In the Wake of MedImmune: What We Have Learned


The following guest post comes from Lisa A. Dolak, Professor of Law at Syracuse University and Practice Center Contributor.

In its 2007 decision in MedImmune, Inc. v. Genentech, Inc., the Supreme Court held that “Article III’s limitation of federal courts’ jurisdiction to ‘Cases’ and ‘Controversies,’ reflected in the ‘actual controversy’ requirement of the Declaratory Judgment Act, 28 U.S.C. § 2201(a)” does not require “a patent licensee to terminate or be in breach of its license agreement before it can seek a declaratory judgment that the underlying patent is invalid, unenforceable, or not infringed.”  Although MedImmune was decided in the context of a non‑breaching licensee’s action against its licensor-patentee, it altered the patent enforcement/licensing landscape more generally, specifically, by expanding the circumstances under which the district courts have the power to entertain declaratory judgment claims.

The Supreme Court held that the Federal Circuit had erred in holding that jurisdiction could not lie under the circumstances because the license agreement insulated MedImmune from a “‘reasonable apprehension of suit’”.   In the three and a half years since MedImmune was decided, the Federal Circuit has had the opportunity to apply its teachings in a variety of contexts.  The following summary highlights the key lessons from those Federal Circuit decisions.

What Has Changed

“The Supreme Court’s opinion in MedImmune represents a rejection of [the Federal Circuit’s] reasonable apprehension of suit test.”  SanDisk Corp. v. STMicroelectronics, Inc. (Fed. Cir. 2007).  “Following MedImmune, proving a reasonable apprehension of suit is only one of many ways a patentee can satisfy the Supreme Court’s more general all-the-circumstances test to establish that an action presents a justiciable Article III controversy.”  Caraco Pharm. Laboratories, Ltd. v. Forest Laboratories, Inc. (Fed. Cir. 2008).

The New Standard

“Article III jurisdiction may be met where the patentee takes a position that puts the declaratory judgment plaintiff in the position of either pursuing arguably illegal behavior or abandoning that which he claims a right to do.” (SanDisk).  “[W]here a patentee asserts rights under a patent based on certain identified ongoing or planned activity of another party, and where that party contends that it has the right to engage in the accused activity without a license, an Article III case or controversy will arise and the party need not risk a suit for infringement by engaging in the identified activity before seeking a declaration of its legal rights.” (SanDisk).

According to Judge Bryson, “the [new] rule . . . will effect a sweeping change in [Federal Circuit] law regarding declaratory judgment jurisdiction.”  (SanDisk) (Bryson, J., concurring in the result).  In his view, the practical result is that declaratory judgment jurisdiction is now available “in virtually any case in which the recipient of an invitation to take a patent license elects to dispute the need for a license and then to sue the patentee.” Id.

Examples of Circumstances Giving Rise to Jurisdiction, Post-MedImmune

  • “A patentee can cause [the requisite jurisdiction-creating injury] by creating a reasonable apprehension of an infringement suit, demanding the right to royalty payments, or creating a barrier to the regulatory approval of a product that is necessary for marketing.”  Prasco, LLC. Medicis Pharm. Corp. (Fed. Cir. 2008).
  • Jurisdiction can be triggered by correspondence from the patentee “assert[ing] a patent as ‘relevant’ to the other party’s specific product line, impos[ing] a short [two-week] deadline for a response, and insist[ing] the other party not file suit”, at least when the correspondence comes from “‘a non-competitor patent holding company’”, which “‘may invoke a different reaction than would a meet-and-discuss inquiry by a competitor, presumably with intellectual property of its own to place on the bargaining table.’” Hewlett-Packard Co. v. Acceleron LLC (Fed. Cir. 2009).

What Still Won’t Suffice to Create Declaratory Judgment Jurisdiction

  • The mere existence of a patent.  (SanDisk (“[J]urisdiction generally will not arise merely on the basis that a party learns of the existence of a patent owned by another or even perceives such a patent to pose a risk of infringement, without some affirmative act by the patentee.”)).
  • “[A] fear of future harm that is only subjective is not an injury or threat of injury caused by the defendant that can be the basis of an Article III case or controversy.”  (Prasco).
  • The mere fact that a patentee has refused to give a covenant not to sue.  (Prasco).
  • “[A] communication from a patent owner to another party, merely identifying its patent and the other party’s product line, without more, cannot establish adverse legal interests between the parties, let alone the existence of a ‘definite and concrete’ dispute.”  (Hewlett-Packard).
  • The following facts, alone or in combination:  (1) the patentee’s marking of products with its patent numbers; (2) a prior suit by the patentee “concerning different products covered by unrelated patents”, even where the declaratory judgment plaintiff was a defendant in the prior suit; and (3) the patentee’s refusal to grant the declaratory judgment plaintiff a covenant not to sue.  (Prasco).
  • The following facts, alone or in combination:  (1) the patentee’s “history of litigation against others, and general propensity to enforce its legal rights”, without more;  (2) the declaratory judgment plaintiff’s successful solicitation from the patentee’s employees of predictions that the patent owner “will act aggressively” upon the market introduction of potentially infringing products, where those employees lacked authority to decide whether the patentee would or would not sue; and (3) the patentee’s knowledge of the declaratory judgment plaintiff’s representation to a third party (the Food & Drug Administration, in this case) about the relevant characteristics of its (potentially infringing) product.  Innovative Therapies, Inc. v. Kinetic Concepts, Inc. (Fed. Cir. 2010).
  • The declaratory judgment plaintiff’s general plan sometime in next several years to initiate potentially infringing activities.  Benitec Australia, Ltd. v. Nucleonics, Inc. (Fed. Cir. 2007).

What Won’t Suffice to Divest the Courts of Declaratory Judgment Jurisdiction

  • A statement by the patentee that it “‘has absolutely no plan whatsoever to sue’” the declaratory judgment plaintiff, where the patentee “approached [the declaratory judgment plaintiff,] made a studied and considered determination of infringement [,] communicated that determination [to the declaratory judgment plaintiff], and then [said] that it does not intend to sue . . ..”  (SanDisk).
  • A covenant not to enforce the patent-in-suit given by the patentee on the eve of the trial of the unenforceability and invalidity issues “based upon any activities and/or products made, used, or sold on or before the dismissal of [the] action”, because the covenant did “not extend to future sales of products of the same structure” as the defendant was selling before it suspended sales after being sued for infringement.  Revolution Eyewear, Inc. v. Aspex Eyewear, Inc. (Fed. Cir. 2009).
  • The patentee’s continuing willingness “to negotiate a ‘business resolution’ to the dispute.”  Sony Electronics, Inc. v. Guardian Media Technologies, Ltd. (Fed. Cir. 2007).  To the contrary:  when the requisite controversy exists, the licensing target has the right “to terminate [negotiations] when it determine[s] that further negotiations would be unproductive.”  Id.
  • The patentee’s failure in correspondence to the potential licensee to “identify specific claims, present claim charts, and explicitly allege infringement.”  (Hewlett-Packard).
  • That before contacting the potential licensee to request an “opportunity to discuss” the patent in question, the patentee had not “conducted an adequate investigation or whether it subjectively believed [the potential licensee] was infringing.” (Hewlett-Packard).

What Hasn’t Changed

“There is . . . no facile, all-purpose standard to police the line between declaratory judgment actions which satisfy the case or controversy requirement and those that do not.”  Cat Tech LLC v. TubeMaster, Inc. (Fed. Cir. 2008).  “The specific facts of each case must be considered, in deciding whether a declaratory action is warranted.” (Innovative).  MedImmune also didn’t alter several other fundamental tenets of declaratory judgment jurisdiction:

  • “[A]cts after the filing of [a] complaint [cannot] establish that an actual controversy existed at that earlier time.”  (Innovative).
  • “[W]hether there has been meaningful preparation to conduct potentially infringing activity remains an important element in the totality of circumstances which must be considered in determining whether a declaratory judgment is appropriate.” (Cat Tech).
  • The district court’s discretion to decline to exercise jurisdiction “is not without bounds.”  (Sony).


MedImmune has altered the way in which the Declaratory Judgment Act applies to patent law cases, requiring that legal interests be evaluated in patent cases under the general criteria of the Act.  [The Federal Circuit’s] jurisprudence must consequently also evolve . . ..”  (Hewlett-Packard).

Read  In the Wake of MedImmune- What We Have Learned for a longer version of  this article– with full citation and additional content.

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