confidentiality: nondisclosure, misuse, and prosecution bars

Confidentiality: Nondisclosure, Misuse, and Prosecution Bars

David HricikProfessor, Mercer Law School

Of Counsel, Taylor English Duma LLP

What is Covered: Confidential Information

Unless parties agree otherwise:– “confidential information” is undefined; – subject to being applied overly-broadly?

Mercer Law School / Taylor English 2

Who People Say May ViewConfidential Information

• One qualified in-house counsel; and

• One or more qualified outside counsel.


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.”


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).


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.”


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).


What Recipient of Confidential Information Cannot Do


No disclosure;

No misuse; and

Subject to prosecution bar to prevent even inadvertent misuse.

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).


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).


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).


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?


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.


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 English 14

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.


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.


Thank You!My article Wrong for the Part Goes

into Lots More Details!

David HricikProfessor, Mercer Law School

Of Counsel, Taylor English Duma LLP


confidentiality: nondisclosure, misuse, and prosecution bars

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