30 / 60 / 90 Launch Plan (Legal)
A compact 30/60/90-day legal launch plan focused on prioritized actions, owners, and deadlines.
IP / FDA Pathway Strategy
Life-science companies that need an IP-aware strategy memo on the interaction between their patent runway and an FDA pathway (e.g., 510(k), De Novo, PMA, BLA, 505(b)(2)).
$4,500.00
Engagement type: Tiered Fee
Attorney fee: $4,500–$8,000
$4,500 – $8,000 (final fee set by complexity)
USPTO / USCO / WIPO fees billed separately at cost.
Best for
Life-science companies that need an IP-aware strategy memo on the interaction between their patent runway and an FDA pathway (e.g., 510(k), De Novo, PMA, BLA, 505(b)(2)).
What’s included
- Working session and review of the product and pathway.
- Strategy memo addressing how IP runway, exclusivities, and pathway choice fit together.
What’s NOT included
- Government, third-party, foreign-associate, translation, courier, and vendor fees.
- Continued prosecution, additional office actions, or post-allowance work beyond what is expressly itemized.
- Litigation, contested proceedings (IPR/PGR/PTAB, oppositions, cancellations), or appeal work.
- Work on additional applications, jurisdictions, classes, or marks not listed in the engagement letter.
- FDA filings or formal regulatory submissions (separate engagement).
Client responsibilities
- Provide complete, accurate, and timely technical / business disclosures.
- Review and approve drafts and filings before submission.
- Pay government and third-party fees in advance of any filing deadline.
Assumptions
- Standard complexity for the service category.
- One primary applicant or business entity; one primary jurisdiction unless otherwise stated.
- One round of substantive client revisions included.
- No material adverse facts (e.g., prior public disclosure, intervening prior art) discovered after engagement.
Scope-change triggers
- Material change in scope, claims, embodiments, classes, marks, or jurisdictions.
- Adversarial action by a third party (opposition, cancellation, declaratory action).
- Expedited / emergency turnaround required to meet a statutory or self-imposed deadline.
- After-discovered prior art, prior use, or undisclosed prior filings.
Deliverables
IP / FDA strategy memo.
Typical timing
Typically 4–6 weeks.
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General Attorney IP Consultation (30 Mins)
A paid consultation with a registered patent attorney, including review of materials you send ahead.
