BPCIA Patent Exchange Checklist: A Practical Checklist

Document type: Checklist Practice area: Intellectual Property — Patents Jurisdiction: United States (federal) Last reviewed: 5 September 2026

Part 1 — Applicant: before filing

Estate mapping:

Assignee, inventor, and family searches across the sponsor's portfolio — there is no Orange Book to consult.
Cover every category: composition, cell line and expression system, culture media and process, purification, formulation, device, method of use, analytical methods.
Include pending applications and foreign counterparts — continuations issuing during development will be on the sponsor's list.
Record expirations, including patent term extension and terminal disclaimers.
Identify which patents your planned process implicates, and feed that to process development while the process can still change.

Exclusivity computation:

Confirm the first licensure date of the reference product — the original licensure, not a later supplement, indication, or presentation.
Twelve years from first licensure before approval; four years before submission. 42 U.S.C. § 262(k)(7).
Add pediatric exclusivity if applicable.
The entry date is the later of the exclusivity and the patents you cannot clear — for a mature product, usually the exclusivity.

Process design-around:

Patent counsel embedded with process development from the first campaign.
For each implicated process patent: does the planned process fall within the claims, and is an alternative available?
Document every design choice contemporaneously, with the avoidance rationale in the development record.
Confirm the redesign does not compromise comparability — coordinate with regulatory affairs.
Track claim scope as the sponsor's continuations issue.

Interchangeability:

Model uptake with and without interchangeability.
Price the additional development under current FDA thinking.
Assess first-interchangeable exclusivity under § 262(k)(6) and whether a competitor will reach it first.
Decide: seek it initially, or enter first and supplement later.

Part 2 — The dance decision (before day 20)

In favor of dancing:

Narrowing — the first action covers only agreed or exchanged patents.
Information — the sponsor's detailed statements reveal its theories before any complaint.
Sequencing — held-back patents come later, on a preliminary injunction posture where the sponsor bears the burden.

Against:

Trade secret exposure — the manufacturing process goes to a competitor.
Time — roughly nine months to the immediate action.
The process is where the patents are.

If declining, understand the consequence:

Submission becomes an act of infringement as to any patent that could have been listed — 35 U.S.C. § 271(e)(2)(C)(ii).
The sponsor may bring a declaratory judgment action on any patent claiming the product or a use — 42 U.S.C. § 262(l)(9)(C).
There is no injunction compelling disclosure — Sandoz Inc. v. Amgen Inc., 582 U.S. 1 (2017).
Decline cleanly; partial participation has its own consequences under § 271(e)(6).
Document the decision in a memorandum before day 20.

Part 3 — Day 20: the disclosure

Provide a copy of the 351(k) application.
Provide information describing the manufacturing process.
Prepare the process description with counsel and the technical team: what the statute requires, and no more.
Propose a supplemental confidentiality agreement layering designation tiers, a defined prosecution bar, sealing procedures, clawback, and return-or-destroy obligations on the statutory floor in § 262(l)(1).
Confirm recipients: outside counsel who does not prosecute in the relevant field, plus one in-house representative under the same restriction.
Log the date. Every subsequent deadline runs from it.
Maintain an internal log of exactly what was disclosed.

Part 4 — Day 80: the sponsor's list

Have the draft list prepared before day 0. Sixty days is not enough to analyze a hundred-patent estate from scratch.
List patents that "could reasonably be asserted."
Avoid over-listing — it invites a fee argument and dilutes the strong positions.
Avoid under-listing — an omitted patent is out of the immediate action.
Identify which listed patents you would license, and on what terms. This is a strategic signal.
Read the applicant's process description against every process patent, with the technical team.

Part 5 — Day 140: the applicant's response

For each listed patent, a detailed statement of the basis for non-infringement, invalidity, or unenforceability — or a statement that you will not market before expiry.
The standard is genuinely detailed; conclusory statements invite an inadequacy argument.
Provide your own list of patents you want resolved now.
Respond to the licensing offer.
Concede what you will not challenge. It narrows the case and builds credibility.

Part 6 — Day 200: the sponsor's reply

For each patent the applicant contests, a detailed statement of the basis for infringement, and a response on validity and enforceability.
Same for each patent on the applicant's list.
Draft this as a litigation position, because it is one.

Part 7 — Days 215–245: negotiation, exchange, and filing

Negotiate which patents go into the immediate action. A negotiated set is usually better for both sides than the exchange.
If no agreement: the applicant states the number it will list; the parties simultaneously exchange lists, with the applicant's number constraining the sponsor's under § 262(l)(5).
Model the exchange arithmetic before choosing a number.
Sponsor files the immediate action within 30 days of agreement or exchange.
Confirm: there is no stay. FDA review proceeds unaffected.

Part 8 — The 180-day notice

Applicant gives notice of commercial marketing 180 days before first commercial marketing — § 262(l)(8)(A).
Give it before licensure, as Sandoz permits, so the 180 days runs concurrently with the tail of FDA review.
Send in writing to the sponsor and any patent owner; document receipt.
Log the date — the launch date depends on it.
Recognize it triggers the sponsor's right to seek a preliminary injunction on listed-but-not-litigated patents under § 262(l)(8)(B).

Part 9 — The preliminary injunction

Sponsor:

Select the held-back patents for strength, not breadth.
Build irreparable harm evidence starting when the application is accepted, not when the notice arrives:
- Price erosion modeling and why net price does not recover.
- Formulary displacement evidence, ideally from an analogous product.
- Market share modeling, with interchangeability status as an input.
- Licensing history showing the patent has never been valued in dollars.
- Why the counterfactual cannot be reconstructed for damages purposes.
Address the balance of equities candidly — the applicant's investment is real.
Prepare the public interest argument; it is frequently decisive.
File promptly after the notice. Waiting invites a delay argument.

Applicant:

Attack likelihood of success first — a substantial question defeats the motion.
Attack irreparable harm: the sponsor's licensing history, its own damages models, its delay, and the measurability of share loss.
Marshal the equities: investment, capacity committed, supply commitments, patients waiting.
Public interest: price differential and access.
Prepare the bond argument under Rule 65(c) — your lost profits during an injunction are a very large number.

Part 10 — Confidentiality

Both sides:

Confirm the statutory floor: recipients limited, use limited to assessing and litigating infringement — § 262(l)(1).
Negotiate a supplemental agreement covering designation tiers, prosecution bar scope and duration, sealed filing, deposition use, clawback, return or destruction, and subpoena notice.

Sponsor's internal discipline:

Segregate received information rigorously.
Confirm no recipient prosecutes in the field.
Keep it away from business and regulatory personnel.

Applicant's internal discipline:

Log what was disclosed and when.
Brief the technical team on what the sponsor now knows.
Route any post-disclosure process change to patent counsel before implementation.

Part 11 — At-risk launch

Revenue during the risk period.
Probability of an adverse judgment, in writing, from trial and appellate counsel.
Damages: the sponsor's lost profits, not your revenue — for a major biologic this can exceed enterprise value.
Enhanced damages and willfulness exposure.
Fees under 35 U.S.C. § 285.
Injunction, recall, and supply disruption, including payer and provider commitments.
Insurance adequacy — usually not, at this scale.
Board decision with documented approval.

Part 12 — Settlement

Entry date.
License — frequently royalty-bearing in this sector, unlike generic settlements.
Acceleration triggers: another biosimilar's entry, an adverse ruling, defined events.
Most-favored-entry provisions.
Interchangeability treatment — is an interchangeable presentation licensed, and on the same date?
Supply or manufacturing arrangements, with a documented arm's-length pricing analysis.
Treatment of any pending PTAB proceedings.
Antitrust analysis under FTC v. Actavis, Inc., 570 U.S. 136 (2013), prepared contemporaneously, with counsel in the structuring.
FTC and DOJ reporting.

Part 13 — The parallel tracks

Regulatory: deficiency letters and inspection findings move the approval date, which moves the optimal notice date. Regulatory affairs must report timeline changes to the litigation team.
PTAB: model 35 U.S.C. § 315(e) estoppel, discretionary denial risk, and the Board's inability to decide non-infringement. Assign one person to check claim-position consistency across forums.
Manufacturing: route any process change to patent counsel before implementation.
Commercial: payer contracting, formulary strategy, device and presentation decisions, and site-of-care economics — each with its own legal exposure, and collectively determining more revenue than the patent case.
One master calendar covering all four, with a named owner.