Federal Circuit Finds No Biosimilars Application Means No Case Or Controversy For Sandoz

In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating to a possible “biosimilar” product, the court was careful to steer clear of the biosimilars statute. Apparently the judges aren’t the only ones trying to avoid the patent provisions of the Biologics Price Competition and Innovation Act. Continue reading this entry

Federal Circuit Notes High Burden Of Invoking Inherency For Obviousness

In Par Pharmaceutical Inc. v. Twi Pharmaceuticals, Inc., the Federal Circuit vacated and remanded the district court decision holding the Par claims at issue obvious. The district court decision rested in part on the doctrine of inherency, but Twi did not establish that the property at issue “necessarily must be present” in the product rendered obvious by the prior art. In reaching this decision, the Federal Circuit emphasizes the “high standard” required to invoke the doctrine of inherency in an obviousness context.

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The Confused USPTO Policy On Certified Copies Of Patent Applications

Obtaining certified copies of patent applications can be essential to perfecting a priority claim. But when a U.S. priority application contains a sequence listing, USPTO practices make it difficult to satisfy this requirement. While there is a work-around, it is cumbersome and potentially costly. The USPTO can solve this problem, but will it? Continue reading this entry

The USPTO Is Off-Key With International Patent Law Harmonization

As a leader in science, technology and innovation, the United States long has played a central role in global intellectual property matters. As the world’s largest economy, the United States has played a central role in trade policy, including its role in setting up the TRIPS agreements that made intellectual property rights a precondition for joining the WTO. The USPTO is continuing this leadership role by hosting a Roundtable on the international harmonization of substantive patent law on November 19, 2014, but it should look at its own practices that keep the United States out of harmony with other major national patent offices.

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Third Time Is The Charm For WildTangent Challenge Of Patent Eligibility Of Ultramercial Patent

In its third opinion reviewing the same district court decision, the Federal Circuit this time affirmed the district court’s grant of WildTangent’s motion to dismiss Ultramercial’s patent infringement complaint because the claims at issue fail to satisfy 35 USC § 101. The Federal Circuit applied the analytical framework set forth in the Supreme Court decision in Alice Corp. v. CLS  Bank, and determined that the claims are directed to non-patent eligible abstract ideas. In his concurrence, Judge Mayer explains his view that the presumption of validity does not attach to § 101 issues, and that only ”technological”–not “entrepreneurial”–methods are patent eligible under Alice. Continue reading this entry