As we previously mentioned in an earlier blog post, Magistrate Judge Leonard P. Stark has been nominated by President Obama to fill the current D. Del. vacant judgeship. (see post here) The Senate Judiciary Committee held a confirmation hearing last Thursday, April 23, 2010 regarding his nomination. The committee members may still provide written questions to Magistrate Judge Stark before the committee votes. The nomination must be approved by the full committee and then confirmed by the full Senate.
For a more comprehensive recap of the hearing, below is a link to the Delaware News Journal Article of April 24, 2010.
Note to Counsel: Remember your duty of candor to the tribunal. In a recent post-trial findings of fact and conclusions of law, Chief Judge Gregory M. Sleet noted in a footnote the following:
“Santarus asserts that Dr. Allen, one of Par’s expert witnesses testified that ‘there are substantial differences between omeprazole and leminoprazole.’… This is, at best, a highly misleading statement and is one of the more egregious examples of the distortions of the record contained in Santarus’ post-trial briefing. The portion of the transcript that Santarus cites for its characterization of Dr. Allen’s testimony contains two questions that call for some comparison between leminoprazole and omeprazole. The first question and its response consisted of the following:
Q. You would agree that Laminoprazole is substantially different from omeprazole; correct?
A. It is a ben—
Q. Thank you, sir.
Tr. 710:19-22. The second question, as reworded after an objection by Par’s counsel, discussed a hypothetical, abstract patent containing leminoprazole and asked whether, for the purposes of doctrine of equivalents rather than non-obviousness, the substitution of omeprazole would constitute a ‘substantial difference’ such that it would not infringe under the doctrine of equivalents. (Tr. 711-25.) To that abstract, hypothetical question concerning a wholly different area of patent law, Dr. Allen answered “I believe that is true. Id. at 712:1. The court is trouble that on this basis, Santarus asserts in the context of its obviousness argument that Dr. Allen ‘testified’ that leminoprazole and omeprazole were substantially different.
Sadly, such distortions are not confined to these examples – both at trial and in the post-trial briefing. At trial, counsel for Santarus implied that one of Par’s witnesses was ‘embarrassed’ by his opinion in this case based on the witness’s statement during deposition that he hoped the confidentiality of his participation in the case would be respected… In its proposed findings of fact and conclusions of law, Santarus’ counsel represented to the court that Dr. Orlando was unable to explain the meaning of an article at trial… Counsel neglects to mention, however, that the testimony cited was in response to a question that counsel withdrew after Dr. Orlando asked to see the context in question… Furthermore, both parties’ briefs cite portions of the transcript that provide no support for the propositions for which they are cited. These tactics make it far more difficult and time-consuming for the court to examine the record when preparing its findings of fact and conclusions of law. Both the court and the parties suffer undue inconvenience when counsel engages in such tactics. Equally important, counsel who engage in such sharp practices run the risk of severely damaging their credibility and, thus, their effectiveness in the place and at the time when they most need to be viewed as honest and ethical brokers of the facts and the law.
Santarus, Inc. v. Par Pharmaceutical, Inc., C.A. No. 07-551-GMS, Memo., at 35 n.10 (D. Del. Apr. 14, 2010).
This opinion follows a series of discovery disputes between the parties surrounding requests for production of documents concerning drugs other than the drug that is the subject of the plaintiffs’ NDA, defendant Mylan’s ANDA and the patent-in-suit. Eurand, Inc. v. Mylan Pharmaceuticals, Inc., C.A. No. 08-889-SLR, Memo. Order (D. Del. Apr. 13, 2010) (Thynge, Magistrate) (see prior opinion and post here). As part of its Second Amended Answer, defendant Mylan asserted the affirmative defense and counterclaim of inequitable conduct alleging that Mylan failed to disclose another material patent during the examination of the patent-in-suit. Mylan sought to discovery documents “evidencing the two inventors’ awareness of and understanding of” certain pieces of prior art during the period prior to and during the filing and prosecution of the patent-in-suit. Id. at 3.
Mylan’s Second Amended Answer asserted a claim of inequitable conduct solely based on one piece of prior art, a U.S. patent. Mylan also sought documents, however, related to two other references that were not mentioned in its Answer, but Mylan argued were relevant to plaintiffs’ subjective intent. Id. at 8-10. Such discovery was necessary, Mylan argued, before it could assert additional claims of inequitable conduct under Rules 9 and 11. Judge Thynge held that “[i]t is improper to use discovery in search of a factual predicate required to be pled in the first instance.” Id. at 10.
However, as to the documents sought to establish knowledge and intent related to the U.S. patent that Mylan did plead in its counterclaim and affirmative defense, those documents are relevant and should be produced. Plaintiffs argued that they conducted a thorough search of all relevant files including all development and product files related to the drug claimed in the patent-in-suit and those files would have encompassed the prior art sought by Mylan. Id. at 5, 11. They further argued that the proposed search by Mylan of the emails of the two inventors would “involve review of a large number of potential emails and substantial expense…and contains terms that have nothing to do with the present inequitable conduct claim.” Id. at 11. Noting the hesitancy of the court to opine on such “mysteries of keyword search techniques,” the court stated that it in determining the “adequacy” of search terms or methodology, a reasonableness test is applied. It further found that plaintiffs’ search of materials related to the drug claimed in the patent-in-suit “did not include keywords on the inventors’ knowledge or awareness of the materiality of the [prior art] patent” and that “[s]uch knowledge under the circumstances…would most likely be found in the emails of the inventors.” Id. at 13. Therefore, the court ordered plaintiffs to search and produce all emails that “are relevant to the inventors’ knowledge and materiality of the [prior art] patent to the [patent-in-suit] and failure to disclose the [prior art] patent during the prosection of the [patent-in-suit]” during the period from the filing of the [prior art] patent to the date of issuance of the [patent-in-suit].” Id. at 14.
Plaintiffs Schering-Plough HealthCare Products, Inc. (makers of Coppertone-brand sunscreen) brought an action under Section 43 of the Lanham Act against Neutrogena Corporation (makers of Neutrogena-brand sunscreen) for releasing advertisements containing false and misleading statements. Defendants counter-claimed under the Act based on advertisements by Plaintiffs.
Defendant's advertisements involved a bar graph showing "UVA" and SPF ratings for the competing products:
Plaintiffs argued that the graphs were misleading, and the Court agreed, based on the literal falsity of the graph's "double-counting" of UVA protection. The upper, yellow portion of the graph represents the sunscreen's UVA protection, while the bottom, red portion of the graph represents the SPF rating. According to the Court, however, the red portion of the graph is based on an SPF measurement that already accounts for UVA protection. Thus, by adding the yellow portion of the graph, Defendants were double-counting their UVA protection, which was literal falsity. The Court was unpersuaded by Defendants' argument that the falsity affected the graphs of both products: "While it is true that these errors are present with respect to both products compared in the graph, the absence of bias caused by the double-counting does not eliminate the falsity of the message." Id. at 12.
Defendants asserted a counterclaim based on claims made in Plaintiff's TV ads. The ads involved an establisment claim that Plaintiff's sunscreen provided "better coverage," as well as text apparently asserting that Defendant's spray sunscreen consisted of "28% Propellant":
The Court held in favor of Defendants on both claims. For the establishment claim, the Court held that Plaintiffs had failed to actually test the properties of the products in the ad, and that "[t]his type of unsubstantiated 'scientific' claim is precisely what the Lanham Act seeks to prevent." For the "28% Propellant" statement, the Court held that
"The overlay of the words "Neutrogena" and "28% propellant" on the (bare) chest of one of the athletes (as compared to, for example, pictures of the respective cans) reinforces the message that 72% sunscreen and 28% propellant is applied to the body, rather than merely contained inside the can. There is no qualifying statement or language from which a consumer could conclude that the propellant is not deposited onto the skin in this amount or, alternatively, that the sunscreen (lotion) expelled by the can is 100% (and not 72%) sunscreen. This is an unambiguous message conveyed by necessary implication and, therefore, is literally false."
In Millenium Pharms., Inc. v. Teva Parenteral Medicines, Inc., C.A. No. 09-105 (D. Del. Apr. 13, 2010), Plaintiffs brought suit after defendants filed their Abbreviated New Drug Application (“ANDA”) for a generic version of Plaintiffs’ drug. Id. at 2. Pursuant to their ANDA, Defendants submitted a Paragraph IV certification that Plaintiffs’ patents in the corresponding New Drug Application (“NDA”) were invalid, unenforceable or would not be infringed. Id. at 3-4. Due to Defendants’ Paragraph IV certification, Plaintiffs had 45 days to bring the suit to establish validity of their patents (which they did), thereby staying Defendants ANDA for 30-months. Because Defendants were the first to file a Paragraph IV certification, they are entitled to a 180-day market exclusivity after ANDA approval, provided Defendants begin marketing their generic drug within 75 days of a final judgment that Plaintiffs’ patents are invalid, unenforceable, or not infringed. In addition to the Paragraph IV certifications, Defendants submitted Paragraph III certifications which would delay FDA certification of Defendants’ ANDA until Plaintiffs’ patents expire, in 2014. The result was that Defendants could lose their 180-day exclusivity period, even if they are successful in the litigation. Id. at 5. Therefore, Defendants subsequently sought a stay of the litigation.
Judge Joyner denied Defendants’ Motion to Stay, however, after weighing the potential hardships to both Plaintiffs and Defendants. Judge Joyner noted that “Defendants have shown that they will be harmed if a stay is not entered, as they will likely forfeit their 180-day exclusivity period. Defendants, however, have only themselves to blame for this result. . . . Although Defendants did not file this suit, they were well aware that their ANDA triggered the start of a 45-day period for Plaintiffs to defend the validity of their patents, and, in this sense, did control the timing of the present litigation.” Id. at 8. Because the harm to Defendants of denying the stay was “one of their own creation,” that harm cannot outweigh any harm to Plaintiffs if the stay is granted. Id.
Magistrate Judge Stark denied defendant's request for entry of a 60 day stay based on a "drastic downturn in [defendant's] financial outlook." Aerocrine AB v. Apieron, Inc., C.A. No. 08-787-LPS, Order Regarding Request for Stay, at 1 (D. Del. Mar. 30, 2010). A court has discretion to enter a stay because of financial hardship on one of the parties. Id. at 1. Finding that there are hardships for both parties, including potential bankruptcy for the defendant and for plaintiffs, the possibility that defendant will continue to infringe the asserted patents and delay of resolution of this litigation which has been pending since 2008, the court chose to deny the stay. "Ultimately, [plaintiff] prefers to proceed with this litigation at the risk that doing so will force [defendant] to file for bankruptcy protection, rather than have the instant action stayed in hopes that the proposed asset sale will be consummated and permit [defendant] to proceed with the litigation." Id. at 2.
In addressing various motions in limine filed in a case set to be tried to the bench this month, Judge Farnan denied the pending motions in limine all addressing the exclusion of evidence at trial. UCB, Inc. v. KV Pharmaceutical Co., C.A. No. 08-223-JJF, Memo. Op. (D. Del. Mar. 9, 2010). In one motion, plaintiffs sought to preclude the defendant from asserting its on-sale bar defense because they did not assert such a defense during discovery. The court denied the motion, finding that plaintiffs did not demonstrate any "actual harm or prejudice" they will incur if the defense is allowed. Furthermore, plaintiffs could not point to any specific discovery they were unable to complete, and in fact responded to defendant's motion for summary judgment on the issue. Id. at 6.
Judge Farnan denied another pending motion in limine on similar grounds finding that defendant was timely in asserting a specific non-infringement defense where it argued the general theory in summary judgment and claim construction. The court found that the issue has long been known and the fact that the "precise" argument was not "expressly disclosed" did not warrant granting the motion. Id. at 8.
In a case involving technology relating to wiper blades, Judge Robinson recently issued a claim construction order construing the terms set forth below:
- "mounted to said concave surface of said support element"
- "mounted directly to the convex surface of said support element"
- "a leading edge face"
- "wherein each crosspiece disposed at the end sections of the two spring stripes is provided with a covering cap"
- "groove-like construction"
- "a wiper blade part"
- "wind deflection strip is disposed between and in contact with each respective end cap and the device piece"
- "base body"
- "bracing itself on the wiper blade"
- "detent shoulder"
- "pointing toward the other end portion"
- "protrusions protuding;" "a protusion protruding"
- "long sides;" "long sides of the support element"
- "hook legs"
- "detent tooth that protrudes from the long side of the support element"
- "the face of the end of the support element"
- "inside wall"
- "pin passage"
- "tail space"
- "forwardmost free end"
- "rearward of said pin passage and said rivet passage"
- "rail-free hook insertion space"
- "engagement tab"
- "outward lateral extent"
Interestingly, the court refused to construe the phrase "wherein said leading edge face is disposed on a face of said support element which faces away from the window" because the "phrase is unsupported by the specification and has no apparent plain meaning. Robert Bosch, LLC v. Pylon Manufacturing Corp., C.A. No. 08-542-SLR, Memo. Order, at 3 (D. Del. Mar. 30, 2010).
In Fuzzysharp Technologies, Inc. v. Nvidia Corp. et al., C.A. No. 09-872 (D. Del. April 6, 2010), Plaintiff filed suit after filing seven separate patent infringement actions, involving the same patents, against multiple defendants in the Northern District of California. Id. at 1. Defendants moved for transfer to the Northern District of California after, in one of the cases, the district judge decided summary judgment invalidating the patents-in-suit under In re Bilski, 545 F.3d 943 (Fed. Cir. 2009). Judge Robinson considered “whether it makes sense for this court to keep the case at bar, necessarily imposing a stay pending the Supreme Court’s review of In re Bilski and/or the Federal Circuit’s Review of [plaintiff’s related case].” Id. at 2. Judge Robinson determined that due to the prior filings in the Northern District of California and the “unusual circumstances[,]” transfer was warranted. Id.
In Brigham and Women’s Hospital Inc., et al. v. Teva Pharmaceuticals USA, Inc., et al., C.A. 08-464 (D. Del. Mar. 31, 2010), Judge Bartle considered whether the attorney-client privilege was waived by plaintiffs when answering certain of defendants’ interrogatories relating to defendants’ inequitable conduct counterclaims. Id. at 4-5. When answering the interrogatories, plaintiffs indicated that they relied on advice of counsel to determine what material was disclosed to the patent office during prosecution of the patents in question. Id. at 5-8. Defendants argued that plaintiffs “relied on advice of counsel as a ‘sword’ to defeat the intent prong of inequitable conduct[,]” but were also “improperly attempting to use attorney-client privilege as a ‘shield’ to deflect inquiry into [related] communications.” Id. at 8-9.
Judge Bartle first determined that Federal Circuit law on attorney-client privilege applied, rather than Third Circuit law, because the privilege issue was “closely related to the substantive issue of inequitable conduct[,]” which is within the realm of the Federal Circuit. Id. at 9-10. Although the Federal Circuit has not decided the issue of waiver in the context of the use of advice of counsel as a defense to inequitable conduct, Judge Bartle looked to cases involving willful infringement. Id. at 11. In the willful infringement context, the Federal Circuit has clearly established, “that a litigant who asserts reliance of the advice of counsel as a defense waives the attorney-client privilege with regard to all communications pertaining to that advice.” Id. at 12. Likewise, Judge Bartle determined that reliance on advice of counsel as a defense to inequitable conduct results in waiver of the attorney-client privilege as to communications between lawyer and client relating to plaintiffs’ failure to disclose certain information to the patent office. Id. at 16.
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