Pharmaceuticals & Drug Delivery

Protecting Therapeutic Compounds, Delivery Systems, and Clinical Innovation

The development of pharmaceutical products involves a complex interplay of chemistry, formulation, regulatory strategy, and IP protection. At Schmeiser Olsen, we help pharmaceutical companies, research institutions, and biotech startups secure robust patent protection for small molecules, biologics, prodrugs, combination therapies, and innovative delivery technologies.

Our attorneys understand the demands of patenting in this field, including the importance of securing exclusivity during critical clinical phases, drafting claims that withstand post-grant challenges, and aligning IP strategy with FDA regulatory timelines and Hatch-Waxman litigation risk.

We protect the chemistry and systems that make modern therapies safe, effective, and commercially viable.

Patent Strategy for Pharmaceutical Innovation

Pharmaceutical patents must not only be novel and non-obvious. They must be scientifically sound, defensible, and strategically structured around product lifecycle, formulation flexibility, and competitive positioning. Our attorneys have technical backgrounds in medicinal chemistry, molecular biology, and bioengineering, and work directly with R&D teams to capture innovations at every stage.

We draft claims with precision around active ingredients, excipients, delivery mechanisms, pharmacokinetics, and therapeutic indications.

We help clients secure patents involving:

Small Molecule & Chemical Entity Claims

  • Novel chemical structures and analogs with therapeutic activity
  • Polymorphs, salts, solvates, hydrates, and stereoisomers
  • Synthetic pathways and intermediates that support scale-up or purity
  • Prodrugs and modified release profiles with improved bioavailability

Drug Formulations & Combinations

  • Sustained- or controlled-release compositions
  • Nanoparticle formulations and solubilization strategies
  • Fixed-dose combination products for enhanced compliance or synergistic efficacy
  • Gastroretentive and mucosal delivery formulations

Targeted Drug Delivery Systems

  • Liposomes, micelles, dendrimers, and polymer-drug conjugates
  • pH-sensitive, temperature-sensitive, or enzymatically triggered systems
  • Transdermal patches, inhalable formulations, and depot injections
  • Tissue-specific targeting via ligands, antibodies, or biomolecular carriers

Clinical Method Claims & Dosage Regimens

  • Optimized dosing schedules based on pharmacokinetic data
  • Routes of administration linked to improved efficacy or reduced toxicity
  • Biomarker-guided treatment regimens
  • Drug-device combinations with synchronized release mechanisms

Our strategies also account for future lifecycle management, such as follow-on formulations, second medical use claims, and strategic continuation practice.

Overcoming Challenges in Pharma Patents

Pharmaceutical patenting presents unique legal and scientific challenges. We help clients navigate:

  • Enablement and written description: ensuring that claims are fully supported by experimental data or scientifically accepted rationale
  • Genus/species tension: drafting broad chemical claims while preserving support for critical variants
  • Patent term extension (PTE) and data exclusivity strategies under Hatch-Waxman
  • FDA-regulatory alignment: ensuring that patent strategy supports NDA/ANDA timelines and potential Orange Book listings
  • Freedom to Operate (FTO): identifying third-party patents that could affect clinical development or launch

We work closely with internal legal teams and regulatory counsel to build patent portfolios that align with clinical milestones and commercialization strategies.

Partner with Counsel Who Understand Therapeutics

At Schmeiser Olsen, we provide patent counsel grounded in medicinal chemistry, regulatory awareness, and commercial strategy. Our team supports the development and protection of drug candidates, from lead optimization through clinical trials and beyond.

Protect your molecule, and the system that delivers it, with patent counsel fluent in pharmaceutical science and product lifecycle planning.

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