Performing Third-Party IP Review on a Drug for Different Markets: A Case Study

Entities owning patent portfolios are often involved in licensing, acquisition, and partnership activities with investors, R&D groups, or start-up accelerators. Such business transactions require thorough due diligence and third-party expert’s opinion to determine the profitability scope for investing/partnering party or licensee. Portfolio owners sometimes take the first step in the IP reviewfor effective negotiations with the potential investors/licensees and to forecast extension to newer markets. However, many businesses reach out to an expert third party for professional IP review and recommendations.

The following case study explains how our IP review services helped a pharmaceutical company get the necessary details on possible threats, market competition, and additional suggestions for strengthening its IP.

IP Review and its Significance

A product in a portfolio predicted to succeed in one market may face different roadblocks in other markets. These challenges may be more on the regulatory and policy front. In such scenarios, a third-party opinion is helpful for portfolio owners as well as parties seeking to invest, license, acquire, etc., based on the IP owned by the business. The review involves an assessment of the entity’s IP, possible edge over existing technology or products, upcoming opportunities according to the IP’s current state and predicted market, potential competition, and risks involved.

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Figure 1: Benefits of a Thorough IP Review

Significance of IP Review

IP review, a part of due diligence, enables businesses to save costs, avoid risks, and more importantly, capitalize on opportunities that would otherwise be missed. The assessment can either be general or specific.

General-purpose IP review helps big companies, start-ups and individuals not only identify opportunities, development needs, and risks but also evaluate and safeguard their IP assets. On the other hand, specific-purpose IP review is generally narrower in scope. One can determine the nature and extent of such an IP review by the objective or upcoming event for which the assessment is to be conducted.

Case Study

Sagacious IP conducted an IP review for a client on a drug useful for treating a type of arthritis. The client was keen to know how its drug fared compared to other drugs in the market, concerning strengths, challenges, opportunities, and impact. Furthermore, the client was interested in information about exclusivities and patent term extensions in three different jurisdictions and wanted an overall opinion and recommendations based on the findings.

Sagacious IP first performed a quick validity check on the patent portfolio to validate the claims and legal status of the portfolio. Subsequently, our team provided a detailed analysis of each patent in the client’s portfolio to see if the formulation at the current stage could be implemented according to the patents’ claims or solutions disclosed, existing applications, and potential applications in the future. The analysis was not restricted to patent search but also involved researching and identifying clinical and regulatory data for the drug formulations. Later, we compared the client’s product with other known drugs used for treating the same conditions.

The impact of the drug formulations was assessed by identifying key problems they were solving, and an overall summary with our findings and recommendations was provided at each step. Further, a detailed table was prepared with information on – data exclusivities, PTE, orphan drug status, and accelerated examinations in jurisdictions of interest. This was crucial for the client to re-evaluate market readiness before stepping into new markets.

Unlike other searches and analysis, IP review provides summaries and recommendations for clients’ specific questions regarding managing and negotiating their IP with businesses. In this case, Sagacious IP specifically provided suggestions to the client on:

  • Possible IP threats.
  • Market competition – based on factors such as clinical data, scaling up, and side effects.
  • Jurisdiction with the most favorable opportunities as per regulations and market.
  • Additional suggestions on strengthening IP such as opting for PCT Article 19 or Article 34 amendments within the prescribed timelines, and opting for voluntary amendment.

Final Thoughts

Sagacious IP provided the client with an overall third-party IP review with answers to specific queries pertaining to market advantage, IP competition, jurisdiction-based opportunities, and challenges. The client utilized this review as a due diligence/first-level IP audit study at various legal and regulatory proceedings for its portfolio across strategic decisions in different jurisdictions.

Sagacious IP offers various patent portfolio-related services, such as patent due diligence, to enable sound business decision-making. Our team of IP professionals specializes in several domains to help our clients in different sectors help overcome challenges regarding their IP. Please visit the service page to know more.

– Devika Saini (Life Sciences and Chemistry) and the Editorial Team

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