Navigating patentability assessments in scientific industries

Scientists Working on Computer In Modern Laboratory

Patents are one of the most important forms of protection for innovations. If you are pursuing or considering a patent, there are several things to keep in mind.

The patentability of scientific innovations has unique challenges due to the complexities of the technology, the barriers to a thorough prior art search, and the ever-changing nature of these industries. This article explores the unique challenges of patentability assessments within scientific industries, offers best practices to help address those challenges, and highlights how CAS can help.

Scientific innovations are complex and multilayered, magnifying the patent search challenge

The more complex a technology is, the more there is to consider and query when performing a patentability assessment. Critical information could be hiding in various sources that go beyond patents and the typical non-patent literature that must be mined to get a comprehensive picture of prior art.

Let’s take a look at RNA innovations.

Nanoparticle delivery, ligands, conjugates, and types of chemical modifications must be considered when performing a patentability assessment. It's not a simple BLAST or motif search to find a related sequence. It's identifying the technology that has evolved over time and understanding who has a stake in it.

Companies turn to CAS Solutions to assist them in identifying the technology that's been disclosed publicly, minimize their risk, innovate earlier, and avoid the risk that comes with not doing due diligence early and thoroughly.

Keep an eye out for possible IP entanglements 

Intellectual property (IP) entanglements refer to situations where a company’s IP rights or freedom to operate are restricted by existing IP owned by another party. Such entanglements can arise due to several reasons including technology convergence, cross-licensing agreements, research collaborations, and mergers and acquisitions. IP entanglements can have a significant impact on the patentability of an invention, particularly in highly regulated industries such as pharmaceuticals and functional materials. Identifying and managing IP entanglements is important as it can impact a company’s ability to innovate, commercialize, and generate revenue.

Take a look at Enbrel, a blockbuster drug for treating rheumatoid arthritis. The drug was initially developed by Immunex Corporation, which was later acquired by Amgen. However, the original patent on Enbrel was co-owned by Immunex and Wyeth Pharmaceuticals, which was later acquired by Pfizer. This led to a complex legal battle over the patent rights of Enbrel, with both Amgen and Pfizer claiming ownership of the patent. The case was finally settled in 2017, with Amgen gaining full ownership of the Enbrel patent.

The development of biosimilars adds another layer of complexity to IP entanglements. The production of biosimilars requires the use of cell lines and manufacturing processes, which may be protected by existing patents.

With the ever-changing patent landscape in the biotechnology industry, how do you keep up?

New patents are being filed every day, and the patent landscape is constantly shifting. For instance, our in-house experts estimated that over 10,000 patents have been issued in the last 10 years of the RNA innovation landscape. This creates challenges for innovators, as the complex documentation and literature to sort through become increasingly difficult to navigate. The question that arises for many in the industry, then, is “How do I keep up?”

The first step to a thorough and up-to-date patentability assessment is investing in a reliable IP search tool

The search tool you choose should be updated regularly with new patents and non-patent literature. There are many search tools on the market today, but not all of them offer the same features or quality of results. Some of the open-source options available lack customizable search algorithms—a must-have for the scientific industries—or do not provide the most relevant and new information.

CAS provides a range of solutions to help customers understand possible IP entanglements in various industries. For example, CAS' scientific and technical solutions, such as CAS SciFindern and CAS STNext, provide access to a wealth of information on patents, scientific literature, and regulatory data, helping customers identify potential IP entanglements and navigate complex competitive environments.

CAS IP ServicesSM provides customized solutions to help customers address specific IP challenges, such as freedom-to-operate assessments, patentability assessments, and patent portfolio analysis. These services leverage CAS' deep expertise in patent searching and analysis, as well as its extensive network of global patent experts.

Check out all that CAS STNext® has to offer!

The effectiveness of your search strategy depends on the data sources

Inconsistent terminology and incomplete indexing are threats to reliable patent assessment for chemistry and biotech innovations. Chemical formulas, structures, biological sequences and modifications can go uncaptured, leading to gaps in your assessment. There is no single search strategy that can be used to efficiently and comprehensively retrieve this information from different data sources.

To identify all relevant prior art and conduct a thorough patentability assessment you need a strategy and effective tools built on comprehensive, well-structured databases.

The CAS Content CollectionTM is built with these challenges in mind, ensuring that complex aspects of patent documents and non-patent literature, including chemical substances, sequences, and Markush structures, are searchable and accessible.

CAS provides unique value with CAS STNext, a trusted solution that allows you to search more than 130 premium global databases in a single interface.

Go beyond the technology and consider geography

Conducting a search in the appropriate geographic scope is extremely important. If you search for literature in a too broad geographic area, you’ll end up with too many documents to sift through. However, if your search is too narrow, you may miss relevant documents and connections.

How do you decide the appropriate geographic scope of your search? Depending on the type of assessment you are considering, the appropriate geographic area may be different. For example:

  • Patentability evaluation: The goal of a prior art search during a patentability evaluation is to find all relevant existing prior art that may impact the novelty of your innovation. If any such information is found, it can derail your R&D strategy. In the United States, any prior art worldwide is considered for patentability determinations.
  • Freedom-to-operate search: When combing through the claims within in-force patents, your search strategy may differ depending on the location in which you plan to operate and sell your innovation. Our FTO search strategy will differ, depending on where you want to operate and sell your invention. Depending on your commercialization strategy, you may be able to narrow the scope of your search to limit to select major patent offices. For a global launch, you will need to be more expansive in your target search.

Summary

With evolving and quickly changing IP landscapes in scientific industries such as functional materials and pharma, having up-to-date and highly comprehensive tools to support IP search is essential.

The STN IP Protection SuiteTM contains the tools you need to protect your scientific IP and conduct thorough and comprehensive prior art and freedom to operate searches. You’ll have access to unparalleled content from patent and non-patent sources, aggregated, curated, and translated by scientists. Mitigate risk and protect your IP assets with monitoring tools, and specialized technology to stay ahead of competitors and protect your inventions. And if you need additional support, our IP experts are ready to help you and act as an extension of your IP team.