Purdue Pharma LP et al. v. Collegium Pharmaceutical, Inc. (15-cv-13099).

Judge Saylor issued a claim construction order in this case, which involves three patents relating to abuse-deterrent and low-toxicity versions of oxycodone. The claims relating to deterrence of abuse required the inclusion of an irritant in an amount sufficient to impart an irritating sensation.  Collegium first sought to require the irritant be something deliberately added to the composition for the purpose of causing irritation – in other words, that would not cover ingredients added for other purposes that happened to also be irritants.  This construction was denied as improperly importing an element of intent into the claims, although Judge Saylor did note that, during prosecution, Purdue had disclaimed instances where the other recited  ingredients (drug, release carrier, excipient) could also serve as the irritant, thus reducing the broadness of the scope from that sought by Purdue.  Judge Saylor refused to find the term “effective amount” indefinite, finding that the term has a customary usage to a person of ordinary skill in the art and that examples were provided in the specification, providing an objective baseline through which the term would be understood.  Finally, with respect to reduced toxicity, Judge Saylor rejected Collegium’s arguments that “removing” a particular impurity should be limited to removing only that particular impurity and removing it completely, as being inconsistent with the usage of the term in the specification.

Brigham and Women’s Hospital, Inc. et al. v. Perrigo Company et al. (13-cv-11640).

Judge Zobel denied Perrigo’s renewed motion for judgment as a matter of law that B&W lacked standing to sue and that U.S. Patent 5,229,137 was anticipated or obvious, but granted Perrigo’s motion that it did not infringe the patent.  The ‘137 Patent is directed to methods of treatment of episodic heartburn that involve co-administration of an antacid and a histamine H2-receptor antagonist in an amount effective to provide “immediate and sustained relief,” which was construed to mean relief that starts within 5-10 minutes and lasts for at least 4-6 hours.  In December of 2016, a jury had found the patent valid and infringed, and awarded B&W $10,210,071 in damages.

Perrigo’s standing objection was based on a requirement that B&W notify its then-licensee, Johnson & Johnson Merck Consumer Pharmaceuticals, of the suspected infringement and allow Johnson & Johnson 120 days to file suit before B&W could sue.  Judge Zobel agreed that there was a notice requirement that was not met, but nevertheless found that B&W had standing because the license did not grant all substantial rights to JJMCP, leaving B&W as the owner of the patent.  On the validity issue, Judge Zobel agreed with Perrigo that B&W failed to corroborate its claim to a priority date that predated the filing of the application because B&W presented only unwitnessed lab notebooks as corroboration.  Despite this, she found that the prior art references at issue failed to disclose or teach the “immediate and sustained relief” limitation.  Judge Zobel did, however, rule in Perrigo’s favor on infringement.  B&W did not present direct evidence on how Perrigo’s drug performed, instead relying on Perrigo’s bioequivalence data from its ANDA as proof that it performed the same as JJMCP’s branded Pepcid Complete product.  Accordingly, to prove infringement, B&W had to prove that Pepcid Complete met all of the claim limitations.  Judge Zobel found that the data presented on Pepcid Complete failed to prove that it met the “immediate and sustained relief” limitation because the clinical studies from JJMCP’s FDA submission did not begin with a low enough pH to qualify as “episodic heartburn,” and that the pH data was not correlated with “relief from pain, discomfort, and/or symptoms associated with episodic heartburn” as the claim required.  In light of this, the damages award was overturned.

Banertek LLC v. ecobee, Inc. (17-cv-12276).

Banertek sued ecobee, a Canadian company, for infringing U.S. Patent 6,839,731, “System and Method for Providing Data Communication in a Network Device.  Ecobee makes smart wi-fi thermostats and room sensors that, according to the complaint, communicate through a central communication device (e.g., a server) with sensors, heating/air conditioning equipment, and smartphones or tablets in a way that infringes the ‘731 patent.  Direct, contributory and induced infringement are alleged.  The case has been assigned to Judge Saris.

In re: Micron Technology, Inc. (Fed. Cir. 2017-138).

Micron Technology was sued in 2016 by Harvard College, prior to the issuance of the Supreme Court’s TC Heartland decision on venue in a patent infringement lawsuit.  Following the TC Heartland decision, Micron moved to dismiss for improper venue.  Judge Young denied the motion as waived, finding that TC Heartland had not changed the venue laws, but had merely reaffirmed prior Supreme Court case law on the subject.  Micron petitioned the Federal Circuit for a writ of mandamus to set aside this ruling, noting the disagreement among many district courts on the subject of whether the venue laws were changed by TC Heartland.  Today the Federal Circuit held that TC Heartland did change the controlling venue law, in that it made available and interpretation of the venue statute that was not previously available.  The Court found that the rarely-applied remedy of mandamus relief was appropriate here to resolve the split in district courts over the issue, and was important to proper judicial administration.  Looking to Rule 12, the Court noted that, for waiver to apply, a defense under that rule must have been “available to the [defendant] when the defendant made the initial Rule 12(b) motion.  As a matter of law, the venue defense made possible by TC Heartland was not “available” prior to that decision’s issuance, given the controlling precedent at the time.  The Court interpreted “available” to mean available at the district court, not available after going through one or more levels of appeal, and under Federal Circuit precedent, the venue defense at issue was not something that could be granted by the district court.  Accordingly, the venue defense was not waived.

This was not, however, a clean win for Micron. The Court remanded the case for consideration of whether Micron’s subsequent venue motion was filed sufficiently soon after the TC Heartland decision so as to preserve the issue, indicating that the district court has discretion under its inherent powers to deem the venue challenge nonetheless waived.  To that end, the Court noted that it had denied mandamus in cases where a post-TC Heartland challenge was brought close to trial.

Avigilon Corp. et al. v. Canon, Inc. (17-cv-11922).

Canon initially sued Avigilon for infringement of five Canon patents in New York; it voluntarily dismissed that complaint after Avigilon gave notice that it intended to move to transfer to Massachusetts. Canon immediately refiled in the Northern District of Texas on October 5, 2017, alleging infringement of five Canon patents.  Later that day, Avigilon brought this declaratory judgment action in Massachusetts on the same five patents, which Canon promptly moved to transfer to N.D. Texas.  Avigilon, contending that venue is not proper in Texas and that other factors should create an exception to the “first-to-file” rule, moved for an expedited determination on Canon’s motion to transfer, seeking to have resolution before the date by which it must answer the Texas complaint (presumably with a motion to dismiss or transfer on the same grounds).  Judge Talwani denied this motion, noting that the Northern District of Texas, as the court in which claims relating to the five patents was first raised, should be the court to determine whether venue is proper and whether any exceptions to the first-to-file rule apply.  Judge Talwani stayed the Massachusetts case pending determination by the Texas court on any venue or transfer related pleadings or motions in the Texas case.

Caris MPI, Inc. v. Foundation Medicine, Inc. (17-cv-12194).

Caris filed suit asserting that Foundation Medicine’s FoundationOne®, FoundationOne® Heme, and FoundationACT® products infringe five Caris patents covering systems for generating reports identifying therapeutic agents for cancer treatment based on molecular profiles of the tumor. Caris alleges willful infringement, citing to statements in Foundation’s 10-K SEC filings that identify Caris as a direct competitor and that indicates that competitors “may also use their patent portfolios, developed in connection with developing their tests, to allege that [Defendant’s] products infringe their patents, and [Defendant] could face litigation with respect to such allegations and the validity of such patents.”

Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. et al. (17-cv-11008).

Janssen Biotech brought this case asserting infringement of a patent related to the manufacture of Remicade®, a biologic medicine used to treat rheumatoid arthritis, plaque psoriasis, Crohn’s disease, and other disorders involving the immune response. Celltrion moved to dismiss, on the grounds that not all co-owners of the patent were joined as plaintiffs – the assignments from some of the inventors was to “the COMPANY,” which was defined elsewhere in the assignment agreement as Centocor, the predecessor to Janssen, and Johnson & Johnson and its existing and future subsidiaries, divisions and affiliates, none of whom were named as plaintiffs.  Judge Wolf, interpreting the agreement under New Jersey law, found that this language did not apply to the assignment itself.  The assignment clause required assignment of any invention made by the employee “during [his] employment with the COMPANY;” yet the inventors worked for only one company and did not work for Johnson & Johnson, which created ambiguity as to what was meant.  Looking to extrinsic evidence to understand what the parties to the contract intended, Judge Wolf determined that the assignment was intended to be only to Centocor, making Janssen the sole assignee.  Accordingly, the motion to dismiss was denied.