Rakoczy Molino Mazzochi Siwik
A Chicago-based litigation and intellectual property law firm focused exclusively on life sciences. The firm provides patent and regulatory counseling and litigation services for pharmaceutical, biologics, biosimilar, and medical device clients, with experience across Hatch-Waxman/ANDA, BPCIA, PTAB/IPR, ITC, FDA regulatory processes, and related appeals and policy work.
Industries
Nr. of Employees
small (1-50)
Rakoczy Molino Mazzochi Siwik
Products
Pharmaceutical Patent Litigation
Legal representation and defense in patent disputes related to pharmaceutical products, including challenges to patent validity and infringement claims.
Pharmaceutical Regulatory Counseling
Advisory services on regulatory compliance and strategy for pharmaceutical products, including guidance on FDA approvals and related regulatory frameworks.
Patent Litigation under Hatch-Waxman Act and BPCIA
Litigation services focused on patent disputes arising under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA), including biosimilar patent challenges.
Pharmaceutical Patent Litigation
Legal representation and defense in patent disputes related to pharmaceutical products, including challenges to patent validity and infringement claims.
Pharmaceutical Regulatory Counseling
Advisory services on regulatory compliance and strategy for pharmaceutical products, including guidance on FDA approvals and related regulatory frameworks.
Patent Litigation under Hatch-Waxman Act and BPCIA
Litigation services focused on patent disputes arising under the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA), including biosimilar patent challenges.
Services
Strategic counseling, petition preparation and filing for PTAB/Inter Partes Review proceedings, and representation in International Trade Commission patent disputes.
Regulatory strategy across product lifecycle including approval pathway selection, expedited review strategies, labeling, risk management, exclusivity and citizen petition work, and agency meeting support.
Prior art searching, FTO opinions, patentability assessments, pre-litigation evaluations, and Paragraph IV preparedness analyses.
Drafting comments on proposed regulations, filing amicus briefs, meeting with policymakers, and advising on legislative issues impacting life sciences IP and regulation.
Patent evaluation and litigation plus device-specific regulatory advice (including human factors and combination product approvals).
Patent trial and appellate representation beyond life sciences plus support for licensing, settlements, and commercialization agreements.
Strategic counseling, petition preparation and filing for PTAB/Inter Partes Review proceedings, and representation in International Trade Commission patent disputes.
Regulatory strategy across product lifecycle including approval pathway selection, expedited review strategies, labeling, risk management, exclusivity and citizen petition work, and agency meeting support.
Prior art searching, FTO opinions, patentability assessments, pre-litigation evaluations, and Paragraph IV preparedness analyses.
Drafting comments on proposed regulations, filing amicus briefs, meeting with policymakers, and advising on legislative issues impacting life sciences IP and regulation.
Patent evaluation and litigation plus device-specific regulatory advice (including human factors and combination product approvals).
Patent trial and appellate representation beyond life sciences plus support for licensing, settlements, and commercialization agreements.
Expertise Areas
- Patent litigation (district courts and appeals)
- Hatch-Waxman / ANDA litigation and Paragraph IV strategy
- BPCIA / biosimilars counseling and litigation
- PTAB / IPR proceedings
Key Technologies
- Small-molecule pharmaceuticals
- Biologics and biosimilars
- Pharmaceutical formulations
- Analytical processes and methods
News & Updates
Chambers & Partners ranked the firm in its USA 2025 legal rankings, recognizing practice strengths in life sciences and Illinois intellectual property.
Four partners at the firm were named on the 2025 IP Patent Stars list by Managing Intellectual Property.
The firm received a high commendation in the IP Boutique of the Year category at the inaugural LSPN Awards USA 2025 and was shortlisted for Life Sciences IP Litigation Firm of the Year.
Multiple individual and firm recognitions across industry rankings and guides for IP and life sciences work.
Chambers & Partners ranked the firm in its USA 2025 legal rankings, recognizing practice strengths in life sciences and Illinois intellectual property.
Four partners at the firm were named on the 2025 IP Patent Stars list by Managing Intellectual Property.
The firm received a high commendation in the IP Boutique of the Year category at the inaugural LSPN Awards USA 2025 and was shortlisted for Life Sciences IP Litigation Firm of the Year.
Multiple individual and firm recognitions across industry rankings and guides for IP and life sciences work.