Copyright Office Announces Electronic Registration

     Last September, the Copyright Office issued an announcement that it had begun beta testing of its web-based registration system, which was part of a new "electronic Copyright Office" (eCO) program (see Copyright Office Announces Electronic Registration Testing). Beginning July 1, 2008, the Copyright Office will offer its online registration system to the public.  Instruction for making claims to copyrighted works may be found here.

     According to a recent Copyright Office announcement, online registration through the eCO is the preferred way to register basic claims for literary works; visual arts works; performing arts works, including motion pictures; sound recordings; and single serials. Advantages of online filing include a lower filing fee; the fastest processing time; online status tracking of your claim; secure payment by credit or debit card, electronic check, or Copyright Office deposit account; and the ability to upload certain categories of deposits directly into eCO as electronic files.

     To register a claim electronically, go to the Copyright Office website at www.copyright.gov and click on the eCO logo shown above.

Wyeth v. Lupin: Maryland District Court Denies Motion to Dismiss

     In Wyeth v. Lupin, Ltd. and Lupin Pharmaceuticals, Inc., No. 07, Civ. 0632 (D. Md Sep. 11, 2007), the District Court for the District of Maryland denied Baltimore-based Lupin Pharmaceuticals, Inc.'s (LPI) motion to dismiss an action against it and its parent, Mumbai, India-based Lupin Ltd. (Lupin), brought by pharmaceutical giant Wyeth. In reaching its decision, the District Court concluded that "when a wholly-owned U.S. subsidiary of a foreign corporation exists to distribute foreign-produced generic drugs in the U.S. and is actively involved in the ANDA process, the subsidiary also 'submits' an ANDA application" making it subject to the Hatch-Waxman Act like its parent.

     This case began when Lupin filed an Abbreviated New Drug Application (“ANDA”) with the FDA seeking approval to market a generic version of EFFEXOR® in the U.S. Under the Hatch-Waxman Act, the filing of an ANDA is an act of infringement. Accordingly, Wyeth, which owns U.S. Patents 6,274,171; 6,403,120; and 6,419,958 for venlafaxine hydrochloride (marketed by Wyeth as EFFEXOR® XR capsules), sued LPI and Lupin within the statutory 45-day period after receiving Lupin's "Paragraph IV" Notice Letter on January 30, 2007.

LPI's Motion to Dismiss

     LPI moved, under F.R.C.P. Rule 12(b)(6), to dismiss the complaint against it, arguing that under the Hatch-Waxman Act, the only act of direct infringement under 35 U.S.C. § 271(e)(2)(A) was Lupin's filing of the ANDA with the FDA. Wyeth sought to maintain LPI in the lawsuit, arguing that there is no “one-defendant-per-ANDA” rule under the Hatch-Waxman Act. LPI, Wyeth said, acted in concert with Lupin to violate Wyeth’s patents.

     The District Court began its analysis by noting that Lupin had made the same arguments, unsuccessfully, in Aventis Pharma Deutschland GMBH v. Lupin Ltd., 403 F. Supp. 2d 484, 494 (E.D. Va. 2005). In that case, the district court found:

"LPI’s relationship with Lupin was that of a subsidiary of the applicant and that subsidiary
submitted the ANDA application to the FDA as agent on the foreign company’s behalf."

     The Maryland District Court also noted that in the Aventis case, LPI had countersigned Lupin's ANDA, which provided further indication that LPI was more than a “mailbox” for Lupin’s U.S. business interests. The District Court then distinguished the present case from SmithKline Beecham Corp. v. Geneva Pharms., Inc., 287 F. Supp. 2d 576 (E.D. Pa. 2002), where an innovator sought to amend it complaint by adding a third-party manufacturer that was supplying an active ingredient for the generic drugs at issue in the disputed ANDA. Concluding that LPI had not met its burden, the Maryland District Court then found:

"LPI is actively involved with filing Lupin’s ANDAs with the FDA, and marketing and distributing the approved generic drugs in the United States. LPI’s role in filing the ANDA is distinct from the future promises of support made by the third-party manufacturers in the SmithKline cases. The Court does not read § 271(e)(2) as broadly as the Aventis court, which placed significance on LPI’s countersignature as part of its agent-principal relationship with Lupin. But when a wholly-owned U.S. subsidiary of a foreign corporation exists to distribute foreign-produced generic drugs in the U.S. and is actively involved in the ANDA process, the subsidiary also 'submits' an ANDA application."

     LPI also moved, unsuccessfully, to dismiss the induced infringement claims against it. In its analysis of LPI's arguments, the District Court noted that the Federal Circuit has recognized a cause of action for induced infringement under § 271(e)(2), Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1331 (Fed. Cir. 2003) (per curiam), and also acknowledged that other district courts before and after Allergan have disagreed about whether inducement liability exists for entities that were not the named ANDA filers (citing S.D. New York., D. of Delaware, N.D. West Virginia, E.D. Pennsylvania, N.D. Illinois). Based on the pleadings in this case, the Court sided with Wyeth: 

"Wyeth has sufficiently alleged that LPI actively induced infringement under § 271(e)(2). Wyeth alleges that LPI was actively involved in the ANDA submission process, aided and
abetted the inducement of the patents-in-suit, and upon FDA approval, will infringe the patents-in-suit 'by making, using, offering to sell, selling and/or importing' Lupin’s proposed generic capsules. As Wyeth’s claim is not foreclosed by § 271(e)(2) and has adequately alleged an inducement claim against LPI, Wyeth has satisfied the notice pleading requirements."

Held:  LPI's motion to dismiss was denied.

Comments:

  • Had the Maryland District Court decided this matter differently, Wyeth would be left suing a foreign entity in a U.S. forum (Maryland) where personal jurisdiction would be based on Lupin's filing of its ANDA with the FDA (which just happens to be located in Rockville, MD), and based on whatever other contacts Lupin has in the forum through its subsidiary, LPI.  See Personal Jurisdiction and the Foreign Defendant, by Lisa Savitt and Melissa Pierre for a good summary of personal jurisdiction issues related to foreign defendants.

  • It's unclear from this case whether a U.S. subsidiary that exists simply to distribute foreign-produced generic drugs in the U.S. and is not actively involved in the ANDA process would prevail on a motion to dismiss in Maryland.

Federal Circuit Clarifies Waiver of Attorney-Client Privilege and Work Product Immunity in Patent Litigation

Summary: The Federal Circuit clarifies the scope of the waiver of attorney-client privilege and work product protection that results when an accused patent infringer asserts an advice of counsel defense to a charge of willful infringement. Case:  In Re Seagate Technology, LLC, Civ. No. 830 (Fed. Cir. 2007) (en banc) (Newman, J., Garjarsa, J., concurring).


     Convolve, Inc., and MIT (“Convolve”) sued Seagate, alleging willful infringement of U.S. Patent Nos. 4,916,635, 5,638,267, and  6,314,473. Prior to the lawsuit, Seagate had obtained from outside counsel three opinion letters covering infringement, validity, and enforceability of those patents. Seagate notified Convolve of its intent to rely upon the three opinions in defending itself against willful infringement.  It then disclosed its outside counsel’s work product and made him available for deposition. Convolve then moved to compel discovery of any communications and work product of Seagate’s other counsel, including its trial counsel. The S.D.N.Y. sided with Convolve, concluding that Seagate waived the attorney-client privilege for all communications between it and any counsel, including opinion, trial, and in-house counsel, concerning the subject matter of the opinion letters. 

     In response, Seagate filed a petition for writ of mandamus with the Federal Circuit, which was granted. After ordering en banc review, the Federal Circuit ordered the S.D.N.Y. to reconsider its order compelling discovery.  In doing so, the Federal Circuit overruled its earlier decision in Underwater Devices Inc. v. Morrison-Knudsen Co., 717 F.2d 1380 (1983), and clarified the scope of the waiver of attorney-client privilege and work product protection that results when an accused patent infringer asserts an advice of counsel defense to a charge of willful infringement. The court’s opinion addressed three significant issues: the standard for awarding enhanced damages, the scope of the waiver of trial counsel-client privileged communications, and the scope of the waiver of trial counsel’s work product.

Standard for Awarding Enhanced Damages in Patent Cases

     The Federal Circuit concluded that the duty of care it announced in Underwater Devices was akin to negligence, which was a lower threshold compared to other comparable civil statutory frameworks. Such a low standard, the court said, “does not comport with the general understanding of willfulness in the civil context…, and it allows for punitive damages in a manner inconsistent with Supreme Court precedent.”  Accordingly, the court overruled the Underwater Devices standard and held that proof of willful infringement permitting enhanced damages requires at least a showing of objective recklessness, a higher standard than negligence. “Because we abandon the affirmative duty of due care,” the court wrote, “we also reemphasize that there is no affirmative obligation to obtain opinion of counsel.”

Scope of Attorney-Client Waiver

     Noting that district courts have reached varying results with respect to whether communications with trial counsel are waived when a client relies upon opinion of counsel as a defense to a charge of willfulness, the Federal Circuit said:

“[W]e conclude that the significantly different functions of trial counsel and opinion counsel advise against extending waiver to trial counsel. Whereas opinion counsel serves to provide an objective assessment for making informed business decisions, trial counsel focuses on litigation strategy and evaluates the most successful manner of presenting a case to a judicial decision maker. And trial counsel is engaged in an adversarial process. * * * Because of the fundamental difference between these types of legal advice, this situation does not present the classic “sword and shield” concerns typically mandating broad subject matter waiver. Therefore, fairness counsels against disclosing trial counsel’s communications on an entire subject matter in response to an accused infringer’s reliance on opinion counsel’s opinion to refute a willfulness allegation. “

     The court supported its position with several additional reasons, but it also noted that in reaching its decision, “[w]e do not purport to set out an absolute rule.”  Trial courts should continue, the court said, to exercise their discretion in unique circumstances to extend waiver to trial counsel, such as if a party or counsel engages in “chicanery” (def'n: trick, trickery, subterfuge).

Scope of Work Product Waiver

     Relying upon the same rationale limiting waiver of the attorney-client privilege with regard to trial counsel, the Federal Circuit concluded that a party relying upon opinion counsel’s work product does not waive work product immunity with respect to trial counsel.   This general limitation is necessary because of the nature of the work product doctrine, the court said, and because protecting lawyers from broad subject matter disclosure “strengthens the adversary process, and . . . may ultimately and ideally further the search for the truth.” However, the Federal Circuit also stated “we leave open the possibility that situations may arise in which waiver may be extended to trial counsel, such as if a patentee or his counsel engages in chicanery.”

Held: Seagate’s petition for a writ of mandamus was granted; the district court was ordered to reconsider its discovery orders in light of the Seagate opinion.

Comments:

  • This case may strengthen the long held belief by patent attorneys that patent litigation trial counsel should be different than opinion counsel. See William L. LaFuze, Matthew R. Rodgers & Michael A. Valek, Exculpatory Patent Opinions and Special Problems Regarding Waiver of Privilege, 6 J. MARSHALL REV. INTELL. PROP. L. 313 (2007) (available here)

  • In the Seagate opinion, the Federal Circuit noted that a willfulness claim asserted in the original complaint must necessarily be grounded exclusively in the accused infringer’s pre-filing conduct. By contrast, when an accused infringer’s post-filing conduct is reckless, a patentee can move for a preliminary injunction, which generally provides an adequate remedy for combating post-filing willful infringement. A patentee who does not attempt to stop an accused infringer’s activities in this manner should not be allowed to accrue enhanced damages based solely on the infringer’s post-filing conduct. Similarly, if a patentee attempts to secure injunctive relief but fails, it is likely the infringement did not rise to the level of recklessness.   What does this say about the use of injunctions in patent cases in the future?