamine, there would no longer be a need for antiemetics, so metoclopramide and caffeine would be unnecessary. Accordingly, Appellants assert, Saadah and Raskin together teach the simultaneous administration of sumatriptan and naproxen, rendering the ’499 and ’458 patents obvious. Pozen contends that a person of ordinary skill in the art motivated to substitute sumatriptan for ergotamine would remove not only metoclopramide and caffeine from the treatment plan but also naproxen because sumatriptan was recognized to have analgesic and anti- inflammatory effects. Therefore, Pozen argues, the formulation would result in sumatriptan monotherapy. The district court held that after reading Saadah, it is not obvious that one could substitute sumatriptan for ergotamine and remove metoclopramide and caffeine as unnecessary. Pozen, 800 F. Supp. 2d at 817. We agree. Saadah disclosed each drug as having a specific purpose, and even though Raskin teaches that antiemetics are unnecessary with sumatriptan, Raskin does not provide the motivation to a skilled artisan to substitute one agent in place of three. Nor does Saadah teach the remaining efficacy limitations, since it gives no reason to assume that an entirely different combination of agents would 8 Raskin teaches that sumatriptan can be used as an anti-migraine without the concurrent use of antinausea agents. J.A.241903. POZEN INC v. PAR PHARMA 18 have the same success as the combination disclosed, nor does it disclose the combination therapy has any added benefits over any of the components given individually. See Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294, 1309 (Fed. Cir. 2010) (“Even if the [patent at issue] were a combination of known elements according to their established functions . . . it yields more than predicable results” and thus is non-obvious.). The district court did not clearly err in determining the scope of Saadah and Raskin. Accordingly, as the district court held, the Saadah reference does not render the ’499 and ’458 patents obvious to a person of ordinary skill in the art.