Dr Amit Goel

Co-Founder & Director

In the complex pharmaceutical IPR landscape, several challenges like patent expirations and increased generic competition are emerging for several popular drugs, thus leading to significant revenue losses. The growth of generics and biosimilar, and FDA’s simplification of norms has enabled generic drug makers to enter markets quickly as patents expire, leading to extreme price drops, often by 80 percent, harming sales for brand name drugs. Lengthy legal battles over patents, regulatory intricacies for getting new drugs approved especially in niches like personalized medicine, and struggles of market access pose more challenges for the brands, and necessitate strengthening of R&D efforts for companies along with devising new strategies to stay ahead of competition.

Effectual Services, a globally recognized and award-winning IP management advisory and consulting firm, addresses these issues to help pharmaceutical companies optimize their IP portfolios and maximize return on investment. The firm provides a wide range of services to Fortune 500 corporations, law firms, research institutions and colleges, and venture capital firms/PE firms worldwide, with the goal of helping businesses protect their competitive advantages.

Strategic Advisory and Consulting

Leveraging its vast experience across geographies, Effectual Services provides focused solutions to its clients, employing strategies like conducting thorough and comprehensive IP audits to identify strengths and vulnerabilities and offer optimization solutions accordingly, strategic patent filing for ensuring protection of innovative products, lifecycle management of the products through identification of opportunities for new patents, licensing and partnerships agreements, competitive monitoring, and education and training.

To protect clients against infringement, the firm offers strategic legal guidance, expert testimony and support, and litigation support services. The firm conducts proactive risk assessment, offers robust IP portfolio management services, comprehensive regulatory and compliance insights, and guidance on negotiation and settlement strategies to support clients in patent infringement cases.

Providing services to a global clientele, Effectual Services has gained expertise in diverse regulatory frameworks applicable in different countries regarding patentability, data exclusivity, and enforcement, the distinctive data protection and privacy laws like GDPR in Europe, and regulations around biosimilars and generics. All these impact pharmaceutical companies severely, posing a grave challenge to stay ahead. Team Effectual Services handles these complexities expertly by implementing strategies like conducting regular regulatory reviews, implementing a global IP strategy, engaging with local experts, integrating compliance into R&D, and monitoring regulatory changes through a dedicated system.

“We are one of the largest IP and business intelligence providers globally. Our multidisciplinary teams of subject matter experts have deep knowledge of best practices across industries, are adept with benchmarking quality standards and use a combination of human and machine intellect to deliver quality projects. Having a global footprint in over five countries helps us to bridge boundaries and work seamlessly across multiple time zones, thus living to the core of our philosophy Innovation is global, so are we”, shares Dr Amit Goel, Co- Founder & Director, Effectual Services.

Staying ahead of the curve, the company also integrates AI and ML, which play a pivotal role in reshaping IP intelligence and management processes in the pharmaceutical industry. The firm offers tailored AI-powered solutions that meet the needs of the pharmaceuticals sector. By implementing AI-tools, the company ensures impeccable patent analytics, streamlines searches, and supports predictive modeling. Beyond analytics, the firm also assists clients in integrating AI and ML into their IP management processes, along with training programs to help clients maximize the use of these tools for enhancing their operations effectively.

“Our AI and ML integrating services allow creation of custom analytics platforms that combine AI capabilities with industry-specific data which enables clients to gain deeper insights into their IP portfolios and market dynamics, ultimately supporting better strategic planning. Moreover, we actively engage in collaborative research initiatives with academic institutions and technology partners to advance AI and ML applications in IP management”, adds Dr Amit Goel.

Tailoring Solutions

Committed to becoming the most innovative and preferred solutions partner, serving the knowledge economy, Effectual Services excels in curating tailored IP strategy recommendations taking into consideration the regulatory environment of the specific emerging market, its competitive landscape, and the local consumer behavior for identifying promising opportunities. Providing insights of the local IP laws and practices, filing strategies, risk mitigation recommendations, collaboration with local experts, and adaptation to regulatory and market changes, the company empowers clients to avoid potential challenges, and seize opportunities of emerging markets.

A significant area of focus for Effectual Services is assisting pharmaceutical companies evaluate IP assets during mergers, acquisitions, or partnerships. For this, the team conducts thorough due diligence, evaluates IP assets, identifies risks and liabilities, conducts market and competitive analysis, and integration planning. Other critical factors like assessment of the patent strength and scope, commercial viability, regulatory compliance, existing licensing agreements, and future R&D potential are also taken into consideration.

Fulfilling the needs of clients that aspire to penetrate multiple geographies, the team strives to understand the local laws, filing strategies, cost management, freedom to operate (FTO), enforcement strategies, and regulatory compliance needs to help navigate through the complex landscape. Aligned with these, the firm offers solutions for development of a global IP strategy that align with the business objectives, developing local expertise by collaborating with local legal experts, filing and maintenance support across diverse geographies, conducting FTO analyses, enforcement guidance, and regulatory compliance support.