Prima facie case of obviousness is not established solely because end point of claimed range is close to disclosed range

Yoshiya Nakamura | July 31, 2014

In re Rajen M. Patel

July 16, 2014

Panel:  O’Malley and Hughes.  Opinion by O’Malley.

Summary

PTAB affirmed Examiner’s rejections of Applicants’ claims reciting a range limitation of weight percent of a polymer component, as being obvious over a cited reference because it discloses a range whose upper limit is very close to the claimed lower limit.  Applicants appealed from the PTO decision and argued before CAFC that the PTAB erred in finding a prima facie case of obviousness where the amounts do not overlap.  CAFC agreed with the Applicants and distinguished this case from its previous cases where range overlapping at least to some degree was required to find obviousness.

出願クレームは、ポリマーの量(26 wt%以上)を記載し、先行技術はポリマーの量(25 wt%以下)を開示していた。その差は僅か1%ほどである。米国特許庁審査官はこの場合、数値は重複していないが、非常に近接しているので、それだけで自明性の存在が一応証明され(prima facie case of obviousness)、したがって、出願人が非自明性(たとえば予期せぬ効果)を証明しなければ特許されないと判断した。同特許庁審判部はこの結論を維持した。この決定を不服として出願人はCAFCに上訴し、クレームの数値範囲に「近い」という理由だけで即座に自明であるとした特許庁の判断は間違いであると主張した。CAFCは出願人の意見に同意し、特許庁の判断を覆した。本件は、先行技術の数値がクレームの数値と重複しておらず、クレームの数値へ増量するという教示が先行技術にはないことに着目し、単に数値が「近い」というだけで自明であるとしてはいけないとの判断である。特許庁のガイドラインは、数値範囲が重複していなくても、同様の特性が予期できる程度に「近い」といえる場合は一応の自明性があると説明しているが、本件はこの基準の適用範囲を制限した判決であると考えられる。


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

Cindy Chen | July 24, 2014

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

June 12, 2014

Summary

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

Lee Wright | 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.

SUMMARY

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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CAFC reminds applicants to be wary of functionally defined genus claims

Linda Shapiro | July 22, 2014

AbbVie Deutschland GMBH & CO., KG et al., v. Janssen Biotech, Inc.

July 1, 2014

Panel:  Lourie, O’Malley, and Chen. Opinion by Lourie. Concurring opinion by O’Malley.

Summary

 Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date.


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