IP Update, Vol. 13, No. 5

Editor: Marc S. Weiner, Esq.

The Hague Agreement – Effective May 13, 2015

As mentioned in the IP Update from April 2, 2015, the Final Rules to the Hague Agreement concerning International Registration of Industrial Designs were issued in the Federal Register.

Please read our Hague Agreement Summary, which provides a list of:
• Advantages;
• Disadvantages;
• Main Rule Changes; and
• Things to Consider.

Also provided is a current timeline for filing a Design application and timeline for filing through the Hague Agreement.

Summary provided by BSKB’s IP Training Department.

Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc. – Inherency Relating to Obviousness

In Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., 773 F.3d 1186 (Fed. Cir. 2014), the Federal Circuit decides issues of inherency as it relates to obviousness over a combination of references.

In this case, Par asserts the claims of U.S. Patent No. 7,101,576 against TWi. Independent claim 1 covers methods for use of nanosized megestrol formulations and includes two “wherein” clauses that address the lack of a food effect in the nanosized megestrol formulation. Both Par and TWi agree that essentially all of the substantive limitations in the independent claim are present in the various prior art references identified by the district court. The point of contention is whether the specific food effect limitations are also disclosed in the prior art. Both TWi and the district court assert that these limitations are an inherent property of the formulation disclosed by the obvious combination of prior art elements.

The Federal Circuit agreed that there was no known food effect for megestrol in the prior art. However, the Federal Circuit concludes that the district court erred in its inherency analysis. The Federal Circuit states, “A party must…meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” Id. at 1192.

Thus, the Federal Circuit indicated that the concept of inherency must be limited when applied to obviousness and is present only when the limitation at issue is the “natural result” of the combination of prior art elements. In other words, the mere fact that a certain thing may result from a given set of circumstances is not sufficient. In contrast, a disclosure that shows that the inherent feature necessarily flows from the teachings of the prior art is sufficient.

The Federal Circuit determined that the district court did not require that TWi present evidence sufficient to prove inherency under this standard. TWi’s expert testified that an improvement in bioavailabilty necessarily results in a decrease in any food effect, and TWi presented evidence that a reduction in particle size improves bioavailability. Therefore, the district court concluded that the reduced particle size would lead to a reduced food effect.

However, the Federal Circuit stated that the district court’s analysis ignores the claim limitations at issue. Claim 1 requires “no substantial difference in Cmax” between the fed and fasted states. The Federal Circuit stated, “While it may be true that a reduction in particle size naturally results in some improvement in the food effect, the district court fails to conclude that the reduction in particle size naturally results in ‘no substantial difference’ in the food effect” (emphasis in original).

Then, the Federal Circuit vacated the district court’s inherency analysis and remanded for the district court to determine if TWi has presented clear and convincing evidence that demonstrates the food effect as claimed is necessarily present in the prior art combination.

Summary provided by Chad M. Rink