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Pharmaceutical Patents Hatch-Waxman Reasonable Expectations Test

Axinn, Veltrop & Harkrider LLP

Vanda Swings for the Fences and Asks the Supreme Court to Heighten the Standard for Obviousness

Among the most established standards in patent law is that obviousness requires a motivation to combine the prior art with “a reasonable expectation of success.” The Federal Circuit alone has employed the “reasonable...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Reverses PTAB Finding Tarceva® Method of Treatment Claims Invalid for Lack of Reasonable Expectation of Success...

In a precedential opinion on October 4, 2019, the United States Court of Appeals for the Federal Circuit, in OSI Pharmaceuticals v. Apotex, No. 2018-1925, reversed the Board’s Final Written Decision in an inter partes review...more

Jones Day

Lead Compound Analysis Not Always Applicable

Jones Day on

The Situation: In a Hatch-Waxman litigation, a district court determined that the claims covering a method of using the drug everolimus to treat kidney cancers were not obvious. The court found a motivation to "pursue"...more

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