81 FR 71653 - Rule Recognizing Privileged Communications Between Clients and Patent Practitioners at the Patent Trial and Appeal Board
DEPARTMENT OF COMMERCE
United States Patent and Trademark Office Federal Register Volume 81, Issue 201 (October 18, 2016)
United States Patent and Trademark Office
Federal Register Volume 81, Issue 201 (October 18, 2016)
| Page Range | 71653-71657 | |
| FR Document | 2016-25141 |
[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)] [Proposed Rules] [Pages 71653-71657] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25141] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE United States Patent and Trademark Office 37 CFR Part 42 [Docket No. PTO-P-2016-0029] RIN 0651-AD10 Rule Recognizing Privileged Communications Between Clients and Patent Practitioners at the Patent Trial and Appeal Board AGENCY: Patent Trial and Appeal Board, United States Patent and Trademark Office, U.S. Department of Commerce. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: This proposed rule would amend the rules of practice before the Patent Trial and Appeal Board to recognize that, in connection with discovery conducted in certain proceedings at the United States Patent and Trademark Office (USPTO or Office), communications between U.S. [[Page 71654]] patent agents or foreign patent practitioners and their clients are privileged to the same extent as communications between clients and U.S. attorneys. The rule would apply to inter partes review, post-grant review, the transitional program for covered business method patents, and derivation proceedings. This rule would clarify the protection afforded to such communications, which is currently not addressed in the rules governing Board proceedings at the USPTO. This new rule will not affect the duty of disclosure and candor before the Office under 37 CFR 1.56. DATES: Comment date: The Office solicits comments from the public on this proposed rulemaking. Written comments must be received on or before December 19, 2016 to ensure consideration. ADDRESSES: Comments should be sent by electronic mail message over the Internet addressed to: [email protected]. Comments may also be submitted by postal mail addressed to: Mail Stop OPIA Director of the United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of ``Soma Saha, Patent Attorney, Patent Trial Proposed Rule on Privilege.'' Comments may also be sent by electronic mail message over the Internet via the Federal eRulemaking Portal at http://www.regulations.gov. See the Federal eRulemaking Portal Web site for additional instructions on providing comments via the Federal e- Rulemaking Portal. Although comments may be submitted by postal mail, the Office prefers to receive comments by electronic mail message to be able to more easily share all comments with the public. The Office prefers the comments to be submitted in plain text, but also accepts comments submitted in ADOBE[supreg] portable document format or MICROSOFT WORD[supreg] format. Comments not submitted electronically should be submitted on paper in a format that accommodates digital scanning into ADOBE[supreg] portable document format. The comments will be available for public inspection at the Office of Policy and International Affairs, currently located in Madison East, Second Floor, 600 Dulany Street, Alexandria, Virginia. Comments also will be available for viewing via the Office's Internet Web site at http://www.uspto.gov/patents/law/comments/index.jsp and at http://www.regulations.gov. Because comments will be made available for public inspection, information that the submitter does not desire to be made public, such as address or phone number, should not be included in the comments. FOR FURTHER INFORMATION CONTACT: Soma Saha, Patent Attorney, by email at [email protected] or by telephone at (571) 272-8652; or Edward Elliott, Attorney Advisor, by email at [email protected] or by telephone at (571) 272-7024. SUPPLEMENTARY INFORMATION: Purpose: This proposed rule would amend the rules of practice before the Patent Trial and Appeal Board (PTAB) to recognize that communications between non-attorney U.S. patent agents or foreign patent practitioners and their clients that pertain to authorized practice before the United States Patent and Trademark Office (Office or USPTO) are privileged to the same extent as communications of that sort conducted between clients and U.S. attorneys. Under the proposed rule, those communications would be protected from discovery in trial practice proceedings at the USPTO. The proposed rule would apply to inter partes review (IPR), post-grant review (PGR), the transitional program for covered business method patents (CBM), and derivation proceedings. Currently, the rules governing proceedings at the USPTO do not address the privilege of communications with patent practitioners, and questions regarding that matter are decided on a case-by-case basis under common law principles. This new rule will not affect the duty of disclosure and candor before the Office under 37 CFR 1.56. Background: Within this notice, the term ``patent practitioner'' includes both those authorized to practice patent matters before the USPTO and those authorized to practice patent matters in foreign jurisdictions. When referring to these groups separately, the terms ``U.S. or domestic patent practitioners'' and ``foreign patent practitioners'' will be used, respectively. In February 2015, the USPTO held a roundtable and solicited comments on attorney-client privilege issues. See Notice of Roundtable and Request for Comments on Domestic and International Issues Related to Privileged Communications Between Patent Practitioners and Their Clients, 80 FR 3953 (Jan. 26, 2015). As part of that process, the USPTO requested comments on whether it should recognize that communications between patent applicants and owners and their U.S. patent agents or foreign patent practitioners are privileged to the same extent as communications between U.S. patent attorneys and patent applicants and owners. Respondents unanimously supported a rule recognizing such privilege. See USPTO, Summary of Roundtable and Written Comments, available at http://www.uspto.gov/sites/default/files/documents/Summary%20of%20Privileged%20Communication%20Roundtable.pdf (``Privilege Report''). The USPTO administers various proceedings that entail discovery procedures, namely the IPR, PGR, and transitional program for CBM patents. In addition, the derivation proceedings provided for by the Leahy-Smith America Invents Act, Public Law 112-29, 125 Stat. 284 (2011) (AIA) permit discovery. Questions regarding privilege issues may arise in the course of discovery, and as some roundtable commenters noted, rules regarding privilege for U.S. patent agents and foreign practitioners during discovery in PTAB proceedings are not well defined. Current Practice: PTAB proceedings are subject to the Federal Rules of Evidence (FRE), which include rules on attorney-client privilege. See 37 CFR 42.62(a). Accordingly, privilege may be asserted in PTAB proceedings by licensed attorneys. However, the FRE does not explicitly address privilege for communications with non-attorney U.S. patent agents or with foreign patent practitioners. The rules governing PTAB practice likewise do not address this matter, and when it arises, PTAB Administrative Law Judges make legal determinations as to which communications may be protected from disclosure on a case-by-case basis, based on common law. See GEA Process Engineering, Inc. v. Steuben Foods, Inc., IPR2014-00041, Paper 117 (PTAB 2014). U.S. courts have devised several different approaches to determine under what circumstances communications with these practitioners are privileged. As the Privilege Report notes, the common law on privilege for domestic and foreign patent practitioners varies across jurisdictions. Different approaches are taken, and results sometimes conflict. This may lead to administrative inefficiencies and inconsistencies in outcomes, as PTAB must select which set of common law rules to follow. (It is also noted that Administrative Law Judges in other agencies recognize certain confidential communications with a patent agent as privileged. See, e.g., USITC Inv. No. 337-TA-339, slip op. at 2, 1992 WL 811804 (ITC 1992) (finding that confidential communications between a U.S. patent agent and his client in connection with [[Page 71655]] a patent prosecution are privileged).) The Federal Circuit recently recognized that attorney-client privilege applies to U.S. patent agents acting within the scope of their authorized practice. See In re Queen's University at Kingston, PARTEQ Research and Development Innovations, No. 2015-145 (Fed. Cir. 2016). The Office has strong policy reasons to establish a privilege rule governing trial proceedings before PTAB. Such a rule would help ensure consistent outcomes with respect to privilege matters that arise at the Office, would improve public understanding of how privilege questions are decided before PTAB, and would help further judicial economy by providing PTAB judges with a clear, concise statement of when privilege applies. Public Comments: In August 2015, the USPTO published in the Federal Register a proposed rule amending the rules for trial practice before the Office. See Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board, 80 FR 50719 (Aug. 20, 2015). Included in that proposed rule was a request for comments on the advisability of a privilege rule for PTAB proceedings. The comments submitted in response to that request are available on the USPTO Web site at http://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/comments-amendments-rules-practice-trials. Those responding to the request universally agreed that a privilege rule for PTAB proceedings should be promulgated. Respondents overwhelmingly favored promulgating such a rule, with some noting that it would lead to clarity and consistency and ``can reduce uncertainty and mitigate discovery costs.'' See Letter from Frederick W. Mau II on behalf of Toyota Motor Corp., David B. Kelley on behalf of Ford Motor Co., and Mark Duell on behalf of American Honda Motor Co., Inc., RE: Comments on Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board, p. 4-5 (Oct. 16, 2015). Others suggested that ``[i]f patent agents are not entitled to have their communications be considered privileged, however, then their utility--and associated cost savings for stakeholders--is lost.'' See Letter from Sharon A. Israel, President of the American Intellectual Property Law Assoc., RE: Response to Proposed ``Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board,'' 80 FR 50720 (August 20, 2015), p. 15-16 (Oct. 21, 2015). Commenters said it ``would be particularly useful for patent agents['] communications to be explicitly protected in the discovery rules for post-grant proceedings (e.g., inter parties [sic] review) before the USPTO.'' See Letter from Dorothy R. Auth, President of the New York Intellectual Property Law Assoc., RE: NYIPLA Comments in Response to ``Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board,'' Federal Register Notice, August 20, 2015, Vol. 80, No. 161 (80 FR 50720), p. 6-9 (Nov. 18, 2015). Commenters suggested that the rule should extend at least to communications made in connection with acts that patent agents are authorized to perform in their particular jurisdictions, such as prosecuting patent applications. The USPTO agrees that the scope of a privilege rule should be defined by the activities that the agent is authorized to carry out. Others suggested that it should be ``a simple rule . . . that explicitly recognize[s] privilege for communications between patent applicants or owners and their domestic patent agents or foreign professional patent practitioners under the same circumstances as such privilege is recognized for communications between applicants or owners and U.S. attorneys.'' See Letter from Andrew D. Meikle, President of the U.S. Section of the International Federation of Intellectual Property Attorneys (FICPI), RE: Comments on ``Recognizing Privilege for Communications With Domestic Patent Agents and Foreign Patent Practitioners'', p. 4 (Nov. 24, 2015). According to these comments, ``[t]his approach would provide the greatest uniformity and certainty, and avoid the need for the PTAB to engage in complex fact based analysis regarding application of the privilege under the common law.'' Id. These views were echoed by a law professor who has studied this issue since 2008: The privilege should be as broad as the ordinary attorney-client privilege. It should cover not only U.S. patent agents, but also foreign legal representatives. While the best solution would be a privilege that applied in all legal tribunals--not only the PTAB, but also federal and state courts--adoption of a privilege only for the PTAB would be a valuable first step toward this goal. See Letter from John T. Cross, Professor of Law at University of Louisville, Possible Adoption of a Legal Representation Privilege in Matters Before the Patent Trial and Appeal Board, p. 2 (Sep. 9, 2015). The USPTO agrees with these views and believes the proposed rule reflects them. As a policy matter, open and frank discussions between practitioners and clients promotes effective legal representation before the Office. Discussion of Specific Rules Taking into consideration comments from the public and insight gained from practice, the Office proposes to amend 37 CFR 42 to add new section 42.57 that clarifies which patent practitioners are eligible for assertions of attorney-client privilege. The term ``patent practitioner'' is used to conform with existing terminology and avoid confusion with other terms used around the world, such as ``IP Advisor'' or ``Patent Advisor.'' It fits with practice elsewhere in Title 37, which refers to domestic ``patent practitioners,'' i.e., U.S. patent agents and patent attorneys registered under 37 CFR 11.6. This narrower meaning is appropriate for most sections of Title 37, which deal with practitioners admitted to practice before the USPTO. For the new rule only, the term also includes comparable foreign counterparts practicing before foreign patent offices. The rule would provide that the privilege only applies where the practitioner performs legal work authorized by the jurisdiction in which the practitioner practices. For instance, communications between clients and U.S. patent agents relating to patent application matters would be protected as privileged under the rule, but communications between these parties regarding litigation strategies would not be protected. The proposed rule also does not recognize privilege as applying to advice given by lay persons in jurisdictions that do not impose professional qualifications as a requirement to practice. However, the proposed rule can apply to communications from an in-house counsel who performs the functions of a patent attorney under appropriate circumstances, even though some civil law jurisdictions may not grant in-house counsel the privilege-type protections given to attorneys. The Office invites the public to provide any comments on the proposed rule to inform further action. Costs and Benefits: This rulemaking is not economically significant, and is not significant, under Executive Order 12866 (Sept. 30, 1993), as amended by Executive Order 13258 (Feb. 26, 2002) and Executive Order 13422 (Jan. 18, 2007). Rulemaking Considerations A. Administrative Procedure Act (APA) This proposed rule revises the rules of practice before PTAB to recognize that [[Page 71656]] communications between non-attorney or foreign patent practitioners and their clients that pertain to authorized practice before the USPTO are privileged. The changes in this rulemaking involve rules of agency practice and procedure and/or interpretive rules. See Nat'l Org. of Veterans' Advocates v. Secretary of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (rule that clarifies interpretation of a statute is interpretive); Bachow Commc'ns Inc. v. F.C.C., 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application process are procedural under the Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals were procedural where they did not change the substantive requirements for reviewing claims). Accordingly, prior notice and opportunity for public comment are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law. See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice and comment rulemaking for ``interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice'' (quoting 5 U.S.C. 553(b)(A))). However, the Office chose to seek public comment before implementing the rule to benefit from the public's input. B. Regulatory Flexibility Act For the reasons set forth herein, the Deputy General Counsel for General Law of the USPTO has certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b). The changes proposed in this rule are to revise the rules of practice before PTAB to explicitly recognize that communications between non-attorney or foreign patent practitioners and their clients that pertain to authorized practice before the USPTO or foreign patent offices are privileged and to define those persons who may avail themselves of this privilege. These proposed changes are expected to create no additional burden to those practicing before the Board as this rule merely clarifies rights and protections for the practitioner and client and does not impose a change in practice or requirements. In fact, this rule may produce a small benefit from a reduction in uncertainty and mitigation of discovery costs. For the foregoing reasons, the changes proposed in this rule will not have a significant economic impact on a substantial number of small entities. C. Executive Order 12866 (Regulatory Planning and Review) This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993). D. Executive Order 13563 (Improving Regulation and Regulatory Review) The Office has complied with Executive Order 13563. Specifically, the Office has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector and the public as a whole, and provided on-line access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes. E. Executive Order 13132 (Federalism) This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999). F. Executive Order 13175 (Tribal Consultation) This rulemaking will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000). G. Executive Order 13211 (Energy Effects) This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001). H. Executive Order 12988 (Civil Justice Reform) This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996). I. Executive Order 13045 (Protection of Children) This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997). J. Executive Order 12630 (Taking of Private Property) This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988). K. Congressional Review Act Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), prior to issuing any final rule, the USPTO will submit a report containing the rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this final rule are not expected to result in an annual effect on the economy of 100 million dollars or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States- based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this final rule is not a ``major rule'' as defined in 5 U.S.C. 804(2). L. Unfunded Mandates Reform Act of 1995 The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the [[Page 71657]] Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq. M. National Environmental Policy Act This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq. N. National Technology Transfer and Advancement Act The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions which involve the use of technical standards. O. Paperwork Reduction Act The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549) requires that the Office consider the impact of paperwork and other information collection burdens imposed on the public. This proposed rule not does not involve any new information collection requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549). Any information collections associated with this rule have been previously approved under OMB control number 0651-0069. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to, a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number. List of Subjects in 37 CFR Part 42 Administrative practice and procedure, inventions and patents. For the reasons set forth in the preamble, 37 CFR part 42 is proposed to be amended as follows: PART 42--TRIAL PRACTICE BEFORE THE PATENT TRIAL AND APPEAL BOARD 0 1. The authority citation for 37 CFR Part 42 continues to read as follows: Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41, 135, 311, 312, 316, 321-326; Pub. L. 112-29, 125 Stat. 284; and Pub. L. 112-274, 126 Stat. 2456. 0 2. Add Sec. 42.57 to read as follows: Sec. 42.57 Privilege for patent practitioners. (a) Privileged communications. A communication between a client and a domestic or foreign patent practitioner that is reasonably necessary or incident to the scope of the patent practitioner's authority shall receive the same protections of privilege as if that communication were between a client and an attorney authorized to practice in the United States, including all limitations and exceptions. (b) Definitions. The term ``domestic patent practitioner'' means a person who is registered by the United States Patent and Trademark Office to practice before the agency under section 11.6. ``Foreign patent practitioner'' means a person who is authorized to provide legal advice on patent matters in a foreign jurisdiction, provided that the jurisdiction establishes professional qualifications and the practitioner satisfies them, and regardless of whether that jurisdiction provides privilege or an equivalent under its laws. Dated: October 12, 2016. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. 2016-25141 Filed 10-17-16; 8:45 am] BILLING CODE 3510-16-P
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Unless we certify that a rule will not NewsEvents/Newsroom/ of Food and Drugs, it is proposed that
have a significant economic impact on PressAnnouncements/2006/ 21 CFR part 216 be amended as follows:
a substantial number of small entities, ucm108592.htm.
the Regulatory Flexibility Act requires 3. Schneeweiss, S., J.D. Seeger, J. Landon, PART 216—HUMAN DRUG
and A.M. Walker, ‘‘Aprotinin During COMPOUNDING
us to analyze regulatory options to Coronary-Artery Bypass Grafting and
minimize any significant economic Risk of Death,’’ New England Journal of
impact of a regulation on small entities. ■ 1. The authority citation for part 216
Medicine, 358:771–783, 2008. continues to read as follows:
Most pharmacies meet the Small 4. Mangano, D.T., Y. Miao, A. Vuylsteke, et
Business Administration definition of a al., ‘‘Mortality Associated With Authority: 21 U.S.C. 351, 352, 353a, 353b,
small entity, which is defined as having Aprotinin During 5 Years Following 355, and 371.
annual sales less than $25.5 million for Coronary Artery Bypass Graft Surgery,’’
■ 2. Amend § 216.24 by adding, in
this industry. We are not aware of any Journal of the American Medical
Association, 297(5):471–479, 2007.
alphabetical order, to the list of drugs
routine compounding of these drug ‘‘Aprotinin’’, ‘‘Bromocriptine mesylate’’,
5. Fergusson, D.A., P.C. Hébert, C.D. Mazer,
products and do not estimate any et al., ‘‘A Comparison of Aprotinin and and ‘‘Ondansetron hydrochloride’’ to
compliance costs or loss of sales to Lysine Analogues in High-Risk Cardiac read as follows:
small businesses as a result of the Surgery,’’ New England Journal of
prohibition against compounding these Medicine, 358(22):2319–2331, 2008. § 216.24 Drug products withdrawn or
drug products. Therefore, we propose to 6. FDA Alert—Aprotinin Injection (Marketed removed from the market for reasons of
certify that this proposed rule will not as Trasylol) (October 25, 2007), available safety or effectiveness.
have a significant economic impact on at http://www.fda.gov/Safety/MedWatch/ * * * * *
a substantial number of small entities. SafetyInformation/SafetyAlertsfor Aprotinin: All drug products
HumanMedicalProducts/ containing aprotinin.
VII. Paperwork Reduction Act of 1995 ucm150815.htm.
7. FDA News Release, ‘‘FDA Requests
* * * * *
FDA tentatively concludes that this Bromocriptine mesylate: All drug
Marketing Suspension of Trasylol’’
proposed rule contains no collection of (November 5, 2007), available at http:// products containing bromocriptine
information. Therefore, clearance by the www.fda.gov/NewsEvents/Newsroom/ mesylate for prevention of physiological
Office of Management and Budget under PressAnnouncements/2007/ lactation.
the Paperwork Reduction Act of 1995 is ucm109021.htm. * * * * *
not required. 8. FDA News Release, ‘‘Manufacturer Ondansetron hydrochloride: All
Removes Remaining Stocks of Trasylol
VIII. Federalism Access Limited to Investigational Use’’
intravenous drug products containing
(May 14, 2008), available at http:// greater than a 16 milligram single dose
We have analyzed this proposed rule
www.fda.gov/NewsEvents/Newsroom/ of ondansetron hydrochloride.
in accordance with the principles set
forth in Executive Order 13132. We PressAnnouncements/2008/ * * * * *
ucm116895.htm.
have determined that this proposed rule 9. FDA–PARLODEL (bromocriptine mesylate) Dated: October 11, 2016.
does not contain policies that have Information, available at http:// Leslie Kux,
substantial direct effects on the States, www.fda.gov/downloads/Advisory Associate Commissioner for Policy.
on the relationship between the Committees/CommitteesMeeting [FR Doc. 2016–25005 Filed 10–17–16; 8:45 am]
National Government and the States, or Materials/Drugs/PharmacyCompounding
BILLING CODE 4164–01–P
on the distribution of power and AdvisoryCommittee/UCM449535.pdf.
responsibilities among the various 10. FDA Fertility and Maternal Health Drugs
levels of government. Accordingly, we Advisory Committee Meeting Minutes
(June 1 and 2, 1989), available at http:// DEPARTMENT OF COMMERCE
conclude that the rule does not contain
www.fda.gov/downloads/Advisory
policies that have federalism Committees/CommitteesMeeting United States Patent and Trademark
implications as defined in the Executive Materials/Drugs/PharmacyCompounding Office
order and, consequently, a federalism AdvisoryCommittee/UCM449535.pdf.
summary impact statement is not 11. FDA Drug Safety Communication— 37 CFR Part 42
required. Abnormal Heart Rhythms May Be
Associated with Use of Zofran [Docket No. PTO–P–2016–0029]
IX. References (Ondansetron)(September 15, 2011), RIN 0651–AD10
The following references are on available at http://www.fda.gov/Drugs/
display in the Division of Dockets DrugSafety/ucm271913.htm. Rule Recognizing Privileged
Management (see ADDRESSES) and are 12. FDA Drug Safety Communication—New
Information Regarding QT Prolongation
Communications Between Clients and
available for viewing by interested Patent Practitioners at the Patent Trial
with Ondansetron (Zofran) (June 29,
persons between 9 a.m. and 4 p.m., 2012), available at http://www.fda.gov/ and Appeal Board
Monday through Friday; they are also Drugs/DrugSafety/ucm310190.htm.
available electronically at http:// 13. FDA Drug Safety Communication—
AGENCY: Patent Trial and Appeal Board,
www.regulations.gov. FDA has verified Updated Information on 32 mg United States Patent and Trademark
the Web site addresses, as of the date Intravenous Ondansetron (Zofran) Dose Office, U.S. Department of Commerce.
this document publishes in the Federal and Pre-Mixed Ondansetron Products ACTION: Proposed rule.
Register, but Web sites are subject to (December 4, 2012), available at http://
www.fda.gov/Drugs/DrugSafety/ SUMMARY: This proposed rule would
Lhorne on DSK30JT082PROD with PROPOSALS
change over time.
ucm330049.htm. amend the rules of practice before the
1. Mangano, D.T., I.C. Tudor, and C. Dietzel, Patent Trial and Appeal Board to
‘‘The Risk Associated With Aprotinin in List of Subjects in 21 CFR Part 216
Cardiac Surgery,’’ New England Journal
recognize that, in connection with
Drugs, Prescription drugs. discovery conducted in certain
of Medicine, 354(4):353–365, 2006.
2. FDA News Release, ‘‘FDA Issues Public Therefore, under the Federal Food, proceedings at the United States Patent
Health Advisory for Trasylol’’ (February Drug, and Cosmetic Act and under and Trademark Office (USPTO or
8, 2006), available at http://www.fda.gov/ authority delegated to the Commissioner Office), communications between U.S.
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a patent prosecution are privileged).) Commenters said it ‘‘would be frank discussions between practitioners
The Federal Circuit recently recognized particularly useful for patent agents[’] and clients promotes effective legal
that attorney-client privilege applies to communications to be explicitly representation before the Office.
U.S. patent agents acting within the protected in the discovery rules for post-
Discussion of Specific Rules
scope of their authorized practice. See grant proceedings (e.g., inter parties [sic]
In re Queen’s University at Kingston, review) before the USPTO.’’ See Letter Taking into consideration comments
PARTEQ Research and Development from Dorothy R. Auth, President of the from the public and insight gained from
Innovations, No. 2015–145 (Fed. Cir. New York Intellectual Property Law practice, the Office proposes to amend
2016). Assoc., RE: NYIPLA Comments in 37 CFR 42 to add new section 42.57 that
The Office has strong policy reasons Response to ‘‘Amendments to the Rules clarifies which patent practitioners are
to establish a privilege rule governing of Practice for Trials Before the Patent eligible for assertions of attorney-client
trial proceedings before PTAB. Such a Trial and Appeal Board,’’ Federal privilege.
rule would help ensure consistent Register Notice, August 20, 2015, Vol. The term ‘‘patent practitioner’’ is used
outcomes with respect to privilege 80, No. 161 (80 FR 50720), p. 6–9 (Nov. to conform with existing terminology
matters that arise at the Office, would 18, 2015). Commenters suggested that and avoid confusion with other terms
improve public understanding of how the rule should extend at least to used around the world, such as ‘‘IP
privilege questions are decided before communications made in connection Advisor’’ or ‘‘Patent Advisor.’’ It fits
PTAB, and would help further judicial with acts that patent agents are with practice elsewhere in Title 37,
economy by providing PTAB judges authorized to perform in their particular which refers to domestic ‘‘patent
with a clear, concise statement of when jurisdictions, such as prosecuting patent practitioners,’’ i.e., U.S. patent agents
privilege applies. applications. The USPTO agrees that the and patent attorneys registered under 37
Public Comments: In August 2015, the scope of a privilege rule should be CFR 11.6. This narrower meaning is
USPTO published in the Federal defined by the activities that the agent appropriate for most sections of Title 37,
Register a proposed rule amending the is authorized to carry out. Others which deal with practitioners admitted
rules for trial practice before the Office. suggested that it should be ‘‘a simple to practice before the USPTO. For the
See Amendments to the Rules of rule . . . that explicitly recognize[s] new rule only, the term also includes
Practice for Trials Before the Patent privilege for communications between comparable foreign counterparts
Trial and Appeal Board, 80 FR 50719 patent applicants or owners and their practicing before foreign patent offices.
(Aug. 20, 2015). Included in that domestic patent agents or foreign The rule would provide that the
proposed rule was a request for professional patent practitioners under privilege only applies where the
comments on the advisability of a the same circumstances as such practitioner performs legal work
privilege rule for PTAB proceedings. privilege is recognized for authorized by the jurisdiction in which
The comments submitted in response to communications between applicants or the practitioner practices. For instance,
that request are available on the USPTO owners and U.S. attorneys.’’ See Letter communications between clients and
Web site at http://www.uspto.gov/ from Andrew D. Meikle, President of the U.S. patent agents relating to patent
patents-application-process/patent- U.S. Section of the International application matters would be protected
trial-and-appeal-board/comments- Federation of Intellectual Property as privileged under the rule, but
amendments-rules-practice-trials. Attorneys (FICPI), RE: Comments on communications between these parties
‘‘Recognizing Privilege for regarding litigation strategies would not
Those responding to the request
Communications With Domestic Patent be protected. The proposed rule also
universally agreed that a privilege rule
Agents and Foreign Patent does not recognize privilege as applying
for PTAB proceedings should be
Practitioners’’, p. 4 (Nov. 24, 2015). to advice given by lay persons in
promulgated. Respondents According to these comments, ‘‘[t]his
overwhelmingly favored promulgating jurisdictions that do not impose
approach would provide the greatest professional qualifications as a
such a rule, with some noting that it uniformity and certainty, and avoid the
would lead to clarity and consistency requirement to practice. However, the
need for the PTAB to engage in complex proposed rule can apply to
and ‘‘can reduce uncertainty and fact based analysis regarding application
mitigate discovery costs.’’ See Letter communications from an in-house
of the privilege under the common counsel who performs the functions of
from Frederick W. Mau II on behalf of law.’’ Id. These views were echoed by
Toyota Motor Corp., David B. Kelley on a patent attorney under appropriate
a law professor who has studied this circumstances, even though some civil
behalf of Ford Motor Co., and Mark issue since 2008:
Duell on behalf of American Honda law jurisdictions may not grant in-house
Motor Co., Inc., RE: Comments on The privilege should be as broad as the counsel the privilege-type protections
Amendments to the Rules of Practice for ordinary attorney-client privilege. It should given to attorneys.
cover not only U.S. patent agents, but also The Office invites the public to
Trials Before the Patent Trial and foreign legal representatives. While the best
Appeal Board, p. 4–5 (Oct. 16, 2015). provide any comments on the proposed
solution would be a privilege that applied in rule to inform further action.
Others suggested that ‘‘[i]f patent agents all legal tribunals—not only the PTAB, but
are not entitled to have their also federal and state courts—adoption of a Costs and Benefits: This rulemaking is
communications be considered privilege only for the PTAB would be a not economically significant, and is not
privileged, however, then their utility— valuable first step toward this goal. significant, under Executive Order
and associated cost savings for 12866 (Sept. 30, 1993), as amended by
See Letter from John T. Cross, Professor
stakeholders—is lost.’’ See Letter from Executive Order 13258 (Feb. 26, 2002)
of Law at University of Louisville,
Lhorne on DSK30JT082PROD with PROPOSALS
Sharon A. Israel, President of the and Executive Order 13422 (Jan. 18,
Possible Adoption of a Legal
American Intellectual Property Law 2007).
Representation Privilege in Matters
Assoc., RE: Response to Proposed Before the Patent Trial and Appeal Rulemaking Considerations
‘‘Amendments to the Rules of Practice Board, p. 2 (Sep. 9, 2015).
for Trials Before the Patent Trial and The USPTO agrees with these views A. Administrative Procedure Act (APA)
Appeal Board,’’ 80 FR 50720 (August and believes the proposed rule reflects This proposed rule revises the rules of
20, 2015), p. 15–16 (Oct. 21, 2015). them. As a policy matter, open and practice before PTAB to recognize that
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![Federal Register / Vol. 81, No. 201 / Tuesday, October 18, 2016 / Proposed Rules 71657
Unfunded Mandates Reform Act of domestic or foreign patent practitioner parties may submit reply comments via
1995. See 2 U.S.C. 1501 et seq. that is reasonably necessary or incident email to crb@loc.gov. Those who choose
to the scope of the patent practitioner’s not to submit reply comments via email
M. National Environmental Policy Act
authority shall receive the same should see How to Submit Reply
This rulemaking will not have any protections of privilege as if that Comments in the SUPPLEMENTARY
effect on the quality of the environment communication were between a client INFORMATION section below for online
and is thus categorically excluded from and an attorney authorized to practice and physical addresses and further
review under the National in the United States, including all instructions.
Environmental Policy Act of 1969. See limitations and exceptions. FOR FURTHER INFORMATION CONTACT:
42 U.S.C. 4321 et seq. (b) Definitions. The term ‘‘domestic Kimberly Whittle, Attorney Advisor, by
N. National Technology Transfer and patent practitioner’’ means a person telephone at (202) 707–7658, or by
Advancement Act who is registered by the United States email at crb@loc.gov.
Patent and Trademark Office to practice
The requirements of section 12(d) of SUPPLEMENTARY INFORMATION: On July
before the agency under section 11.6.
the National Technology Transfer and ‘‘Foreign patent practitioner’’ means a 25, 2016, the Judges published a
Advancement Act of 1995 (15 U.S.C. person who is authorized to provide proposed rule and requested comments.
272 note) are not applicable because this legal advice on patent matters in a 81 FR 48371. The proposed rule was
rulemaking does not contain provisions foreign jurisdiction, provided that the based upon a partial settlement 1
which involve the use of technical jurisdiction establishes professional regarding copyright royalty rates and
standards. qualifications and the practitioner terms applicable during the upcoming
satisfies them, and regardless of whether rate period for the section 115 statutory
O. Paperwork Reduction Act license for making and distributing
that jurisdiction provides privilege or an
The Paperwork Reduction Act of 1995 equivalent under its laws. phonorecords of nondramatic musical
(44 U.S.C. 3501–3549) requires that the works. See Joint Motion to Adopt Partial
Office consider the impact of paperwork Dated: October 12, 2016. Settlement, Docket No. 16–CRB–0003–
and other information collection Michelle K. Lee, PR (2018–2022) (June 15, 2016).
burdens imposed on the public. This Under Secretary of Commerce for Intellectual On or before August 24, 2016, the
proposed rule not does not involve any Property and Director of the United States Judges received two timely comments,
new information collection Patent and Trademark Office. one from the American Association of
requirements that are subject to review [FR Doc. 2016–25141 Filed 10–17–16; 8:45 am] Independent Music (A2IM) that
by the Office of Management and BILLING CODE 3510–16–P supported it and one from Sony Music
Budget (OMB) under the Paperwork Entertainment (‘‘Sony’’) that supported
Reduction Act of 1995 (44 U.S.C. 3501– it in part and opposed it in part.
3549). Any information collections LIBRARY OF CONGRESS On August 30, 2016, the National
associated with this rule have been Music Publishers’ Association and the
previously approved under OMB Copyright Royalty Board Nashville Songwriters Association
control number 0651–0069. International filed a joint Motion for
Notwithstanding any other provision 37 CFR Part 385 Leave to Respond to the Comments and
of law, no person is required to respond [Docket No. 16–CRB–0003–PR (2018–2022)] Objections of Sony Music Entertainment
to, nor shall any person be subject to, a Concerning Proposed Settlement (Joint
penalty for failure to comply with a Determination of Rates and Terms for Motion). In the interest of promoting a
collection of information subject to the Making and Distributing Phonorecords more complete record with regard to the
requirements of the Paperwork (Phonorecords III); Comment Period proposed rule, the Judges will grant the
Reduction Act unless that collection of Extension Joint Motion. In addition, the Judges
information displays a currently valid hereby announce that they will accept,
AGENCY: Copyright Royalty Board,
OMB control number. without additional motions required,
Library of Congress.
additional reply comments, if any, to
List of Subjects in 37 CFR Part 42 ACTION: Proposed rule; extension of the comments filed by A2IM and Sony.
Administrative practice and comment period for reply comments. The reply comments, if any, must be
procedure, inventions and patents. submitted no later than November 17,
SUMMARY: The Copyright Royalty Judges
For the reasons set forth in the announce that they will accept reply 2016.
preamble, 37 CFR part 42 is proposed to comments in response to comments How To Submit Reply Comments
be amended as follows: they received about a proposed rule
Interested members of the public must
regarding rates and terms applicable
PART 42—TRIAL PRACTICE BEFORE submit reply comments to only one of
during the upcoming rate period for the
THE PATENT TRIAL AND APPEAL the following addresses. If not
section 115 statutory license for making
BOARD submitting by email or online,
and distributing phonorecords of
commenters must submit an original of
■ 1. The authority citation for 37 CFR nondramatic musical works.
their reply comments, five paper copies,
Part 42 continues to read as follows: DATES: Reply comments for the and an electronic version in searchable
Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41, proposed rule published July 25, 2016 PDF format on a CD.
(81 FR 48371) are due no later than Email: crb@loc.gov; or
Lhorne on DSK30JT082PROD with PROPOSALS
135, 311, 312, 316, 321–326; Pub. L. 112–29,
125 Stat. 284; and Pub. L. 112–274, 126 Stat. November 17, 2016. Online: http://www.regulations.gov; or
2456. ADDRESSES: The proposed rule and the
■ 2. Add § 42.57 to read as follows: comments filed in response to it are 1 The participants filing the motion were Church
posted on the agency’s Web site Music Publishers Association, Nashville
§ 42.57 Privilege for patent practitioners. Songwriters Association International, National
(www.loc.gov/crb). The proposed rule is Music Publishers Association, Harry Fox Agency,
(a) Privileged communications. A also posted at Regulations.gov and Songwriters of North America, and licensees
communication between a client and a (www.regulations.gov). Interested Universal Music Group and Warner Music Group.
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Document Created: 2016-10-17 23:52:11
Document Modified: 2016-10-17 23:52:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Contact | Soma Saha, Patent Attorney, by email at [email protected] or by telephone at (571) 272-8652; or Edward Elliott, Attorney Advisor, by email at [email protected] or by telephone at (571) 272-7024. | |
| FR Citation | 81 FR 71653 | |
| RIN Number | 0651-AD10 | |
| CFR Associated | Administrative Practice and Procedure and Inventions and Patents |
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