Navigating Publications, Presentations and Patents

This tension often leads to the misconception that academic scientists must choose one or the other.

Fortunately, publication and commercialisation are not mutually exclusive and, when planned carefully, will be advantageous for both the academic and commercial partner. There is a way to safely continue publishing papers while progressing a project along the development pipeline with a well-considered publication strategy.

 

What is considered public disclosure and how does it affect commercialisation?

The forms of “public disclosure” can include publications as well as abstracts, posters, and oral presentations at conferences and meetings. This also includes presentations within your own institution.

Any public disclosure of your work by you, or others, may be used by patent examiners as examples of “prior art.” Prior art is any information (art) that may demonstrate that the perceived novelty in potential intellectual property (IP) does not actually exist, as that information was publicly available prior to an application for legal protection of the potential IP.

While public disclosures may vary in their extent, timing and audience, if they are not carefully and strategically planned, they risk the future of a promising potential therapeutic.

 

What is a publication strategy?

A good project will achieve both publication and commercialisation. When a project starts, a publication strategy should be developed in conjunction with the timeline. With careful planning, publications can add value to commercial deals.

Exploratory biology publications are good as they attract interest to the area. However, it is key to maintain one’s competitive advantage (e.g., by avoiding premature disclosure of a validated target (or means of targeting) to maintain one’s developmental lead time) so that you preserve the possibility of being first to market and still attract investors further down the development pipeline by offering them something of value that they themselves have not yet explored.

Publications around development of the novel therapeutic itself need to be carefully staged. For example, if you are developing a small molecule drug, it is desirable to create more than one chemical series. One series could be developed as a “tool compound” which can be disclosed and published. The other series (or multiple series) would be developed as the potential drug candidate and advanced along the drug discovery pipeline with no external disclosures (see Figure 1).

 

 

A similar approach applies to other therapeutics such as antibodies. Antibody sequences we well as their mechanism of action (if unique) should not be disclosed and/or published until an appropriate value inflection point (see Figure 2). This applies to both therapeutic antibodies and ‘tool’ antibodies such as ‘surrogates’.

 

 

When to Apply for a Patent

Timing of patent filing is crucial. Only patent when you have something of true value to investors. Filing for a patent too early will reduce the time window for recouping costs and providing a return on investment. As such, in order to attract the large amount of industry investment required to take a candidate drug through clinical trials, sufficient patent life must remain at the end of that process.

To get a patent granted, you need to be able to make novel and non-obvious claims, and a strong patent position is essential to attract investors. Patents with broad unexemplified claims will incur significant costs and time as they will almost definitely be subject to rejections once they reach national phase.

You also need to ensure that no earlier patent (including your own!) will count as prior art against you.  Remember that as soon as a patent publishes (18 months after the earliest priority date), everything contained within is public knowledge. Should you decide your invention needs more work your patent will be cited by examiners as prior art against your new claims.

 

Different Types of Patents

There is no such thing as a novel target. The genomes of most species have been sequenced, and all potential targets are public knowledge. It is the application of the target to a disease process, uncovering its function, and means of therapeutic use which is valuable IP.

If a target has been linked to a novel biology, a ‘methods of use’ patent application could be filed. This will protect the new biological concept, link to disease, and therapeutic mechanism of action. A ‘methods of use’ patent could apply to using existing reagents for a new purpose (e.g., use of existing monoclonal antibody for a companion diagnostic).

Even if there is no linkage of a target to a disease process or novel function, but a new therapeutic (and variants thereof) is being developed, a ‘composition of matter’ patent application should be filed. This protects the novel sequence of your therapeutic antibody or the inventive medicinal chemistry steps to make a therapeutic small molecule and will claim some of the characteristics of the molecule (i.e., potency, cross-reactivity, and/or developability). A composition of matter patent for a final therapeutic is typically filed after a ‘methods of use’ patent and, since it defines and protects your actual drug candidate, is the basis of the drug’s potential value. Thus, protecting this IP and filing it as late as possible is preferred.

 

How can BioCurate help?

BioCurate is committed to supporting researchers in achieving impact from their research and advancing their career through publications. This commitment, together with extensive knowledge and experience  working at the intersection of research and industry, enables the BioCurate team to develop a publication strategy that can result in desired academic and commercial outcomes.

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