Johns Hopkins Courses this Academic Year

Innovation Management, Technology Transfer and Legal Aspects of Biotechnology

With appreciation to the masters degree program in biotechnology at JHU for providing a forum for online teaching — these topics are among the “core” competencies for managing innovation strategically and effectively! This semester (Spring 2017), my course in “legal aspects” focuses on managing legal (and business) risk in both for-profit and not-for-profit biotechnology enterprises. I’ve been using VoiceThread as a presentation/sharing tool on the Blackboard platform this year, and it’s been popular with students after getting past the interface training. Despite my initial misgivings, this is not just for high school students. It’s truly an effective way for grad students to develop a sense of community because commenting in context on presentations by voice or text is so easy to do and to review!

 

FLC’s Technology Transfer Desk Reference — Useful Background Info (FLC, 2013)

FLC logo

The Federal Laboratory Consortium for Technology Transfer (FLC) is a national network of federal laboratories that are involved with the patenting and licensing of inventions. These labs include, as examples, the National Institutes of Health, National Institute of Standards and Technology. Moving technology from place to place, usually from innovator to commercial developer, is a major part of an overarching strategy to manage innovation.

I was involved in the early 90s with the FLC while heading up the NIH technology transfer office, and appreciated very much the networking and information sharing with colleagues. As an historical footnote, the Association of Federal Technology Transfer Executives (AFTTE) was also very active in this space. I was involved in its launch along with a few colleagues and good friends, Joe Allen, Jon Soderstrom, Mary Ann Guerra, among others. Members were later encouraged to move to the FLC and to the Association for University Technology Managers, another excellent professional society.

The FLC publishes a very helpful reference book (linked to this post’s title), which is free to download. I recommend Section 3 for anybody looking for a general overview of the considerations involved in the technology transfer process. And, particularly, the graphic on page 20 of the book. Section 7 about marketing and communications could also be useful to skim. Overall, it’s mostly useful for the staff of a federal technology transfer office as it gets a bit granular about how to do what they do. But there is some great background coverage that could be useful as various stages along the path arise. However, it doesn’t have much by way of practical guidance. Look to up-coming posts in this blog for some “how-tos” and best practices!

Two Essential Questions to Ask BEFORE You Start a Negotiation!

One of the best ways to accomplish something with other people, including business negotiations, is to communicate effectively. That doesn’t always happen despite one’s expectations and best intentions.

Shot of two young men having a discussion indoors

Shot of two young men having a discussion indoors

Last month, I negotiated a very simple and conventional material transfer agreement (MTA) for a client that wanted to give some pharmaceutical compound samples to an academic scientist for pre-clinical studies. My assumption — proved wrong — was that the scientist (and his legal support) were familiar with similar transactions and documents, and the way we communicated wasn’t helpful.

The basics. A material transfer agreement generally is a simple contract, of a few pages in length, that sets out rules for the use of materials that someone is providing. Usually, it serves to retain various rights (ownership of the material), prohibits some uses (like transferring the material to others, using the material for therapeutic purposes), confirms that the recipient can publish the results of their studies using the materials, and gives the provider an opportunity to review publications before submission to consider whether patentable discoveries might need to be protected. Usually there’s no charge for the materials and academic research is facilitated. For more information, the National Institutes of Health has some useful model agreements.

In this instance, the marked-up document returned by the university reacted to unmentioned and unintended issues that went beyond the scope and language of the MTA itself. For instance, the draft MTA said the university owned the results of its research although it didn’t explicitly say that such results included patent rights. This was perceived as overreaching on the part of my client. The markup also truncated customary periods of time to review a draft manuscript describing the use of the material from 30 days to 5 days, which simply is not enough time.

Shortly after I started working at NIH, I learned an elegant and effective conversation and negotiation approach from Josh Kalkstein and Paul Armond, both then at Pfizer. They started a negotiation with a question: “What’s important to you about this transaction?” I’ve used their approach with appreciation for almost 30 years. Ask that question and you might hear about institutional policy concerns, timing and deadlines or even hopes and dreams for the underlying research!

Back to my MTA kerfuffle of last month, I should have asked another question about the scientist’s familiarity with deal negotiations and the patent process. As it turns out, he’s never been involved with a patent application. So he truly didn’t know that reviewing a manuscript for inventive content takes time — more than five days — and involves multiple people at the material-providing enterprise (that is, management, scientists and IP attorney). And his familiarity with contracts like this MTA also was very limited.

To sum up: ask both of these questions as you start negotiating a transaction rather than just sending a draft agreement by email. And tell me what works for you in a comment below?