Court of Appeals for Federal Circuit

In an inter-partes review proceeding (IPR), a challenger can rely only on patents and printed publications to challenge the validity of a patent claim. In contrast, in a post grant review (PGR) proceeding, a challenger can rely on any ground related to patentability, including prior sale, to challenge a patent claim.  In particular, 35 U.S.C. §102(a)(1) bars a person from receiving a patent on an invention that was “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.”
Continue Reading Supreme Court Holds That AIA On-Sale Bar Applied to Secret Sales

In an inter partes review proceeding, a challenger cannot raise patent-eligibility as a ground of invalidity.  Rather, the invalidity grounds are limited to lack of novelty and obviousness.  Notwithstanding, in construing claim terms, the PTAB can decide not to give patentable weight to certain claim limitations that are not patent-eligible. In Praxair Distribution., Inc. v. Mallinckrodt Hospital Products IP Ltd., No. 2016-2616, 2016-2656 (Fed. Cir. May 16, 2018) the PTAB had employed the so-called “printed matter doctrine” not to give patentable weight to certain limitations as merely “providing information”  and the CAFC affirmed the PTAB’s claim construction.

Mallinckrodt is the owner of U.S. Patent No. 8,846,112, which is directed to methods of distributing nitric oxide gas cylinders for pharmaceutical applications.

Claim 1 recites a method of providing pharmaceutically acceptable nitric oxide gas, which includes obtaining a cylinder containing compressed nitric oxide gas, supplying the cylinder to a medical provider who is responsible for treating neonates who have hypoxic respiratory failure, including some who do not have left ventricular dysfunction. Claim 1 further includes the step of providing to the medical provider “(i) information that a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure is 20 ppm nitric oxide and (ii) information that, in patients with preexisting left ventricular dysfunction, inhaled nitric oxide may increase pulmonary capillary wedge pressure (PCWP), leading to pulmonary edema, the information of (ii) being sufficient to cause a medical provider considering inhaled nitric oxide treatment for a plurality of neonatal patients who (a) are suffering from a condition for which inhaled nitric oxide is indicated, and (b) have pre-existing left ventricular dysfunction, to elect to avoid treating one or more of the plurality of patients with inhaled nitric oxide in order to avoid putting the one or more patients at risk of pulmonary edema.”

Independent claim 7 includes a “recommendation that, if pulmonary edema occurs in a patient who has pre-existing [LVD] and is treated with inhaled nitric oxide, the treatment with inhaled nitric oxide should be discontinued” (the “recommendation” limitation). Claim 9 depends on claim 7 and further comprises the following steps: performing at least one diagnostic process to identify a neonatal patient who has hypoxic respiratory failure and is a candidate for inhaled nitric oxide treatment; determining prior to treatment with inhaled nitric oxide that the neonatal patient has pre-existing left ventricular dysfunction; treating the neonatal patient with 20 ppm inhaled nitric oxide, whereupon the neonatal patient experiences pulmonary edema; and in accordance with the recommendation of [claim 7], discontinuing the treatment with inhaled nitric oxide due to the neonatal patient’s pulmonary edema. Id.

The Board applied the printed matter doctrine to interpret the providing information, evaluating, and recommendation claim limitations “to be either printed matter or purely mental steps not entitled to patentable weight, as those limitations lacked a functional relationship to the other claim limitations except in claim 9.” In particular, the PTAB was not persuaded by Mallinckrodt’s argument that the recitation of “a pharmaceutically acceptable nitric oxide gas” in the preamble of the claims would require considering information provided in the label of the supplied product.  Rather, the PTAB construed this limitation as simply “nitric oxide gas that is suitable for pharmaceutical use.”
Continue Reading CAFC Affirms PTAB’s Decision That Printed Matter Doctrine Can Be Used In Claim Construction

On May 23, 2018, in XY, LLC v. Trans Ova Genetics, L.C., CAFC held that its affirmance of PTAB’s invalidity decision regarding certain claims of a patent owned by XY in a separate appeal involving a different defendant must be given “immediate issue preclusive effect” with respect to the same claims in the present

On October 4, 2017, the Court of Appeals for the Federal Circuit, sitting en banc, overruled an earlier panel decision and found that the Patent Trial and Appeal Board (PTAB) had been impermissibly placing the burden of proving the patentability of amended claims on the Patent Owner, rather than the Petitioner.   See, Aqua Products

In the case of Phygenix, Inc. v. ImmunoGen, Inc., the Court of Appeals for the Federal Circuit (CAFC) held that the petitioner (Phygenix) that had unsuccessfully challenged certain claims of ImmunoGen’s U.S. Patent No. 8,337,856 (“the ‘856 patent”) in an inter partes review (IPR) lacked standing to appeal a Patent Trial and Appeal Board (PTAB) decision that affirmed the validity of the challenged claims because Phigenix had “not offered sufficient proof establishing that it has suffered an injury in fact…”  Although the Federal Circuit has required appellants to demonstrate standing in other proceedings, the Phygenix case is the first time this doctrine has been applied to bar an appeal of a final written decision in an IPR proceeding.

ImmunoGen owns the ‘856 patent, which is directed to an antibody-maytansinoid conjugate that is purportedly useful in combating a variety of cancers. Genentech has a worldwide exclusive license to the ‘856 patent for producing the drug Kadcyla®. Phigenix in turn owns U.S. Patent No. 8,080,534 (“the ‘534 patent”). Phigenix alleged that the ‘534 patent covers Genentech’s activities relating to Kadcyla and hence the subject matter claimed in the ‘856 patent.

The America Invents Act (AIA) provides that “a person who is not the owner of a patent may file with the Office a petition to institute an inter partes review of the patent.” 35 U.S.C. 311(a). The AIA does not impose a standing requirement for a challenger to request the institution of an inter partes review (IPR) of a patent.  However, the patent appellate court recently held that an IPR petitioner must have standing in order seek the appellate review of a PTAB’s final decision.

Phigenix sought inter partes review of the claims of the ‘856 patent based on an obviousness challenge.  The PTAB initiated a trial but ultimately found the challenged claims to be nonobvious.  Following the final written decision, Phigenix appealed the PTAB’s decision to the CAFC.  In response, ImmunoGen filed a motion to dismiss arguing that Phigenix lacked standing to appeal the PTAB’s decision.  A single judge of the CAFC denied ImmunoGen’s motion but requested that the parties file briefs addressing the standing issue. 

Phigenix provided declarations in support of its standing to appeal the PTAB’s decision and argued that ImmunoGen’s ‘856 patent increases competition between itself and ImmunoGen and increased competition represents a cognizable injury.  In particular, Phigenix argued that “[t]he existence of ImmunoGen’s ‘856 patent has … encumber[ed] Phigenix’s licensing efforts while ImmunoGen receives millions of dollars in licensing revenue.” Phigenix did not, however, contend that it faced the risk of infringing the ‘856 patent, or that it was an actual or prospective licensee of the ‘856 patent, or that it planned to take any action that would implicate the ‘856 patent.

The CAFC emphasized that a party’s standing to sue is a doctrine that is rooted in the case or controversy requirement of Article III of the U.S. constitution. In particular, in order to have standing, an appellant “must have (1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the [appellee], (3) that is likely to be redressed by a favorable judicial decision.”  Further, the CAFC stressed that although Article III standing is not necessarily a requirement to appear before an administrative agency, “an appellant must nonetheless supply the requisite proof of an injury in fact when it seeks review of an agency’s final action in a federal court.” 
Continue Reading Federal Circuit Requires Standing To Appeal An IPR Decision

The Federal Circuit reversed a Patent Trial and Appeal Board (PTAB) invalidity decision last week that had found a patent for a molasses-based, road deicing agent obvious over earlier patents on sugar-related inventions.  The Federal Circuit panel of Judges Pauline Newman, Raymond C. Clevenger and Kathleen M. O’Malley concluded that the U.S. Patent and Trademark Office (USPTO) finding of invalidity during reexamination proceedings was faulty because the USPTO had failed to set forth a prima facie case explaining why a person of ordinary skill in the art would have been motivated to combine references from disparate technological fields.  In Re Natural Alternatives, LLC (Fed. Cir. No. 2015-1911, August 31, 2016).

Univar, Inc., a licensee of U.S. Patent No. 6,080,330 owned by Natural Alternatives, LLC., filed three reexamination requests in 2011, seeking review of the licensed patent. The reexamination proceedings were consolidated, and the examiner found the claims drawn to a deicing composition comprising 25-99% desugared sugar beet molasses obvious in light of an earlier Polish patent combined with certain secondary prior art references.  Natural Alternatives appealed the reexamination decision to the PTAB but the board affirmed the examiner’s position, and the patent owner then appealed to the Court of  Appeals for the Federal Circuit.

In a decision handed down on August 31, 2016, the Federal Circuit disagreed with the PTAB’s reasoning.  First, the panel found the PTAB’s reliance on a 1990 Polish Patent No. PL 164018 to Zdzislaw (“Zdzislaw”) was misplaced because it did not teach the use of “desugared” molasses.  The process described in the Polish patent retained approximately 50% of the sugar in the molasses, while the patent at issue described processes for removal of most of the sugar.  Second, the Federal Circuit panel found one of the secondary references to be so far afield of the invention that a skilled artisan would not have motivated to combine it with Zdzislaw.  Finally, the panel found the examiner and the PTAB had improperly ignored the patent owner’s evidence of commercial success.

In particular, the decision criticized the PTAB’s reliance on U.S. Patent No. 5,639,319 to Daly (“Daly”); alone or together with a journal article titled “Winter is Hell,” published July 1997 in Public Works (“Public Works”).  The Daly patent was directed to the use of desugared sugar beet molasses (DSBM) as tire ballast, which served the unrelated purpose of stabilizing and balancing tires.  The Federal Circuit panel agreed with the patent owner that a person having ordinary skill in the art would not have found Daly to be reasonably pertinent to the problem of deicing road surfaces.
Continue Reading Despite PTAB “Sweet Talk” Federal Circuit Reverses Invalidity Of Deicing Patent

Under 35 U.S.C. 315(e)(1), a petitioner in an inter partes review of a claim in a patent that has resulted in a final written decision by the Board may not request or maintain a proceeding before the Patent Office with respect to that claim on any ground that the petitioner raised or reasonably could have

In a rare case of disagreeing with the Patent Trial and Appeal Board (PTAB), the Court of Appeals for the Federal Circuit (CAFC) vacated and remanded a PTAB decision invalidating claims 10-25 of PPC Broadband, Inc.’s U.S. Patent No. 8,323,060, which were challenged in an inter partes review (IPR) proceeding by Corning Optical Communications RF, LLC. (IPR2013-00342).

The challenged claims of PPC’s patent relate to a coaxial cable connector and require that the cable connector include “a continuity member having a nut contact portion positioned to electrically contact the nut and positioned to reside around an external portion of the connector body when the connector is assembled …” The Board held that the broadest reasonable construction of “reside around” was “in the immediate vicinity of; near.” Based on this construction, the Board concluded that the claims were obvious in view of the references cited by the petitioner, Corning, against the claims.

The Board reached this construction by relying on the broadest dictionary definition of the term “around.” In contrast, PPC (the patent owner) had proposed that the broadest reasonable construction of the term “reside around” in light of the claims and the specification is “encircle or surround.”

The CAFC sided with the patent owner and held that in the context of the patent the Board’s construction was not reasonable. The CAFC explained that “[t]he fact that ‘around’ has multiple dictionary meanings does not mean that all of these meanings are reasonable interpretations in light of the specification.” The CAFC further stated that all of the claims of the patent are directed to coaxial cable connectors and the components of these connectors partially or wholly encircle the inner electrical conductor. The CAFC emphasized that “[g]iven the context of this technology, it seems odd to construe the term ‘reside around’ without recognizing the context of its use in terms of the coaxial cable at issue.”
Continue Reading CAFC Vacates a PTAB Decision Due To Faulty Claim Construction

The Court of Appeals for the Federal Circuit decided an appeal earlier this month in a long-running battle between footwear manufacturers Nike and Adidas that gives Patent Owner Nike a partial (and perhaps fleeting) victory. The Federal Circuit affirmed the Patent Office decision in-part, vacated-in-part and remanded the case for further proceedings.

On November 28, 2012, Adidas AG petitioned the Patent Trial and Appeal Board (the “Board”) to institute an Inter Partes Review (“IPR”) to invalidate all of the claims of Nike’s 7,347,011 patent. (IPR2013-00067). After a trial was instituted, Nike did not file a Patent Owner Response but instead filed a Motion to Amend, requesting the Board cancel claims 1-46 and add new substitute claims 47-50. The Board granted the motion to cancel all of the original patent claims but denied the motion as to the proposed new claims 47-50, stating that Nike provided only a conclusory statement that the proposed claims were patentable which failed to persuade the Board to grant the motion. In the alternative, the Board also stated that Nike failed to prove patentability of the substitute claims over the prior art references identified by Petitioner Adidas. Nike appealed the decision. Nike, Inc. v. Adidas AG, No. 2014-1719, 2016 BL 38897 (Fed. Cir. Feb. 11, 2016).

Under § 316(e), the Petitioner carries the burden of proving that the patented claims under attack in an IPR proceeding are unpatentable. Nike argued that this burden also applies to new substitute claims submitted by the patent owner in a Motion to Amend. In other words, Nike argued that it does not carry the burden of proving that its new substitute claims were patentable. However, the Federal Circuit did not agree and concluded that section 316(e) does not keep the burden of proving unpatentability with the Petitioner for new substitute claims. Id. at 4. Accordingly, Nike carries the affirmative duty to justify why the newly drafted claims, which had never been evaluated by the USPTO, should be entered. Id. at 5.

However, the Federal Circuit concluded that at least one of reasons advanced by the Board for denying the Motion to Amend as to Nike’s substitute claims was improper. The court concluded that the statement used by Nike, that the proposed substitute claims were patentable over the prior art of record and over the prior art not of record but known to the patent owner, was adequate to address “known prior art” not of record in the proceeding absent an allegation of conduct violating the duty of candor. Id. at 21.
Continue Reading Battle Between Sneaker Makers Nike and Adidas Will Go Another Round

The Federal Circuit will apply a relaxed standard for review of the Patent Office’s post grant patent review proceedings and will give a good deal of deference to PTAB “findings of facts.”
Continue Reading Federal Circuit Affirms Invalidity Of A Merck Patent Based On Substantial Evidence Standard