The extent of in-house IP expertise in a company can vary depending on factors such as the company’s industry, size, and extent of R&D. Every innovative organization that makes patentable inventions should have at least one person designated to ensure that the inventions are identified and protected. That person can also consider freedom-to-operate factors. This article will call that role the “IP professional”, but that person is not necessarily a dedicated patent agent. The role could reside with an engineer, scientist, or another person whose role is only partly to manage IP. The IP professional works with a variety of departments within the company and gets involved in the product development from early stages of inventing process. This article discusses the key factors for the IP professional to consider throughout the various stages of the product development cycle.
In the stage of product evaluation, the IP professional conducts market and patent analysis to identify competitors and to evaluate their IP activity. While companies who are already selling products in the same field can be easily identified, potential future competitors can be uncovered through patent analysis. Patent documents identified in the analysis also provide an insight into potential infringement risks and help determine which aspects of the product are novel and how broad they can be protected. Other types of applicable IP, such as designs, copyright, and trademarks, may also be considered at a preliminary level. The role of the IP professional, in this stage, is to evaluate the position of the potential product compared to the competitors’ products and to develop an IP strategy. Effective strategy aims at obtaining the best possible protection for the company’s IP and ensures product launching with significantly lower infringement risks.
When it comes to patent protection, it is important to consider the business objectives of the product. Therefore, the IP professional should cooperate with the business team and evaluate which innovative aspects of the product will provide a competitive advantage and value in the target market.
In the pharmaceutical sector, the IP strategy must also be consistent with the regulatory requirements in the target markets. Innovative drugs in Canada, for example, may benefit from NOC regulations (by listing patents on the Patent Register) and patent term restoration. In both cases, eligible patents must meet strict timing requirements. For generic drugs and biosimilars, the IP professional should determine whether companies owning brand name drug have market exclusivity and patents listed on the Patent Register. These regulatory systems will significantly affect the IP strategy as well as the launching of the product and must be considered.
Throughout the next stage of the product development, the IP professional should monitor the competitor’s IP activities regularly. While patent applications undergoing examination do not pose a threat yet, their status should be followed. In some cases, patent applications are abandoned or invalidated making the use of the technology available. However, in other cases the outcome may bear a legal risk, which the company should be aware of and prepared for.
When the product is being developed, the data obtained in the patent analysis and monitoring is used as a source of information. If potential legal risks have been identified, the course of the development may need to be adjusted. There are various approaches that may be taken. Depending on business objectives, it may be decided to work around the patents, challenge their validity or launch the product once the patents are no longer in force. During the fine-tuning of the product, the IP professional should work closely with the researchers. Any changes in the product may require additional patent analysis and IP strategy re-evaluation. Therefore, maintaining good communication with the R&D team in this stage is critical.
Finally, the IP professional works on patent filings. By regular assessment of the product during its optimization, the IP professional should ensure that all valuable aspects of the product are captured. Depending on the company’s practices, patent applications may be drafted and prosecuted in-house or through an external patent professional. Nevertheless, the role of the IP professional is to ensure that a company’s IP obtains the most effective protection. Apart from these responsibilities, the IP professional may help with defining ownership rights of the product, advise on other IP issues such as design, TM and copyrights and provide support in litigation.
As can be seen, the in-house IP professional has an important role to play throughout the lifecycle of the product development process. Looking from various angles and cooperating with multiple departments allows better understanding of the needs of the product and market. But most of all, it is the good communication with the relevant stakeholders that allows identification of issues early on, to provide effective solutions and reduce future legal risks..