Few industries face as many watchers as this one: regulators, payers, investors, and patients all scrutinize the products healthcare and life sciences companies build. A digital health platform holds protected health information. A biotech company's value sits in a handful of patents and a licensing deal. A device maker's software update may need FDA review before it ships. When things go wrong, the dispute usually involves the same assets: data, IP, and the contracts that allocate them. We are a litigation and transactional firm focused on intellectual property, technology, and business disputes. For this sector, that means negotiating the licenses, collaborations, and technology agreements it depends on, and litigating when a partner, a competitor, or a former employee puts those assets at risk.
Providers, Biotech, And Devices
Our healthcare and life sciences work covers three sectors. Healthcare covers hospitals and health systems, physician groups, and digital health and telehealth companies, with a focus on HIPAA and health data privacy, technology contracts, and the IP that comes with delivering care through software. Life sciences and biotechnology covers pharmaceutical, biotech, and research tools companies, from university spinouts to commercial-stage businesses, with work on licensing, collaborations, FDA-driven deal strategy, and patent disputes. Medical devices covers companies making everything from implants to software as a medical device, working through 510(k), De Novo, and PMA pathways, quality obligations, and product liability. Many clients sit in more than one sector, such as a device company whose product is mostly software or a provider that licenses its own clinical data.
The Rules That Shape The Sector
A short list of federal laws drives most of the work. HIPAA's Privacy, Security, and Breach Notification Rules govern covered entities and their business associates, and the FTC's Health Breach Notification Rule reaches health apps that fall outside HIPAA. Washington's My Health My Data Act and other state laws add consent requirements for consumer health data. The Anti-Kickback Statute, the Stark Law, and the False Claims Act shape arrangements among providers, manufacturers, and referral sources. The Federal Food, Drug, and Cosmetic Act sets the approval and clearance pathways for drugs, biologics, and devices, and FDA's Quality Management System Regulation, aligned with ISO 13485, now governs device manufacturing. The 21st Century Cures Act adds information blocking rules for health IT developers and providers.
IP And Disputes In Life Sciences
In life sciences, intellectual property and business strategy are the same conversation. Drug patents interact with FDA exclusivities, and generic and biosimilar entry is litigated under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act. Device companies compete over patents and trade secrets in crowded product categories. University licenses carry Bayh-Dole obligations, including government license rights and march-in provisions. On the healthcare side, disputes often begin with technology: an EHR implementation that fails, a data-sharing arrangement a partner exceeds, or a health app accused of disclosing data through tracking pixels. We understand both the science and the software well enough to find the facts that decide these disputes and to explain them clearly to a judge, jury, or arbitrator.
Litigation And Investigations
We litigate the disputes healthcare and life sciences companies face in federal and state court and in arbitration. That includes patent infringement cases, including Hatch-Waxman and biosimilar litigation and inter partes review at the PTAB, trade secret cases against departing scientists and former partners, and breach claims under license, collaboration, supply, and clinical trial agreements. We handle milestone and royalty disputes, which often turn on how a contract defines net sales or commercially reasonable efforts. We defend health technology companies against privacy class actions under state wiretap and consumer protection laws. When a government inquiry arrives, such as an HHS Office for Civil Rights investigation after a breach or a civil investigative demand under the False Claims Act, we respond and work toward resolution.
Licensing, Collaborations, And Contracts
Our transactional work follows the product lifecycle. Early on we negotiate exclusive and nonexclusive licenses with universities and research institutions, sponsored research agreements, and material transfer agreements. As programs advance we handle collaboration and co-development agreements, clinical trial agreements with sites and CROs, manufacturing and supply agreements with CMOs and the quality agreements that go with them, and distribution deals. For providers and digital health companies we draft business associate agreements, EHR and SaaS agreements, data use and data licensing agreements, and telehealth platform terms. We also run IP due diligence for investors and acquirers. We do not prepare patent applications; our patent work is licensing, freedom to operate review, opinions, and enforcement.
How We Work In Healthcare
Healthcare matters often involve clinical, regulatory, and commercial teams, and each speaks a different language. We start by learning the product and its regulatory status, whether it is a cleared device, a drug in Phase 2, or a platform handling protected health information. We confirm the scope and cost in writing, then work directly with your business, clinical, and technical leads. Where a matter turns on FDA submissions or reimbursement, we coordinate with your regulatory consultants and regulatory counsel so the contract reflects the regulatory plan. In disputes, we preserve lab notebooks, batch records, source code, and audit logs early, because those records usually decide who is right and who invented what.
Pricing For Defined And Open Work
We sell standardized work as flat-fee products with a fixed price, a stated scope, and a set turnaround. In healthcare and life sciences, that includes NDAs, business associate agreements, privacy policies and app terms, material transfer agreements, and trademark registration. Licensing negotiations, collaborations, investigations, and litigation are less predictable, so we scope them and provide a written estimate before starting. The estimate explains what is included and what would change it, and we update it when the facts move. For companies operating on grant funding or a venture budget, that predictability matters, and we build our engagements around it so legal costs do not crowd out the research.
