What You Should Know About Patent Prosecution: The Strategy Behind Building a Patent Estate

Building a successful life sciences patent estate can seem like a daunting task, but a foundation of strategic decisions early on can be a big help long term. It is important to not only cover the patentable aspects of current inventions and innovations, but also to consider anticipated preclinical and clinical developments and future improvements.

Here are five tips for building a robust patent portfolio that provides a solid intellectual property framework:

1. Aim High With Provisional Applications

Provisional applications may seem to be just stepping-stones to a “real” utility filing, but they are more than just a stake in the ground: they are the first time the invention is being described. A robust provisional application can ease the rest of the patent family’s way through prosecution across multiple jurisdictions.

A. Establishing a Priority Date

The filing date of a provisional application determines the priority date for the family that builds from it. A key feature of that priority date is that it determines what qualifies as a prior art reference that can be cited against family members stemming from that provisional application during prosecution. Thorough written support and descriptions of the inventive concepts and features establish a solid application with an early priority date that can protect the invention.

In order to provide thorough written support, the provisional application should contain as much information as possible. Include descriptions of the invention in terms of structure and function and descriptions of how to make and use the invention, along with any experimental data that has been generated. Planned experiments and hypothetical outcomes can also be useful to show what kind of scope was being contemplated at this early stage.

B. Patentability Assessments

Patentability assessments provide a wealth of information for developing written description support for the invention. Intellectual property landscape and state of the art analyses provide insights about trends for a specific technology field, activities of potential competitors, possible opportunities for acquisition or collaboration, and assessment of risks. Conducting these assessments at the provisional application stage helps direct strategic planning that can mean long-term success for the family as a whole.

C. File Follow-On Applications as New Data Rolls In

Keep patent counsel informed on refinements to the invention during the one-year period between filing the provisional and the deadline to file a utility application. A follow-on provisional with additional data or embodiments can be filed before that one-year anniversary of the provisional filing. Follow-on filings may be especially important if there is a planned disclosure of some or all parts of the invention, such as a presentation at a conference or during a collaboration or negotiation with a third party.

2. Identify Inventive Concepts “Early and Often”

A. Define the Technical Problem to Be Solved

A patent application should set out a description defining the technical problems solved by the invention. The details should not only outline the inventive concepts of the application but should also define how and why the invention is patentable. This overview of the inventive features can be particularly helpful for getting patents issued in jurisdictions that tend to look more favorably on having verbatim support in the specification.

B. Terminology Can Change Over Time

The most patentable features of a life sciences technology platform may need to be described in multiple ways. For example, different inventors studying the same concept may have given it different names over the years. It can be helpful to lean on terms used in relevant publications and generally by those in the technology field to support patentability arguments during prosecution.

Balancing with the use of diverse terminology is taking caution to ensure that a term is used or defined consistently, not only within the context of a single patent family, but also across the patent estate. That kind of clarity can further arguments during prosecution.

C. Use Multiple Approaches When Conducting Landscape Reviews

Just as multiple ways of describing an invention is useful for building an application, such strategies also should be taken into account when performing landscape, patentability, and freedom to operate analyses. Not everyone describes the same technology using the same words, and conducting broad searches can reveal otherwise hidden competitors or patentability risks.  

3. Even “Bad” Data Can Sometimes Be Useful

It may seem intuitive that only the best data should go into a patent application and that negative results should be set aside. However, in some cases, including the experiments that did not work can help showcase the inventive or nonobvious features of the invention that did work.

For example, in recent years, there has been an effort to use combinations of multiple therapeutic drugs to treat cancer patients. The fact that some combinations are not effective can help convince a patent examiner that the combination that is being claimed is novel and superior to other combinations – in other words, that the claimed invention is an unexpected result.

4. Invention Catching and Coverage Is an Exercise in Organization

Organization is a key component of any successful patent portfolio and can help save time and money. Helpful items to track can include:

1. An invention disclosure that includes a description of the invention and background information can be used to define how the invention is different from the current state of the art. Such forms should be used consistently across the organization and include identification of individuals who helped with the project as a whole to assist with downstream inventorship determinations. 
2. Tracking of dates of potential upcoming disclosures such as presentations at scientific conferences and business development meetings with third parties help with invention capture by providing an effective timeline for filing applications.
3. Regular meetings with scientific teams regarding planned experiments can be an effective way of identifying works in progress that have enough inventive features for new or follow-on applications.

5. All Parts of a Patent Estate Can Be Useful, But Not Necessarily All in the Same Way

1. Some patent families should be grown to cover exactly where research and development is at present. This is the baseline type of filing to provide protection for work in progress.
2. Some patent families should be grown to establish space in the landscape to protect inventive features as they evolve during further research and commercial development. Once a particular inventive concept is identified to be strategically useful for business goals, features and uses around that concept can be protected in new filings and establishment of additional patent families.
3. Some patent families should be grown around ideas that may be useful for trade in joint venture and other types of negotiations. If there are plans to discuss inventive ideas with a third party, it is best to get an application on file prior to that discussion to protect IP interests.

For more tips and tricks, contact Gargi Talukder.