Introducing The Office of Intellectual Property (OIP)

The OIP, which is split between the London and New York Offices (Figure 1), manages the process of protecting intellectual property (IP) that covers the novel findings arising from the Institute’s basic and clinical research. Typically we think of intellectual property as being a patent or a trademark, but copyright, designs, and trade secrets are also forms of IP. The OIP is mostly concerned with patents, and the following article describes the patent process and why LICR should patent research findings.

 

What is a patent?

Conceptually a patent is two things. First, it is a disclosure of an ‘invention’ (the technical jargon used to describe a novel finding) to the public, and secondly it is an exclusive right to the invention for a defined period of time. The time or ‘term’ of a patent is usually 20 years. This is essentially a deal between the scientific community and the ‘inventor’; in return for revealing to the public the best way of making or using the invention, the inventor receives exclusive rights for a defined term. The inventor relinquishes such exclusive rights when the term of the patent expires, but the disclosure remains in the public domain.

A patent consists of two parts, a long descriptive section called the specification, and a list of statements called claims. The specification must describe the invention in sufficient detail and with adequate information to enable another person to understand it and put it into practice. Typically this will include: a description of the technical field and background ‘art’ to which the invention relates; a description of the invention as a solution to a problem and the advantages that this invention would confer; at least one specific example of a way of using the invention, and; a description of at least one way the invention may be exploited in industry. Claims are a series of statements, which recite the invention in the most general way possible. The function of the claims is to define the scope of legal protection afforded by the patent.

The exclusive right provided by the patent is the right to exclude others, meaning that consent must be obtained from the owner (LICR) for any commercial use or development of something that is claimed by the patent. Academic use of something claimed by the patent does not require permission from the owner. It is important to note that a patent does not necessarily give the inventor the right to use their invention. The inventor’s freedom of use of the invention may be dependent on other pre-existing patents. For example, consider a situation in which Scientist A has patented a cell surface protein, and the patent claims antibodies that target that protein. Now Scientist B makes and patents an antibody that targets the protein claimed by Scientist A’s patent. Scientist B will have to obtain permission (generally given freely for academic use), or pay for a license (if there is a commercial application or company involved) to use the antibody that he/she has patented.

 

Why does LICR patent research?

As an academic institution, LICR encourages its investigators to publish their research in the scientific literature, so it is reasonable to ask why we bother with patent protection. The simple answer is that patents protect the invention and the resources of the Institute, and allow LICR investigators to develop the invention without hindrance from competing groups or claims in new patents. LICR is committed to facilitating the translation of its basic and clinical discoveries into novel therapeutic practices for the benefit of patients. Thus the period of commercial exclusivity gained through patent protection provides the incentive for the investment of resources necessary for further testing of promising laboratory findings in the clinic, and perhaps eventually therapy development. Additionally, a strong scientific, clinical and IP “package” will better attract interest and investment from commercial partners and venture philanthropists (who make donations in exchange for a percentage of any future royalties), furthering the potential for the successful development of the original finding (see upcoming NewsLink article on the Office of Technology Licensing).

 

How do I benefit from LICR patenting my research?

As with any other scientific publication, patent applications can be useful in assessing a particular research program. An issued patent arguably represents independent corroboration of the usefulness of a particular piece of research, although this is clearly based upon different requirements than traditional peer review of scientific publications. Information concerning patents or patent applications originating from an investigators research is increasingly being requested as part of competitive grant applications, presumably as another means for assessing the novelty and usefulness of an applicant’s research proposal. Patents are also counted as a publication by the inventor(s) for resumés and job applications.

Another benefit might one day result from any potential licensing of the invention; as with most universities and research institutes, LICR shares a portion of any income generated with inventors. Finally, there is the intangible benefit of seeing your ideas and efforts being judged as having real potential for actual use in therapy.

 

What can be patented?

Patentable subject matter may fall in one or more of the following categories: a process or method of doing something; a composition of matter; a manufactured article; or a machine of some sort. Whatever your type of invention, it must meet three standards for patentability. First, an invention must be useful (the legal term refers to an invention’s ‘utility’), which distinguishes an invention from a discovery. For example, it is a discovery to isolate and sequence a new gene, but the new gene becomes an invention if it can be shown to have tumor associated expression or over-expression, and thus might be used in a method to identify such cancers. Second, an invention must be different from anything already known or available (‘novelty’). Third, at the time an invention is made it must not have been obvious to a person with appropriate knowledge in the respective field, often referred to as a person of “ordinary skill in the art” (the legal term for this is ‘nonobviouness’). Determining nonobviousness is often difficult to assess, as in hindsight inventions often seem fairly obvious. Criteria used to help determine nonobviousness include whether the invention provides a solution to an identified problem, particularly one which previous attempts to solve have failed. An invention that produces surprisingly good (or bad), or unexpected results is arguably nonobvious. Other criteria such as commercial success or copying of an invention may indicate a nonobvious invention.

 

Who is an inventor?

Inventorship is a legal standard. An inventor must contribute significantly to the ‘conception’ or the ‘reduction to practice’ of the invention. Conception is the formation of the definitive idea of the invention and a means for making or using it, while reduction to practice is the actual experimental work downstream of conception, such as the successful configuration of a working example or embodiment of the invention. Even though LICR staff assign their rights to a common owner of the patent (the Institute) it is still important to be accurate over inventorship on the patent. Co-authors on a scientific publication are not automatically inventors. Should the patent be challenged in the future, the OIP must be able to justify the original naming of the inventors by providing evidence of significant contributions by each inventor.

 

What do I do if I think my research finding could be patented?

A manuscript submission process has been operating within LICR for many years, and this allows the OIP to review the potential inventions of the Institute (see accompanying NewsLink article ‘Submitting Your Manuscripts to the LICR Intellectual Property Database’). However, investigators are strongly encouraged to contact the relevant individual at the OIP (Figure 1) directly to discuss any questions, concerns, or ideas they might have as soon as they suspect they might have a novel discovery. This might be especially important if you intend to present your data at a scientific meeting or workshop since public disclosure includes oral, electronic and print publication. Premature disclosure of an invention before the filing of a patent application will generally preclude obtaining valid patent protection.

As described earlier the patent specification must adequately describe the invention, preferably with at least one working example, in such a way that someone of appropriate skill or training could exploit or use it. It is generally the case that a patent specification is a record of work done. However, a patent may include some ‘prophetic examples’ together with those describing actual experiments. Extrapolating from the actual results to describe how an invention could be applied may secure a broader claim scope than one based solely upon the experimental data. Patents will nearly always be predictive about the scope of application of an invention.

 

Will filing a patent application slow down publication of my manuscript?

Generally it should not, since a patent application may be prepared and filed at the same time that the journal submission and review process is going on. While a manuscript is under review at a scientific journal it remains confidential and must be treated as such by the journal and its reviewers. The day it actually appears in print or electronic form represents its date of public disclosure. Even in the days of electronic submission and review it still takes several weeks for review and publication of a manuscript. As long as the OIP receives the manuscript at the time of its submission there is usually adequate time to take the appropriate action to establish a patent priority date before the eventual date of publication. Of course the earlier the OIP receives the information the more time there is to ensure that it can be adequately protected.

 

What if I am collaborating with another institution?

Some additional attention is needed if an invention arises from a collaborative project with another institution, but this is certainly not an insurmountable problem. Most likely investigators from each institution will be named as inventors and their respective employers co-assignees (co-owners) of the patent. Generally this situation requires a formal agreement defining each party’s responsibilities in managing the patenting and future licensing of the intellectual property and the expectations with respect to royalty distributions of revenues from such licenses. These agreements are negotiated by the OIP in consultation with the IP office of the collaborating institution.

 

What has the LICR patented?

The Ludwig Institute’s patent portfolio falls into several general areas:

 

Have any patents been licensed?

Many of the LICR’s patents have been licensed to a number of pharmaceutical companies such as Aventis, GlaxoSmithKline, Wyeth, Amrad, and Berlex, and biotechnology companies such as CSL, Genzyme, Piramed Ltd (see September 2003 NewsLink), Cell Genesys, Therion and Dendreon. The OIP (and Office of Technology Licensing) endeavors to use these licenses to develop strategic relationships with the licensing partners, such that LICR is involved in the development and use of the invention, particularly with the early-phase clinical trials and clinical discovery process (see January 2004 NewsLink). This is partly to ensure that, as much as possible, the inventions by LICR staff are carefully, appropriately, and fully investigated.

 

Dr. A. Munro Neville, Director

 

Dr. Deborah Carter, Associate Director of London Office

 

Dr. Jonathan Skipper, Manager of New York Office

 

Figure 1. The organization of the Office of Intellectual Property and the personnel responsible for the different areas of scientific expertise in which the Institute is involved. The Office was originally established in Zürich in 1985 by Dr. Neville, but was later relocated to London. In 2000, the need for an IP presence at the New York Office was recognized, and as a result Dr. Jonathan Skipper was transferred to New York where he has established a group to cover some of the IP activities.

 

How many patents does LICR own?

The United States Patent and Trademark Office (USPTO) database http://www.uspto.gov/patft/index.html currently lists 326 issued US patents with LICR as an assignee. The European Patent Office (EPO) database http://ep.espacenet.com/ current lists 70 published European patents with LICR as an applicant.