Pharmaceutical R&D Law: What Biotech and Pharma Companies Must Know

An IND application requests FDA authorization to administer an investigational drug to human subjects and must include the drug's composition, a summary of pre-clinical safety data, a Phase I clinical protocol, and the investigators' qualifications. FDA has thirty days to review and may place the IND on clinical hold if data are insufficient to assess safety risks, preventing any study from beginning until the developer satisfactorily addresses FDA's concerns.

FDA drug approval process and healthcare compliance and regulatory counsel can advise on IND application requirements, assess whether pre-clinical data and protocols satisfy FDA standards, and develop the IND submission strategy.

Clinical trials under an IND must comply with FDA's Good Clinical Practice regulations establishing quality standards for trial design, conduct, monitoring, and reporting. Each site must obtain IRB approval before enrolling subjects, the IRB must review and approve informed consent documents, and every subject must provide written consent describing the research, the risks, and the right to withdraw without penalty.

Healthcare and life sciences and pharmaceutical R&D compliance counsel can advise on GCP, IRB, and informed consent obligations, assess whether current trial practices comply, and develop the clinical trial compliance strategy.

A pharmaceutical developer should pursue claims at multiple layers, beginning with a composition of matter claim on the drug molecule and adding method of treatment claims, formulation patents, and process patents covering the manufacturing method. The timing of filings relative to public disclosures is critically important because premature disclosure without a patent application on file destroys novelty and eliminates patent protection.

Patent counseling and prosecution and patent prosecution and portfolio management counsel can advise on pharmaceutical patent filing strategy, assess the strength of existing claims, and develop the patent portfolio and prosecution strategy.

The Hatch-Waxman Act allows a developer to apply for an extension of a patent's twenty-year term compensating for time spent under FDA regulatory review, adding up to five years with a maximum of fourteen years remaining after approval. The developer must file the PTE application within sixty days of FDA approval and identify the specific patent and product, with the calculation based on time the drug spent under active FDA review.

Patent counseling and FDA drug approval process counsel can advise on patent term restoration requirements, assess the amount of PTE the product qualifies for, and develop the PTE application strategy.

Biotech patent and intellectual property counsel can advise on available protection mechanisms, assess which apply to the specific drug product, and develop the integrated patent and exclusivity strategy.

Data exclusivity prevents FDA from approving a generic ANDA relying on the innovator's clinical data, blocking generic entry independently of patent protection. New chemical entity exclusivity prevents ANDA submissions for five years from NDA approval, while three-year exclusivity applies when new clinical studies essential to approval support a label change such as a new indication or dosage form.

Pharmaceutical regulatory compliance and life sciences licensing counsel can advise on applicable data exclusivity periods, assess how exclusivity interacts with patent protection, and develop the exclusivity and generic entry management strategy.

A drug treating a rare disease affecting fewer than two hundred thousand U.S. .atients qualifies for orphan drug designation, which provides seven years of exclusivity blocking same drug approval for the same indication, a fifty percent tax credit for qualified clinical testing, waiver of the NDA user fee, and priority review. A sponsor must demonstrate the disease affects fewer than two hundred thousand patients and provide a rationale for the drug's potential effectiveness.

FDA regulatory and pharmaceutical R&D compliance counsel can advise on orphan drug designation requirements, assess whether the drug and disease qualify, and develop the orphan drug strategy.

Pharmaceutical R&D collaboration agreements range from early-stage academic licenses under the Bayh-Dole Act to fully integrated co-development agreements allocating R&D costs, decision rights, milestones, and royalties across the entire development lifecycle. The IP ownership provisions are the most critical terms because they determine which party owns patents on improvements made during the collaboration.

Technology licensing and IP transactions and technology transfer counsel can advise on R&D collaboration agreement structure, assess IP ownership and royalty provisions, and develop the collaboration agreement drafting and negotiation strategy.

A freedom to operate analysis assesses whether a company's planned drug product or manufacturing process would infringe valid and enforceable third-party patents, and it is essential before initiating significant R&D investment because discovering a blocking patent after spending hundreds of millions on clinical trials is potentially catastrophic. An FTO analysis identifies relevant patents, assesses whether the planned product falls within any claims, evaluates their validity, and identifies options for designing around, challenging, or licensing the blocking patent.

Patent infringement litigation and technology licensing counsel can advise on the freedom to operate analysis process, assess the risk of infringing third-party patents, and develop the FTO risk mitigation strategy.