Inequitable Conduct

THERASENSE, INC. V. BECTON, DICKINSON AND CO. (a new stndard)

• "To prevail on the defense of inequitable conduct, the accused infringer must prove that the applicant misrepresented or omitted material information with the specific intent to deceive the PTO. The accused infringer must prove both elements—intent and materiality—by clear and convincing evidence. If the accused infringer meets its burden, then the district court must weigh the equities to determine whether the applicant’s conduct before the PTO warrants rendering the entire patent unenforceable."



• "While honesty at the PTO is essential, low standards for intent and materiality have inadvertently led to many unintended consequences, among them, increased adjudication cost and complexity, reduced likelihood of settle-ment, burdened courts, strained PTO resources, increased PTO backlog, and impaired patent quality. This court now tightens the standards for finding both intent and materiality in order to redirect a doctrine that has been overused to the detriment of the public."
  



• "To prevail on a claim of inequitable conduct, the accused infringer must prove that the patentee acted with the specific intent to deceive the PTO."
  



• "In other words, the accused infringer must prove by clear and convincing evidence that the applicant knew of the reference, knew that it was material, and made a deliberate decision to withhold it."
  



• "Intent and materiality are separate requirements. A district court should not use a 'sliding scale,' where a weak showing of intent may be found sufficient based on a strong showing of materiality, and vice versa. Moreover, a district court may not infer intent solely from materiality. Instead, a court must weigh the evidence of intent to deceive independent of its analysis of materiality. Proving that the applicant knew of a reference, should have known of its materiality, and decided not to submit it to the PTO does not prove specific intent to deceive."
  



• "Because direct evidence of deceptive intent is rare, a district court may infer intent from indirect and circumstantial evidence. However, to meet the clear and convincing evidence standard, the specific intent to deceive must be the single most reasonable inference able to be drawn from the evidence. Indeed, the evidence must be sufficient to require a finding of deceitful intent in the light of all the circumstances. Hence, when there are multiple reasonable inferences that may be drawn, intent to deceive cannot be found."
  



• "The absence of a good faith explanation for withholding a material reference does not, by itself, prove intent to deceive."
  



• "This court holds that, as a general matter, the materiality required to establish inequitable conduct is but-for materiality. When an applicant fails to disclose prior art to the PTO, that prior art is but-for material if the PTO would not have allowed a claim had it been aware of the undisclosed prior art. Hence, in assessing the materiality of a withheld reference, the court must determine whether the PTO would have allowed the claim if it had been aware of the undisclosed reference."
  



• "Often the patentability of a claim will be congruent with the validity determination—if a claim is properly invalidated in district court based on the deliberately withheld reference, then that reference is necessarily material because a finding of invalidity in a district court requires clear and convincing evidence, a higher evidentiary burden than that used in prosecution at the PTO. However, even if a district court does not invalidate a claim based on a deliberately withheld reference, the reference may be material if it would have blocked patent issuance under the PTO’s different evidentiary standards."

AMERICAN CALCAR, INC. V. AMERICAN HONDA MOTOR CO., INC.

• Intent and materiality are separate requirements. A district court should not use a “sliding scale,” where a weak showing of intent may be found sufficient based on a strong showing of materiality, or vice versa.


• To prove inequitable con-duct, the accused infringer must provide evidence that the applicant (1) misrepresented or omitted material information, and (2) did so with specific intent to deceive the PTO. Under Therasense, the materiality required to establish inequitable conduct is, in general, but-for materiality. When an applicant fails to disclose prior art to the PTO, that prior art is but-for material if the PTO would not have allowed a claim had it been aware of the undisclosed prior art.


• Inequitable conduct is equitable in nature, with no right to a jury, and the trial court has the obligation to resolve the underlying facts of materiality and intent.
  

OPTIUM CORP. V. EMCORE CORP.

• “Inequitable conduct resides in failure to disclose material information, or submission of false material information, with an intent to mislead or deceive the examiner, and those two elements, materiality and intent, must be proven by clear and convincing evidence.”



• “When both materiality and intent have been established, the court must balance the equities and determine whether the applicant’s conduct in prosecuting the patent application was egregious enough to warrant holding the entire patent unenforceable.”



• “Despite some divergence, the great weight of Federal Circuit authority has followed Kingsdown Medical Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876–77 (Fed. Cir. 1988) (en banc), and applied the rule that the ‘intent’ element of inequitable conduct is not simply intent to take the action or omission complained of, but intent to deceive or mislead the patent examiner into granting the patent.”

AVID IDENTIFICATION SYS. V. CRYSTAL IMPORT CORP.

• “What constitutes substantive involvement in the preparation or prosecution of the application, the issue on which this case turns, has not previously been addressed by this court. We read ‘substantively involved’ to mean that the involvement relates to the content of the application or decisions related thereto, and that the involvement is not wholly administrative or secretarial in nature.”
  



• “Once a court finds that the individual had a duty of candor, the court must proceed to the dual prongs of materiality and deceptive intent, to determine whether that duty was violated.”
  



• “If an individual is unable to assess the materiality of the information at issue, then he would lack the deceptive intent required to find that he committed inequitable conduct.”

ASPEX EYEWEAR INC. V. CLARITI EYEWEAR, INC.

• “Intent to deceive cannot be inferred from even a high degree of materiality, but must be separately proved by clear and convincing evidence.”

Enablement

ALZA CORP. V. ANDRAX PHARMACEUTICALS, LLC.

• “To satisfy the plain language of § 112, ¶ 1, [a patentee is] required to provide an adequate enabling disclosure in the specification; it cannot simply rely on the knowledge of a person of ordinary skill to serve as a substitute for the missing information in the specification.”
• A court may consider the following factors “when determining if a disclosure requires undue experimentation: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
• See also In re Wands, 858 F.2d 731 (Fed. Cir. 1988).

Magsil Corp. v. Hitachi

• The open claim language chosen by the inventors does not grant them any forgiveness on the scope of required enablement.

Rule Against Recapture

MBO LABORATORIES V. BECTON, DICKINSON & CO.

• “This court bars recapture because a patentee is only entitled to a reissue patent for broader claims when the patentee claimed less than he had a right to claim in the patent through error without any deceptive intent, not through deliberate amendments or arguments designed to convince an examiner to allow the claims.”


• “[W]e seek to clarify that a patentee may violate the rule against recapture by claiming subject matter in a reissue patent that the patentee surrendered while prosecuting a related patent application.”


• “When a reissue patent contains the unmodified original patent claims and the reissue claims, a court can only invalidate the reissue claims under the rule against recapture.”

AIA ENGINEERING LTD. V. MAGOTTEAUX INTERNATIONAL S/A

• Notwithstanding the limited ability to enlarge claim scope through reissue, the recapture rule prevents a patentee from regaining subject matter deliberately surrendered during the prosecution of the original patent.
  


• A three-step test guides the analysis:(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims; (2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and (3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule.

Joint Infringement

AKAMAI TECHNOLOGIES, INC. V. LIMELIGHT NETWORKS, INC.

• Cases that had been considered under the joint infringement/divided infringement/single-entity rule will now be decided under the law of induced infringement.
• "[W]e reconsider and overrule the 2007 decision of this court in which we held that in order for a party to be liable for induced infringement, some other single entity must be liable for direct infringement.  BMC Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007).  To be clear, we hold that all the steps of a claimed method must be performed in order to find induced infringement, but that it is not necessary to prove that all the steps were committed by a single entity."
• "It would be a bizarre result to hold someone liable for inducing another to perform all of the steps of a method claim but to hold harmless one who goes further by actually performing some of the steps himself."
• "Unlike direct infringement, induced infringement is not a strict liability tort; it requires that the accused inducer act with knowledge that the induced acts constitute patent infringement.  See Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060, 2068 (2011)."

Joint Inventorship

VANDERBILT UNIV. V. ICOS CORP. [REVISED]

• "The interplay between conception and collaboration requires that each co-inventor engage with the other co-inventors to contribute to a joint conception."
• "A primary focus of section 116 has thus always been on collaboration and joint behavior."
• "A person must contribute to the conception of the claimed invention to qualify as a joint inventor."
• "Our precedent has long required proof of misjoinder or nonjoinder of co-inventors by clear and convincing evidence."

Declaratory Judgment Jurisdiction

ARRIS GROUP, INC. V. BRITISH TELECOMMUNICATIONS PLC

• An “adverse legal interest” requires a dispute as to a legal right—for example, an underlying legal cause of action that the declaratory defendant could have brought or threatened to bring. In the absence of a controversy as to a legal right, a mere adverse economic interest is insufficient to create declaratory judgment jurisdiction.



• [E]conomic injury alone is insufficient to create standing….



• We have recognized that, where a patent holder accuses customers of direct infringement based on the sale or use of a supplier’s equipment, the supplier has standing to commence a declaratory judgment action if (a) the supplier is obligated to indemnify its customers from infringement liability, or (b) there is a controversy between the patentee and the supplier as to the supplier’s liability for induced or contributory infringement based on the alleged acts of direct infringement by its customers.



• When the holder of a patent with system claims accuses a customer of direct infringement based on the customer’s making, using, or selling of an allegedly infringing system in which a supplier’s product functions as a material component, there may be an implicit assertion that the supplier has indirectly infringed the patent.6 Likewise, when the holder of a patent with method claims accuses the supplier’s customers of direct infringement based on their use of the supplier’s product in the performance of the claimed method, an implicit assertion of indirect infringement by a supplier may arise.



• While direct communication between a patentee and a declaratory plaintiff is not necessary to confer standing, the nature and extent of any communications between the declaratory plaintiff and the patentee are certainly relevant factors to consider when evaluating whether there is an Article III case or controversy between the parties.[W]e have held that a patentee’s grant of a covenant not to sue a supplier for infringement can eliminate the supplier’s standing to bring a declaratory judgment action….

INNOVATIVE THERAPIES, INC. V. KINETIC CONCEPTS, LTD.

• "The district court found that these informal conversations did not constitute a threat of suit for patent infringement against a device that had not been seen and evaluated for infringement of any patent. We agree that the indirection reflected in these conversations did not produce a controversy of such 'immediacy and reality' as to require the district court to accept declaratory jurisdiction.



• "MedImmune did not hold that a patent can always be challenged whenever it appears to pose a risk of infringement."

ABB INC. V. COOPER IND., LLC.

• “[A] specific threat of infringement litigation by the patentee is not required to establish jurisdiction, and a declaratory judgment action cannot be defeated simply by the stratagem of a correspondence that avoids magic words such as ‘litigation’ or ‘infringement.’”
  



• “In determining whether there is federal subject matter jurisdiction for declaratory judgment actions: ‘[I]t is the character of the threatened action, and not of the defense, which will determine whether there is federal-question jurisdiction in the District Court.’”
  



• “Because the actual controversy in this case is over infringement, the declaratory defendant’s hypothetical coercive complaint here is a patent infringement suit. It is well-established that a claim for infringement arises under federal law. Even if the only issue in that suit would be a state law defense, subject matter jurisdiction does not depend on whether a federal law issue will be the crux of the case but instead whether federal patent law creates the cause of action.”



• “The general rule, articulated repeatedly by the Supreme Court, is that declaratory judgment jurisdiction exists where the defendant’s coercive action arises under federal law. … We see no reason to depart from that general principle where the defense is non-federal in nature.”

CREATIVE COMPOUNDs, LLC. .V STARMARK LABORATORIES

• "The concept of adverse legal interests requires that there be a dispute as to a legal right, such as an underlying legal cause of action that the declaratory defendant could have brought or threatened to bring, if not for the fact that the declaratory plaintiff had preempted it."

Preamble

AMERICAN MEDICAL SYSTEMS, INC. V. BIOLITEC, INC.

• "[T]here is no simple test for determining when a preamble limits claim scope."

HEARING COMPONENTS, INC. V. SHURE, INC.

• "A preamble to a claim may or may not be limiting, depending on the circumstances. In considering whether a preamble limits a claim, the preamble is analyzed to ascertain whether it states a necessary and defining aspect of the invention, or is simply an introduction to the general field of the claim. Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366, 1375 (Fed. Cir. 2008) (quotation marks omitted). A term is often limiting when the patentee has relied on it during prosecution to distinguish prior art, as such reliance demonstrates that the feature disclosed in the preamble is necessary to the patentability of the claim."

Indefiniteness

WELLMAN, INC. V. EASTMAN CHEMICAL CO.

• "Claims need not be plain on their face in order to avoid condemnation for indefiniteness; rather, claims must only be amenable to construction."
  


• "Claim terms must provide a discernible boundary between what is claimed and what is not claimed…."
  


• "However, an inventor need not explain every detail because a patent is read by those of skill in the art. … Well known industry standards need not be repeated in a patent."




• "This court has repeatedly stated that a patent applicant need not include in the specification that which is already known to and available to a person of ordinary skill in the art."

HAEMONETICS, CORP. V. BAXTER HEALTHCARE CORP.

• “[B]ecause claim construction frequently poses difficult questions over which reasonable minds may disagree, proof of indefiniteness must meet ‘an exacting standard.’ Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1249 (Fed. Cir. 2008). Only claims ‘not amenable to construction’ or ‘insolubly ambiguous’ are indefinite. Id. at 1250 (quoting Datamize, 417 F.3d at 1347). A claim is not indefinite merely because parties disagree concerning its construction. An accused infringer must thus demonstrate by clear and convincing evidence that one of ordinary skill in the relevant art could not discern the boundaries of the claim based on the claim language, the specification, the prosecution history, and the knowledge in the relevant art.”

HEARING COMPONENTS, INC. V. SHURE, INC.

• "Not all terms of degree are indefinite. However, the specification must provide some standard for measuring that degree."


• "Although 'readily'does not refer to a mathematical measure of degree, in Datamize [417 F.3d 1342, 1351 (Fed. Cir. 2005)], we addressed the 'purely subjective' claim term 'aesthetically pleasing' and stated that, as with terms of degree, “a court must determine whether the patent’s specification supplies some standard for measuring the scope of the phrase."

POWER-ONE, INC. V. ARTESYN TECHNOLOGIES, INC.

• "Claims using relative terms such as ‘near’ or ‘adapted to’ are insolubly ambiguous only if they provide no guidance to those skilled in the art as to the scope of that requirement."


• "Here, a person of ordinary skill in the field would understand the meaning of ‘near’ and ‘adapted to’ because the environment dictates the necessary preciseness of the terms."


• "The fact that the claim is not defined using a precise numerical measurement does not render it incapable of providing meaningful guidance to the jury because the claim language, when taken in context of the entire patent, provides a sufficiently reasonable meaning to one skilled in the art of distributed power systems."

ENZO BIOCHEM, INC. V. APPLERA CORP.

• “The claims are not indefinite even if some experimentation is required to determine the exact level of detection achieved by the applicants using their exemplary linkage groups.”


• “As a preliminary matter, we observe that a claim cannot be both indefinite and anticipated. … If a claim is indefinite, the claim, by definition, cannot be construed. Without a discernable claim construction, an anticipation analysis cannot be performed.”