unexpected results : CAFC Alert

Somewhat unexpected results yield to strong evidence of obviousness to try

| August 8, 2014

Roche and Genentech v. Apotex Inc; Roche and Genentech v. Dr. Reddy’s laboratories; Roche and Genentech v. Watson etc.; Roche and Genentech v. Orchid chemicals & pharmaceuticals etc; and Genentech v. Mylan etc.

April 11, 2014

Before  Newman, Lourie, and Bryson.  Opinion by Bryson. Dissent by Newman


Plaintiff Roche appeals from the decision of the U.S. District Court for the District of New Jersey granting the defendant generic drug companies summary judgment of invalidity of Roche’s two patents related to Boniva®, a commercial drug for the treatment of osteoporosis. CAFC affirms.

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Post-filing recognition of a drug compound’s unexpected property may not be sufficient to establish the compound’s nonobviousness.

| July 24, 2014

Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA, Inc.

June 12, 2014


The Federal Circuit found that a patent claim directed to a drug compound for treating hepatitis B was invalid as an obvious modification to a structurally similar lead compound. In so finding, the Federal Circuit dismissed evidence of later discovery, after the time of invention, that the lead compound was highly toxic and therapeutically useless. The Federal Circuit then determined that evidence of the drug compound’s later-discovered unexpected lack of toxicity was insufficient to prove nonobviousness, despite additional evidence demonstrating the drug compound’s unexpectedly high potency and unexpectedly high barrier to resistance. The Federal Circuit’s decision may have taken some bite out of the court’s precedents that an invention’s properties and advantagesneed not be fully known as of the filing date of the patent application to be relevant to nonobviousness.

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Not All Secondary Considerations are Probative of Nonobviousness

| July 23, 2014

Galderma Labs v. Tolmar, Inc.

December 11, 2013

Before NEWMAN, BRYSON, and PROST, Circuit Judges. Opinion for the court filed by Circuit Judge PROST. Dissenting opinion filed by Circuit Judge NEWMAN.


This Hatch-Waxman case is based on Tolmar’s filing of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic drug (Differin® Gel,0.3%), which is a topical medication containing 0.3% by weight adapalene approved for the treatment of acne.

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Unexpected result for combination therapy using two known drugs

| July 24, 2013

Novo Nordisk A/S v. Caraco Phamaceutical Laboratories, Ltd.

June 18, 2013

Panel:  Newman, Dyk and Prost.  Opinion by Prost.  Dissent by Newman.


A patent claims a combination therapy using two drugs.  The patent was issued by overcoming prior art as an examiner recognized an unexpected result proved by an inventor’s declaration.  In the district court, defendant presented new evidence challenging the validity of the patent.   The evidence showed that one of the claimed drugs was well known to be used in the therapy, and another drug having similar mechanism as the other was also well known to be used in such combination therapy.  Relying on the evidence, the district court hold that the patent was obvious because the evidence created a strong prima facie case of obviousness, and it was so strong that the patentee’s evidence showing certain superior effects did not overcome the prima facie obviousness. The majority agreed with the district court holding.  Judge Newman dissented.



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