• USPTO Building FacadeThe U.S. Patent and Trademark Office has announced the agenda for the next biotechnology/chemical/ pharmaceutical (BCP) customer partnership meeting to be held on December 1, 2011.  The proposed agenda is as follows:

    Morning Session

    • Meet & Greet and Opening Remarks (9:00 – 9:45 am EDT):  Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

    • Patent Reform Legislation (AIA) (9:45 – 11:15 am):  Janet Gongola, Patent Reform Coordinator

    • Break (11:15 – 11:30 am)

    • Track I Briefing (11:30 am – 12:30 pm):  Krista Zele, SPE, Art Unit 2453

    • Lunch (12:30 – 1:30 pm)

    Afternoon Session

    • Professional Responsibility for IP Practitioners (1:30 – 2:30 pm):  William Covey, Office of Enrollment and Discipline

    • Break (2:30 – 3:00 pm)

    • TC1600 35 U.S.C. § 112 Supplemental Guideline Training (3:00 – 4:00 pm):  Bennett Celsa, QAS, TC1600

    Therasense and Duty of Candor (4:00 – 5:00 pm):  Hans Sauer, Associate General Counsel for Intellectual Property

    • Closing Remarks/Discussion (5:00 – 5:15 pm):  Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

    The meeting can be attended in person at the USPTO's Madison Auditorium, 600 Dulany Street, Alexandria, VA, or viewed online here (select the "enter as guest" option).  The Patent Office asks that non-USPTO employees login using their e-mail addresses.  Those wishing to attend the meeting should contact Cecilia Tsang by phone at 571-272-0562, by fax at 571-273-0562, or by e-mail at Cecilia.Tsang@uspto.gov by November 25, 2011 to confirm their attendance.  Additional information regarding the BCP customer partnership meeting can be found here.

  • ABAThe American Bar Association (ABA) Section of Intellectual Property Law, Section of Intellectual Property Law Young Lawyers Action Group, and Center for Continuing Legal Education will be offering a live webinar entitled "The America Invents Act: Key Facts You Need To Know Now About Provisions that Are Already Law" on November 17, 2011 from 1:00 – 2:30 PM (Eastern).  David Postolski of the Innovation Division of Cantor Fitzgerald, LP (moderator), Orion Armon of Cooley LLP, Ann N. Cathcart Chaplin of Fish & Richardson, and Christa Zado of Cisco Systems, Inc. (representing the Coalition for Patent Fairness), will offer in-depth analysis of the AIA provisions that became effective, including:

    • Prior user rights;
    • Joinder limitations;
    • USPTO fee increases;
    • Tax strategies within prior art;
    • Best mode changes;
    • Virtual marking;
    • False marking litigation restrictions;
    • New standards for petitioning for inter partes reexamination; and
    • New best mode requirements.

    In particular, the panelists will provide in-depth explanation regarding each change in the law and how the changes affect the planning, strategy, and budgets of patent owners, applicants and litigants, with a special emphasis placed on how these provisions impact litigation proceedings.

    The registration fee for the webcast is $95 for members of any of the sections sponsoring the webinar, $99 for government attorneys, $150 for ABA members, and $195 for the general public (for group fee options, please visit the event website).  Those interested in registering for the webinar, can do so here or by calling 800-285-2221.

  • By Kevin E. Noonan

    President Signs HR1249_cropAnother significant change effected by the Leahy-Smith America Invents Act relates to the power of an assignee, or someone who has obligated an inventor to assign, to file an application without obtaining an oath or declaration (or even permission or knowledge) of the inventor, raising an interesting Constitutional question as discussed below.

    This change is effected by Section 4 of the Act, which amends 35 U.S.C. § 115.  As in the current version of § 115, new § 115(a) provides that an application requires the name of the inventor or inventors and an oath or declaration stating that the application was made (or was authorized to be made) by the affiant/declarant, and that the individual believes himself/herself to be the original sole or joint inventor of the claimed invention (§ 115(b)).  In the first of several delegations of authority from the statute to the Director, § 115(c) gives the Director the right to "specify additional information relating to the inventor and the invention that is required to be included in an oath or declaration."

    It is in new § 115(d) that the effects of the changes begin to become evident.  Section 115(d)(1) provides that an assignee ("the applicant") can file an application in the name of an inventor who is deceased, "under legal incapacity" or "cannot be found after diligent effort" (Section 115(d)(2)(A)), or who is "under an obligation to assign" but has refused to do so (Section 115(d)(2)(B)).  The substitute statement under these circumstances must contain the identification of the individual, "set forth the circumstances representing the permitted basis for the filing of the substitute statement in lieu of the oath or declaration" and (again) "any additional information, including any showing, required by the Director (Section 115(d)(3)).

    New § 115(e) permits the "required statements" of §§ 115(b) and (c) to be included in the assignment document, and new § 115(f) prohibits the Director from issuing a Notice of Allowance unless there has been submitted "each required oath or declaration under subsection (a) or has filed a substitute statement under subsection (d) or recorded an assignment meeting the requirements of subsection (e)."  This language suggests that the assignment document might be substituted for the oath/declaration to satisfy the requirements under circumstances other than those where the inventor is unable, unavailable, or unwilling to sign (provided the assignment document is signed).  Since assignment documents are traditionally not constrained by the limitations of oaths or declarations (i.e., that neither the application nor the oath/declaration can be altered after the oath/declaration is signed), there is at least the possibility (particularly in view of the latitude given the Director) for assignments to be accepted under circumstances where an inventor (or, more likely, a co-inventor) is unaware that an application has been filed.  Similar possibilities exist for later-filed applications (continuations, divisionals, or continuations-in-part), since new § 115(g) provides that a new oath/declaration need not be filed if in the earlier application an oath/declaration pursuant to new § 115(a) (according to § 115(g)(1)(A)), a substitute statement under new § 115(d) (according to § 115(g)(1)(B)),  or an assignment under new § 115(e) (according to § 115(g)(1)(C)) has been filed, although the Director is empowered to require that the "applicant" file a copy of such documents (§ 115(g)(2)).

    New § 115(h)(1) further provides that "[a]ny person making a statement required under this section may withdraw, replace or otherwise correct the statement at any time" pursuant to regulations established by the Director "under which any such additional statements shall be filed."  In addition, "the Director may not  . . . require that any individual [] make any additional oath, declaration or other statement" once that individual has fulfilled the requirements of §§ 115(a) or (e) (i.e., the assignment shall be sufficient under this section) (§ 115(h)(2)).  This part of the statute also has an express "savings clause" (§ 115(h)(3) permitting any irregularities in the oath or declaration to be cured by such "corrective statements."  New § 115(i) contains the provision that "any willful false statement made in such declaration or statement is punishable under section 1001 of title 18 by fine or imprisonment of not more than 5 years, or both."

    In addition to certain conforming amendments under Section 4(b)(1), the Act amends current 35 U.S.C. § 118 (filing by other than inventor) as follows:

    A person to whom the inventor has assigned or is under an obligation to assign the invention may make an application for patent.  A person who otherwise shows sufficient proprietary interest in the matter may make an application for patent on behalf of and as agent for the inventor on proof of the pertinent facts and a showing that such action is appropriate to preserve the rights of the parties.  If the Director grants a patent on an application filed under this section by a person other than the inventor, the patent shall be granted to the real party in interest and upon such notice to the inventor as the Director considers to be sufficient.

    Section 4(b)(2) amends 35 U.S.C. § 251 to permit the applicant (assignee) to file a reissue application (and presumably sign the oath/declaration attesting that the patent for reissue is defective).

    In keeping with the reflection of the statute-writing process, Section 4(c) revises 35 U.S.C. § 112 to replace paragraph designations with subsections; thus, § 112, 1st paragraph, is changed to § 112(a), § 112, 2nd paragraph, is changed to § 112(b), etc.  There is no indication why this change has been included in the bill.  Section 4(d) contains conforming amendments to §§ 111(b)(1)(A) and (b)(2) to reflect these amendments to § 112.

    The effective date of these provisions is "1 year after the date of the enactment of this Act [i.e., September 16, 2012] and shall apply to patent applications that are filed on or after that effective date" under Section 4(e).

    For additional information regarding this topic, please see:

    • "AIA Overview: Supplemental Examination," October 26, 2011
    • "AIA Overview: Changes to Provisions Relating to Third Party Submissions of Prior Art," October 24, 2011
    • "AIA Overview: Changes to Inter Partes Re-examination," October 23, 2011
    • "AIA Overview: Post-grant Review Provisions," October 20, 2011
    • "AIA Overview: Prior User Rights Defense," October 19, 2011
    • "AIA Overview: First-Inventor-to-File Provisions," October 11, 2011
    • "USPTO Seeking Comment on AIA Mandated Studies," October 10, 2011
    • "USPTO Implements AIA Changes to Inter Partes Reexamination," September 28, 2011
    • "USPTO Implements Prioritized Examination Track under AIA," September 26, 2011
    • "President Signs AIA into Law; USPTO Begins Implementation of Act," September 20, 2011

  • By Donald Zuhn

    NVCALast week, the National Venture Capital Association (NVCA), a trade association representing the U.S. venture capital industry, released the results of its MoneyTree Report on venture funding for the third quarter of 2011.  The NVCA quarterly study, which the group conducts with PriceWaterhouseCoopers using data from Thomson Reuters, indicates that venture capitalists invested $6.95 billion in 876 deals during the third quarter, which constituted a 12% decrease in dollars and a 14% decrease in deals as compared with the second quarter of 2011 when $7.9 billion was invested in 1,015 deals (the NVCA revised its second quarter numbers, adding $400 million in funding and 49 deals to the totals for the last quarter).  Although venture funding and the number of deals dropped in the third quarter, the NVCA noted that the totals for the first three quarters of 2011 ($21.2 billion invested in 2,725 deals) represented a 20% increase in dollars and a 3% increase in deals over the first three quarters of 2010.

    Dollars Invested
    The Life Sciences sector (biotechnology and medical devices) saw an 18% decrease in dollars and a 21% decrease in deals in the third quarter — the sector's worst showing since the first quarter of 2005.  The biotech industry alone received $1.1 billion via 96 deals, which marked an 18% decrease in dollars and a 20% decrease in deals as compared to the second quarter of 2011.  In terms of dollars invested, the biotechnology industry placed second (to the software industry, which collected $2.0 billion for its best quarter since the fourth quarter of 2001) among the industries tracked by the NVCA.  The Life Sciences sector was not alone, as the NVCA report noted that of the seventeen sectors its tracks, fourteen experienced decreases in dollars invested in the third quarter.

    Dollars by Sector Tracy Lefteroff, the global managing partner of the venture capital practice at PwC US noted that "[c]hallenges in the regulatory environment for Life Sciences companies are prompting VCs to look to other industries to put their money to work for a faster return on their investment," and as a result, "over the past two quarters, we've seen a clear shift in Life Sciences investments from Seed/Early Stage companies over to more Later Stage companies."  While "VCs are continuing to support the companies in their pipeline," Ms. Lefteroff noted that they "appear to be curbing their investments in new Life Sciences companies."  NVCA president Mark Heesen, stated that "[p]ublic policy challenges in the life sciences and clean technology sectors are impacting investment levels this quarter as is the IPO market that basically came to a screeching halt in August."  Noting that "[v]enture fundraising levels are the lowest they have been in nearly a decade," Mr. Heesen suggested that "it is reasonable to expect investment levels to decline in the coming years."

    For additional information regarding this and other related topics, please see:

    • "Life Sciences Venture Funding up 37% in Second Quarter," August 1, 2011
    • "VentureSource Reports 35% Increase in 1Q Venture Funding," April 26, 2011
    • "NVCA Reports Modest Gains in First Quarter Venture Funding," April 19, 2011

    • "NVCA Reports 31% Drop in Venture Funding for Third Quarter," October 17, 2010

    • "NVCA Reports 34% Increase in Venture Funding for Second Quarter," July 22, 2010

    • "NVCA Report Shows First Quarter Drop in Venture Funding," April 20, 2010

    • "Biotech/Pharma Financing Improving, R&D Spending Up," August 31, 2009
    • "NVCA Study Shows Increase in Third Quarter Venture Funding," October 23, 2009

    • "First Quarter Venture Capital Funding at 12-Year Low," April 23, 2009

    • "NVCA Study Shows Decline in 2008 Investment; BIO Study Predicts Biotech Rebound in 2009," February 16, 2009

    • "NVCA Predicts Another Slow Year for Venture-backed Businesses in 2009," December 18, 2008

  • By Kevin E. Noonan

    President Signs HR1249_cropOne provision in the Leahy-Smith America Invents Act (AIA) that appears to benefit (or at least be intended to benefit) patentees is the Supplemental Examination revision set forth in Section 12.

    This section revises 35 U.S.C. § 257 to include a new "Request for Supplemental Examination" that is limited to filings by the patent owner (§ 257(a)).  The Request permits the patentee to "consider, reconsider, or correct information believed [by the patent owner] to be relevant to the patent," by far the most extensive grounds for Patent Office reconsideration of all the avenues of reconsideration in the statute (ex parte reexamination, inter partes review, or post-grant review).  The statute provides that the supplemental examination must be considered by the Office within three months of filing the request, and be concluded by issuance of a certificate indicating "whether the information presented in the request raises a substantial new question of patentability" (SQP).  If the Director's determines that a SQP exists, then the Director will order reexamination (§ 257(b)).

    Re-examination is conducted pursuant to current ex parte re-examination practice (save the provisions of 35 U.S.C. § 304), i.e., by the examining corps and the Director "shall consider" each SQP raised in the request, "notwithstanding the limitations in chapter 30 relating to patents and printed publication or any other provision of such chapter [30]" (§ 257(b)).  The benefits of this supplemental examination are set forth in § 257(c), wherein a patent "shall not be held to be unenforceable" bsed on any information "that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent" that was considered by the Office during supplemental examination.  Moreover, the statute provides that either making or failing to make a request "shall not be relevant to enforceability of the patent under section 282" (§ 257(c)(1)).

    The statute provides several exceptions to this particular form of absolution, including that the benefits of filing a supplemental examination request "shall not apply to an allegation pled with particularity in a civil action" or to an allegation contained in a Paragraph 4 notice received by the patentee under the provisions of the Hatch-Waxman Act (§ 505(j)(2)(B)(iv)(II) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 355(j)(2)(B)(iv)(II)) before the filing of the supplemental examination request (§ 257(c)(2)(A)).  In addition, the protections afforded by § 257(c)(1) "shall not apply" to any section 337(a) action under the Tariff Act of 1930 or a civil action for patent infringement under 35 U.S.C. § 281 "unless the supplemental examination, and any reexamination ordered pursuant to the request, are concluded before the date on which the action is brought," thus preventing a patentee to attempt to inoculate itself from an inequitable conduct allegation after litigation has ensued (§ 257(c)(2)(B)).

    A significant limitation to the protections afforded by § 257(c)(1) is set forth in § 257(e), which excludes instances of "material fraud" from the provisions of § 257(c)(1).  If "material fraud" is found, the Director is empowered to take any action otherwise authorized (including cancelling a claim or claims under 35 U.S.C. § 307) and in addition is directed ("shall") to "refer the matter to the Attorney General for such further action as the Attorney General may deem appropriate" (although such referral "shall be treated as confidential, shall not be included in the file of the patent, and shall not be disclosed to the public unless the United States charges a person with a criminal offense in connection with such referral").  In this regard the statute "preclude[s] the imposition of sanctions based upon criminal or antitrust laws" (§ 257(f)(1)) or "to limit the authority of the Director to investigate issues of possible misconduct and impose sanctions for misconduct in connection with matters or proceedings before the Office" (§ 257(f)(2)).

    Fees and regulations are to be set by the Director ((§ 257(d)), with the express provision that the Office is entitled to collect fees associated with ex parte reexamination in addition to supplemental examination fees if reexamination is ordered pursuant to § 257(b).

    Section 12(c) of the AIA provides that the effective date of these provisions is "upon the expiration of the 1-year period beginning on the date of the enactment of this Act" (September 16, 2012) "and shall apply to any patent issued before, on, or after that effective date."

  • By Donald Zuhn

    USPTO SealYesterday, the U.S. Patent and Trademark Office and European Patent Office announced the launch of a new website regarding the Cooperative Patent Classification (CPC) initiative.  The CPC project seeks to combine the best classification practices of both the U.S. and European systems with the aim of developing a joint IPC based classification system to be used for the search and examination of U.S. and EP patent applications.  The website was created to serve as EPO-EPCan informative resource on the progress of the CPC project for USPTO and EPO staff, as well as other patent offices worldwide and the user community.  The EPO press release regarding the website launch can be found here.

    For additional information regarding this topic, please see:

    • "USPTO and EPO Agree to Principles of Joint Patent Classification System," February 14, 2011
    • "USPTO and EPO to Develop Joint Patent Classification System," October 25, 2010

  • By Kevin E. Noonan

    Federal Trade Commission (FTC) SealThe Federal Trade Commission is nothing if not consistent.  Yet again, the Commission has released a Report on the negative effects of reverse payment (or, in Commission parlance, "pay-for-delay") agreements, in the face of competing studies (see "Generic Pharmaceutical Association Releases Report on Value of Pay-for-Delay Agreements") and well-reasoned appellate decisions (see "Second Circuit Denies En Banc Reconsideration in Cipro® Case") that, in the main, settlement agreements in ANDA litigation between branded and generic pharmaceutical companies are actually pro-competitive and result in generic drugs reaching the market sooner than they would in the absence of such agreements.

    Washington - Capitol #4The Commission's latest audience is the Congressional "Super Committee" on the budget (having failed to convince the judiciary up to and including the Supreme Court).  The ostensible reason is that banning reverse payment agreements would "reduce the deficit and lower [the] nation's health care costs" (a mantra of patent reform proponents with almost equally little factual basis).  Calling it a "recent anticompetitive trend," the Report characterizes reverse payment agreements as merely a way for branded pharmaceutical companies to delay generic entry, thus delaying "the introduction of lower-cost prescription drug alternatives for American consumers."  The FTC Chairman was quoted as saying that "[w]hile a lot of companies don't engage in pay-for-delay settlements, the ones that do increase prescription drug costs for consumers and the government each year.  Fortunately, Congress has the opportunity to fix this problem through the Joint Select Committee on Deficit Reduction — and save the government and American taxpayers billions of dollars," something the FTC has not been able to accomplish through litigation or the normal Congressional process (see "Sen. Kohl Introduces Bill to Prohibit Reverse Payments").  The Commission contends that the cost savings from a ban on reverse settlements would amount to $2.67 over 10 years due to savings from Medicare and Medicaid expenses.

    Under the Medicare Prescription Drug, Improvement and Modernization Act of 2003, settlements between innovator drug companies and generic competitors must be filed with the FTC.  The text of this Report is an update of the Report released earlier this year (May 2011) providing a synopsis of such agreements between 2003 and 2010.  The update adds data from 2011:  according to the Report, the FTC received information on 156 "final resolutions" of ANDA litigation between branded and generic drug makers.  Of these, 28 contained a combination of compensation to the generic pharmaceutical company and a restriction on the ability of the generic drug maker to market the generic drug.  These settlements "involved 25 different branded" drugs having annual sales of more then $9 billion in total.  Another 100 settlements contained restrictions on marketing the generic drug without any "explicit" compensation, while the remaining 28 settlements had neither compensation nor market restrictions.  Of particular interest were settlements involving "first" ANDA filers, who were potentially entitled to a 180-day market exclusivity period.  Of these 54 agreements, 18 (one-third) had provisions that both compensated the generic drug maker and restricted access to the marketplace, with 10 of the 18 having express provisions prohibiting the branded pharmaceutical company from competing with an "authorized generic" or contained an exclusive license from the branded pharmaceutical company that permitted the generic drug maker to produce an authorized generic drug.  Another 29 settlements restricted market access by the generic drug maker but provided no compensation.  As part of the Report, a Table was provided that integrated the 2011 data with the previously released data from 2004-2010:

    Table
    While the total number of settlements continues to increase, the percentage containing reverse payments is decreasing, particularly among first filers.  This trend seems to indicate that the scrutiny occasioned by FTC displeasure over these agreements (or the threat of antitrust litigation (from state as well as private "attorneys general"; see "Second Circuit Denies En Banc Reconsideration in Cipro® Case") is having the FTC's desired effect.  It is also possible that the real trend here is the overall increase in ANDA litigation settlements, which may indicate that the industry (both branded and generic) is coming to recognize that the Hatch-Waxman ANDA regime is wasteful of resources that might better be spent addressing deficiencies in the pharmaceutical pipeline (see "Maybe Hatch-Waxman Data Exclusivity Isn't So Good For Traditional Drugs After All").  It seems evident that the Commission will continue with its ideological idée fixe to ban reverse payment settlement agreements, regardless of whether they are either necessary or in the public interest.

  • By Kevin E. Noonan

    President Signs HR1249_cropThe Leahy-Smith America Invents Act (AIA) revises the law relating to third-party submissions of patent and printed publications in patents (Section 6(h)) and patent applications (Section 8).  In both instances the scope of the prior art, the type of art that can be cited, and/or the timing for citing such art has changed.

    Section 6(h) revises 35 U.S.C. § 301 to include "statements of the patent owner filed in a proceeding before a Federal court or the Office in which the patent owner took a position on the scope of any claim of a particular patent" (§ 301(a)(2)) to "prior art consisting of patents or printed publications which that person believes to have a bearing on the patentability of any claim of a particular patent" (§ 301(a)(1)).  In addition, § 301(b) provides that an explanation in writing of "the pertinence and manner of applying the prior art or written statements to at least 1 claim of the patent" will result in the statements and explanation becoming part of the official patent file.  In addition to the conventional categories of prior art, the AIA provides that the "written statements" can include "any other documents, pleadings, or evidence from the proceeding in which the statement was filed that addresses the written statement" (§ 301(c)).  However, the statute limits the purposes to which written statements can be used, specifically ex parte reexamination, inter partes review, or post-grant review proceedings (§ 301(d)).  Unlike other provisions of the AIA relating to third-party submissions, amended § 301(e) permits the third party to keep its identity confidential.  These provisions become effective on the one-year anniversary of the statute's enactment (i.e., September 16, 2012) and apply to any patent application filed before, on, or after" that date.

    Section 8 concerns third-party submissions to the Office relating to pending applications.  Revisions to 35 U.S.C. § 122(e) provide a window for submitting "any patent, published patent application, or other printed publication of potential relevance to the examination of the application" before the earlier of the date a Notice of Allowance is issued by the Office (§ 122(e)(1)(A)) or the later of 6 months after publication of the application or the date the application was first rejected during examination (§ 122(e)(1)(B)).  The submission must be in writing and "set forth a concise description of the asserted relevance of each submitted document" (§ 122(e)(2)(A)), as well as being accompanied by any fee the Director may require (§ 122(e)(2)(B), and "include a statement by the person making such submission affirming that the submission was made in compliance with this section" (§ 122(e)(2)(C)).  These provisions become effective on the one-year anniversary of the statute's enactment (i.e., September 16, 2012) and apply to any patent application filed before, on, or after" that date.

  • By Donald Zuhn

    USPTO Building FacadeLast week, the U.S. Patent and Trademark Office announced that it had met or exceeded all of its goals for fiscal year 2011 (FY2011).  The most significant goal to be met on the patent side was the reduction of unexamined patent applications to 669,625, which constituted a five-year low and represented a 10% drop in the backlog since FY2009 when Director David Kappos took office.  The reduction in the application backlog was all the more impressive given an average annual increase in application filings of 5%.  Additional data regarding USPTO performance in FY2011 will be made available next month when the Office releases its annual performance and accountability report.

  • By Kevin E. Noonan

    President Signs HR1249_cropIn addition to an entirely new post-grant review procedure, the AIA contains significant revisions to the current inter partes re-examination proceedings (which are now termed "inter partes review").  Section 6(a) of the AIA sets forth these revisions to inter partes review.  The most significant of these is a change in the standard for granting a request (now termed a "petition") for inter partes review, from raising a "substantial new question of patentability" under current law to "a reasonable likelihood that the petitioner will prevail with regard to at least one claim" (§ 314(a)).  The revisions to the statute maintain the express prohibition against the patentee requesting inter partes review (§ 311(a)), as well as limiting the scope of review to patents and printed publications (§ 311(b)).  To accommodate the new post-grant review proceedings, petitions for inter partes review are permitted at the later of 9 months from the grant date of a patent or reissued patent, or the date of termination of post-grant review (§ 311(c)(1) or (2)).  Also consistent with current law are provisions that the Director's decision whether to grant inter partes review cannot be appealed (§ 314(d)).

    Inter partes review petitions cannot be filed anonymously, requiring identification of all real parties in interest (§ 312(a)(2)), and must identify "in writing and with particularity, each claim challenged, the grounds on which the challenge to each claim is based, and the evidence supporting the challenge to each claim" (§ 312(a)(3)).  The petition must be accompanied by copies of all patents or printed publications and any affidavits containing supporting evidence or opinion (§§ 312(a)(3)(A) and (3)(B)), as well as "any other information that the Director may require by regulation" (§312(a)(4)).  The petition and all supporting evidence must be supplied to the patent owner or a designated representative (§312(a)(5)).  As with other proceedings concerning granted patents, inter partes review is public and made available "[a]s soon as practicable after receipt of a petition" for review (§ 312(b)).

    The patentee has the option of responding to the petition within a time period set by the Director, which response is limited to providing reasons why the petition fails to meet any of the requirements for its grant (§313).  Petitions must put forth evidence (presumably in light of any evidence or argument in the patentee's response) that if unrebutted would establish a "reasonable likelihood" that at least one challenged claim would be invalidated (§ 314(a)).  The Director must make the determination to institute post-grant review within three months after receiving the patentee's response or when the time for that response has expired (§ 314(b)), by notifying the petitioner and the patentee (and the public), wherein the notice contains the date on which the review will commence (§ 314(c)).

    There are additional limits to when post-grant review petitions can be filed.  The bill prohibits grant of inter partes review to a petitioner who has filed a "civil action challenging the validity of a claim of the patent" (§ 315(a)(1)) (which includes declaratory judgment actions but expressly excludes counterclaims in patent infringement litigation; § 315(a)(3)).  Should an inter partes review petitioner file such an action after filing the petition, the statute provides for an "automatic" stay of such a civil action (§ 315(a)(2)) until either the patent owner moves for the stay to be lifted (§ 315(a)(2)(A)), the patent owner files a civil action alleging infringement against the petitioner (§ 315(a)(2)(B)), or the petitioner moves for dismissal of the civil action (§ 315(a)(2)(C)).  In addition, an inter partes review proceeding will not be instituted if the petition is filed "more than one year after the date on which the petitioner . . . is served with a complaint alleging" patent infringement (§ 315(b)).  The bill grants the Director the authority to consolidate petitions in the case of multiple filings by third parties (§ 315(c)), as well as determining whether to "stay, transfer, consolidate[e] or terminat[e]" ex parte or inter partes review proceedings, interferences or (presumably) derivation proceedings (§ 315(d)).  The bill also contains estoppel provisions, wherein a petition is estopped from "request[ing] or maintain[ing] a proceeding before the Office with respect to any claim on any ground that the petition raised or reasonably could have raised during post-grant review" (§ 315(e)(1), and is also estopped from bringing a civil action (e.g., a declaratory judgment action) or an action before the International Trade Commission based on any ground that was raised or reasonably could have been raised during the inter partes review (§ 315(e)(2)).

    Unlike current inter partes reexamination, however, inter partes review proceedings are to be held before the Patent Trial and Appeal Board and not replicate ex parte examination under 35 U.S.C. §§ 132-133 (§ 316(c)).  The Director is granted the authority under these provisions of the bill to establish regulations, including:

    (1) providing that the file of any proceeding under this chapter shall be made available to the public, except that any petition or document filed with the intent that it be sealed shall, if accompanied by a motion to seal, be treated as sealed pending the outcome of the ruling on the motion;

    (2) setting forth the standards for the showing of sufficient grounds to institute a review under section 314(a);

    (3) establishing procedures for the submission of supplemental information after the petition is filed;

    (4) establishing and governing inter partes review under this chapter and the relationship of such review to other proceedings under this title;

    (5) setting forth standards and procedures for discovery of relevant evidence, including that such discovery shall be limited to—

    (A) the deposition of witnesses submitting affidavits or declarations; and

    (B) what is otherwise necessary in the interest of justice;

    (6) prescribing sanctions for abuse of discovery, abuse of process, or any other improper use of the proceeding, such as to harass or to cause unnecessary delay or an unnecessary increase in the cost of the proceeding;

    (7) providing for protective orders governing the exchange and submission of confidential information;

    (8) providing for the filing by the patent owner of a response to the petition under section 313 after an inter partes review has been instituted, and requiring that the patent owner file with such response, through affidavits or declarations, any additional factual evidence and expert opinions on which the patent owner relies in support of the response;

    (9) setting forth standards and procedures for allowing the patent owner to move to amend the patent under subsection (d) to cancel a challenged claim or propose a reasonable number of substitute claims, and ensuring that any information sub- mitted by the patent owner in support of any amendment entered under subsection (d) is made available to the public as part of the prosecution history of the patent;

    (10) providing either party with the right to an oral hearing as part of the proceeding;

    (11) requiring that the final determination in an inter partes review be issued not later than 1 year after the date on which the Director notices the institution of a review under this chapter, except that the Director may, for good cause shown, extend the 1-year period by not more than 6 months, and may adjust the time periods in this paragraph in the case of joinder under section 315(c);

    (12) setting a time period for requesting joinder under section 315(c); and

    (13) providing the petitioner with at least 1 opportunity to file written comments within a time period established by the Director.

    The only constraint the Section puts on the Director is a consideration of "the effect of any such regulation on the economy, the integrity of the patent system, the efficient administration of the Office, and the ability of the Office to timely complete proceedings instituted under this chapter" (§ 316(b)).

    The patentee is given the right to file one motion to amend one or more of the challenged claims, either by cancelling the claims outright or proposing a "reasonable number" of substitute claims for each cancelled claim (§ 316(d)(1)(B)).  Any further motion to amend can be filed only as an agreed motion between the patentee and the petitioner (§ 316(d)(2)) (although the Director is given the authority to promulgate regulations affecting this statutory limitation), and any amendments filed in any motion under this section "may not enlarge the scope of the claims . . . or introduce new matter" (§ 316(d)(3)).  The petitioner bears the burden of proof by a preponderance of the evidence (§ 316(e)).

    An inter partes review can be terminated by settlement (§ 317) or decision of the Board (§ 318).  While similar to current provisions for settlement in interferences, the provisions differ in that whether review is terminated or the Board renders a decision is at the discretion of the Director (§ 317(a)).  Review terminated by settlement does not raise any of the estoppels provided for in (§ 315(e)).  As with interferences, any such settlement must be in writing and filed with the Office before review will be terminated and, although the settlement will not be published with the remainder of the review proceedings, settlements will be available to Federal Government agencies upon written request, or anyone upon a showing of "good cause" (§ 317(b)).

    The provisions regarding decisions of the Board provide for a certificate "canceling any claim of the patent finally determined to be unpatentable, confirming any claim of the patent determined to be patentable, and incorporating in the patent by operation of the certificate any new or amended claim determined to be patentable" (§ 318(b)).  Amendments or new claims can raise intervening rights pursuant to 35 U.S.C. § 252 (§ 318(c)).  The Office is tasked with making available the length of time it takes for the Board to complete its review (§ 318(d)).

    Any party is entitled to appeal a "adverse" decision after post-grant review, under any of the provisions of 35 U.S.C. §§ 141-144 (§ 319).

    The Office must establish regulations for implementing these changes "not later than" a year after the enactment date of the bill into law (Section 6(c)(1)) and "shall apply to all patents issued before, on or after" the effective date (Section 6(c)(2)(A)).  The Director also has discretion to limit the number of inter partes review petitions granted for the first four years after enactment, provided that the number is at least as many requests/petitions that were granted "in the last full fiscal year prior to the enactment date" of the revised law (Section 6(c)(2)(B)).  The bill also contains "transition provisions" (Section 6(c)(3)) amending the current statute to incorporate the changed standard (from "substantial new question of patentability" under current law to "a reasonable likelihood that the petitioner will prevail with regard to at least one claim") (Section 6(c)(3)(A)) for inter partes review requests filed between the date of the bill's enactment and the effective date of the revisions (Section 6(c)(3)(B)).  Inter partes reexamination shall proceed under current law and regulation "as if subsection (a) had not been enacted" for requests filed before the effective date (September 16, 2012)(Section 6(c)(3)(C)).