Case Study: Cytiva Life Sciences and Clearstone FTO


Purpose-Built FTO Workflow Technology: The Backbone of a Successful Patent Clearance Program

CYTIVA is a global life sciences leader with 10,000 associates operating in over 40 countries dedicated to advancing and accelerating the delivery of life-changing therapeutics. With 75% of FDA-approved biotherapeutics manufactured using Cytiva’s technologies, the company has more than 100,000 systems in use globally driven by its rich culture of exploration and discovery in its quest to transform human health.

Integral to the company’s commercial success is taking its pipeline of innovative products to market, requiring a sound freedom-to-operate strategy. We sat down with Dominic O’Brien, Cytiva’s Vice President of Intellectual Property and Dr. Dileep Vangasseri, Senior Patent Analyst to hear their story on how the Clearstone FTO platform has transformed how they manage patent clearance and investigations.

“I don’t usually spend an hour of my time lauding workflow software but Clearstone FTO is a world class solution worth talking about.

We need to standardize work as much as possible because it’s essential to cost-savings, efficiency, and accuracy, which is why the Clearstone FTO platform has become the backbone of our robust FTO program at Cytiva.”

— Dominic O’Brien | Cytiva VP of Intellectual Property

The Challenge & Opportunity

Typical of many successful patent teams, Cytiva was relying on a home-grown, hard-coded tool to manage its freedom-to-operate and patent claims analysis. In theory the tool was intended to bring consistency and process to internal FTO analysis and collaboration between legal and R&D teams. However, the technology was clunky and had limited options for improving functionality. In addition to a cumbersome user-experience, the in-house tool could not rank patents, track projects or cross reference previous analysis.

“The architecture of the Clearstone FTO platform organizes our FTO analysis around our products and product features.”

Enter Purpose-Built FTO Workflow Technology

After retiring its internal tool and briefly managing FTO analysis in spreadsheets, Cytiva implemented the Clearstone FTO platform in late 2020. The purpose built platform shared similar objectives of its home-grown solution, but had powerful features and functionality that transformed how it managed patent claims analysis and FTO investigations, radically improving FTO management at Cytiva:

  • Platform architecture organizes our FTO analysis around our products and product features.
  • Claims analysis and commentary are cross-referenced with related matters and archived for future reference.
  • Collaboration outputs and communication are safely contained and managed within the system with functionality to help preserve attorney-client privilege.
  • Relevant pending applications are easily monitored and accessible without leaving the platform.
  • The platform met Cytiva’s stringent IT infrastructure, security and compliance requirements.

Simplified Workflows Deliver Greater Efficiency & Richer Analysis

Clearstone FTO quickly become the backbone of Cytiva’s FTO program, delivering a simplified yet robust workflow connecting IP and product teams for optimized collaboration. The efficient manner in which communication, feedback, comments, analysis and positions are collected, shared and documented allows for more complex FTO investigations while achieving more qualitative analysis:

  • Purpose-built workflows reduce “back and forth” between IP and technical teams, aiding more focused analysis.
  • Intuitive review functionality keeps collaborators focused on the task at hand while working in tandem for quicker response times and no versioning issues.
  • FTO stakeholders can easily track progress and identify outstanding actions.
  • IP Counsel can dive deeper into a matter by easily accessing file wrap- pers, legal status, and maintenance events all from the platform.
  • Collaborators can easily retrieve, share and comment on relevant applications and cross-reference worldwide patent family data.
  • Alerts to monitor and follow up on relevant patent applications are easily activated.

“Clearstone FTO makes it possible to effectively work through our volume of FTOs with a robust process that reduces risk while not having to recruit and hire additional headcount to manage the work.”

Tighter Collaboration with R&D Teams

Since implementing the platform, collaboration between technical and IP teams has yielded higher quality analysis. Through convenient and on-demand training, Cytiva’s technical team quickly got up to speed on the platform which helped accelerate user adoption. In short order, the teams came to appreciate the ease and intuitive user experience and as adoption increased, more engaged, richer collaboration has been observed between FTO stakeholders.

FTO collaboration is further simplified and accelerated as the platform facilitates multiple contributors to work on the same matter in real time:

  • Sharing capabilities increase confidence that technical commentary in the claims analysis is properly aligned with advancing innovation and risk management objectives.
  • Intuitive dropdown options and highlighting capabilities allow R&D teams to quickly contribute technical feedback to an FTO matter and then refer back to their commentary in future matters.
  • Over time, a living repository of patent claims analysis, determinations and legal and technical rationale is created, serving as a referenceable knowledge base for future FTO projects.

“IP is a long-term strategy and traceability is critical; we often need to revert to analysis several years back. Clearstone FTO gives us the ability to archive and access previous analysis, which has been a game changer for Cytiva.”

Bringing Ease & Peace of Mind to FTO Risk

The Clearstone FTO platform has become an integral component in Cytiva go-to-market strategy. The IP legal team has a high degree of confidence that a thorough freedom-to-operate analysis and defendable recommendation is being made to the business.

  • Platform functionality enables Cytiva to maintain a robust process to assess and determine freedom-to-operate while avoiding the creation of an unhealthy paper trail.
  • A central repository of patent analysis provides transparency that allows the IP team to ensure a clean record of diligence.
  • The architecture of the solution and the process it defines leave little room for errant or ill-advised commentary, encouraging precision and conciseness.

Time Savings is a Game Changer

Since implementing Clearstone FTO, Cytiva has completed over 150 FTO reviews and a number of complex multi-feature product reviews. Through the platform, their resource requirements to support their FTO program have been reduced.

  • Patent reviews are completed faster through a streamlined workflow and leveraging their growing library of claims analysis.
  • A considerable amount of valuable time has been given back to its patent analysts, thus creating more bandwidth to focus on other strategic matters.
  • Under Cytiva’s current FTO model, they require fewer patent analysts and are retaining top talent to spend more time on high value work analyzing patent data versus managing it.

“We feel very comfortable that the platform allows us to maintain a robust FTO process in launching products that don’t infringe on third-party’s IP.”