Tips for stronger IP searches during biologics R&D

Challenges in sequence searching

Decades of exponential growth in biologics intellectual property underscores the massive opportunities for driving business value for drugmakers by developing stronger patent programs at every stage of R&D.

Reliable sequence searches are crucial for pinpointing the business value of innovations during R&D and in building patent programs to protect them. However, information on sequences is difficult to search and retrieve because sequences:

• May have chemical modifications, but some sequence database records lack that essential information.
• Are often claimed in different ways within patents.
• Are described inconsistently in scientific and patent literature over time.
• Can be one component of a complex invention (for example, antibody-drug conjugates with the antibody, drug payload, and linker).

Solutions

As you perform sequence searches or work with outside searchers, the following guidance can help you build stronger search strategies to develop and protect biologics innovations.

Build a highly collaborative R&D, IP, and search team

The complexity of the biologics space puts a premium on close collaboration between R&D, IP, outside counsel, and search professionals. Teams should be aligned in expectations and goals while participating in cross-functional responsibilities. Searches are dynamic and results should be reviewed and refined as new data emerges during R&D. Each team member has some level of responsibility for reducing human error by participating in the verification of the scientific and patent data.

Think beyond the substance you want to search for and have your end goal in mind

Do not be surprised if your ultimate search strategy is different from your initial request. The search process is iterative, moving forward one set of results at a time. An initial sequence request might be for a linker with five repeatable units, but an experienced searcher who understands the space might recommend evaluating linkers with fewer units to disclose nearby patent issues. Instead of going into the search process thinking “What do I want to search?” approach it in terms of “What would I be concerned about in a disclosed patent claim?”

Do not rely on a traditional search approach for sequence work

The diversity of information that R&D and IP teams must have to make patent decisions leads to sequence searches being highly demanding. There are few basic searches in the sequence space, and default search approaches may have to be adjusted to deliver the right results. Queries may need to cover sequences, their chemical modifications, keywords, and structures. Simple BLAST or motif searches often will not suffice. Skilled searchers will select from a variety of databases and search platforms to customize search strategies and more efficiently perform queries involving large numbers of sequences.

Consider additional analytical tools and methods for certain sequence search approaches

For certain information requests, analytical tools may be chosen for efficient evaluation of sequence search results. Traditional methods of analyzing search results can be highly manual, time-consuming, and prone to human error, requiring searchers to spend days combing through citations and assembling reports. Data analytics platforms and analytical methods, such as variation analysis, can be used to interpret search results, significantly streamline analysis, and put data into reporting formats that can be easily filtered, reviewed, and understood.

Use FTO (freedom to operate) searches throughout R&D to test every claim and clear every innovation  that arises

Think of the patent program as an onion, with the initial core composition of matter patent filing surrounded by multiple protective patent filings for innovations that arise during R&D.

In building a robust patent program, attorneys often make core filings early in R&D, especially when clients want first-to-file status to seek outside investors. These early searches cover patentability and freedom to operate to pinpoint IP value and clear the core innovation. Larger companies not seeking investments or licensing opportunities may file later in the product lifecycle when they have a more robust data package.

As R&D progresses, additional filings can be made for novel uses, delivery mechanisms, formulations, processes, methods, and other innovations. All of these must be cleared for freedom to operate.

Perform IP searches at the critical R&D stages of lead development and proof of concept

IP searches are especially valuable at two R&D stages: lead development and after Phase II proof of concept. Companies report that IP insights are not considered early enough in R&D when they can guide research and be useful in building strong claims for the initial composition of matter filings. During lead development, Freedom to Operate searches can be performed with wide variability around the lead candidates to identify likely patent threats. After Phase II trials, when proof-of-concept is established, claims can be cleared with a much broader, global FTO search to discover every possible patent threat to the core sequence and layers of related innovations.

Regularly monitor your patent space throughout R&D

New patent applications generally are not published for 18 months, so it is important to have a monitoring program that alerts you to newly published applications that might affect your innovations in development. Your monitoring program should also alert you to new scientific publications, changes in legal status, and changes in prosecution.

Contact our CAS IP Services℠ search experts to discuss your next sequence search strategy IPServices@cas.org

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