The Leahy-Smith America Invents Act (H.R. 1249) introduces Post-Grant Review

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1 PATENT ACT 2011: SIMILARITIES AND DIFFERENCES BETWEEN U.S. POST-GRANT REVIEW PROCEEDINGS AND EUROPEAN PATENT OFFICE OPPOSITIONS The Leahy-Smith America Invents Act (H.R. 1249) introduces Post-Grant Review proceedings into U.S. patent laws, by adding a new Chapter 32 to Title 35 of the United States Code (U.S.C.). These post-grant review provisions will come into effect on September 16, one year after the date of enactment of the Act. Although current provisions of the U.S. patent laws permit a form of post-grant review of issued patents through reexamination proceedings (35 U.S.C. 302 and 311), the reexamination proceedings are limited to issues of patentability relating to prior art patents or printed publications that establish a substantial new question of patentability (35 U.S.C. 303 and 312). The America Invents Act significantly expands these options, by providing a new Post- Grant Review proceeding in Section 6(d) of H.R that is, in many respects, similar to foreign oppositions but not in all. The table below provides a brief overview of some of the similarities and differences between the U.S. Post-Grant Review provisions and the Opposition procedure before the European Patent Office (EPO). Citations given for the U.S. Post-Grant Review provisions are to Title 35, United States Code, as amended by the America Invents Act. Citations for the European Opposition procedure are to the Articles of and the Implementing Regulations to the Convention on the Grant of European Patents (EPC). George F. Lehnigk Quadeer A. Ahmed [1]

2 Who May Petition? Scope Grounds Filing Deadline Requirements U.S. Post-Grant Review Any person (natural person or legal entity) who is not the patent owner. 35 U.S.C. 321(a) At least one claim of the patent. 35 U.S.C. 321(b) Non-patentable subject matter Lack of novelty Obviousness Failure to comply with the written description, enablement or definiteness requirements of 35 U.S.C. 112 Failure to comply with requirements with respect to reissue patents A novel or unsettled legal question is presented. 35 U.S.C. 321(b) 35 U.S.C. 324(b) Not later than nine (9) months after patent grant date or date of issuance of a reissue patent. 35 U.S.C. 321(c) Fee Identify the real parties in interest Identify each claim challenged Grounds on which the challenge to each identified claim is based Evidence that supports the grounds for the challenge Provide copies to patent owner. 35 U.S.C. 322(a) EPO Opposition Any person (natural person or legal entity) who is not the patent owner. See Article 99(1) EPC (see also Decision G 9/93). At least one ground for opposition. Article 100 EPC Rule 76(2)(c) EPC Non-patentable subject matter Invention is offensive to public order or morality Invention is a plant or animal variety or a process for producing a plant or animal (unless it is microbiological) Methods for treatment of the human or animal body by surgery or therapy and related diagnostic methods Lack of novelty Lack of inventive step Lack of industrial applicability The patent discloses the invention insufficiently clearly and completely The patent subject matter extends beyond the content as filed. Article 100 EPC Article 53 EPC Within nine (9) months from the publication of the mention of patent grant in the European Patent Bulletin. Article 99(1) EPC Fee Particulars of the opponent (who may, however, be a straw man ) The number of the EP patent being opposed Statement of the extent to which the EP patent is opposed Grounds on which the opposition is based Evidence that supports the grounds for opposition. Rule 76 EPC [2]

3 Public Availability Preliminary Response Applicable Standards Relationship to Civil Actions Preliminary Injunctions The petition for, the institution of, and the proceedings themselves of a post-grant review are available to public, except for documents placed under seal. 35 U.S.C. 322(b) 35 U.S.C. 324(d) 35 U.S.C. 326(a)(1) Patent owner has a right to file a preliminary response within a time period (still to be set) giving the reasons why no post-grant review should be instituted. 35 U.S.C. 323 Petitioner has burden to plead a prima facie case of unpatentability of at least one claim for a post-grant review to be instituted. 35 U.S.C. 324(a) Once the post-grant review is instituted, petitioner has the burden of proof by a preponderance of the evidence. 35 U.S.C. 326(e) If petitioner files a civil action, the petitioner is barred from thereafter filing a post-grant review petition. 35 U.S.C. 325(a)(1). If civil action is filed by petitioner on or after date of filing post-grant review petition, the civil action is automatically stayed until: Patent owner moves the court to lift stay, or Patent owner files civil action or counterclaim alleging petitioner infringed patent. 35 U.S.C. 325(a)(2) If civil action by patent owner alleging infringement of patent is filed within 3 months after patent grant date, court cannot stay its consideration of the patent owner s motion for preliminary injunction against petitioner even if post-grant [3] Opposition proceedings are available to the public (subject to some exceptions in Rule 144 EPC) Article 128(4) EPC Opposition Division must give the patent proprietor an opportunity to file observation and/or amend the patent. Rule 79(1) EPC Principle of free evaluation of evidence: each piece of evidence is given weight commensurate with its probative value (in essence, a sliding scale). See, e.g., Guidelines Part C Chapter. IV - Paragraph No automatic stay in national courts. Some national courts allow a revocation action to be filed in parallel with opposition. National courts often have discretion to either: Stay the national proceedings (until opposition proceedings completed), or Allow the revocation proceedings to continue. This varies from country to country in Europe. See Glaxo Group Ltd v Genentech Inc & Anor [2008] EWCA Civ 23 (31 January 2008). This is country-dependent in Europe Generally, obtaining a preliminary injunction is possible while opposition proceedings are ongoing.

4 Joinder Estoppel Provisions Possibility to Amend Oral Hearing Submission of Evidence Discovery review petition is filed by petitioner. 35 U.S.C. 325(b) If more than one post-grant review petition is properly filed against a single patent, the petitions may be consolidated by the Patent Office into single post-grant review. 35 U.S.C. 325(c) A petitioner may not request a proceeding before the USPTO, with respect to any ground that petitioner raised or could have raised during post grant review. Similarly, in a civil action or ITC proceeding, the petitioner is estopped from raising arguments that the petitioner raised or could have raised during post grant review. 35 U.S.C. 325(e) Patent owner can move to amend the patent either to cancel a challenged claim or to propose a reasonable number of substitute claims. 35 U.S.C. 326(d) Parties will have the right to an oral hearing. 35 U.S.C. 326(a)(11) The petition for post-grant review must provide evidence that supports the grounds for the challenge to each claim. 35 U.S.C. 322(a)(3) Regulations will set standards and procedures for discovery of relevant evidence. 35 U.S.C. 326(a)(5) There is only one opposition per patent; multiple opponents are consolidated into one opposition proceeding. See also Article 105 (governing intervention by accused infringer) EPO Opposition decision does not preclude a subsequent challenge by an unsuccessful opponent at the national level even on the same grounds raised at the EPO. The European patent may be amended so long as the amendment does not extend beyond the content as filed or extend the scope of protection conferred and so long as the amendments are occasioned by a ground for opposition. Article 123(2)-(3) EPC Rule 80 EPC Oral proceedings shall take place if requested by any party or at the instance of the EPO. Article 116 EPC Evidence is given or obtained on request of a party and/or where the EPO considers it necessary. Article 117 EPC Rule 117 EPC No adversarial discovery in EPO, but evidence is given or obtained on request of a party and/or where the EPO considers it necessary. See Article 117 EPC See Rule 117 EPC. [4]

5 Final Determination Appeal Costs Sanctions Settlement Not later than one year following institution, extendable by USPTO by not more than six additional months. 35 U.S.C. 326(a)(11) Any party to the post-grant review may appeal the final decision to the Court of Appeals for the Federal Circuit. 35 U.S.C. 329 Whether the post-grant review is in fact instituted or not is, however, not subject to appeal. 35 U.S.C. 324(e) Regulations will set the fees in such amounts as determine[d] to be reasonable. 35 U.S.C. 321(a). In the U.S., each party generally bears its own costs unless sanctioned. Regulations will prescribe sanctions for abuse of discovery/process or any other improper use of post-grant review proceeding. 35 U.S.C. 326(a)(6) Post-grant reviews can be terminated upon joint request of any petitioner and the patent owner. Settlement moots estoppel provisions. 35 U.S.C. 327 No fixed schedule for the opposition procedure per se- time limits may be extended. Article 120 EPC An opposition generally may last about two years. Decisions of the Opposition Divisions are subject to appeal to the EPO Board of Appeal. Article 106 EPC Rule 99 EPC Decisions to reject an opposition as inadmissible are subject to appeal to the EPO Board of Appeal as well. See Article 106 EPC See Rules 77 and 99 EPC Article 104 states that each party shall bear the costs it has incurred. Opposition Division may order modification to apportionment of costs for reasons of equity. Article 104 EPC EPC does not to provide any express settlement provisions under opposition rules. However, parties may reach a settlement, although the EPO may continue the opposition proceedings of its own motion despite the settlement. Article 114 EPC Rule 84 EPC [5]