A panel of administrative patent judges (APJs) at the Patent Trial and Appeal Board (PTAB) issued a final written decision ending a series of inter partes review (IPR) proceedings targeting patents covering a popular multiple sclerosis (MS) treatment developed and sold by Ardsley, NY-based Acorda Therapeutics (NASDAQ:ACOR). The decision strengthens the patent portfolio covering Acorda’s Ampyra pharmaceutical even as competition from generic manufacturers has ramped up in recent months. The IPRs, instituted after petitions from the Kyle Bass-backed Coalition for Affordable Drugs (ADORCA), targeted four patents listed in the U.S. Food and Drug Administration’s (FDA) Orange Book.
LAB sued Eli Lilly & Company, alleging marketing of the drug Cialis induced infringement of LAB’s patent. Eli Lilly subsequently requested that the Board conduct inter partes review of the patent. The Board agreed to do so and ultimately found the patent to be obvious in light of three prior art references… The Court then found the Board’s construction of certain claim terms to be overly broad, stating the Board’s construction “would make the patent claims applicable to individuals with erectile dysfunction not caused by penile fibrosis.”
The PTAB agreed with Apple and invalidated the patent. The Federal Circuit remanded because the Board failed to adequately explain its finding that a skilled artisan would have had a motivation to combine the references used to find obviousness… IPR practitioners should brief the Board with explicit reasoning why a skilled artisan not only could (or could not), but would (or would not) be motivated to combine the asserted references, and how those references work together (or do not).
Mylan had to show by clear and convincing evidence that the idea for the ’445 patent claim was conceived by someone at the FDA and communicated to Mr. Pavliv, the named inventor. The Court agreed with the district court that Mylan did not carry the burden of showing that someone other than Mr. Pavliv had conceived a “definite and permanent idea” of an EDTA-free Acetadote formulation. Mylan argued that Mr. Pavliv’s prior communications with the FDA, including the FDA’s request for justification of the inclusion of EDTA, required Cumberland to undertake research that would have inevitably led to the invention. However, this was not the same as a suggestion to remove EDTA. Derivation is not proved by showing conception and communication of an idea different from the claimed invention, even if that idea would make the claimed idea obvious.
Practitioners dealing with a magistrate judge’s report and recommendation should be sure to preserve objections for appeal, since failing to object may lead to a more deferential, plain error standard of review, depending on the applicable circuit law. Further, in seeking a preliminary injunction, evidence of harm from pre-issuance of the asserted patent is relevant to show likelihood of irreparable harm from similar injuries in the future.
The patent owner made a successful argument regarding secondary considerations, specifically relating to the success of the bottle cap in the country of Peru, which led in large part to PTAB upholding the validity of the ‘271 patent. A 7 percent increase in market share in that country during a five-year period after the new cap product was released to the Peruvian market led PTAB to find that the market share increase was attributable to the merits of the new product. The petitioner had argued that the use of Peruvian economic data was dismissable evidence but PTAB found that the evidence to support the petitioner’s view was lacking.
The Court’s opinion stresses that in an obviousness analysis, it should consider “whether the improvement is more than the predictable use of prior art elements according to their established functions.” An explicit teaching, suggestion, or motivation in the references is not necessary to support a conclusion of obviousness… Judge Newman dissented with the majority’s finding there was motivation to combine the references without hindsight. She argued that the references recite thousands of polymer and copolymer components for stent coating materials, but not the copolymer of the ’844 patent.
The Board’s determination was “potentially lawful but insufficiently or inappropriately explained.” The finding of obviousness was vacated and the case was remanded for further proceedings… Obviousness findings grounded in common sense must contain explicit and clear reasoning that provides some rational underpinning as to why common sense compels such a result.
To come up with the list below I’ve reviewed all of our patent articles, and have come up with these top 10 patent stories for 2016. They appear in chronological order as they happened throughout the year. Just missing the top 10 cut were the Supreme Court denying cert. in Sequenom and the USPTO being sued for Director Lee declaring a federal holiday. As interesting as those stories may have been, there was far more consequential patent news in 2016. Also missing the cut, but particularly interesting were the rather egregious and insulting response filed in an Office Action in September, and the embarrassing concurring decision by Judge Mayer in Intellectual Ventures. While the latter two were truly train wreck moments, they were fleeting. Judge Mayer has completely marginalized himself on the Federal Circuit with no one embracing his extreme and inaccurate reading of Alice, and that type of albeit cringe-worthy and unprofessional response to an Office Action happens very rarely.
In Europe and the US, patentability depends on a showing of inventiveness that is based on similar legal requirements but practice differs substantially and the resulting patent quality varies… At the USPTO, patent applications are rejected for obviousness (35 USC §103) already in a first Office Action by an examiner and his/her supervisor… Over in Europe the examination of inventive step begins with an opinion following which the applicant is invited to comment/amend.
NuVasive owns a patent relating to spinal fusion implants. Medtronic petitioned the Patent Trial and Appeal Board (the “Board”) to institute an inter partes review challenging the validity of NuVasive’s patent over several references. The Board instituted the IPR and found the challenged claims obvious over a combination of references.
In 2013, Google, Inc. (“Google”) filed inter partes review and covered business method petitions challenging the validity of Unwired Planet, LLC’s (“Unwired”) patent, at issue on appeal. The patent describes a prioritization of search results based upon the location of a mobile device and including prioritization of “preferred providers” within those search results, in turn providing a “farther-over-nearer” ordering of the results. The Board invalidated all of the challenged claims as obvious. The Federal Circuit concluded, “[b]ecause the use of alphabetical order as prioritization information would sometimes meet the farther-over-nearer claim elements, the Board was correct to conclude that the proposed combination” rendered claim 1 obvious.
A divided panel of the Federal Circuit affirmed the Board’s rejection of all pending claims as obvious in an appeal arising from a method for treating or preventing influenza by oral inhalation of zanamivir. The teaching here seems to be that references can be combined to show that it would have been obvious to zero in on one of a few options disclosed in the prior art. Judge Newman filed a dissenting opinion.
It is well known that hindsight reconstruction is an insidious error that infects patent prosecution. The Federal Circuit has noted that it is a difficult task to avoid “subconscious reliance on hindsight” and tools are available to “inoculate the obviousness analysis against hindsight”. However, it is well known that practitioners could benefit in countering the pernicious problem of subconscious hindsight directed analysis with additional tools. This article is intended to provide an additional tool outlining a new analytical approach to detecting hindsight: 1) identification of a proxy problem upon which an “obvious” advantage is predicated, and 2) showing that either a) the proxy problem is secondary to the problem solved by the inventor and would have been insufficient to drive advancement of the art, and that the examiner has failed to show that a person of ordinary skill in the art (POSITA) would have regarded the proxy problem as sufficiently significant so as to require solution, or b) a showing that the proxy problem posed to POSITA presupposes the problem and its solution as solved by the inventor and is derivative. Once it is shown that the proxy problem is subsidiary or presupposes the problem solved by the inventor it becomes a less difficult task to show that the invention was not considered as a whole or that the problem was improperly phrased.
The Court found substantial evidence to support the jury’s finding of infringement. While Samsung’s expert offered conflicting testimony, a reasonable jury could have credited Apple’s expert. Thus, there was no error in the district court’s conclusion that substantial evidence supported the jury verdict of infringement… Note that the underlying dispute in this case does not concern design patents that were also asserted against Samsung, and which are currently being reviewed by the Supreme Court.