Maryland IP Litigation 2008: Lawsuit Summaries Nos. 8-11

Posted on February 17, 2008 by Brian Wm. Higgins

     Below are summaries of recent IP-related lawsuits filed in the the U.S. District Court for the District of Maryland in 2008 (source: Justia). The first summary involves a discovery matter relating to a patent lawsuit filed in the E.D. Texas.

     This lawsuit was filed in and is pending in the U.S. District Court for the Eastern District of Texas (No. 9-06-cv-277RHC). It involves patents covering treatment of wrinkles in the skin using radiation-emitting devices (U.S. 5,810,801; 6,120,497; and 6,659,999). 

     The case is before the U.S. District Court for the District of Maryland to enforce a subpoena duces tecum issued from the Maryland court to Dr. Hema Sundaram, ordering her to permit production, inspection, and copying of specified documents sought by patentee Candela. Candela's theory of infringement is that Palomar has induced physicians and others to use the accused devices, and it now seeks information from 16 physicians about how they operated the accused devices, and whether communications from Palomar to those physicians indicated how the accused devices should be operated for wrinkle treatment. That type of evidence is classic inducement evidence that patentees typically seek. 

     Candela's motion recognizes a number of privacy issues involved in seeking production of medical-related documents from physicians in patent infringement cases. Objecting to the subpoena, Dr. Sundaram's counsel stated that the protective order in place was insufficient to protect medical records or patient information in view of the Health Insurance Portability and Accountability Act (HIPAA). Patent counsel need to be aware of HIPAA's requirements because redactions alone may not be in compliance unless they remove all "individually identifiable health information."

     Green, a Michigan resident, alleges ownership of U.S. Patent No. 5,315,083, which is directed to a microwave cooking utensil as shown in the patent (see below). Green sued ConAgra, which is reportedly a Nebraska company, in Maryland because ConAgra sold infringing utensils in Maryland, according to the complaint.

      This trademark infringement, false designation of origin, unfair competition, and passing off case involves Elkridge, MD-based The Lindy Bowman Company, and defendants Jeanmarie Creations and Walgreens. Plaintiff alleges ownership and use of GIFT WRAP IN A SNAP mark for pre-packaged gift wrap kits. Plaintiff is seeking an injunction, an accounting, and unspecified monetary relief.

     This patent infringement case involves EO Mfg., an Illinois company and the assignee of U.S. Patent No. 7,096,764, which is directed to a pipe wrench. Defendant Ridge Tool is an Ohio company. Jurisdiction is predicated on allegations of defendant's sale of allegedly infringing products in Maryland.

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2008 Advanced Patent Law Institute

Posted on January 10, 2008 by Brian Wm. Higgins

     If you're in the D.C.-Maryland-Virginia area and would like to learn more about managing patent infringement litigation, don't forget about the 2008 Advanced Patent Law Institute being held in Alexandria, Virginia, starting today, January 10, 2008. My colleague, Keeto Sabharwal, a partner in Blank Rome’s Washington, DC, office, will be discussing the law of induced patent infringement tomorrow.  The session will include advice on how to effectively litigate a claim of active inducement from both the plaintiff’s and the defendant’s perspectives, and it will offer a discussion of the most recent federal circuit case law addressing the issue. Here is a link to the course for more information.

     Update:  The presentation mentioned above was switched in the schedule and presented this morning. If you're interested in a copy of the presentation materials, please email me.

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Joint or Divided Patent Infringement Law Provides Loophole for Infringers, Challenge for Patentees

Posted on September 24, 2007 by Brian Wm. Higgins

Summary:  The Court of Appeals for the Federal Circuit clarifies the standard for assessing whether two different entities are jointly liabile for patent infringement.

     As illustrated in a post on this web site over a month ago, consider the hypothetical situation where a business performs steps A and B of a patented process, and another company performs steps C and D. Neither company would appear to be a direct infringer of a patent claim reciting steps A, B, C, and D. And as long as no one is directly infringing the claim by practicing all steps A through D, neither company should be held liable for contributory or induced infringement of the claimed process either. That's where the theory of "joint" or "divided" patent infringement liability comes into play. In BMC Resources, Inc. v. Paymentech, L.P., 2006-1503 (Fed. Cir. 2007), the Federal Circuit considered the proper standard for joint or divided infringement by multiple parties of a single claim.

     At the outset, the Federal Circuit reiterated that liability for patent infringement requires a party to make, use, sell, or offer to sell a patented invention, meaning the entire patented invention. For example, direct patent infringement requires a party to perform or use each and every step of a claimed method. When a defendant participates in or encourages infringement but does not directly infringe a patent, the normal recourse under the law is for the court to apply the standards for liability under a theory of indirect infringement. However, the court said, indirect infringement requires, as a predicate, a finding that some party amongst the accused actors has committed the entire act of direct infringement.

    In addressing the specific issue on appeal in BMC Resources, the Federal Circuit stated that the rules for vicarious liability might seem to provide a loophole for a party to escape infringement by having a third party carry out one or more of the claimed steps on its behalf. However, a party cannot avoid infringement, the court said, simply by contracting out steps of a patented process to another entity. In those cases, "the party in control would be liable for direct infringement." It would be unfair, the Federal Circuit went on to say, for the mastermind in such situations to escape liability.

     Nevertheless, the Federal Circuit acknowledged that the standard requiring "control or direction" for a finding of joint infringement may in some circumstances allow parties to enter into arms-length agreements to avoid infringement. Recognizing that such agreements could form the basis for a defense to infringement, the court tried to assuage concerns by noting that patentees are allowed to structure their claims to capture infringement by a single party (citing Mark A. Lemley et al., Divided Infringement Claims, 33 AIPLA Q.J. 255, 272-75 (2005)). That is, methods of use or process claims could be drafted, the court intimated, in a manner that logically requires all of the recited steps to be performed by a single party, or at least does not make it easy for the individual steps to be performed by separate parties working under arms-length agreements.

Held:  "Applying these standards to BMC’s charges against Paymentech properly results in a finding of no infringement."

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Foreign Drug Manufacturer's Future Commercial Activity Contributorily Infringes U.S. Patent, Federal Circuit Says

Posted on September 5, 2007 by Brian Wm. Higgins

Summary:  Foreign supplier of active pharmaceutical drug to U.S. applicant seeking FDA approval to market generic Lexapro® was enjoined along with the U.S. applicant based on supplier's commercial partnership with the U.S. applicant.  Case:  Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc., 07civ1059 (Fed. Cir. 2007) (Schall, J., dissenting-in-part).

 

     Ivax Pharmaceuticals, Inc., submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market generic tablets containing escitalopram oxalate (“EO”), the active ingredient in Lexapro®.  Forest Laboratories, Inc., which owns the patent for Lexapro®, sued Ivax under the Hatch-Waxman Act, which provides that the mere filing of an ANDA is an act of infringement.  During discovery, Forest learned that part of Ivax's ANDA submission included information provided by Mumbai-based Cipla, Ltd., Ivax's alleged EO drug supplier. Cipla was joined in the lawsuit. After the parties stipulated to infringement and the district court found the patent-at-issue not invalid nor unenforceable, it included Cipla in the injunction against Ivax.

     On appeal, the Federal Circuit agreed with the district court's decision to include Cipla:

"Here, we do not know if Cipla first approached Ivax or vice versa, but the plan to manufacture, import, market, and sell the EO products described in the ANDA was undoubtedly a cooperative venture, and Cipla was to manufacture and sell infringing EO products to Ivax for resale in the United States. Under the standards for inducement which we apply to 35 U.S.C. § 271(b), Cipla has therefore actively induced the acts of Ivax that will constitute direct infringement upon approval of the ANDA, and it was thus not inappropriate for the district court to include Cipla within the scope of the injunction."

     The Federal Circuit cited Allergan, Inc. v. Alcon Labs, Inc., 324 F.3d 1322 (Fed. Cir. 2003) for the notion that merely filing an ANDA is a constructive act of infringement, and may support a cause of action for induced infringement.

     The dissent asserted that the safe harbor provision of § 271(e)(1) exempted Cipla from being enjoined with Ivax; however, the majority disagreed with that conclusion, saying:

"Cipla is providing information, and will provide material, that Ivax will use to obtain FDA approval. Up to that point, there is indeed no infringement. And, in fact, Ivax is not currently liable for infringement, as long as it is only pursuing FDA approval, not commercially manufacturing or selling the infringing product. However, just as Ivax will be liable for, and hence is being enjoined from, the commercial exploitation of [EO] when it is approved by the FDA and during the life of the patent, so should Cipla be enjoined. They are partners. Cipla would be contributing to the infringement by Ivax, so the injunction should cover both partners. It is true that, as the dissent states, § 271(e)(2) defines Ivax's filing of its ANDA as an infringement, and Cipla did not file the ANDA; however, when the question of an injunction against commercial activity arises, Cipla is as culpable, and hence entitled to be enjoined, as Ivax."

Result:  Ivax and Cipla are enjoined from infringing the patent-in-suit. 

Comments:

  • The claims that the parties stipulated to infringing included claims directed to the drug EO, a pharmaceutical formulation containing EO as an active ingredient, and methods of making the EO

  • Links to Teva Pharmaceuticals (reportedly owns Ivax), Cipla Ltd., and Forest Laboratories

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A Joint Patent Infringement Doctrine? Still Holding Our Breath

Posted on August 16, 2007 by Brian Wm. Higgins

Summary:  Although teasing about things to come, the Court of Appeals for the Federal Circuit (CAFC) adverted to, but then sidestepped, the question of whether two separate entities can jointly infringe a patent.


      If you're a patent practitioner, this issue has likely come across your radar screen at some point.  Say a business performs steps A and B of a patented process, and another company performs steps C and D.  Neither company would appear to be a direct infringer of a patent claim reciting steps A, B, C, and D.  And as long as no one is directly infringing the claim by practicing all steps A through D, neither company should be held liable for contributory or induced infringement of the claimed process either.  That's where the theory of "joint" or "divided" patent infringement liability comes into play.

     In PharmaStem Therapeutics, Inc. v. Viacell, Inc., No. 05 Civ. 1490 and 1551 (Fed. Cir. July 9, 2007) (Newman, J., dissenting), the CAFC acknowledged that the parties and the district court discussed the issue of joint infringement in the context of determining whether there was infringing conduct sufficient to serve as a predicate for a finding of contributory infringement.  Under that theory, the court said, "two related parties are both deemed liable for direct infringement of a method patent when each performs some steps of the claimed method."  However, while recognizing that the viability and scope of the joint theory of liability has been the subject of considerable debate, the CAFC said the issue was not squarely raised on appeal such that it could address the merits of the theory, leaving the liability "loophole" in tact. 

      So what about the tease mentioned above?  The CAFC pointed out that the joint liability issue has been directly appealed in another case--BMC Resources, Inc. v. Paymentech, L.P., No. 2006-1503--currently pending before the CAFC.  Perhaps, then, the bar will have some clarity soon.

Comments:

  • Other materials addressing the joint liability issue: 

    • On Demand Mach. Corp. v. Ingram Indus., Inc., 442 F.3d 1331, 1334 (Fed. Cir. 2006);
    • Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1311 (Fed. Cir. 2005);
    • Kristin E. Gerdelman, Subsequent Performance of Process Steps by Different Entities: Time to Close Another Loophole in U.S. Patent Law, 53 Emory L.J. 1987 (2004);
    • Mark A. Lemley et al., Divided Infringement Claims, 33 AIPLA Q.J. 255 (2005);
    • Sriranga Veeraraghavan, Joint Infringement of Patent Claims: Advice for Patentees, 23 Santa Clara Computer & High Tech L.J. 211 (2006).

 UPDATE:  See related post here, concerning the Federal Circuit's BMC Resources, Inc. v. Paymentech, L.P. opinion.

 
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