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The Latest on Inherent Obviousness (Intellectual Property)

On December 3, 2014, the Federal Circuit issued a decision in Par Pharmaceutical, Inc. and Alkermes Pharma Ireland Limited v. TWI Pharmaceuticals, Inc., agreeing with the district court’s analysis and conclusions on motivation to combine, reasonable expectation of success, and objective indicia of nonobviousness but vacating and remanding for further analysis on the issue of inherency.

Patent at Issue

Par obtained U.S. Patent No. 7,101,576 to a method of using megestrol nanoparticles to increase body mass in a human patient suffering from anorexia, cachexia, or loss of body mass, wherein after a single administration in a human subject, there is no substantial difference in the Cmax of megestrol when the formulation is administered in a fed versus a fasted state (“the food effect limitation”). The FDA approved Par’s New Drug Application for its megestrol nanoparticle formulation, Megace ES, and Par listed the ‘576 patent in the Orange Book. TWI filed an Abbreviated New Drug Application, asserting among other things that the claims of the ‘576 patent are invalid as obvious under 35 U.S.C. §103. Specifically, TWI argued that the food effect limitation was disclosed in the prior ar t under the principle of inherency.  The district cour t agreed and held the ‘576 patent invalid as obvious.

The Federal Circuit’s Analysis

The Federal Circuit agreed that all elements of the claimed invention were disclosed in the prior ar t.  However, the Federal Circuit disagreed with the district court that the food effect limitation was inherently disclosed in the art. In particular, the district court held that even though the prior art did not explicitly disclose the food effect differences as claimed, “[t]he claimed pharmacokinetic parameters with respect to a food effect . . . are inherent proper ties of the obvious nanoparticulate formulation.” The reduced food effect was thus “an inherent result” of nanosized megestrol “even if it was previously not known in the prior ar t that a food effect existed.”

The Federal Circuit has recognized that “inherency may supply a missing claim limitation in an obviousness analysis.”  (Id. at page 14.)  However, inherency cannot be based on what may happen but what must happen by a combination of prior art that purportedly will inherently have a proper ty recited as an affirmative limitation in a claim being examined for obviousness.  (Id.)   Thus, “if the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” (Id.)

The Federal Circuit acknowledged that “it may be true that a reduction in particle size naturally results in some improvement in the food effect, [but] the district court [has] failed to conclude that the reduction in particle size naturally results in “no substantial difference” in the food effect.”  (Id.) Thus, the panel vacated the district court’s inherency analysis and remanded.

Is Inherent Obviousness Still Alive?

Yes. It appears that on remand the district court is likely to hold that the reduction in particle size results in “no substantial difference” in the food effect and that the claimed pharmacokinetic proper ties with respect to a food effect, are inherent proper ties of the obvious nanoparticulate formulation claimed by the ‘576 patent. In fact, the ‘576 patent itself states that this is the case. (The ‘576 patent, col. 8, line 50 to col. 9, line 17.)  If, on remand, Par argues a nanoparticle megestrol acetate formulation within the claims does not necessarily exhibit the food effect limitation, Par runs the risk of a lack of enablement attack on the claims.  This case is another example of the tension that could arise between obviousness and enablement.

© 2020 Sterne Kessler

About this Author

Gaby L. Longsworth, PhD. Biotechnology Chemical Attorney Sterne Kessler law firm
Director

Gaby L. Longsworth, Ph.D., is a Director in the Biotechnology/Chemical Group.   Dr. Longsworth is sought out by both innovator and generic pharmaceutical companies for her insights and knowledge of intellectual property and brand product lifecycle management strategies.

A large part of Dr. Longsworth's practice is focused on representing international and domestic generic pharmaceutical companies in patent cases involving Abbreviated New Drug Applications (ANDAs) that include a Paragraph IV (pIV) certification to one or more Orange Book listed patents.  She has been involved in...

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Marsha Rose Gillentine, Ph.D., Director, Sterne Kessler Law Firm
Director

Dr. Gillentine is a Director in the Biotechnology/Chemical Group focusing on the pharmaceutical industry.  Because Dr. Gillentine is intimately familiar with the Hatch-Waxman Act, and understands patent litigation strategy in the context of the Abbreviated New Drug Application process and Patent Office Litigation, Dr. Gillentine is sought by both innovator and generic pharmaceutical companies for assistance with intellectual property issues related to their pharmaceutical products. 

Dr. Gillentine is experienced in working with clients to implement lifecycle management strategies, including those for personalized medicine patent portfolios.  Her practice encompasses both domestic and foreign patent prosecution, including patent drafting and patent prosecution.  She has drafted and prosecuted patents related to various pharmaceutical issues. For example, Dr. Gillentine has prosecuted patents related to small molecules, polymorphs, chemical synthesis, pharmaceutical formulations, methods of treatment, drug delivery devices, animal models, vaccines, polymers, genes, and gene expression systems, proteins, and antibodies.

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