Posts Tagged: "Judge Richard Taranto"

The Federal Circuit held that there was no statutory language that made section (8)(A) non-mandatory. Further, Amgen v. Sandoz disposed of Apotex’s argument that (8)(A) would extend the 12-year exclusivity period given to a sponsor by 180 days (six additional months). Even when market entry is delayed under (8)(A) by 12 years plus 180 days, the result is the same, because the 12-year date is established as the earliest date, not the latest date, on which a biosimilar license can take effect. The Court affirmed that section (8)(A) covers applicants that filed (2)(A) notices as well as those that did not. This is to ensure that the necessary decision-making regarding further patent litigation starts from when the applicant’s product, uses, and processes are fixed by the FDA license. The 180-day period gives the sponsor essential time to assess its infringement position for the final FDA approved product and the as to yet-to-be-litigated patents. This is confirmed by the legislative history of the Biologics Act. Thus, an applicant must provide a reference product sponsor with the 180-day notice under 8(A), after approval and before commercial marketing begins, whether or not the applicant previously provided a (2)(A) notice of the FDA review.

The Court found that “fractionation” referred only to distillation-based techniques. The specification’s use of the term “fractionation” controlled even if the definition was idiosyncratic. By that standard, the Court found that “fractionation” did not encompass solubility-based techniques. The specification identified the limits of “conventional fractionation” which were only limits of “conventional distillation,” and no other fractionation techniques known in the art were mentioned. Therefore, the specification equated “conventional fractionation” and “conventional distillation.” More broadly, this demonstrated that the specification equated the terms “fractionation” and “distillation.” This finding was further supported by the repeated and consistent use of the term “fractionation” in discussion of processes to separate mixtures by distillation.

The Federal Circuit held that it is not the case that a patent must spell out a claim element’s function, way, and result, for the doctrine of equivalents to apply. It looked to what the claim element’s function in the claimed composition is to one of skill in the art, which it held may be determined by looking at extrinsic evidence. The Court found no error in the district court’s finding of infringement under the doctrine of equivalents. In applying the two part test (constructing a hypothetical claim that covers the accused device and comparing that claim to the prior art), the district court correctly determined that the hypothetical claim properly included the disputed excipients, i.e. Glenmark’s excipient.

Where the claims are directed to an improvement to computer functionality, they are not abstract under the first step of Alice, and thus no step-two analysis is necessary. Here, the Federal Circuit found that Enfish’s self-referential table was directed to a specific improvement in computer capabilities, unlike Alice, where the claimed technology only added a computer to a traditional business practice. For this reason, the Court held that Enfish’s claims were not abstract under the first step of Alice, and therefore did not warrant the application of step two.

The Court vacated the judgment against Mankes and remanded the case for further consideration. Because the law was in a state of flux, the Plaintiff pled facts that arguably would have supported an infringement theory under the law applicable when it was filed. The plaintiff could not have known the facts necessary to support a complaint under the law as it exists now. Because of this, the Court declined to affirm or reverse, and instead remanded the case to the district court for reconsideration under the new standards. Presumably, this would also give the Plaintiff an opportunity to amend the complaint.

The Federal Circuit held that Mylan Pharmaceuticals, Inc. (“Mylan”), a generic drug manufacturer, was subject to specific personal jurisdiction in Delaware because Mylan had filed an abbreviated new drug application (“ANDA”) and “contemplate[d] plans to engage in marketing of the proposed generic drugs” in the state.[1] The ruling affirmed two different decisions by judges in the United States District Court for the District of Delaware that Mylan was subject to specific jurisdiction in Delaware.[2] However, as noted below, it looks like Mylan intends to seek panel or en banc rehearing and possibly pursue a petition for certiorari if the Federal Circuit does not grant the rehearing or re-hears the case and continues to find personal jurisdiction.

Pride Mobility appealed, and noted that the Board construed claim 7 as requiring a “substantially planar” mounting plate “oriented perpendicular” to the axis of the wheelchair’s drive wheel, which the Board found in Goertzen. The Court found that the Board had misconstrued Claim 7, because the claim language made clear that the surface which rendered the mounting plate “substantially planar” must be perpendicular to the drive axis, not some other geometric feature of the mounting plate.

On March 10, 2016 the Federal Circuit sent two Patent Trial and Appeal Board (“PTAB” or “Board”) reexaminations back to the Patent Office. In proceedings initiated by IBM and SAS Institute Inc., the PTAB rejected claims for analyzing investment data in two patents owned by InvestPic LLC. The Board’s ruling turned upon two claim terms: (1) a “bias parameter” that determines a degree of randomness in sample selection in a resampling process”; and (2) “a statistical analysis request corresponding to two or more selected investments.”

Over the course of several amendments, Disney granted increasing rights to Candella, by which Disney specifically intended to give Candella standing to sue for patent infringement. The court held that the rights retained by Disney were not “substantial rights” sufficient to deprive Candella of standing, because Disney did not retain a right to exclude. Disney merely had a financial interest in any enforcement efforts by Candella. Thus, Candella did not have to join Disney to maintain the lawsuit.

The Federal Circuit took the case en banc to review the applicability of the patent exhaustion doctrine under Mallinckrodt and Jazz Photo, in view of the Supreme Court’s decisions in Quanta and Kirtsaeng. The Federal Circuit affirmed the holdings in Mallinckrodt and Jazz Photo, and distinguished them from the Supreme Court’s decisions. In Quanta, the Supreme Court was reviewing whether a patentee’s rights in a product were exhausted by a licensee’s sale of a product.

In a painfully long decision that at one point analyzed a 1628 statement of Lord Coke as relating to British common-law principles and what light that might shed on modern day patent exhaustion, the Federal Circuit held that when a patentee sells a patented article under otherwise-proper restrictions on resale and reuse communicated to the buyer at the time of sale, the patentee does not confer authority on the buyer to engage in the prohibited resale or reuse. The patentee does not exhaust its rights to charge the buyer who engages in those acts—or downstream buyers having knowledge of the restrictions—with patent infringement. The Federal Circuit also held that a foreign sale of a U.S. patented article, when made by or with the approval of the U.S. patentee, does not exhaust the patentee’s U.S. patent rights in the article sold, even when no reservation of rights accompanies the sale. Loss of U.S. patent rights based on a foreign sale remains a matter of express or implied license.

In a January 29, 2016 decision, the Federal Circuit vacated a jury judgment of non-infringement and ordered the District of Delaware to conduct a new trial where construction of a claim term based on prosecution history disclaimer was found to be too narrow. In rejecting the district court’s construction as too limiting, the Court emphasized the high standard for finding prosecution history disclaimer of claim scope. Examining the two prosecution history passages said to be a disclaimer, the Court found that each was readily susceptible to a narrower reading than the one needed to support the district court’s conclusion.

Waters argued that Agilent could not appeal, because Aurora was the third-party requester of the reexamination, not Agilent. The Court held that the relevant question was whether Agilent was a member of a class of litigants that may enforce a legislatively created right under 35 U.S. C. § 141 (reexamination appeals). If so, that party has a ‘cause of action’ under the statute, and this cause of action was a necessary element of his ‘claim.’ See Davis v. Passman, 442 U.S. 228, 239 (1979). The Court held that both 35 U.S. C. § 141 and 35 U.S. C. § 315(b) confirm that the right to appeal an adverse reexamination decision is reserved only to patent owners and third-party requesters.

The plaintiff moved to strike the re-asserted invalidity defense under §101 as not made with good cause and as unfairly prejudicial. The defendant argued that the change was made in view of the Supreme Court’s §101 decision in Alice v. CLS Bank, which was decided two months before the final invalidity contentions were served. The district court agreed that the Alice decision was sufficient cause to re-assert the §101 defense in the final invalidity contentions.

The Court held that printed matter must be claimed for what it communicates, and it is only afforded patentable weight if the claimed informational content has a functional or structural relation to the substrate. In this case, the Court held that the Board erred in finding that the origins of the web assets made them printed subject matter, because nothing in the claim called for the origin to be part of the web asset.