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Federal Circuit Affirms NJ District Court Decision on Obviousness
Practical Law Legal Update 2-519-3549 (Approx. 4 pages)
Federal Circuit Affirms NJ District Court Decision on Obviousness
by PLC Intellectual Property & Technology
| Published on 08 May 2012 • USA (National/Federal) |
On May 7, 2012, in Otsuka Pharmaceutical Co. v. Sandoz, Inc., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of New Jersey's determination sustaining the validity of asserted claims of US Patent 5,006,528 in the face of the defendants' obviousness and obviousness-type double patenting defenses.
Key Litigated Issue
In Otsuka Pharmaceutical Co. v. Sandoz, Inc. the key litigated issue before the US Court of Appeals for the Federal Circuit was whether the district court erred in finding that the asserted claims of US Patent 5,006,528 ('528 patent) were not invalid for either:
- Obviousness under Section 103 of the Patent Act.
- Non-statutory obviousness-type double patenting.
Background
Otsuka Pharmaceutical Co. filed suit against Apotex Inc., and several Abbreviated New Drug Application (ANDA) filers for infringement of its '528 patent. Otsuka brought the action after the defendants filed for FDA approval to engage in the commercial manufacture, use or sale of generic aripiprazole, the active ingredient in an antipsychotic drug covered by the '528 patent. The defendants conceded that their ANDA filings constituted literal infringement of the '528 patent, but they asserted in defense and counterclaimed that the claims were invalid for:
- Obviousness under Section 103.
- Obvious-type double patenting based on the defendants' assertion that the relevant '528 patent claims are an obvious modification of the invention in claim 13 of Otsuka's earlier US Patent 4,734,416.
Following a bench trial, the district court concluded that the defendants failed to prove by clear and convincing evidence that the asserted claims would have been obvious under Section 103 to one of ordinary skill or were invalid for nonstatutory double patenting.
Outcome
The Federal Circuit affirmed the district court's decision.
Obviousness
The Federal Circuit confirmed the two-step inquiry for determining whether a new chemical compound would have been prima facie obvious over particular prior art compounds. This inquiry requires the court to determine whether:
- A chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds or starting points for further development. In determining whether a chemist would have selected a prior art compound as a lead, the analysis is guided by the compound's pertinent properties, such as:
- activity;
- potency; and
- toxicity.
- The prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success. In keeping with the flexible nature of the obviousness inquiry, the reason or motivation for modifying a lead compound may come from any number of sources and need not necessarily be explicit in the prior art.
Obviousness-type Double Patenting
In its affirmance, the Federal Circuit noted that a finding of obviousness-type double patenting in chemical compound cases:
- Does not depend on whether a skilled artisan would have selected the earlier compound as a lead compound but necessarily focuses on the earlier claimed compound over which double patenting has been alleged, whether or not it is a lead compound.
- Requires identifying some reason that would have led a chemist to modify the earlier compound to make the later compound with a reasonable expectation of success.
Practical Implications
Alleged infringers of chemical compound claims asserting an obviousness defense based on the modification of a prior art lead compound should note that they must avoid hindsight reasoning and instead focus on evidence supporting its position that:
- The skilled artisan would have had reason to select the lead compound from any of the known compounds in the prior art.
- The prior art would have supplied the motivation to modify the lead compound to make the claimed compound with a reasonable expectation of success.
Additionally, in obviousness-type double patenting, the alleged infringer must also show some reason that would have led the chemist to modify the earlier compound to make the later compound with a reasonable expectation of success.