AIPLA Meeting Washington, DC 23 October 2015 Impact of Global Dossier and Harmonization on Patent System- Advantages for All Lawrence T. Welch Assistant General Patent Counsel Senior Director, Patent Operations © 2014 Eli Lilly and Company

Harmonization Vision of Users A system which allows for uniform, objective, predictable, and cost effective acquisition and enforcement of patents globally This would be good for all stakeholders. 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Group B+ View of Harmonization Harmonization needs to: “Be coherent and balanced: a) Offering a fair level of protection to inventors/applicants from all backgrounds b) Providing a fair balance between the rights of inventors/applicants and third parties (ii) Provide legal certainty to inventors/applicants and third parties alike (iii)Promote high quality patents by ensuring that patent protection is provided only to inventions that are new, involve an inventive step and are capable of industrial application (iv)Support economic growth: a) Enabling global patent rights to be acquired in an efficient manner b) Promoting consistent results in multiple jurisdictions c) Promoting innovation and competition “ Statement by the Chair, Group B+, Objectives and Principles, /SG/2/10 27 May 2015 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Company Confidential © 2014 Eli Lilly and Company How do we get there? Requires the cooperation of the offices Meetings of Trilateral and IP5 Offices with corresponding Trilateral and IP5 Industry groups has been extraordinary Many initiatives suggested by users have been rapidly implemented, see, e.g. the following procedural and substantive harmonization successes: Common App Format (CAF); Common Citation Doc (CCD); XML formats One Portal Dossier (OPD); WIPO CASE; Global Dossier Patent Prosecution Highway (PPH); Cooperative Patent Classification (CPC) 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

IP5 Procedural Harmonization Projects Citation of Art (overlaps with the Global Dossier developments Unity of Invention Written Description 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Company Confidential © 2014 Eli Lilly and Company Global Dossier Vision “[The Global Dossier] will allow users to efficiently access all available information about all applications and patents in the participating offices, and to utilize the electronic services of the offices.” - Global Dossier Taskforce industry delegation statement 1 March 2013 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Company Confidential © 2014 Eli Lilly and Company Overall Vision An efficient, more predictable IP world, with less duplication of effort, more transparency and information sharing between offices, the users and third parties, resulting in higher quality patents worldwide. 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Global Dossier (GD)-Active vs. Passive Components GD will have two parts Passive part for Global File accessibility by all All offices will provide access to the same information in the way which makes most sense for the users of that office Active part for cross filing of documents by users to more than one office Both Integrated using “one portal” Passive part is now available for Examiners in IP5 offices Public deployment of passive part is now available in most offices, will be available at USPTO November 13 (latest information) 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Company Confidential © 2014 Eli Lilly and Company Advantages To Examiners Facilitated work sharing between offices Improve quality since common information available across offices Increased uniformity and potential harmonization To Applicants Will be able to monitor global portfolio More uniformity in patent coverage Reduce litigation risk of inconsistent arguments Reduce ID5 burdens Reduce costs To Third Parties Facilitate searching Reduce litigation costs Ease due diligence opinions Reduce translation burdens 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Future Vision- User Views Global Dossier future Vision for Future Improvements– Endorsed by IP5 Heads in May 7, 2015 Alerting: Provide timely updates to users on status or file wrapper changes to all IP5 family members of an application being watched XML Based Documents Maintain focus on the increasing provision by IP5 offices of all file wrapper documents in XML Applicant name standardization Harmonize and normalize applicant names across IP5 patent document Collections Legal status Agree on the sharing approach for legal status reporting of patents and applications across the IP5 Proof of Concept (Applicant Initiated Inter-Office Document Exchange) Demonstrate the feasibility of cross filing documents or changes over the entire IP5 using an example submission achievable in today’s IP5 legal framewor 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Citation of Art- User Views If it is publically available to examiner, it should satisfy the applicant’s duty to cite the art Should be an expectation and an obligation for examiner to consult documents in GD Format should be the same in all offices Minimize the burden for all Provide maximum transparency to all offices and public Open to other non-IP5 offices (e.g. India? Section 8 concerns) 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Substantive Harmonization Discussions between Trilateral Industry Group and B+ Group has limited the issues Grace Period (a.k.a. non-prejudicial disclosures) Prior User Rights Conflicting applications (prior are effect of prior filed, later published applications) How to implement any changes 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Company Confidential © 2014 Eli Lilly and Company Grace Period Limited to disclosures from the inventor Includes misappropriation or “evident abuse” Would not include independent third party disclosures not derived from inventor What is not yet clear: Will declarations or disclosures be required to take advantage of the grace period? When, and under what conditions? What is the sanction for failing to provide? How long? (12 months?) Commencement date (from priority date) 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Company Confidential © 2014 Eli Lilly and Company Prior User Rights Would provide an exemption for a “good faith” exploitation of a claimed invention by a third party occurring prior to the effective filing date of a patent Requires serious and effective efforts prior to filing date Issues include territorial scope, and definition of good faith 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

Conflicting Applications How do we reconcile the disparate treatment of prior filed, later published applications, i.e., the use of a first-filed application as prior art against a second-filed application. Trilateral offices have three different approaches: Prior art used for novelty, enlarged novelty, or also with inventive step. Other open issues include “self collision,” i.e., use of applicants own prior disclosure and treatment of PCT applications. Should a published PCT application become prior art for all designations 9/22/2018 Company Confidential © 2014 Eli Lilly and Company

What Should Be The Overall Goal? We should work for a system that is best for owners, third parties, the offices, and other users of the system. A “one stop” system should insure accuracy and quality with a minimum of duplication and in a cost effective manner. Ultimately, this benefits all stakeholders. Avoiding duplication, while maintaining quality, means less work needs to be done, which may mean that in the short term some participants in the system (e.g., those doing administrative work) will have a lesser role. However, the goal is to reduce costs and to improve the quality of the system and the resulting rights for all.