In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s finding that two Orange Book-listed patents for Cephalon’s FENTORA® product were invalid, but affirmed the district court’s finding that Watson’s ANDA product would not infringe the patents. The Federal Circuit decision reviews the “undue experimentation” standard for lack of enablement, and underscores the importance of aligning evidence of infringement with the governing claim construction.Continue reading this entry
In AstraZeneca Pharmaceuticals LP v. Apotex Corp., the Federal Circuit held that the district court had jurisdiction over AstraZeneca’s ANDA complaint, but also held that the complaint should be dismissed for failing to state a viable claim for relief because the ANDAs included Section viii statements that carved out the methods claimed in the patents at issue. Continue reading this entry
While most provisions of the Leahy-Smith America Invents Act do not take effect until September 16, 2012 or March 16, 2013, several litigation-related provisions took effect immediately, on September 16, 2011. Among those is the newly expanded prior commercial use defense, which includes terms that are directly relevant to the pharmaceutical industry.
In Retractable Technologies, Inc. v. Becton, Dickinson and Company, the Federal Circuit affirmed-in-part and reversed-in-part the district court’s finding that two of Becton, Dickinson’s retractable syringes infringed Retractable’s patents. The Federal Circuit found that one, but not both, of Becton, Dickinson’s syringes infringed the patents. For many, the conflicting approaches to claim construction espoused by Judge Lourie and Judge Plager on one hand and Judge Rader on the other will be more interesting than the conflict between Retractable and Becton, Dickinson.
In Duramed Pharmaceuticals, Inc. v. Paddock Laboratories, Inc., the Federal Circuit rejected Duramed’s arguments that prosecution history estoppel did not bar application of the doctrine of equivalents under Festo because the equivalent at issue was not foreseeable. In so doing, the Court illuminated the rather narrow applicability of the “unforeseeable” route to rebutting a presumption of prosecution history estoppel.
The difference between patentability and freedom to operate took the forefront in Siemens Medical Solutions USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc. The Federal Circuit upheld the district court’s denial of JMOL after a jury found that Saint-Gobain was liable for infringing Siemens’ patent under the doctrine of equivalents, even though Saint-Gobain’s product was covered by a separate (and later) patent.
In Akamai Technologies, Inc. v. Limelight Networks, Inc., the Federal Circuit clarified the requirements for establishing joint infringement—a theory of direct infringement that may be used when a single party does not perform all of the steps of a method claim. The decision provides a good reminder to consider "who" is likely to perform each step of a method claim. This analysis can be particularly important in the context of diagnostic and personalized medicine methods.
The Patents At Issue
The patent involved in the joint infringement issue (U.S. 6,108,703) relates to web page content delivery services, whereby a host stores and serves embedded objects displayed on a content provider’s web site. Claims 19 and 34 were the independent claims at issue:
19. A content delivery service, comprising:
replicating a set of page objects across a wide area network of content servers managed by a domain other than a content provider domain;
for a given page normally served from the content provider domain, tagging the embedded objects of the page so that requests for the page objects resolve to the domain instead of the content provider domain;
responsive to a request for the given page received at the content provider domain, serving the given page from the content provider domain; and
serving at least one embedded object of the given page from a given content server in the domain instead of from the content provider domain.
34. A content delivery method, comprising:
distributing a set of page objects across a network of content servers managed by a domain other than a content provider domain, wherein the network of content servers are organized into a set of regions;
for a given page normally served from the content provider domain, tagging at least some of the embedded objects of the page so that requests for the objects resolve to the domain instead of the content provider domain;
in response to a client request for an embedded object of the page:
resolving the client request as a function of a location of the client machine making the request and current Internet traffic conditions to identify a given region; and
returning to the client an IP address of a given one of the content servers within the given region that is likely to host the embedded object and that is not overloaded.
As reflected in the highlighted steps, the embedded objects must be "tagged" in order to be served from the host in accordance with the claimed methods.
Akamai’s Theory of Joint Infringement
Akamai relied on the theory of joint infringement to establish direct infringement by Limelight, because Limelight did not itself tag embedded objects. Rather, Limelight’s customers were contractually required to select and tag the embedded objects that Limelight would host and serve. Limelight also provided its customers with detailed tagging instructions.
Akamai relied on these contractual terms and cited the Federal Circuit’s analysis in BMC Resources, Inc. v. Paymentech, L.P. (Fed. Cir. 2007), where the court stated that joint infringement can be established when one party "control[s] or direct[s]" the activities of another.
The jury reached a verdict of infringement, after which Limelight moved for judgment as a matter of law (JMOL) of non-infringement.
While the case was pending at the district court, the Federal Circuit issued its decision in Muniauction, Inc. v, Thomson Corp. (Fed. Cir. 2008), which held that "an accused infringer’s control over its customers’ access to an online system, coupled with instructions on how to use that system, was not enough to establish direct infringement."
The district court found "’no material difference between Limelight’s interaction with its customers and that of Thomson in Muniauction," and so granted JMOL of non-infringement.
The Federal Circuit’s Statement of Joint Infringement Law
The Federal Circuit began its analysis by emphasizing that "direct infringement requires a single party to perform every step of a claimed method." The court explained that the "direct or control" language in BMC stemmed from legal principles of vicarious liability and the notion that a party should not be able to avoid infringement liability "simply by contracting out steps of a patented process to another entity." The court explained that the relationship between the parties must be "such that acts of one may be attributed to the other."
This court therefore holds as a matter of Federal Circuit law that there can only be joint infringement when there is an agency relationship between the parties who perform the method steps or when one party is contractually obligated to the other to perform the steps.
Applying this test to the case before it, the Federal Circuit found no joint infringement:
- The Federal Circuit found that the tagging instructions that Limelight provided to its customers did not create an agency relationship. In particular, the court found no evidence that Limelight had any right to control its customer’s actions.
- The Federal Circuit found that Limelight’s customer contracts did "not obligate [its] customers to perform any of the method steps. It merely explains that the customer will have to perform the steps if it decides to take advantage of Limelight’s service."
The court concluded that Limelight’s customers "acted principally for their own benefit and under their own control" and so their actions could not be attributed to Limelight.
A Problem of Claim Drafting?
The Federal Circuit decision includes a discussion that raises red flags for patent practitioners:
While acknowledging the difficulty of proving infringement of claims that must be infringed by multiple parties, this court has noted that such concerns “can usually be offset by proper claim drafting. A patentee can usually structure a claim to capture infringement by a single party.”
The court noted:
Here, the asserted claims were drafted so as to require the activities of both Limelight and its customers for a finding of infringement. Thus, Akamai put itself in a position of having to show that the allegedly infringing activities of Limelight’s customers were attributable to Limelight.
Of course, we do not know why these claims were drafted this way, and it can be too easy to second-guess any claiming strategy with 20/20 hindsight in view of an unfvorable court decision!
A Problem Of Infringement Theory?
The Federal Circuit decision notes that Akamai "waived any assertion of indirect infringement before trial." Thus we do not know whether Akamai might have been successful with a claim of contributory infringement or induced infringement. On the other hand, even contributory infringement and induced infringement usually require that someone was a direct infringer.
Questions for Diagnostic & Personalized Medicine Method Claims
Akamai brings to mind a discussion in the Federal Circuit’s recent decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services. Prometheus’s claims were directed to
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
(Not all claims recited the "administering step.)
The Federal Circuit acknowledged that "the final ‘wherein’ clauses are mental steps and thus not patent-eligible per se," but reasoned that "when viewed in the proper context, the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus’s claimed methods as a whole." The court continued:
No claim in the Prometheus patents claims only mental steps. Therefore, contrary to Mayo’s assertions, a physician who only evaluates the result of the claimed methods, without carrying out the administering and/or determining steps that are present in all the claims, cannot infringe any claim that requires such steps.
Viewing this passage through the lens of Akamai raises several questions:
- Who would perform each of the method steps of Prometheus’s claims?
- If the patient self-administers the drug, does he or she do so as an agent of the doctor?
- If a lab determines the metabolite level, does it do so as an agent of the doctor, or under a contractual obligation to do so?
- If a doctor orders a test from a lab to determine the level of metabolite, does the doctor do so as an agent of the patient, and the lab do so as an agent of the doctor or under a contractual obligation to do so?
- Do the requirements for induced infringement or contributory infringement need to be satisfied to find a lab (or test kit manufacturer) liable for infringement (as Mayo was)?
- Would you chose the doctor or the patient as the underlying direct infringer?
This week brings two en banc hearings at the Federal Circuit. Inequitable conduct issues will be addressed in Therasense, Inc. v. Becton, Dickinson & Co., and contempt proceedings issues will be addressed in Tivo Inc. v. Echostar Corp. Both hearings are scheduled for Tuesday, November 9, at 10:00 am, in courtroom 201.
Therasense, Inc. v. Becton, Dickinson & Co.
The en banc order in Therasense asked the parties to address the following questions:
- Should the materiality-intent-balancing framework for inequitable conduct be modified or replaced?
- If so, how? In particular, should the standard be tied directly to fraud or unclean hands? If so, what is the appropriate standard for fraud or unclean hands?
- What is the proper standard for materiality? What role should the United States Patent and Trademark Office’s rules play in defining materiality? Should a finding of materiality require that but for the alleged misconduct, one or more claims would not have issued?
- Under what circumstances is it proper to infer intent from materiality?
- Should the balancing inquiry (balancing materiality and intent) be abandoned?
- Whether the standards for materiality and intent in other federal agency contexts or at common law shed light on the appropriate standards to be applied in the patent context.
Tivo Inc. v. Echostar Corp.
The en banc order in Tivo asked the parties to address the following questions:
- Following a finding of infringement by an accused device at trial, under what circumstances is it proper for a district court to determine infringement by a newly accused device through contempt proceedings rather than through new infringement proceedings? What burden of proof is required to establish that a contempt proceeding is proper?
- How does “fair ground of doubt as to the wrongfulness of the defendant’s conduct” compare with the “more than colorable differences” or “substantial open issues of infringement” tests in evaluating the newly accused device against the adjudged infringing device?
- Where a contempt proceeding is proper, (1) what burden of proof is on the patentee to show that the newly accused device infringes and (2) what weight should be given to the infringer’s efforts to design around the patent and its reasonable and good faith belief of noninfringement by the new device, for a finding of contempt?
- Is it proper for a district court to hold an enjoined party in contempt where there is a substantial question as to whether the injunction is ambiguous in scope?
Placing Bets Around the Table
I expect the courtroom to be crowded on Tuesday. Interested parties, practitioners, students and reporters will try to figure out which way the judges are leaning from the questions they ask or don’t ask, and from the lines of argument they follow or cut short. While some judges may show their hand during oral hearing, some are inclined to bluff with their questions, testing the limits of each party’s arguments. Tuesday should be an interesting morning at the Federal Circuit, but we won’t know how the court will answer these questions for a few more months, when the written opinions are released.
In Solvay S.A. v. Honeywell International, Inc., the Federal Circuit discussed the contours of 35 USC § 102(g)(2). The court found that Honeywell’s prior (secret) use of the process claimed in Solvay’s patent did not qualify as an invalidating prior invention because Honeywell was not an original inventor of the subject matter at issue. This case underscores some of the quirks of the United States "first to invent system," and highlights the dangers of relying on (secret) work developed outside the United States when developing your own technology.
Can the doctrine of equivalents be invoked to establish infringement of a claim that recites a numerical value?
Yes, according to the Federal Circuit’s decision in Adams Respiratory Therapeutics, Inc. v. Perrigo Co.
Can the concept of significant digits be used to establish infringement?
Although the court does not say so directly, its opinion indicates that the answer to this question also is "yes."