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.
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.
Yoshiya Nakamura | January 22, 2014
Institute Pasteur v. Focarino (Fed. Cir. 2013)
Decided December 30, 2013
Before NEWMAN, CLEVENGER, and TARANTO, Circuit Judges. TARANTO, Circuit Judge.
Key Words: non-obviousness, biotechnology, enzyme, reasonable expectation of success
Institute Pasteur (Pasteur) owned patents claiming inventions related to a group of enzymes, i.e., Group I intron-encoded (GIIE) endonucleases. The enzymes are useful as laboratory tools to cut a DNA sequence at a particular site of the sequence in vitro or in situ. In reexamination of the patents, the Board of Appeals rejected the claims as being obvious over cited references. Pasteur appealed to the CAFC. The CAFC vacated the Board decision and remanded for consideration of what would constitute motivation for one skilled in the art to pursue the claimed invention because the Board misread the teachings in prior art and failed to weigh properly substantive evidence of non-obviousness.
John M. Wang | December 6, 2013
Decided November 15, 2013
Before Dyk (Circuit Judge), Bryson (Circuit Judge) and Reyna (Circuit Judge). Opinion by Reyna.
Keywords: collateral estoppel, obviousness, inequitable conduct, reexamination, and rule of reason.
OWW initiated a suit against Alps for patent infringement. After a long legal battle including two ex parte reexaminations, two District Court proceedings, and two CAFC appeals, OWW lost two patents and was charged with inequitable conduct.
OWW is the owner of US Patent No. 5,830,237 (the ‘237 patent), entitled “Gel and Cushioning Devices,” filed on March 5, 1996. The ‘237 patent disclosed cushioning devices designed to cover the residual stumps of amputated limbs, acting as a shape-conforming buffer, as illustrated below, to make the use of attached prostheses more comfortable. The primary invention was a cushion liner comprising a fabric covering in the shape of a tube sock coated on only one side with mineral oil-based polymeric gels.
On December 27, 2004, OWW filed its complaint against Alps for infringement of the ‘237 patent. After the District Court issued its Claim Construction order in the proceedings, Alps filed its first request for an ex parte reexamination of the ‘237 patent. The District Court stayed the litigation for the duration of reexamination proceedings, pending resolution of the validity of the disputed patent.
Kumiko Ide | October 24, 2013
High Point Design LLC, et al. v. Buyer’s Direct, Inc.
September 11, 2013
Panel: O’Malley, Schall, and Wallach. Opinion by Schall
This case addresses obviousness and functionality analysis for design patents. The CAFC stated that the obviousness of a design patent must be analyzed from the perception of a designer of ordinary skill in the field to which the design pertains. With regards to functionality, a design that can perform functions can be protected under design patent so long as the claimed design is “primarily ornamental” and not “primarily functional.”
CAFC Reminds the Patent Office to Play Fair When Issuing New Grounds of Rejection and Evaluating Objective Evidence of Non-Obviousness
Cindy Chen | October 3, 2013
Rambus Inc. v. Rea
September 24, 2013
Panel of Moore, Linn, and O’Malley, Opinion by Moore
The Court of Appeals for the Federal Circuit in Rambus Inc. v. Rea reminds Examiners and the Board of Patent Appeals and Interferences (now the Patent Trial and Appeal Board) that procedural checks remain in place for issuing new grounds of rejection. Examiners and the Board cannot bury a new ground of rejection in a decision, without ensuring that a patent applicant has had a fair opportunity to respond to the rejection. Indeed, whether the applicant has had a fair opportunity to react to the thrust of the rejection is reiterated as the ultimate determination of whether a rejection is considered “new”.
In line with the Federal Circuit’s recent decision in Leo Pharmaceutical Products v. Rea, Rambus is also a reminder that objective evidence of non-obviousness must be given due consideration and weight. Examiners and the Board cannot undercut an applicant’s objective evidence of non-obviousness through an overly stringent interpretation of the nexus and “commensurate in scope” requirements.
Stephen G. Adrian | September 27, 2013
Leo Pharmaceutical Products v. Rea
August 12, 2013
Panel of Rader, O’Malley and Reyna; opinion by Rader
The Court of Appeals for the Federal Circuit recently provided excellent guidance for responding to obviousness rejections which at first blush seem strong. In Leo Pharmaceutical Products Ltd. v. Rea, decided August 12, 2013, it reversed the Board of Patent Appeals and Interferences because the Board incorrectly weighed the objective indicia of non-obviousness.
The appeal arises from an inter partes reexamination of U.S. Patent No. 6,753,013 (the ‘013 patent). Claim 1 is directed to a pharmaceutical composition for dermal use which included a vitamin D analog, a corticosteroid and a solvent. During the inter partes reexamination proceeding, claim 1 had been amended to include the phrase “wherein said pharmaceutical composition is storage stable and non-aqueous,” which proved to be pivotal in securing the favorable decision for Leo Pharmaceutical Products, Ltd.
Did the CAFC Extrapolate From the Teachings of the References to Reach the Conclusion of Obviousness?
Bill Schertler | August 12, 2013
In re Adler
July 18, 2013
Panel: Prost, Reyna and Wallach. Opinion by Wallach
The Examiner rejected all of the pending claims under 35 U.S.C. §103 as obvious over several prior art references, including International Patent Publication WO 00/22975 (“Meron”) in view of Masaru Hirata et al., Study of New Prognostic Factors of Esophageal Variceal Rupture By Use of Image Processing With a Video Endoscope, 116 Surgery 8–16 (1994) (“Hirata”).
The Board of Patent Appeals and Interferences (“the Board”) affirmed the Examiner’s rejection of all pending claims of U.S. Patent Application No. 10/097,096 (the ‘096 application) under 35 U.S.C. §103 as being obvious over a combination of prior art references. Adler appealed the Board’s decision to the Court of Appeals for the Federal Circuit (CAFC). The CAFC affirms holding that the Board did not err in rejecting the pending claims as obvious and did not rely on new grounds for rejection.
Yoshiya Nakamura | 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.
CAFC clarifies the presumption that prior art is enabled after In re Antor Media Corp (Fed. Cir. 2012)
Michael Caridi | April 10, 2013
In re Steve Morsa
April 5, 2013
Panel: Rader, Lourie and O’Malley. Opinion by O’Malley.
The Board of Patent Appeals and Interferences (“Board”) had affirmed an Examiner’s finding that a short press release, relied on for an anticipation rejection, was enabling. In making its decision, the Board had held that arguments alone by the applicant were insufficient to rebut the presumption that a reference was enabling. The CAFC found that the Board and the examiner had failed to engage in a proper enablement analysis of the reference and vacated the anticipation finding.
Board Should Consider Appellee’s Grounds For Affirming Rejection Presented To Examiner During Reexamination, Even If Grounds Had Not Been Raised On Appeal
Bill Schertler | February 6, 2013
Rexnord Industries v. Kappos
January 23, 2013
Panel: Newman, Lourie, Prost. Opinion by Newman.
In 2003 Habasit filed an infringement suit against Rexnord in the United States District Court for the District of Delaware for infringement of its U.S. Patent No. 6,523,680 (the ’680 patent). Rexnord then requested inter partes reexamination of the ’680 patent, and the district court stayed the infringement suit pending completion of reexamination.
On reexamination, the examiner held all of the claims in the ’680 patent unpatentable for anticipation and obviousness. Habasit appealed the examiner’s decision to the United States Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (Board). On appeal, the Board reversed the examiner’s decision and held the claims patentable.
Rexnord appealed to the CAFC. The CAFC affirmed that the claims are not anticipated, and reversed the Board’s determination that the claimed invention is not obvious in view of certain prior art.Next Page »