An International Guide to
Patent Case Management for Judges

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10.15 Appendix

Table 10.A1 Comparison of U.S. district court patent adjudication, USITC patent investigations and Patent Trial and Appeal Board inter partes review
Characteristic U.S. district courts USITC patent investigation PTAB IPR proceedings
General or specialized court?
  • General jurisdiction courts.
  • Specialized court, presiding over alleged “unfair trade practices,” which includes importation of products that infringe U.S. intellectual property rights.
  • Patent investigations represent approximately 85% of the USITC docket.
  • Specialized court, presiding over disputes on validity (35 U.S.C. §§ 102, 103 grounds) of issued patents.
First-instance decision-maker
  • District court judges rarely have science or technology backgrounds.
  • Few district judges have significant experience with patent cases, although most cases are filed in a handful of district courts (Delaware, Eastern and Western Texas, Northern California), where those judges have become experienced in patent matters.
  • USITC ALJs do not generally have science or technology backgrounds but do have specialized experience in unfair trade practices and patent investigations.
  • PTAB APJs have science or technology backgrounds and specialize in patent review.
Decision-maker: judge or jury?
  • Jury trial if requested by either party. Jury members do not generally have science or technology backgrounds or patent expertise.
  • Pharmaceutical patent cases are typically heard by a judge, not a jury.
  • ALJ; no jury.
  • Three-APJ panel; no jury.
Initiation of action
  • Filing of a complaint.
  • Filing of a complaint.
  • After a complaint is filed, the USITC determines whether to institute an investigation within 30 days.
  • Filing of a petition by a patent challenger.
  • Parties must seek a proceeding within 12 months of being served with a complaint alleging infringement of the patent and are barred from seeking or maintaining an IPR if they file an action for a declaratory judgment that the patent is invalid.
Threshold for initiating proceeding
  • Low threshold (plausible claims of infringement and jurisdictional requirements of ownership).2
  • Complaint must be sufficient; Office of Unfair Imports reviews the matter and advises the USITC as to its sufficiency with regard to Section 337’s procedural requirements and substantive elements: (1) sale for importation, importation or sale after importation of goods; (2) unfair acts or methods of competition, such as infringement of a U.S. patent; (3) presence of a domestic industry; and (4) proof of substantial or threatened injury in the case of non-statutory intellectual property rights complaints.
  • “Reasonable likelihood of success” based on the information presented in the petition and the patent owner’s response to the petition.
Time frame for proceeding
  • No designated time frame (varies significantly by district).
  • Often takes 3 years or more to reach trial.
  • 16 months.
  • 12–18 months.
Parties

  • In non-pharmaceutical cases:

    • patent owner (usually plaintiff)
    • alleged infringer (usually defendant, but can be plaintiff in a declaratory relief action).

  • In pharmaceutical cases:

    • Hatch-Waxman:

      • NDA holder (typically patent owner) usually plaintiff (but can be defendant in a declaratory relief action)
      • generic company (ANDA holder) typically defendant.

    • BPCIA:

      • BLA holder (typically patent owner) usually plaintiff (but can be defendant in a declaratory relief action)
      • aBLA holder or biosimilar manufacturer usually defendant.
  • Complainant (patent owner seeking to protect domestic industry from unfair competition).
  • Respondent (importing allegedly infringing product).
  • Office of Unfair Imports and Investigations (USITC investigatory body).
  • Petitioner (patent challenger).
  • Respondent (patent owner).
Intervention rules
  • FRCP 24.
  • Consolidated in the same proceeding as the complaint.
  • Governed by a standard similar to FRCP 24.
  • Joinder of additional parties possible.
  • PTAB will often deny “serial” petitions on the same patent, even if petitioners are different.
  • “Parallel” petitions on the same patent are not favored by the PTAB.
Agency input
  • None.
  • Section 337 requires the USITC to consult with the U.S. Department of Justice, Federal Trade Commission, and other agencies it deems appropriate during the course of the investigation.
  • IPRs are administrative adjudications governed by the APA that occur within the USPTO.
Pleading standard
  • Notice pleading of a plausible claim of infringement.3
  • Fact pleading
  • Must present infringement contentions (at least one patent claim and how it is infringed) and domestic industry contention.
  • Higher than notice pleading standard in district court.
  • The PTAB has discretion in deciding whether to institute an IPR and strictly limits the petitioner to the patentability challenge grounds identified in the petition and the specific bases supporting those grounds.
  • Petition should identify the real party in interest and include all evidence supporting the patentability challenges, where each claim element is found in the prior art, how the PTAB should construe each disputed claim, and the specific relief requested.
  • Petitioner must file a separate petition for each patent challenged.
Filing fees
  • As of 2020, USD 402 to file a civil action in district court.
  • No fee.
  • Request stage: USD 19,000 (basic fee) plus USD 375 (for each claim over 20).
  • Post-institution Stage: USD 22,500 (basic fee) plus USD 750 (for each claim over 20).
Counterclaims
  • Consolidated in the same proceeding as the complaint.
  • In a declaratory judgment proceeding, the patentee (defendant) will typically file an infringement counterclaim.
  • Permitted, but must request their immediate removal to district court.
  • Pending district court actions on common issues at the USITC can be stayed at the respondent’s option; counterclaims are not stayed (although they are subject to the district court’s case management determinations).
  • n.a.
Subject matter jurisdiction
  • Infringement of a U.S. intellectual property right.
  • Importation of products in violation of a U.S. intellectual property right where there is a domestic industry practicing the infringed intellectual property right.
  • Validity of issued patents on 35 U.S.C. § 102 (anticipation) and § 103 (obviousness) grounds.
Personal jurisdiction
  • Whether the applicable state long-arm statute is satisfied and whether the exercise of personal jurisdiction is consistent with the Due Process Clause of the Constitution. Patent cases typically do not raise substantial issues of personal jurisdiction since the defendant is alleged to have sold or offered for sale infringing products within the district, which usually provides specific personal jurisdiction over the infringement dispute.
  • Not applicable; based on in rem jurisdiction.
Subpoena power
  • Nationwide subpoena power.4
  • Nationwide subpoena power.
  • The PTAB does not issue subpoenas directly.
  • 35 U.S.C. § 24 authorizes a party to seek a subpoena (by motion) from the district court wherein testimony would be taken, for a contested matter before the USPTO.
In rem jurisdiction
  • Not available.
  • Available.
  • Available: “IPR is similarly an in rem proceeding – a proceeding to reevaluate the validity of an issued patent.”5
Venue
  • “[W]here the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.”6
  • Subject to forum non conveniens doctrine that allows courts to transfer a case to a more convenient forum.
  • The USITC in Washington, D.C.
  • The USPTO in Alexandria, VA (or USPTO regional offices).
Effects on parallel proceedings

  • Other district court proceedings:

    • generally first-filed district court case takes priority over later-filed cases, but courts have some discretion.

  • USITC investigation or decision:

    • USITC respondents are entitled to a motion for stay of district court proceedings on the same patents or issues as a matter of right.7
    • A USITC decision does not have res judicata effect on district court proceedings, but decisions can be persuasive.

  • PTAB institution or decision:

    • Parties frequently seek stays of district court actions while PTAB proceedings are pending.
    • Challenger is estopped from raising any ground in district court that was already raised or that reasonably could have been raised at the PTAB.
    • PTAB decision does not have res judicata effect on district court proceedings unless affirmed by the Federal Circuit.

  • PTAB institution or decision:

    • Challenger is estopped from raising any ground in USITC that was already raised or that reasonably could have been raised at the PTAB.

  • USITC investigation or decision:

    • The PTAB will not discretionarily deny petitions for IPR based solely on a parallel USITC proceeding.8
    • A USITC decision does not have res judicata effect on PTAB proceedings, but decisions can be persuasive.

  • Previous PTAB decision:

    • Challenger is estopped from raising any ground in district court that was already raised or that reasonably could have been raised at the PTAB in subsequent USPTO proceedings.
Procedural rules
  • FRCP.
  • FRE.
  • Augmented in many of the most patent-intensive districts by “patent local rules” and standing orders.
  • APA: formal adjudication.
  • USITC Rules of Practice and Procedure (which parallel the FRCP and FRE).
  • ALJ-specific “ground rules.”
  • USPTO regulations.9
  • FRE (except as specified in USPTO regulations).
Discovery
  • Any nonprivileged information relevant to any party’s claim or defense and proportional to the needs of the case.
  • All information reasonably likely to lead to discovery of admissible evidence within the allowable period (usually limited to 6 months).
  • Responses to interrogatories and document requests typically limited to 10 days after service.
  • Nationwide subpoena power available against foreign respondents; sanctions available against foreign respondents who fail to comply with discovery.
  • Parties may depose witnesses submitting affidavits or declarations and seek such discovery as the USPTO determines is otherwise necessary in the interests of justice.
Preliminary relief
  • Issuance of a preliminary injunction is based upon a balancing of the following equitable factors: (1) a reasonable likelihood of success on the merits, (2) irreparable harm if temporary relief is not granted, (3) a balance of hardships tipping in its favor, and (4) the temporary relief’s favorable impact on the public interest.
  • Two-part test in determining whether to issue a TEO: (1) whether there is “reason to believe” that there is a violation of Section 337, and (2) whether issuance of a TEO serves the public interest.
  • The USITC also applies the same standard as in a preliminary injunction.
  • No preliminary relief, but the decision process is completed within 12 months.
Claim construction
  • Typically handled during the pre-trial phase.
  • Interpretation done by the trial judge applying the Phillips standard.
  • Practices vary across cases and ALJs, but are increasingly done prior to trial.
  • Employs the Phillips standard.
  • Interpretation done by the PTAB panel applying the Phillips standard.
Summary adjudication
  • FRCP 56: no genuine issue of material fact.
  • Summary determination rules.
  • No summary determination.
Elements of proof
  • Infringement of intellectual property rights subject to all legal and equitable defenses.
  • Importation requirement.
  • Domestic industry requirement (economic and technical prongs).
  • Infringement of intellectual property rights subject to most legal and equitable defenses.
  • The PTAB may invalidate patent claims on 35 U.S.C. § 102 (anticipation) and § 103 (obviousness) grounds based solely on patent and printed publication prior art.
Presumption of patent validity
  • Yes: clear and convincing evidence standard for invalidating patent claims.
  • Yes: clear and convincing evidence standard for invalidating patent claims.
  • No: preponderance of the evidence standard for invalidating patent claims.
Role of experts
  • Experts must be qualified under FRE 702.
  • Experts used to apply scientific, technical, or economic methodology to facts of the case, and to evaluate hypothetical legal constructs.
  • Daubert standard used by district courts to assess the reliability of scientific testimony (testing of methodology, peer review and acceptance in scientific community, rates of error, and standards and controls).
  • Daubert motions can limit or exclude the testimony of expert witnesses.
  • Experts must be qualified under FRE 702.
  • Motions to wholly preclude the testimony of experts rarely made in USITC proceedings; may limit portions of testimony.
  • The PTAB permits expert testimony in the form of a declaration to be submitted with the petition, preliminary response, and at other appropriate stages in a proceeding as ordered or allowed by the panel overseeing the trial.
Trial/hearing
  • Judicial trial, subject to Seventh Amendment right to jury.
  • FRE.
  • Trial times vary, although judges are increasingly using time limits per side (e.g., 20 hours).
  • APA: formal adjudication.
  • Similar to the FRE but sometimes less strictly applied (e.g., the hearsay rule might not be used).
  • ALJ-specific “ground rules.”
  • Hearings usually last 1–2 weeks.
  • Each party has the right to request an oral hearing.
Record
  • Pleadings, rulings on motions, trial transcript and exhibits, and post-trial briefs.
  • Pleadings, final written decision, any findings or reports on which the final written decision is based, and the evidence and other parts of the proceeding before the USITC.
  • Pleadings, final written decision, any findings or reports on which the final written decision is based, and the evidence and other parts of the proceeding before the PTAB.
Remedies
  • Invalidation of patent claims.
  • Monetary relief available.
  • Attorney fees and costs potentially available.
  • Injunctive relief subject to equitable balancing.
  • No monetary relief.
  • Exclusion orders if infringement of valid patent found, unless public interest factors override.
  • Cease and desist orders.
  • Invalidation of patent claims.
  • No monetary relief.
Effect of decision on patent
  • Power to invalidate the patent.
  • Res judicata effect.
  • Initial determination by ALJ becomes final if not reviewed by the USITC within 45 days.
  • No res judicata effect: no effect on patent validity, only exclusion from the U.S. market.
  • Power to invalidate patent claims.
Enforcement
  • Contempt power.
  • Exclusion orders enforced by U.S. Customs & Border Protection.
  • Invalidation of patent claims.
Review by agency and/or Federal Circuit
  • No administrative agency review.
  • Federal Circuit appeal.
  • USITC review of ALJ initial determination.
  • Presidential review: the President has authority to disapprove USITC remedies on policy grounds (rarely invoked).
  • Federal Circuit appeal.
  • USPTO Director may review all PTAB decisions.10
  • Decisions of the PTAB can be appealed to the Federal Circuit.11
  • USPTO may intervene in Federal Circuit appeal to defend its decision.
Standard(s) of review
  • Hybrid standard of review of claim construction determinations (factual determinations underlying claim construction rulings are subject to the “clearly erroneous” (or “abuse of discretion”) standard of review, while the Federal Circuit exercises de novo review over the ultimate claim construction determination).
  • Substantial evidence or “clearly erroneous” standard for factual determinations.
  • De novo review for legal determinations.
  • Reviewed under standards of the APA.
  • Hybrid standard of review of claim construction determinations (factual determinations underlying claim construction rulings are subject to the “clearly erroneous” (or “abuse of discretion”) standard of review, while the Federal Circuit exercises de novo review over the ultimate claim construction determination).
  • Substantial evidence standard for factual determinations.
  • De novo review for the USITC’s legal determinations.
  • Reviewed under standards of the APA.
  • Substantial evidence standard for factual determinations.
  • De novo review for the PTAB’s legal conclusions.

Note: aBLA = Abbreviated Biologic License Application; ALJ = Administrative Law Judge; ANDA = Abbreviated New Drug Application; APA = Administrative Procedure Act; APJ = Administrative Patent Judge; BLA = Biologic License Application; BPCIA = Biologics Price Competition and Innovation Act; Federal Circuit = U.S. Court of Appeals for the Federal Circuit; FRCP = Federal Rule(s) of Civil Procedure; FRE = Federal Rule(s) of Evidence; IPR = inter partes review; NDA = New Drug Application; PTAB = Patent Trial and Appeal Board; TEO = temporary exclusion order; U.S.C. = U.S. Code; USITC = United States International Trade Commission; USPTO = United States Patent and Trademark Office.

1 35 U.S.C. §§ 102, 103.

2 FRCP 12(b)(6), 12(c).

3 See FRCP 12(b)(6); Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007); Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard).

4 FRCP 45.

5 Regents of the Univ. Of Minn. v. LSI Corp., 926 F.3d 1327, 1345 (Fed. Cir. 2019).

6 28 U.S.C. § 1400(b).

7 28 U.S.C. § 1659(a).

8 USPTO, Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022), available at https://www.uspto.gov/sites/default/files/documents/interim_proc_discretionary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf.

9 37 C.F.R. § 42.

10 United States v. Arthrex, Inc., 141 S. Ct. 1970 (2021).

11 35 U.S.C. § 141.