How to Select a Life Sciences and Biotechnology Attorney: A Step-by-Step Guide

A biotechnology or life sciences company needs legal help at several points that call for different expertise: protecting inventions, working with the Food and Drug Administration, licensing technology in or out, and resolving disputes. One attorney may not cover all of them equally, and some of the work can be done by registered practitioners or consultants who are not attorneys. For each need, published FDA and USPTO rules let you test what candidates tell you.

Step 1: Define the Work You Need Now

Write down which of these you need in the next year:

Patent work: preparing and prosecuting patent applications, and assessing whether your product may infringe others’ patents.
FDA regulatory work: planning the path to approval or clearance, preparing for meetings with FDA, and responding to agency letters.
Licensing and partnering: licensing technology from a university or company, or licensing yours to a partner.
Disputes: patent litigation, contract disputes with partners, or responses to enforcement.

Ask each candidate: “Which of these do you do yourself, and which would you refer to someone else?” Write the answers next to your list; the gaps are where the handoffs will be.

For patent and FDA work, the next question is which kind of professional each item calls for, because the answer is not always an attorney.

Step 2: For Patent Work, Confirm Registration and Technical Fit

Patent applications are prosecuted before the USPTO by registered practitioners, and a registered patent agent with a scientific background in your field is a genuine option alongside patent attorneys (37 CFR § 11.6). The USPTO’s practitioner search shows whether a person is currently registered and listed as an attorney or an agent (USPTO Patent Practitioner Search). Registration settles authorization; for a biotechnology company, the harder question is technical fit.

For technical fit, ask:

“What is your scientific training, and in which technologies have you drafted claims?” A candidate whose training matches your field, for example antibodies, small molecules, gene therapy, or diagnostics, can engage with the science in your disclosure.
“Can you show me issued patents you prosecuted in a related area?” Issued patents are public, and they let you see the candidate’s claim drafting.
“Who will draft, and who will review?” In a team, the person with the right technical background should be the one drafting.

If you also need an opinion on whether your product may infringe another party’s patent, or representation in litigation, ask whether the candidate is an attorney and handles that work, or would bring in a litigator.

Step 3: For FDA Work, Test Experience With the Agency’s Own Processes

FDA regulatory strategy can involve attorneys, regulatory consultants, or both. Ask each candidate: “What would you do in this matter that a regulatory consultant would not, and when would you recommend involving both?” A clear line between legal and regulatory work for your matter is more useful than a claim to do both.

Then test experience with specific FDA processes.

Meetings with FDA

FDA’s regulations describe meetings during drug development. Under 21 CFR § 312.47(a), “meetings between a sponsor and the agency are frequently useful in resolving questions and issues raised during the course of a clinical investigation.” Under § 312.47(b)(1), “the purpose of an end-of-phase 2 meeting is to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan and protocols and the adequacy of current studies and plans to assess pediatric safety and effectiveness, and to identify any additional information necessary to support a marketing application for the uses under investigation.” The regulation adds that while this meeting “is designed primarily for IND’s involving new molecular entities or major new uses of marketed drugs, a sponsor of any IND may request and obtain an end-of-Phase 2 meeting,” and it describes “pre-NDA” meetings “held near completion of Phase 3 and before submission of a marketing application” (21 CFR § 312.47).

Timing and preparation are part of the regulation. Under § 312.47(b)(1)(iii), “to be most useful to the sponsor, end-of-Phase 2 meetings should be held before major commitments of effort and resources to specific Phase 3 tests are made,” and under § 312.47(b)(1)(iv), “at least 1 month in advance of an end-of-Phase 2 meeting, the sponsor should submit background information on the sponsor’s plan for Phase 3,” including summaries of earlier investigations and “the specific protocols for Phase 3 clinical studies.” Ask: “Working back from when we expect to commit to Phase 3, when would you schedule the meeting and the background submission?” The schedule should be built around your program’s decisions, not the other way around.

Earlier meetings are available for some programs. In FDA’s regulations for “Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses,” 21 CFR § 312.82(a) provides that “prior to the submission of the initial IND, the sponsor may request a meeting with FDA-reviewing officials,” and that “the primary purpose of this meeting is to review and reach agreement on the design of animal studies needed to initiate human testing.” Under § 312.82(b), “when data from phase 1 clinical testing are available, the sponsor may again request a meeting,” with the primary purpose “to review and reach agreement on the design of phase 2 controlled clinical trials” (21 CFR § 312.82). If your product targets such an illness, ask whether the candidate has used these early consultations and what agreement they produced.

Ask: “How many end-of-Phase 2 or pre-NDA meetings have you prepared a sponsor for, and what did you do to prepare?” A description of what the preparation involved tells you more than a count, so ask for both. For a device or diagnostic, ask the equivalent question about the meetings and submissions for your product type.

Responding to a complete response letter

If FDA will not approve an application as submitted, the agency explains why. Under 21 CFR § 314.110(a), “FDA will send the applicant a complete response letter if the agency determines that we will not approve the application or abbreviated application in its present form,” and “a complete response letter will describe all of the specific deficiencies that the agency has identified.” If FDA determines “that the data submitted are inadequate to support approval, the agency might issue a complete response letter without first conducting required inspections and/or reviewing proposed product labeling” (21 CFR § 314.110).

The regulation also sets what must happen next. Under § 314.110(b), “after receiving a complete response letter, the applicant must take one of following actions,” beginning with resubmission “addressing all deficiencies identified in the complete response letter.” A resubmission FDA classifies as “Class 1” starts “a new 2-month review cycle,” and one classified as “Class 2” starts “a new 6-month review cycle,” each “beginning on the date FDA receives the resubmission.” Under § 314.110(c)(1), “FDA may consider an applicant’s failure to take any of such actions within 1 year after issuance of a complete response letter to be a request by the applicant to withdraw the application, unless the applicant has requested an extension of time in which to resubmit the application,” and “FDA will grant any reasonable request for such an extension.” The triggering event for that one-year period is the issuance of the letter.

Resubmission is one of three paths the regulation lists. The applicant may instead withdraw the application, and “a decision to withdraw an application or abbreviated application is without prejudice to a subsequent submission.” Or it may ask FDA for “an opportunity for a hearing on the question of whether there are grounds for denying approval.” Each path fits a different situation: resubmission when the deficiencies can be fixed with the data in hand or soon available, withdrawal when the program needs a longer reset, and a hearing request when the company disagrees with the grounds themselves. Ask each candidate how he or she would choose among the three for a letter like the one you fear, and what facts would change the choice. If every past letter ended in resubmission, ask how the candidate would recognize a case for one of the other two.

Ask: “Have you helped a sponsor respond to a complete response letter, how was the resubmission classified, and how did you manage the one-year period?” This tests experience at a stage where the stakes for the company are high, and whether the candidate tracks the deadline that follows the letter. The arithmetic is simple once the dates are fixed. If a complete response letter issues on May 1, the one-year period runs to the following May 1 unless an extension is requested. If the company resubmits in November and FDA classifies the resubmission as Class 2, a new 6-month review cycle begins on the date FDA receives it, which puts the next action in the following spring. A candidate should be able to lay out that calendar for your program, and say what he or she would do if the data needed for resubmission were not ready in time.

Step 4: Ask How Development Activities Fit the Patent Landscape

A company developing a drug may use patented inventions in its research. The Patent Act provides a specific rule. Under 35 U.S.C. § 271(e)(1), “it shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention” with a stated exception for certain new animal drugs and veterinary biological products, “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products” (35 U.S.C. § 271).

The word “solely” and the phrase “reasonably related” are where questions arise. Bring a list of your planned research and manufacturing activities and ask the candidate which ones the safe harbor would cover and which might not. Going through the list activity by activity analyzes it against the statute; a blanket statement that research is protected leaves the list unexamined.

After approval: patent term extension

Regulatory review can consume part of a patent’s term, and the Patent Act provides a way to recover some of it, subject to a short filing window. Under 35 U.S.C. § 156(d)(1), “to obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Director,” and, except as the statute provides, “such an application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use” (35 U.S.C. § 156). The triggering event is the marketing approval.

For selection, this is a point where patent and regulatory work meet. Ask: “Who would prepare a patent term extension application after approval, which patent would we choose to extend, and how will you make sure the sixty-day window is not missed?” The window opens on approval, so the plan has to exist before approval does. Sixty days from an approval in early March ends in early May, a window that can pass while a company is focused on launch.

Step 5: For Licensing, Ask Which Side the Candidate Represents

Licensing agreements in life sciences can involve universities, research institutions, and companies on both sides. Ask whether the candidate represents licensors or licensees more often, since that is the side he or she knows best; whether he or she has negotiated with this university’s or company’s licensing office before; and which terms in your license deserve the most attention, such as field of use, diligence obligations, royalties, or sublicensing. Terms named for your product, with reasons, give you a negotiation plan you can compare.

Step 6: Check for Conflicts

A firm may represent several companies in the same therapeutic area. Before you share confidential information, ask whether the firm represents any company developing products in your area, or any company you may license from or partner with. If a conflict exists, ask how it would be handled and ask for the disclosure and your consent in writing, so there is a record of what was agreed. Then ask how the firm separates confidential information between clients in the same field. For a company whose value is its unpublished data, that answer matters as much as the conflict check itself.

Step 7: Understand the Fee Arrangement

Ask how each candidate would price the work: hourly, a fixed fee for a defined task such as a provisional application, a capped fee for a stage, deferred fees, equity, or a combination. Then compare by what each proposal covers:

Patent work. Does the fee cover drafting only, or also responses to USPTO actions? Are government fees and foreign filing costs separate?
FDA work. Does the fee cover meeting preparation, briefing documents, and attendance?
Licensing. Does the fee cover negotiation through signing?
Equity or deferred fees. If the candidate would receive equity or defer fees, ask how the arrangement is documented and whether it could affect the candidate’s advice.

Ask for the fee terms in writing before work begins.

Step 8: Interview, Compare, and Decide

Bring a non-confidential summary of your technology with a dated list of any public disclosures, your existing patents, applications, and licenses, your regulatory status and FDA correspondence, and any term sheets or license drafts. With the same materials in front of each candidate, ask four things: who will do the work and who you will speak with; what would make your position harder than it looks, where a good answer names prior public disclosures, competing patents, or gaps in data; how patent strategy and regulatory strategy will be coordinated, since timing in one affects the other; and what the candidate needs from your scientists, and when.

Then compare the candidates on the same points: registration and status for anyone prosecuting patents; technical fit with your science; experience with the FDA processes you face; licensing side; conflicts; who would do the work; and what the fee covers. A bar listing confirms a license to practice law, and the USPTO search confirms registration; neither measures life sciences experience, and a firm’s website shows only which technologies and stages it describes.

For a company whose value sits in unpublished data, two checks come before everything else: registration for anyone who will prosecute your patents, and a conflict check before you describe your technology. After those, general answers about FDA meetings or complete response letters, a blanket view of the research safe harbor, and a promised patent or approval, which only the USPTO and FDA can decide, are the answers to press on.

If candidates disagree about your regulatory path or your patent timing, put the disagreement on a single timeline: the next FDA meeting, the filing dates, the expected approval, and the sixty-day extension window. Ask each candidate to mark the timeline in writing. An explanation tied to your data and your dates gives you a stronger basis for comparison than one that is not.

Legal disclaimer: This guide provides general information about selecting legal and regulatory help for a life sciences company. It is not legal advice. Rules change; speak with a licensed attorney or registered practitioner about your situation.