ACI’s 9th Annual Paragraph IV Disputes PTO Proceedings Retrospect: Exploring the Growing Use of IPR, PGR and CBM review in Hatch-Waxman Litigation April 27, 2015 1 Tweeting about this conference? #ParagraphIV Speakers Laura A. Lydigsen Shareholder and Co-Chair, Appellate Practice Group Brinks Gilson & Lione Gregory A. Morris Of Counsel Paul Hastings LLP Irena Royzman Partner Patterson Belknap Webb & Tyler Martin B. Pavane Member and Vice-Chair, IP Department; Co-Chair, ANDA and Biologics Cozen O'Connor Paul Ragusa \ Partner Baker Botts, LLP 2 #ParagraphIV PTAB Petitions for Orange Book Patents Statistics Year IPR (Listed/Total) CBM (Listed/Total) PGR (Listed/Total) 2012 3/94 (3.2%) 0/15 0 2013 9/695 (1.3%) 0/89 0 2014 42/1495 (1.7%) 6/173 1/3 2015 (4/15) 25/446 (5.6%) 0/38 0/2 3 #ParagraphIV PTAB Petitions for Orange Book Patents Statistics (Continued). • Grounds for challenge: • Obviousness (~90%) • Anticipation (~35%) • Types of claims challenged: • Formulation (~80%) • Method of Treatment (>50%) • Compound (~15%) • IPRs as Tool for Hedge Funds 4 #ParagraphIV Agenda • Initial IPR Considerations • Laura A. Lydigsen • Claim Construction and Instituting Trial • Irena Royzman • Lessons Learned After The First IPR Final Written Decisions • Gregory A. Morris • PTAB Trial Practice • Martin B. Pavane • IPR Appeals • Laura A. Lydigsen • PGRs & CBMs 5 • Paul Ragusa #ParagraphIV Initial IPR Considerations Laura Lydigsen Shareholder, Brinks, Gilson & Lione 6 #ParagraphIV Initial Considerations: Advantages of PTAB Patent Challenges • Lower burden of proof for invalidity • PTAB: preponderance of the evidence, 35 U.S.C. § § 316(e) (IPR), 326(e) (PGR/CBMPR) • District Court: clear and convincing evidence • Claim construction standard • PTAB: Broadest reasonable interpretation (BRI), 37 C.F.R. § § 4.2100(b), 200(b), 300(b); In re Cuozzo Speed Techs., LLC., _ F.3d _, 2015 WL 448667 (Fed. Cir. Feb. 4, 2015) • District Court: ordinary meaning at the time of invention. Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) #ParagraphIV 7 Initial Considerations: Advantages of PTAB Patent Challenges Cont’d • Time to decision • PTAB: 18 months, extendable to 24 months after filing of petition. 35 U.S.C. § 3.14(b); 37 C.F.R. § 42.100(c) • District court: ~2.5 years (source: http://www.pwc.com/en_US/us/forensicservices/publications/assets/2014-patent-litigation-study.pdf) • Grounds • PTAB: • IPR: anticipation and obviousness based on printed publications. 35 U.S.C. § 311(b). • CBM/PGR: • Any grounds that is a condition for patentability. 35 U.S.C. § 321(b); 37 C.F.R. § 304(b)(2) • PGR: Important new or unsettled legal questions. 37 C.F.R. § 42.208(d). • District Court: Any grounds that is a condition for patentability. 35 U.S.C. § 282. #ParagraphIV 8 Initial Considerations: Orange Book Patents • Prior decision upholding validity of OB patents • Teva v. Viiv, IPR2015-00550 (filed Jan. 8, 2015) (challenging OB patent for Trizavir®/abacavir sulfate+doutegravir sodium+vamivudine that is the subject to Fed. Cir. Appeal Nos. 14-1303, -1304, -1315) • Noven v. Novartis, IPR2014-00549, -550 (filed Apr. 2, 2014) (IPR instituting on two OB patents for Exelon® patch/rivastigmine extended release transdermal, one of which was instituted notwithstanding brand argument that D.Del. “has upheld the validity of the ‘023 patent over many of the same references raised”) • Manageable number of OB patents • But see: Amneal v. Jazz (challenging some of 15 OB patents listed for Xyrem®/sodium oxybate) 9 #ParagraphIV Initial Considerations: Orange Book Patents Cont’d • Non-FTF status • Consider pre-suit PTAB challenge • Late second filer option • Multi-defendant litigation • Best known prior art already before the USPTO • Complex technology/validity arguments • Strong secondary considerations evidence • Potentially weak validity defense 10 #ParagraphIV Initial Considerations: Timing • Time restrictions on filing at the PTAB • IPR: 1 year or less after petitioner served with infringement complaint. 35 U.S.C. § 315(b). Includes counterclaims. St. Jude Medical v. Volcano Corp., 749 F.3d 1373 (Fed. Cir. 2014). • CBM: Can file any time after 9 months from patent issuance. 37 CFR § 42.303. • PGR: Must be filed 9 months or less after issuance of patent or broadening reissue patent. 35 U.S.C. § 321(c). 11 #ParagraphIV Initial Considerations: Timing (Cont’d) • Joinder exception to the 1-year rule • “The [1-year] time limitation set forth in the preceding sentence shall not apply to a request for joinder under subsection (c).” • Joinder must be sought “no later than one month after the institution date of any inter partes review for which joinder is requested.” 37 C.F.R. § 42.122(b) • Teva v. ViiV, IPR IPR2015-00550 (filed Jan. 8, 2015, pending): Teva seeks to join IPR filed by Apotex that was instituted on Dec. 8, 2014 (Trizavir®/abacavir sulfate+doutegravir sodium+vamivudine) • Amneal v. Endo, IPR2014-1365 (filed Aug. 22, 2014, joinder granted Feb. 4, 2015): Amneal permitted to join its own prior IPR (Opana ER®/oxymorphone) #ParagraphIV 12 Claim Construction and Grounds for Instituting IPR Irena Royzman, J.D., Ph.D. Partner Patterson Belknap Webb & Tyler LLP 13 #ParagraphIV BRI v. Phillips: A Tale of Two Standards Prosecution History Claim Language Specification PTAB (unexpired patents) Broadest Reasonable Interpretation 37 C.F.R. §42.100(b) Extrinsic Evidence District Courts PTAB (expired patents) Ordinary & Customary Meaning #ParagraphIV Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc) 14 BRI v. Phillips: An Academic Concern? 15 #ParagraphIV BRI v. Phillips: An Academic Concern? BRI Phillips “The broadest reasonable interpretation of a claim term may be the same as or broader than the construction of a term under the Phillips standard. But it cannot be narrower.” Facebook, Inc. v. Pragmatus AV, LLC, 582 Fed. Appx. 864, 869 (Fed. Cir. 2014) #ParagraphIV 16 BRI v. Phillips: Two Bites at the The Federal Circuit also addressed the corresponding method claim 4 of the ’149 Patent, but split in a 2-1 decision in which the majority interpreted the claim more narrowly than the dissent and found it not invalid. However, when interpreted under the broadest reasonable interpretation standard applicable in inter partes review proceedings, claim 4 would have been obvious for the same reasons as the composition claims of the ’463 Patent. 17 Ferrum Ferro Capital, LLC v. Allergan Sales, LLC, IPR2015-00858, Petition at 3 (March 9, 2015) #ParagraphIV BRI v. Phillips: In re Cuozzo Panel Majority (Dyk and Clevenger) • BRI has been used in PTO proceedings for over 100 years. • Claims can be amended during IPR. • AIA vests PTO with power to prescribe regulations. Dissent (Newman) • Phillips should be the standard in IPRs same as in district court. • IPRs are a “surrogate” for district court litigation over validity. • No unfettered ability to amend claims in IPR. In re Cuozzo Speed Techs., LLC., 778 F.3d 1271 (Fed. Cir. 2015) #ParagraphIV 18 BRI v. Phillips: In re Cuozzo Dissent (Newman): • “[BRI] serves not to state the correct meaning of the claim, but to provide a framework for clarification and amendment.” • “Adoption of a broadest interpretation renders the PTAB rulings legally unreliable ….” • “PTAB tribunals cannot serve as a surrogate for district court litigation if the PTAB does not apply the same law to the same evidence.” 19 In re Cuozzo Speed Techs., LLC., 778 F.3d 1271 (Fed. Cir. 2015) #ParagraphIV BRI v. Phillips: In re Cuozzo • Cuozzo filed a petition for rehearing en banc on whether BRI is appropriate in IPR and whether there is judicial review of PTAB’s decision to institute IPR on appeal of a final decision. • Amici IPO, PhRMA, and 3M Company et al. urged en banc review and adoption of Phillips standard. • NYIPLA urged en banc review of both issues raised by Cuozzo’s petition. • Rehearing en banc? • SCOTUS? 20 #ParagraphIV Grounds for Instituting IPR 21 #ParagraphIV Grounds for Instituting IPR: In re Cuozzo Panel Majority (Dyk and Clevenger): • PTAB’s institution of IPR of claims based on references not identified in the petition for those claims is not reviewable even after final decision. • “The fact that the petition was defective is irrelevant because a proper petition could have been drafted.” • “The failure to cite those references in the petition provides no ground for setting aside the final decision.” In re Cuozzo Speed Techs., LLC., 778 F.3d 1271 (Fed. Cir. 2015) #ParagraphIV 22 Grounds for Instituting IPR: In re Cuozzo Panel Majority (Dyk and Clevenger): • “It is not clear that IPR is strictly limited to grounds asserted in the petition.” • “[M]andamus may be available to challenge the PTO’s decision to grant a petition to institute IPR after the Board’s final decision ….” • “[W]e did not decide the question of whether the decision to institute review is reviewable by mandamus after the Board issues a final decision ….” In re Cuozzo Speed Techs., LLC., 778 F.3d 1271 (Fed. Cir. 2015) #ParagraphIV 23 Grounds for Instituting IPR: In re Cuozzo Dissent (Newman): • “[T]he PTAB decision relies on arguments and evidence that had not been raised in the petition to institute, although the statute requires that all arguments and evidence must be presented in the petition.” • “The panel majority holds that ‘[t]he fact that the petition was defective is irrelevant because a proper petition could have been drafted.’ Such broad and conflicting departure from the statutory provisions cannot have been intended.” In re Cuozzo Speed Techs., LLC., 778 F.3d 1271 (Fed. Cir. 2015) #ParagraphIV 24 Role of PTAB: Examiners or Judges? or 25 #ParagraphIV Role of PTAB: Examiners or Judges? “An inter partes review is neither a patent examination nor a patent reexamination. Rather, it is a trial, adjudicatory in nature and constitutes litigation.” Google Inc. & Apple Inc. v. Jongerius Panoramic Technologies, LLC, IPR2013-00191, Decision at 4 (February 13, 2014) #ParagraphIV 26 Role of PTAB: Referee or Player? or 27 #ParagraphIV Lessons Learned • Argue claim construction in Patent Owner Preliminary Response. • Continue to argue claim construction. It may change through final decision. • Argue claim construction under both BRI and Phillips. • Stay flexible. Present evidence under alternative claim constructions. • Make use of existing testimony, claim construction and admissions from district court proceedings. • Point out differences between grounds in petition and decision to institute IPR. • Mandamus to challenge decision to institute IPR after PTAB issues a final decision? #ParagraphIV 28 Lessons Learned After the First IPR Final Written Decisions Gregory Morris, J.D., Ph.D. Of Counsel Paul Hastings 29 #ParagraphIV IPRs on OB Patents by the Numbers 106 4 FWDs 7 Settled Petitions filed 81 14 Pending at some stage Not instituted 13 Filed by hedge funds #ParagraphIV The First Four Data Points 1 Amneal v. Supernus IPR2013-00368 Dec. 9, 2014 Oracea 2 Amneal v. Supernus IPR2013-00371 Dec. 9, 2014 Oracea 3 Amneal v. Supernus IPR2013-00372 Dec. 9, 2014 Oracea 4 Apotex v. Wyeth IPR2014-00115 Apr. 20, 2015 Tygacil 31 #ParagraphIV Amneal v. Supernus Three OB patents challenged: • 8,206,740 (Chang II) • 8,394,405 (Chang III) • 8,394,406 (Chang IV) 32 IPR2013-00368 IPR2013-00371 IPR2013-00372 #ParagraphIV Amneal v. Supernus F F Amneal Files Petition June 2013 F D PO Preliminary Response Sept. 2013 E P E P A Amneal’s Petition Granted PO Response Dec. 2013 March 2014 PO Discovery Period D Amneal Files Reply to PO Response May 2014 Amneal’s Discovery Period Oral Hearing Aug. 2014 Final Written Decision Dec. 2014 PO Discovery Period 33 #ParagraphIV Amneal v. Supernus Challenged claims of all three patents found not invalid after FWD F F Amneal Files Petition June 2013 F D PO Preliminary Response Sept. 2013 E P E P A Amneal’s Petition Granted PO Response Dec. 2013 March 2014 PO Discovery Period D Amneal Files Reply to PO Response May 2014 Amneal’s Discovery Period Oral Hearing Aug. 2014 Final Written Decision Dec. 2014 PO Discovery Period 34 #ParagraphIV Amneal v. Supernus No appeal F F Amneal Files Petition June 2013 F D PO Preliminary Response Sept. 2013 E P E P A Amneal’s Petition Granted PO Response Dec. 2013 March 2014 PO Discovery Period D Amneal Files Reply to PO Response May 2014 Amneal’s Discovery Period Oral Hearing Aug. 2014 Final Written Decision Dec. 2014 PO Discovery Period 35 #ParagraphIV Apotex v. Wyeth OB patent challenged: • 7,879,828 36 IPR2014-00115 #ParagraphIV Apotex v. Wyeth C C F E A Apotex Files Petition Apotex’s Petition Granted PO Response Nov. 2013 Apr. 2013 July 2014 PO Discovery Period Apotex Files Reply to PO Response Nov. 2014 Oral Hearing Jan. 2015 Final Written Decision Apr. 2015 Apotex’s Discovery Period 37 #ParagraphIV Apotex v. Wyeth Challenged claims found not invalid after FWD C C F E A Apotex Files Petition Apotex’s Petition Granted PO Response Nov. 2013 Apr. 2013 July 2014 PO Discovery Period Apotex Files Reply to PO Response Nov. 2014 Oral Hearing Jan. 2015 Final Written Decision Apr. 2015 Apotex’s Discovery Period 38 #ParagraphIV Apotex v. Wyeth PTAB: “Dr. Nelson’s unsupported and unexplained opinions are not persuasive.” C C F E A Apotex Files Petition Apotex’s Petition Granted PO Response Nov. 2013 Apr. 2013 July 2014 PO Discovery Period Apotex Files Reply to PO Response Nov. 2014 Oral Hearing Jan. 2015 Final Written Decision Apr. 2015 Apotex’s Discovery Period 39 #ParagraphIV Lessons Learned • Branded pharmaceutical patents, even formulation patents, can be successfully defended before the PTAB 40 #ParagraphIV Lessons Learned • Interpretation of the facts by experts is critical • Carefully select experts whom PTAB will credit and prepare declarations addressing in detail how a POSA would view the cited art • Cross-examine opposing experts in depositions in same manner as at a trial because they won’t testify live 41 #ParagraphIV Lessons Learned • Use clear and persuasive demonstratives that cite to the record to drive your points home before the PTAB at oral argument 42 #ParagraphIV Lessons Learned • Use clear and persuasive demonstratives that cite to the record to drive your points home before the PTAB at oral argument • KNOW YOUR RECORD COLD! 43 #ParagraphIV Practice Before the Patent Trial and Appeal Board Presented By: Martin B. Pavane Cozen O'Connor Vice Chair, Intellectual Property Department Co-Chair, ANDA and Biologics Practice Group 277 Park Avenue | New York, NY 10172 P: 212.883.4994 | F: 646-588-1478 mpavane@cozen.com • Process begins with a third party filing a petition within 9 months after the grant of the patent or reissue patent • Other than for business method patents, post-grant review is available only for patents that have a priority date later than March 15, 2013 • Any ground of invalidity may be asserted. Not limited to 35 U.S.C. §§ 102 or 103 or prior art patents and printed publications • Petitioner cannot file if it has initiated a litigation • Requester showing that it is more likely than not that at least one challenged claim is unpatentable • Entitled to “routine” discovery; additional discovery if agreed to, or requested and granted by the Board; additional discovery must be “for good cause” • If the proceeding is instituted, a final determination by the Board will be issued within 1 year after institution (extendable for good cause by 6 months) #ParagraphIV 45 Overview - Post Grant Review • Process begins with a third party filing a petition: • For patents having a priority date later than March 15, 2013 - 9 months or more after the grant of the patent or reissue patent (unless a post-grant review was instituted, in which case, a petition cannot be filed until after the termination of such post-grant review) • For patents having a priority date of March 15, 2013 or earlier – any time • Petitioner cannot file petition if it already initiated a litigation or was served with a Complaint in patent infringement action more than one year prior to filing petition for inter partes review • Inter partes review may only be based on 35 U.S.C. §§ 102 or 103, and only on prior art consisting of patents or printed publications • Inter partes review may be instituted upon a showing that there is a reasonable likelihood that at least one challenged claim is unpatentable • “Comparing the two standards, the ‘reasonable likelihood’ standard is lower than the ‘more likely than not’ standard. The reasonable likelihood standard allows for the exercise of discretion but encompasses a 50/50 chance whereas the ‘more likely than not’ standard requires greater than a 50% chance of prevailing.” Message from Chief Judge James Donald Smith, Board of Patent Appeals and Interferences: USPTO Discusses Key Aspects of New Administrative Patent Trials (http://www.uspto.gov/aia_implementation/smith-blog-extravaganza.jsp#heading-1) • Entitled to “routine” discovery; additional discovery if agreed to, or requested and granted by the Board; additional discovery must be “in the interests of justice” • If the proceeding is instituted, a final determination by the Board will be issued within 1 year after institution (extendable for good cause by 6 months) #ParagraphIV 46 Overview – Inter Partes Review • For both post grant review and inter partes review • Pre-AIA: “the estoppel provision of § 315 is triggered not when examination is completed but only after all appeal rights have been exhausted.” Bettcher Indus. v. Bunzl USA, Inc., 661 F.3d 629, 642-643 (Fed. Cir. 2011) • AIA: Estoppel attaches upon PTAB’s final written decision, after which the petitioner “may not assert either in a civil action … or in a proceeding before the International Trade Commission … that the claim is invalid on any ground that the petitioner raised or reasonably could have raised during” post-grant or inter partes review. See 35 U.S.C §§ 315, 325 • Since invalidity grounds that petitioner can raise in post grant review are broader than inter partes review, scope of estoppel will likely be broader • Parties can settle post grant review or inter partes review – no estoppel without final written decision #ParagraphIV 47 Overview - Estoppel • No need for case or controversy for PTAB proceedings. Note that there is a need for case or controversy to appeal a PTAB decision to CAFC. See Consumer Watchdog v. Wisconsin Alumni Research Found., 753 F.3d 1258 (Fed. Cir. 2014). • Claim Construction: Broadest reasonable construction vs. court interpretation • Standard of Proof: preponderance of evidence vs. clear and convincing evidence • Discovery: limited in PTAB proceedings vs. full discovery in litigation • Patentee can amend claims (once) during post grant review or inter partes review (but PTAB has not granted many requests to amend claims) • Cost #ParagraphIV 48 Overview - Differences Between Litigation and Post Grant Review/Inter Partes Review • Still available after AIA • May only be based upon patents or printed publications • Requires a showing that the prior art establishes a substantial and new question of patentability • Requester can be anonymous • Other than petition for ex parte reexamination, requester is not involved (unless patent owner files response to petition) • No estoppel • Patentee can amend claims more freely than in post grant review or inter partes review #ParagraphIV 49 Overview - Ex Parte Reexamination • Three categories of discovery: • Mandatory initial disclosures; • “Routine” discovery; and • Additional discovery. #ParagraphIV 50 PTAB Proceedings - Discovery PTAB Proceedings - Discovery • Information a party must provide to the other side • No need for motion practice or discovery request. Nichia Corp. v. Emcore Corp., IPR2012-00005, Paper 19, page 2 #ParagraphIV 51 • Routine Discovery Routine Discovery • “any exhibit cited in a paper or in testimony must be served with the citing paper or testimony”; • “Cross examination of affidavit testimony”; and • “relevant information that is inconsistent with a position advanced by the party during the proceeding.” #ParagraphIV 52 • Routine discovery: • Party must provide such discovery at the same time it serves a paper or testimony citing it • No requirement to create materials • Does not require that “all the underlying data and lab notebooks be produced” with a paper that references an experiment. See Corning Inc. v. DSM IP Assets B.V., IPR2013-00043, Paper 27, page 3. #ParagraphIV 53 Exhibits Cited in a Paper or Testimony • Party relying upon declarant must arrange to make that witness available for cross-examination • Burden and expense falls upon party relying upon declarant #ParagraphIV 54 Cross Examination of Affidavit Testimony • Does not include material protected by attorney-client privilege or attorney work product immunity • “[N]arrowly directed to specific information known to the responding party to be inconsistent with a position advanced . . . , and not broadly directed to any subject area in general within which the requesting party hopes to discover such inconsistent information.” Garmin Int'l Inc. et al. v. Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 26, pages 3-4. #ParagraphIV 55 Information Inconsistent With a Party’s Position • The parties may agree to additional discovery • If the parties fail to agree, a party may move for additional discovery • If parties do not agree, requests for additional discovery are rarely granted #ParagraphIV 56 Additional Discovery • The moving party must show that additional discovery: • Is “in the interests of justice” in an IPR proceeding • Meets the “good cause” standard in a post-grant review proceeding • “interests of justice” standard is slightly higher than the “good cause” standard, but PTAB looks at same factors (Garmin factors) in both cases. See Bloomberg Inc. v Markets-Alert, Pty Ltd., CBM 201300005, Paper 32 (May 29, 2013). #ParagraphIV 57 Additional Discovery • PTAB in Garmin v. Cuozzo, IPR2012-00001, Paper 20 (Feb. 14, 2013) identified five factors to consider when determining whether additional discovery will be permitted: (1) Request must be based upon “more than a possibility and mere allegation”; (2) Requests that seek discovery of litigation positions and case theories are not appropriate; (3) Requests for information a party can reasonably figure out or assemble are not appropriate; (4) The requests should be easily understandable; (5) The requests must not be overly burdensome to answer. #ParagraphIV 58 Additional Discovery - Factors • To satisfy the first factor, the requesting party must: (1) possess evidence tending to show that the requested discovery will lead to further evidence; and (2) establish that something useful will be found. • PTAB decisions suggest that the first factor must be met to have any possibility of getting additional discovery. See Redline Detection, LLC v. Star EnviroTech, Inc., IPR 2013-00106, Paper 31, page 5 (Aug. 27, 2013) (emphasis added). #ParagraphIV 59 Additional Discovery – First Factor Joinder • “If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314.” #ParagraphIV 60 • 35 U.S.C. § 315(c): Joinder • “The Leahy-Smith America Invents Act (AIA) permits joinder of like review proceedings. Thus, an inter partes review (IPR) may be joined with another inter partes review, and a post-grant review (PGR) may be joined with another post-grant review.” #ParagraphIV 61 • Microsoft Corp. v. Proxyconn, Inc., IPR201300109, Paper 15, page 3 (February 25, 2013): • Requests for joinder can be used by defendants in related district court patent infringement actions to ensure that an IPR will proceed even if the patent owner settles with one IPR petitioner/litigation defendant • The request should: • Explain why joinder is appropriate; • Identify grounds of unpatentability asserted in the petition; • Explain what impact, if any, joinder would have on the trial schedule for the existing proceeding; and • Address how briefing and discovery may be simplified. See Kyocera Corporation v. Softview LLC, IPR2013-00004, Paper 15, page 4 (April 24, 2013) #ParagraphIV 62 Joinder • 37 C.F.R. §42.101(b) (and 35 U.S.C. §315(b)) include a oneyear bar, i.e., an inter partes review may not be instituted if the petition requesting the proceeding was filed more than one year after the date on which the petitioner, real party in interest or privy of the petitioner was served with a patent infringement complaint • However, the one-year bar does not apply when the petition for IPR is accompanied by a request for joinder. See 37 C.F.R. §42.122(b); Microsoft Corp. v. Proxyconn, Inc., IPR2013-00109, Paper 15, page 3 (February 25, 2013) #ParagraphIV 63 Joinder – Exception to the OneYear Ban • Can petition for joinder be filed by same party that filed original petition? • In Target Corp. v. Destination Maternity Corp., IPR2014-00508, expanded PTAB panel majority found that joinder was permissible even though Target was the petitioner in both proceedings. #ParagraphIV 64 Joinder – Exception to the OneYear Ban 65 Settlement • http://www.uspto.gov/sites/default/files/documents/040915_aia_stat_ graph.pdf #ParagraphIV Settlement • Preauthorization is required • May be filed at any stage of the proceeding, even before institution • Board has discretion to proceed to final written decision; more likely at an advanced stage when all briefing is complete • Board is more likely to grant early motions to terminate, i.e., without written decision #ParagraphIV 66 • Parties may file a joint motion to terminate a proceeding on the basis of settlement PTAB Appeals Laura Lydigsen Shareholder, Brinks, Gilson & Lione 67 #ParagraphIV PTAB Appeals • Notice of appeal • Timing for notice: 63 days v. 60 days (37 C.F.R. § 90.3) • Content of the notice of appeal • Involvement of USPTO solicitor • The merits? • How is the Federal Circuit handling multiple IPRs on the same patent? • Briefing • Argument • Early outcomes 68 #ParagraphIV Post Grant Review & Covered Business Method Review Paul Ragusa Partner, Baker Botts, LLP 69 #ParagraphIV Post-Grant Review • Of 5 filed to date, 1 against an Orange Book patent. • Accord Healthcare, Inc. v. Helsinn Healthcare S.A., et al., IPR2014-00010 • Petition filed on September 2, 2014 • Asserted invalidity under Section 112. • PGR Terminated November 24 • "Under these circumstances, and in view of the preliminary stage of the current proceeding, we determine that it is appropriate to enter judgment and terminate the proceeding without rendering a final decision." #ParagraphIV 70 Covered Business Method Review • Who can petition for CBM? • Petitioner must have been sued for infringement or have standing to bring DJ action against patent. • 37 CFR 42.302(a). • Covered business method patent: • "a patent that claims a method or corresponding apparatus for performing data processing or other operations used in the practice, administration, or management of a financial product or service, except that the term does not include patents for technological inventions." 37 CFR 42.301(a). 71 #ParagraphIV Covered Business Method Review (cont.) • "Financial Product or Service" • Term refers to products/services that concern money, and not necessarily the financial services industry • SAP Am., Inc. v. Versata Dev. Group, Inc. CBM2012-000001 • Par Pharm., Inc., et al. v. Jazz Pharms., Inc. • Patents listed in Orange Book as covering Risk Evaluation and Mitigation System (REMS) for Sodium Oxybate • Institution denied - not CBM patents • Claims and spec did not apply to financial services 72 #ParagraphIV Covered Business Method Review (cont.) • "Technological Inventions" • A claim is not technological if: • its technical elements merely recite known technologies, such as computer hardware, communication or computer networks, software, memory, computer readable storage media, scanners, display devices, databases, etc.; • it merely recites known prior-art technology to accomplish a process or method, even if that process or method is itself novel and nonobvious; • it combines prior art structures to achieve the normal, expected, or predictable result of that combination. • A single non-technological claim of a patent is sufficient to institute a CBM review. 73 #ParagraphIV Questions? 74 #ParagraphIV