1. Confidentiality: Nondisclosure, Misuse, and Prosecution Bars David Hricik Professor, Mercer Law School Of Counsel, Taylor English Duma LLP

2. What is Covered: Confidential Information Unless parties agree otherwise: – “confidential information” is undefined; – subject to being applied overly-broadly? Mercer Law School / Taylor English2

3. Who People Say May View Confidential Information One qualified in-house counsel; and One or more qualified outside counsel. Mercer Law School / Taylor English3

4. In-House: What Statute Says To qualify as a recipient, the person must: (a)be an attorney; (b)who represents the RPS; (c) who is an employee of the RPS; and (d)who does not (i) “formally or informally” engage in (ii) “patent prosecution” that is (iii) “related to the reference product.” Mercer Law School / Taylor English4

5. Three Interpretive Issues Patent agents aren’t attorneys (minor). What if attorney works for a sub, parent, or affiliate of the RPS, but not the RPS itself? –Absurd, or… does “employed” ensure liability of RPS and not allow corporate veils to block? Scope of prosecution bar (soon). Mercer Law School / Taylor English5

6. Outside Counsel: What Statute Says To qualify as a recipient, the person must: (1) be an attorney; (2) who is an “employee” of an entity other than the RPS; (3) who does “not engage, formally or informally, in patent prosecution relevant or related to the reference product.” Mercer Law School / Taylor English6

7. Three Interpretative Issues Patent agents aren’t attorneys. Partners aren’t employees of law firms. Can multiple “in-house” lawyers who are employees, not of the RPS but of affiliated entities, qualify? The prosecution bar’s scope (later). Mercer Law School / Taylor English7

8. What Recipient of Confidential Information Cannot Do Mercer Law School / Taylor English8 No disclosure; No misuse; and Subject to prosecution bar to prevent even inadvertent misuse.

9. Disclosure: Straightforward “No person… shall disclose any confidential information to any other person or entity… without the prior written consent of the subsection (k) applicant, which shall not be unreasonably withheld.” –§ 262 (l)(1)(C). Mercer Law School / Taylor English9

10. Injunctive Relief if Disclosure “The disclosure of any confidential information… shall be deemed to cause the… applicant to suffer irreparable harm for which there is no adequate legal remedy and the court shall consider immediate injunctive relief to be an appropriate and necessary remedy for any violation or threatened violation of this paragraph.” –§ 262 (l)(1)(H). Mercer Law School / Taylor English10

11. No Misuse “Confidential information shall be used for the sole and exclusive purpose of determining… whether a claim of patent infringement could reasonably be asserted if the… applicant engaged in the manufacture… of the biological product that is the subject of the application….” –§ 262 (l)(1)(D). Mercer Law School / Taylor English11

12. Misuse: No Injunction Trigger? By the statute’s terms, courts are to consider injunctive relief to be appropriate for disclosure. No mention of misuse; just disclosure. –Intended? Mercer Law School / Taylor English12

13. Prosecution Bars: In-House and Outside Counsel General rule in litigation: a protective order that limits use of CBI to the case is sufficient to prevent misuse. Exception: Prosecution bars can be imposed to require “competitive decision- makers” to stop that work, or not see CBI. Mercer Law School / Taylor English13

14. BCPIA: Broad and Narrow? In litigation bars cover competitive decision-making, not prosecution as such. –bars often cover more than prosecution – product design, business roles (in-house), licensing, IPR, reissue, etc. BCPIA seems to limit bar solely to prosecution. Also: does “prosecution” include, e.g., IPR? In litigation, bars do not include all forms of prosecution (some prosecution is not C-D). –BCPIA assumes all prosecution – and even informal involvement in it -- justifies a bar. Mercer Law School / Taylor English14

15. BCPIA: Broad and Narrow? What is “informal” involvement in prosecution? What does “related” to the product mean? –Scope of the bar oft-litigated issue in litigation- related prosecution bars. How long does the bar last? –In litigation-related bars, usually bar runs until two years after end of suit. Mercer Law School / Taylor English15

16. Two Takeaways Be very thoughtful about both sides of this: –What might opposing counsel be doing, besides prosecution, that creates risk? –What might your “side” be doing? To extent possible get agreement rather than leave to vagaries of this statute or judicial interpretation of it. Mercer Law School / Taylor English16

17. Thank You! My article Wrong for the Part Goes into Lots More Details! David Hricik Professor, Mercer Law School Of Counsel, Taylor English Duma LLP Mercer Law School / Taylor English17