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

Judge Saylor granted Collegiums request for leave to file an amended answer pleading the reverse doctrine of equivalents as an affirmative defense. He found this defense not clearly futile, but expressly indicated that he was taking no position as to whether the reverse doctrine of equivalents is an affirmative defense that must be pled or whether it remains a viable legal doctrine.

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

Purdue alleges that Collegium infringed three patents relating to abuse-deterrent extended-release oxycodone by filing an NDA for Collegium’s XTAMPZA ER product. Collegium sought summary judgment of non-infringement on two theories – that its active ingredient (oxycodone myristate) is not the equivalent of Purdue’s oxycodone hydrochloride, and that Collegium’s product lacks the claimed “irritant.” Collegium also asserted that one of the patents should be deemed invalid under issue preclusion or collateral estoppel, based on a final judgment in a New York court that three related patents were invalid and the PTO’s requirement, during examination of the patents at issue, that a terminal disclaimer be filed to overcome obviousness-type double patenting over the related patents.

The invalidated claims from the prior litigation were all product-by-process claims; while the Judge in that case acknowledged the process was novel, the claims stood or fell based solely on the product limitations, which did not describe a patentably-distinct compound. In evaluating the collateral estoppel argument, Judge Saylor noted that it had not been applied by the District of Delaware in an infringement case involving one of the patents of this suit. Judge Saylor applied Federal Circuit law on the preclusion and estoppel issues, which allows for preclusion on patent invalidity where the differences between the unadjudicated and adjudicated claims do not materially alter the question of patentability. He determined that the PTO’s double patenting analysis fails to satisfy this requirement, and that Purdue’s filing of the terminal disclaimers (particularly while expressly indicating its lack of agreement with the rejections) could not be converted into an admission or acquiescence on the merits of the rejections. He also determined that the claims at issue included additional limitations that materially alter the patentability as compared with the previously-invalidated claims, as the new claims included limitations relevant to the process that were not considered in the New York litigation. Collegium asserted that these limitations were inherently present in the invalidated Purdue patents, but Judge Saylor declined to apply the doctrine of inherency where the references in question, related Purdue patents, would not qualify as prior art, and noted that in any event there were unresolved issues of material fact that precluded summary judgment on the issue. While rejecting the preclusion issue, Judge Saylor did note that the findings of fact by the New York court rendered the validity of at least some of the asserted claims doubtful.

Collegium next sought to apply prosecution history estoppel to preclude a finding of infringement by equivalents, asserting that Purdue had specifically distinguished its hydrochloride form of oxycodone over other forms of oxycodone. Judge Saylor, however, determined that the scope of disavowal extended not further than products including oxycodone free base and declined to estop the equivalency argument. He found factual issues as to whether the two forms were equivalent that precluded summary judgment of non-infringement.

Collegium sought judgment of non-infringement on method claims, asserting that it does on itself complete all of the method steps because its product is manufactured by two companies that it does not control; Judge Saylor determined that Collegium could not demonstrate an absence of material fact on this issue, and denied summary judgment. Collegium’s last effort was to escape infringement of two of the patents on the basis that the myristic acid it utilized in its product is not an “irritant,” but instead is included to dissolve the oxycodone base. Looking back to the construction of “irritant,” the Court noted that Purdue had disavowed from the scope of that term components that both served both as an irritant and provided some other benefit, such as serving as an excipient. Noting that Purdue concedes that myristic acid in the XTAMPZA ER provides an excipient function, Judge Saylor granted summary judgment of non-infringement of all claims requiring an irritant, which effectively resulted in non-infringement on two of the three asserted patents.

Maquet Cardiovascular LLC v. Abiomed, Inc. et al. (17-cv-12311).

After being sued for patent infringement by Maquet, Abiomed filed non-infringement counterclaims against Maquet its corporate parent, Swedish company Getinge AB. Judge Saylor granted Getinge’s motion to dismiss, agreeing that Getinge lacks standing to sue Abiomed and determining that this insulates Getinge from the declaratory judgment counterclaim. Judge Saylor noted that the counterclaim does not allege that a written agreement exists by which Getinge was given any rights in the subject patent, and absent a written transfer of rights, Getinge can have no rights in the patent. He refused to extend the doctrine of equitable title, stating that there is nothing inherently unfair or inequitable in a corporate subsidiary owning all rights in a patent or in the parent then exercising substantial control over the subsidiary that would require bringing the parent into the controversy. Accordingly, the counterclaim was dismissed as applied to Getinge (although it remains in place against Maquet).

Abiomed, Inc. v. Maquet Cardiovascular, LLC (16-cv-10914).

Abiomed filed a declaratory judgment action seeking a declaration of non-infringement and invalidity of six Maquet patents relating to guidable intravascular blood pumps, and Maquet brought infringement counterclaims. Judge Saylor partially granted Abiomed’s motion to compel supplemental responses to Abiomed’s invalidity contentions. Maquet had originally asserted 98 claims, and Abiomed provided invalidity contentions as to all 98 claims. In response to a court order, Maquet narrowed the case to 35 claims; pursuant to the court’s order, Maquet will have to further narrow their case to 18 claims following the Markman order, after which Abiomed will have to narrow its list of primary references to 12. Maquet objected to responding to Abiomed’s invalidity contentions because they necessarily cover claims and prior art that will ultimately not be a part of the trial, and also asserted that Abiomed improperly sought expert analysis prematurely. Judge Saylor disagreed, noting that Maquet had the benefit of seeing Abiomed’s invalidity contentions prior to its initial narrowing of claims and that therefore Abiomed should get to see Maquet’s validity contentions prior to reducing the references it was asserting. Judge Saylor did, however, postpone the date by which Maquet would have to respond to the date that it would have to provide its final listing of 18 asserted claims, and limited Maquet’s response to validity contentions concerning those 18 claims. In a separate order, Judge Saylor denied Abiomed’s motion to compel discovery of Maquet’s patent assessments and valuations. Maquet had produced a presentation given to a different heart pump company that included reference to a proposal made by Maquet that made reference to the amount Maquet believed the company could obtain from Abiomed should the company acquire the patents. Abiomed, believing that this would reveal a substantially lower valuation than Maquet was seeking in damages, sought additional information on how Maquet came to the valuation in the proposals; Judge Saylor accepted Maquet’s representation that it had no non-privileged valuations to produce.

SiOnyx, LLC et al.v. Hamamatsu Photonics K.K. et al. (15-cv-13488).

Judge Saylor granted in part SiOnyx’s renewed motion to compel in this patent infringement, correction of inventorship, and breach of contract case. SiOnyx had entered into an agreement with Hamamatsu to explore a possible business relationship surrounding laser-textured infrared-sensing silicon photonic devices. The business relationship never came to fruition, and Hamamatsu subsequently applied for patents directed to similar technology. A discovery dispute arose over whether SiOnyx could obtain information on products that were textured by some means other than a laser, with Hamamatsu taking the position that the infringement contentions did not accuse such products and the former SiOnyx founder now working for Hamamatsu did not contribute to the invention of non-laser-textured devices. SiOnyx’s initial motion to compel was denied without prejudice, because at the time there was insufficient evidence to support a charge of infringement; since then, SiOnyx was able to develop sufficient information that the products infringe, and that an offer for sale of the accused products has been made that, if accepted, would generate significant sales. Judge Saylor found that SiOnyx’s evidence related to the breach of contract and use of confidential information claims (that the Hamamatsu engineers who were exposed to this information developed the non-laser-textured products) was insufficient to overcome the significant differences in the resulting textures that negate an inference that they were developed using SiOnyx’s confidential information. Because the motion was granted only with respect to the patent claims, Hamamatsu was compelled to produce information relating only to U.S. sales or imports.

Palomar Technologies, Inc. v. MRSI Systems, LLC (18-cv-10236).

Judge Saylor denied MRSI’s motion to compel more detailed infringement contentions. This case was originally brought in 2015 in the Southern District of California, with Palomar asserting infringement of U.S. Patent No. 6,776,327. In 2016, the case was stayed pending resolution of an IPR proceeding filed by MRSI; the case resumed progress when most of the claims were deemed valid by the PTO. In August 2017, MRSI moved to transfer venue to the District of Massachusetts in light of the TC Heartland decision on patent venue, and the case was transferred in February of this year. In denied the motion to compel, Judge Saylor noted that the district’s new local patent rules do not apply to this case, as the scheduling order was issued prior to June 1, 2018, that the prior applicable rule did not require any particular level of detail for infringement contentions, and that the scheduling order itself required only an identification of the claims asserted, products that are accused of infringing those claims, and whether the infringement is literal or by equivalents. While he noted that the contentions are skeletal, Judge Saylor determined that they met the requirements of the applicable rule and the scheduling order, and he indicated that at the early stage of the proceeding, there is no requirement for the claim construction contentions sought by MRSI.

SiOnyx, LLC v. Hamamatsu Photonics K.K. et al. (15-cv-13488).

SiOnyx alleged that Hamamatsu, following an aborted attempt to form a business partnership involving devices that improve the detection of near-infrared light, had violated a non-disclosure agreement and obtained patents on SiOnyx technology without naming SiOnyx personnel as inventors. Hamamatsu filed twelve motions for partial summary judgment. Judge Saylor granted three of these, denied three, and deferred judgment on the remaining six.

Hamamatsu’s bid to prevail on breach of contract and unjust enrichment claims on statute of limitations grounds was denied. While the relevant events occurred longer ago than the six-year time period provided by the statute of limitations on these types of claims, Massachusetts law follows the discovery rule, by which the cause of action arises not when the events occurred, but when the plaintiff discovers or should reasonably have discovered. Here, there were issues of fact as to when SiOnyx should reasonably have become aware of these claims, brought about by Hamamatsu’s repeated assurances that it had developed the relevant technology on its own, independent from any knowledge acquired under the NDA. Judge Saylor denied summary judgment of breach of contract, finding issues of fact as to the scope of use of confidential information, while granting Hamamatsu’s motion with respect to the unjust enrichment claims of both SiOnyx and co-plaintiff Harvard, because under Massachusetts law, unjust enrichment cannot be found where there is a valid contract defining the rights of the parties. Applying First Circuit law, Judge Saylor denied Hamamatsu’s motion with respect to consequential damages on the grounds that the testimony offered in support of this theory, SiOnyx’s recollection of statements as to why a third-party agreement was terminated made by an executive of the third party, constituted an exception to hearsay under Rule 803(3) as a statement of intent or motive. Finally, he granted Hamamatsu’s motion that a SiOnyx employee was not a co-inventor on Hamamatsu’s patents, as the testimony of the employee was not sufficiently corroborated by documentary evidence.