Patent, trade-secret, and regulatory-overlay disputes for pharmaceutical, biotech, and medical-device companies, where a single asset can carry the franchise. Handled with registered patent and specialist counsel where required.
A brand manufacturer that receives a Paragraph IV notice has 45 days to sue. File within them and the FDA cannot approve the generic for 30 months; file on day 46 and the stay is gone, the case proceeds without it, and the generic may launch the day it is approved. Nothing else in the practice turns on a single date so completely.
The rest of the calendar is just as fixed. A new chemical entity has five years of data exclusivity, and a Paragraph IV filing in year four stretches the stay to seven and a half years from approval. The first generic to file holds 180 days of exclusivity it can forfeit by waiting. A biologic has twelve years before a biosimilar can be licensed, and the patent exchange that follows an accepted biosimilar application runs on 20-, 60- and 180-day steps the applicant may decline to join.
We handle these disputes with registered patent counsel and scientific experts where the forum or the work requires them, and we keep the FDA file and the litigation file as one record.
Prosecuting and defending patent infringement and validity disputes for pharma, biotech, and medtech companies, with the claim-construction, infringement, and invalidity record built alongside registered patent counsel and technical experts.
Representation in Hatch-Waxman matters arising from ANDA filings and Paragraph IV certifications, managing the 30-month-stay timeline and the regulatory record alongside the patent case.
Counsel on the BPCIA patent-exchange process for biologics and biosimilars, covering the "patent dance," information exchanges, and the litigation that follows, for reference-product sponsors and biosimilar applicants alike.
Enforcement and defense of trade-secret and proprietary-know-how claims, including departing-scientist matters and competitive misappropriation, with the employment and regulatory questions handled in the same plan.
Representation in inter partes review and other contested proceedings before the PTAB, and in Section 337 matters before the ITC, coordinated with counsel admitted to the relevant forum where required.
Resolution of disputes over license terms, royalties, field-of-use limits, and research-collaboration agreements, protecting the deal value and the IP behind it when a partnership turns adversarial.
Only a patent claiming the drug substance, the drug product or an approved method of use may be listed, and only a listed patent triggers a Paragraph IV certification and the stay. A patent listed without that basis can be ordered delisted on the generic's counterclaim, and an improper listing invites an antitrust claim.
A generic may omit a patented use from its label and certify it seeks no approval for that use, taking the method patent out of the case. The carve-out holds only if what remains of the label does not still teach the use; a label that does is evidence of inducement.
Patent prosecution and certain proceedings call for registration before the USPTO and specialist admission; we coordinate with registered patent and specialist counsel so the work is done by those qualified to do it.
Once the stay expires or the generic wins in the district court, it may launch before the appeal is decided. If the patent is then upheld the generic owes the brand's lost profits on every unit sold; a brand that wins an injunction pending appeal posts a bond against the chance it was wrong.
Since 2023 a claim to every antibody that binds a target and performs a function is valid only if the patent teaches the public to make and use them all, not a few examples and a research plan. Biologic patents are now tested on enablement before anyone reaches infringement.
Work reasonably related to an FDA submission, including making and testing the patented compound, is exempt from infringement by statute, so a brand cannot sue during development. Filing an ANDA with a Paragraph IV certification is itself an act of infringement, which is what lets the case start before a single pill is sold.
A Paragraph IV notice letter or a BPCIA disclosure lands, and the statute starts counting: 45 days to sue under Hatch-Waxman, exchange windows under the biosimilar framework. We read the certification against the Orange Book listings and decide, fast, which patents are worth the fight.
Claim construction, infringement, and invalidity contentions are assembled with registered patent counsel and scientific experts, from the batch records, lab notebooks, and prosecution history that will decide the case long before trial. The FDA record is managed as part of the same file.
An IPR petition at the PTAB, a Section 337 complaint at the ITC, or both can open against the district-court case. We coordinate estoppel exposure, stay motions, and inconsistent-position risk across every forum so one proceeding never undercuts another.
Claim construction reshapes the case. From there the matter moves to trial, settlement, or a license, measured against launch dates, exclusivity runway, and at-risk-launch exposure. The endgame is the franchise's market position, and the judgment is one input into it.
In life sciences, the calendar is a litigant. Our job is to keep it from winning.
Life sciences IP litigation is the resolution of intellectual-property disputes for pharmaceutical, biotechnology, and medical-device companies. It covers patent enforcement and defense, trade-secret claims, and regulatory-overlay disputes such as Hatch-Waxman and BPCIA matters. It combines core patent and trade-secret law with the FDA, ITC, and PTAB frameworks that are specific to regulated products, so the technical record and the regulatory posture have to be managed together.
Hart David Carson LLP's focus is dispute resolution, meaning the enforcement and defense of patents and trade secrets in litigation and contested proceedings. Patent prosecution and other work requiring registration before the USPTO is handled in coordination with registered patent counsel and technical specialists, so the patent strategy and the litigation strategy stay aligned without overstating any single firm's role.
We advise on patent infringement and validity disputes, trade-secret misappropriation, Hatch-Waxman ANDA litigation and BPCIA biosimilar exchanges, licensing and collaboration disputes, and competitive matters before the ITC. Each is handled with the technical record, the regulatory pathway, and the commercial stakes considered together.
We represent clients in inter partes review and other contested proceedings before the Patent Trial and Appeal Board, in Section 337 matters before the International Trade Commission, and in disputes that turn on FDA regulatory questions. Where a matter requires specialist admission or technical registration, we coordinate with registered patent and specialist counsel admitted to the relevant forum.
Exclusivity, measured in months. A brand that loses a Hatch-Waxman case faces generic entry at the end of the 30-month stay or sooner, and a brand that wins keeps the market until the last listed patent expires, plus six months of pediatric exclusivity if it completed the studies the FDA requested. For the first generic filer the prize is 180 days of exclusivity against other generics, which can be forfeited by failing to launch within 75 days of a final decision. For a biosimilar the stake is the twelve-year exclusivity of the reference product and the timing of the 180-day notice of commercial marketing. These are the numbers a settlement is priced against, and a settlement that pays the generic to stay out invites antitrust scrutiny.
By building the record from the documents that already exist. The prosecution history fixes what the patentee told the examiner and cannot now take back; the lab notebooks and batch records fix what was actually made and when; the FDA correspondence fixes what the company told the agency about the product, and all three must agree with what the experts say in court. We retain scientists in the relevant discipline early, under the protective order, and we coordinate with registered patent counsel where the forum or the work requires it. The technical case is then pressure-tested from the other side before the first filing, so the weakness is found by us rather than by the generic's expert.
Protection and enforcement of intellectual property rights, trade secrets, and proprietary information through litigation and dispute resolution.
Explore →Defense for healthcare and life sciences institutions facing regulatory scrutiny, privacy exposure, and industry disputes.
Explore →Trial advocacy for complex business disputes, contract breaches, and commercial conflicts in state and federal courts.
Explore →Arbitration, mediation, and other alternative dispute resolution services to resolve conflicts efficiently while preserving business relationships.
Explore →Reviewed by Jonathan D. Herpy, Sr., Senior Partner · Last updated October 2026 · Educational overview · Not legal advice
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