Novartis Pharm. Corp. v. Noven Pharm., Inc.

Determining if compounds are similar for obviousness requires analysis of the entire structure.

October 15, 2015

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Novartis Pharm. Corp. v. Noven Pharm., Inc., Civ. No. 13-527-RGA, 2015 U.S. Dist. LEXIS 115246 (D. Del. Aug. 31, 2015) (Andrews, J.) 

Drug Product and Patents-in-Suit: Exelon® (rivastigmine); U.S. Patent No. 6,335,031 ("the '031 patent")

Nature of the Case and Issue(s) Presented: Noven asserted that the challenged claims of the ’031 were obvious under § 103 and obviousness-type double patenting. While the district court had rejected similar arguments for the challenged claims in a prior litigation, which was affirmed by the Federal Circuit, the Court determined that Noven had presented new evidence not considered in the prior litigation.  

Noven asserted that the prior art taught that rivastigmine was susceptible to oxidative degradation because of a particular carbon-hydrogen bond in the compound. Noven further argued that one of skill in the art would have compared the similarities between rivastigmine and nicotine to find that rivastigmine would oxidize. Lastly, Noven argued that the claims were invalid under obviousness-type double patenting because a prior related patent included the same scope as the challenged claims and were owned by the same company.

Novartis argued that the prior art did not disclose that rivastigmine was susceptible to oxidative degradation because an analysis of the entire structure demonstrated that it was not obvious that it would be susceptible. As to the nicotine comparison, Novartis asserted that the compounds were quite different in structure because they lacked several similar components. Novartis argued that obviousness-type double patenting did not apply because the prior related patent did not disclose rivastigmine’s susceptibility to oxidation and was not owned by the same entities that owned the ‘031 patent.

The district court held that the challenged claims were not invalid under § 103 or obviousness-type double patenting.

Why Novartis Prevailed: The district court rejected Noven’s argument concerning rivastigmine’s susceptibility to oxidation based on a single carbon-hydrogen bond.  The court agreed with Novartis’ expert that one of skill would look at the entire structure of the compound to determine if it would be susceptible. The court noted that no actual testing was done to determine if any actual degradation occurs.

The court further rejected the comparison to nicotine.  The court noted that the two structures were different in several regards, and in particular nicotine lacked several functional groups present in rivastigmine. Even if one of skill would consider them the same, the court found that one of skill would not make any determination regarding stability of rivastigmine.

For obviousness-type double patenting, the court found that the two patents were not owned by the same entities because the prior related patent was only owned by Novartis AG while the ‘031 was owned by Novartis and LTS.  Further, the patents did not have common inventorship. 

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