Amend your complaint or face dismissal of your action. This is what Judge Robinson informed the plaintiffs in Eidos Communications, LLC v. Sype Technologies SA, C.A. No. 09-234-SLR, Memo. Op. (D. Del. Feb. 24, 2010), where the complaint failed to allege that any specific product or category of products infringe the patents-in-suit. Plaintiffs in this case alleged that defendants’ “communication system products and/or methodologies” infringe the patents-in-suit. Id. at 2. There are no specific products or methods described in the complaint and the only language that even comes close to such a description is a general description of the technology found in the background section of the complaint. Even that general description, however, “does not indicate whether a product or method (or both) are at issue or whether the suit is directed to the transmission of or to the control of either voice or message data.” Id. at 5. The Court ordered plaintiffs to amend their complaint, finding that “[P]laintiffs were obligated to specify, at a minimum, a general class of products or a general identification of the alleged infringing methods.” Id. at 5.
In Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc., C.A. No. 08-290-SLR (D. Del. Feb. 24, 2010), Judge Robinson recently construed the following claim language of plaintiff's patent:
"truncated Factor VIII Protein which is an active procoagulant"
A Factor VIII protein that promotes blood coagulation and lacks a portion of the amino acid sequence of the human Factor VIII protein.
"having a peptide sequence of human factor VIII:C but lacking a peptide region selected from the group consisting of"
Having the amino acid sequence of the human Factor VIII protein lacking only the particular segment of the human Factor VIII protein in one of the specified alternatives (a), (b) or (c).
Here, plaintiff had argued for a broad interpretation of the claim (i.e., "lacking a peptide region of at least the regions identified in (a), (b) or (c)."). Id. at 3. Plaintiff argued, among other things, that the PTO's granting of a term extension for its patent based on its construction of the relevant claim be given great deference. Id. However, Judge Robinson noted that "[c]laim construction is a matter of law and, therefore, does not fall within the PTO's technical expertise (assuming that the PTO went through the claim construction exercise in the first instance)." Id. at 4.
In Cordis Corporation v. Boston Scientific Corporation, C.A. No. 03-27-SLR (D. Del. Jan. 28, 2010), Judge Robinson had an opportunity to lay out her views on In re Seagate Techonology, LLC, 497 F.3d 1360 (Fed. Cir. 2007) (en banc). In Re Seagate held that "to establish willful infringement, a patentee must show by clear and convincing evidence that the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent. . . . If this threshold objective standard is satisfied, the patentee must also demonstrate that this objectively-defined risk (determined by the record developed in the infringement proceeding) was either known or so obvious that it should have been known to the accused infringer." Id. at 2, quoting Seagate.
Judge Robinson expressed her view that this holding allows consideration only of pre-litigation evidence, excluding things like prior court decisions:
It cannot be emphasized enough that the litigation process is a complicated one, comprising multiple steps and moved forward by multiple decisions, ranging from resolving a discovery dispute to a case-dispositive motion. Consequently, I am very uncomfortable with characterizing administrative and court decisions as "objective evidence" for presentation to a jury. As recognized by counsel, a jury is going to give such evidence great weight, even when the procedural and substantive bases for most such decisions will not be apparent to the jury. This strikes me either as the kind of evidence better suited for review by a court' or as eliciting the kind of hindsight review that is so strenuously discouraged in other aspects of patent law. See KSR Intern. Co, v. Teleflex Inc., 550 U.S. 398, 421 (2007). Therefore, consistent with the reasoning of the Seagate decision as a whole (and its emphasis on prelitigation conduct), generally only evidence regarding the prelitigation landscape of the dispute will be admitted.
Id. at 3-4. Further, even pre-litigation evidence remains subject to the Rule 403 standard. Id. at 5. Based on those rules, Judge Robinson excluded various evidence from the damages portion of the case, including a prior preliminary judgment decision, the outcome of other prior litigation, and statements issued during re-examination proceedings. Id. at 4-5.
District judge Sue L. Robinson this week issued a rare win to a party asserting a laches defense. According to the Court, eleven patent applications and ten abandonements, among others, adequately demonstrated the patent-in-suit's unenforceability:
"Taken in the totality, this case involves eleven patent applications, ten abandonements, and no substantive prosecution for a decade. CRCT's primary justification for delay, that neither Examiner Ford nor Examiner Richter would have allowed the applications at issue absent human data, is not objectively reasonable in view of the fact that CRCT never attempted to traverse the rejections (thereby either validating its position or obtaining allowance of its claims). CRCT's delay, therefore, cannot 'be explained by reference to [ ] legitimate considerations and/or expectations.' . . . CRCT introduced no contemporaneous evidence substantiating its position or establishing that CRCT sought to develop the technology prior to the Schering license. CRCT only engaged the PTO once it had a profit motive to do so."
With these delays, the ANDA filer established the abuse of the patent system necessary to a successful prosecution-laches defense.
In her opinion, Judge Robinson had emphasized the importance of a patentee's conduct during prosecution for later claims of infringement. In the underlying action, the patentee alleged that defendant's ANDA product, which covered an oral tablet that dissolved without water, contained distinct disintegrating and swelling agents, as required by the patent. The Court disagreed, resting its conclusion of non-infringement in part on the patentee's own disavowal of the purportedly infringing disintegrating agent.
Plaintiffs Boston Scientific Corporation and Boston Scientific Scimed Inc. (“BSC”) brought four patent infringement actions against Johnson & Johnson Inc. and Cordis Corporation (“J&J”) seeking a judgment of invalidity for four coronary stent patents. Boston Scientific Corporation, et al. v. Johnson & Johnson Inc., et al., C.A. No. 07-333-SLR (D. Del. Jan. 20, 2010) (consolidated). BSC moved for summary judgment of invalidity. Judge Robinson granted BSC’s motion on the basis that J&J’s patent specifications contain insufficient written descriptions. For example, three of the patents contained “no definitions, examples, or experimental models provided for determining whether a compound is a structurally similar analog as contemplated by the patentees.” Id. at 24. Because, based on the disclosure, a person skilled in the art would not recognize a description of the claimed analogs, “no reasonable jury could find that the written description requirement has been met with respect to the claimed analogs.” Id. at 26. In addition, Judge Robinson found non-enablement because a person with ordinary skill in the art could not make the claimed invention without undue experimentation. Id. at 27.
Judge Robinson also determined that the fourth patent was invalid due to failures in the written description. Id. at 30. Specifically, the relevant analogs were not “named, structurally depicted, exemplified, or otherwise described in the ‘662 patent specification.” Id. Moreover, “although limited by function, the claims of the ‘662 patent are drawn to a genus of [certain] analogs without any description of any species within the genus. The Federal Circuit has required the identification of ‘sufficient species’ to show that the totality of the genus was invented and disclosed.” Id. at 31 (citing Carnegie Mellon Univ. v. Hoffman-LaROche Inc., 541 F.3d 1115, 11261 (Fed. Cir 2008)).
In Boston Scientific Corp., et al. v. Johnson & Johnson, Inc., et al., C.A. No. 07-333-SLR (D. Del. Jan. 20, 2010), Judge Robinson construed the following terms as follows:
1. Stent
A device for providing support for a lumen in the body.
2. Biocompatible
Able to perform its function in the body with an acceptable biological response.
3. Therapeutic agent
A substance administered to treat or prevent a disease or condition.
4. Drug
A substance administered to treat or prevent a disease or condition.
5. Polymer
A material formed by polymerization and comprising repeating units of the same (homopolymer) or different (copolymer) types of monomers.
6. Copolymer
A polymer having two or more different types of monomers.
7. Polymeric carrier
A material comprised of at least one polymer that is formulated with the therapeutic agent.
8. Polymeric coating; coating
Covering layer(s) comprising a mixture of both a polymer and the therapeutic agent or drug.
9. Acrylate-based polymer or copolymer
A polymer in which at least one of the types of monomers is based on the structure of a salt or ester of acrylic acid.
10. Fluorinated polymer
A polymer containing one or more fluorine atoms.
11. Poly(ether-ester) copolymer
A polymer containing one monomer that includes an ether and another monomer that includes an ester.
12. Rapamycin or a macrocyclic lactone analog thereof
Sirolimus or a macrocyclic lactone molecule with a striction similar to sirolimus.
13. Rapamycin
Sirolimus and all analogs, derivatives and congeners that bind FKBP12 and possess the same pharmacologic properties as sirolimus.
14. Macrocyclic triene analog
A macrocyclic triene molecule with a structure similar to rapamycin and that binds FKB12.
15. An amount effective to inhibit neointimal proliferation
An amount sufficient to diminish neointimal proliferation.
16. Provides a controlled release of said therapeutic agent over a period of several weeks
Therapeutic agent is discharged gradually over the course of several weeks.
17. Releases
Discharges
18. Mixture; mixture thereof; blend thereof; incorporated into
Combination of two or more substances, or the act of combining said materials.
19. Applied; applied thereto; onto the stent; affixed to the intraluminal stent
Attached to the stent.
20. In-stent late loss
The minimal lumen diameter within the stent immediately following implantation minus minimal lumen diameter within the stent at a specified time following implantation.
Plaintiff moved to compel certain communications between the defendant and its third-party supplier on the grounds that these communications are not subject to the common interest privilege or joint defense strategy. Robert Bosch LLC v. Pylon Manufacturing Corp., C.A. No. 08-542-SLR, Memo. Order (D. Del. Dec. 23, 2009). The Court found that there was no waiver of the privilege where the documents contained the "possible disclosure of attorney advice obtained by a third party [not defendant] and related to [defendant], rather than [defendant] disclosing advice from its counsel." Id. at 13. Furthermore, these documents involve patents other than the patents-in-suit and the opinions provided are "very general, broad and nonspecific." Therefore, defendant's production of these documents is not a waiver of the attorney-client privilege on infringement and invalidity. Id. at 14.
Plaintiff further argued that regardless of any waiver or lack thereof, these documents are not subject to any other form of privilege and therefore any redacted or withheld communications between the defendant, its third-party supplier and defendant's counsel should be produced. Id. The Court found that there was an understanding that the defendant and the supplier were using the same counsel to address concerns about possible patent liability and therefore a "joint-client relationship" exists supporting the claims of privilege. Id. at 14-15. Judge Robinson further noted, that the "fact that this arrangement was not memorialized in written form until later does not defeat the relationship...and the protection of the attorney-client privilege." Id. at 14.
District judge Sue L. Robinson recently denied a request for a permanent injunction in part on the ground that the movant failed to supply the necessary documentary and analytical evidence to prove irreparable harm. By doing so, the Court implicitly gave guidance to litigators seeking to satisfy their evidentiary burden under the so-called e-Bay factors:
"[P]laintiff's case suffers from several fatal flaws. It is most problematic that plaintiff points to no documentary (or other) evidence regarding the effects of defendants' infringement (on plaintiff). As noted previously, the court has no market data before it. There is also no clear indication of a direct link between defendants' infringing sales . . . , loss of goodwill to plaintiff or, more broadly, a change in the market landscape." (at 9-10)
Notably, the Court also dismissed the credibility of the evidence plaintiff did offer - a declaration by plaintiff's president of product strategy - characterizing it as "rife with impermissible speculation" (at 6 n.11) and "self-serving" statements (at 9 n.15). The lesson is clear: an argument on irreparable harm must be built on some evidence beyond a party's declaration.
Where is the line between rehashing arguments and offering new evidence in seeking reconsideration of a ruling? According to a recent decision by district judge Sue L. Robinson, the waiver doctrine can play a primary role in this determination.
In disposing of a request to recalculate a lost-profits award, the Court noted that the movant never raised its remittitur argument in the initial post-trial proceedings. As a result, the movant not only waived its ability to raise the argument, but also prompted a rebuke from the Court:
"The present motion reflects a fundamental misunderstanding of the limited appropriateness of motions for reconsideration. There is no alleged change in law or new evidence. A 'manifest injustice' does not result from the court's failure to consider arguments not properly made by defendant in its prior motion to amend the judgment. As this court has iterated in previous cases, a motion for reconsideration is not properly grounded on a request that a court rethink a decision already made."
Strong words to consider when formulating positions for a post-trial (or any) motion.
