Intellectual Property Specialist

Job Description Intellectual Property

Organization : Orbicular Pharmaceutical Technologies Pvt Ltd

Industry : Pharmaceutical - Formulation Research & Development

Work Location : ALEAP, Pragathinagar, Hyderabad.

Qualification : M. Pharm (Pharmaceutics)

Experience : 7 - 12 Years

Position : Asst.Mgr/Dy.Mgr

Reporting to : DGM - IP

Department : IP

Company_Overview:

Orbicular Pharmaceutical Technologies Pvt. Ltd. is a research-driven company specializing in the development of niche generic and specialty pharmaceutical products. Our CI-TOP SPIN strategy focuses on Complex Injectables, Topicals, Ophthalmic, Parenteral, Nasal Sprays, and Inhalations, targeting complex and profitable domains. With expertise in formulation and drug delivery technologies, we offer a diverse range of solutions across therapeutic areas and dosage forms. Partnering with national and international drug manufacturers, and backed by a team of experienced techno-entrepreneurs and renowned scientists, we have a strong track record of delivering innovative products from concept to commercialization.

Role summary:

To support and drive the Intellectual Property strategy by managing end-to-end patent lifecycle activities, with a strong focus on formulation technologies and peptide-based products. The role aims to enable early market entry, freedom to operate (FTO), and robust global IP protection, aligned with business and R&D objectives.

Key Responsibilities

1. Patent Searching, Review & Analysis

• Conduct patentability, novelty, and FTO searches independently related to:
• Pharmaceutical formulations (oral, parenteral, and complex formulations)
• Peptide-based drug products
• APIs, excipients, delivery systems, and drug-device combinations
• Prepare patent landscape and white space analysis reports for APIs, formulations, and peptides.
• Identify design-around opportunities, strategic IP gaps and provide clearance.

2. Patent Filing & Prosecution

• Coordinate and manage patent drafting and filing activities (National & International):
• Provisional and Complete specifications
• PCT and foreign filings
• Work closely with inventors, formulation scientists, peptide teams, and external patent attorneys.
• Handle patent prosecution activities, including:
• Office action responses
• Claim amendments and prosecution strategy
• Review/ Maintain patent docketing, timelines, and compliance.

3. IP Reporting, Litigation & Strategy

• Prepare/ Review:
• IP summary reports and IP strategy documents
• Invalidation and prior art search reports
• Data support for oppositions and litigation
• Address IP-related queries for:
• APIs, formulations, peptides
• Vendors, suppliers, and collaborators
• Support pre- and post-ANDA / litigation activities, where applicable.
• Review API IP reports and provide comments
• Review Litigation documents and respond to external counsels or attorneys

4. Early Launch & Business Support

• Identify early launch opportunities for Marketing and Business Development teams.
• Evaluate launch status of third-party products for BD portfolio assessment.
• Prepare Global Launch Calendars (GLC) covering:
• Constraining patents
• Market-wise entry timelines (US, EU, ROW)
• Provide potential market entry dates for regulated and semi-regulated markets.

5. Cross-Functional & Ideation Support

• Support R&D ideation teams in:
• Initial IP evaluation
• Patentability assessment and idea generation
• Collaborate closely with FR, Portfolio/BD, and RA teams.
• Assist in IP due diligence activities.
• Perform Trade Mark Search and make a brief/detailed report of same.

Technical & Domain Knowledge

• Strong understanding of:
• Pharmaceutical formulations
• Peptide chemistry, synthesis, stability, and delivery challenges
• Exposure to complex injectables and specialty products is preferred.
• Sound knowledge of:
• Patent laws (India, US, EU basic level)
• ANDA / 505(b)(2) IP considerations (added advantage)

Key Skills & Competencies

• Expertise in patent databases/tools
• Strong analytical and scientific writing skills
• Ability to translate R&D data into strong IP positions
• Cross-functional collaboration and communication
• Strategic thinking with strong business alignment

The above-mentioned JD and responsibilities include, but are not limited to, the job.