On Wednesday, April 21, 2010, I had the pleasure of conducting an exclusive, on the record interview with Jim Greenwood, former Congressman and current President & CEO of BIO. Over the last year, as I have increasingly written about biotechnology patent and innovation policy, I have admired Greenwood’s work at BIO and have even opined that I wished all of our industry organizations were run as such a well oiled machine. If all innovation and patent industry groups were run as efficiently and capably as BIO, we would likely have better, more coherent patent laws.
It was a treat to chat with Jim Greenwood. Our conversation lasted about 35 minutes, and we talked about his decision to leave Congress to take over at BIO, exciting new technologies BIO companies are working on, healthcare reform, the importance of patents to start-up companies and capital investment requirements. We also learn that he is an avid bird watcher and has started to become a bit of a gym rat.
Without further ado, a transcript of my conversation with Jim Greenwood follows.
The Road Forward: Software Patents in the Post-Alice Market
Join Gene Quinn and Scott Alter for a discussion on patent eligibility, techniques for claiming software, prosecution strategies and more. Wednesday, March 4, 2015 at 12pm ET ~ CLICK HERE to REGISTER
* * * * * * * * * * * * * * * * * * * * *
Quinn: Just to provide some context, one of things I try and do with interviews is to get a behind the scenes look and try and give those on the outside a better perspective. In looking at your bio, what jumps out is your 12 years in Congress and then you decided not to run for re-election. Shortly thereafter, you joined BIO and I was wondering if you might be able to tell us a little about what attracted you to the BIO position and why you decided to take this opportunity.
Greenwood: Well, I had served in the State Legislature for 12 years and I served in Congress for 12 years, and then in 2004, I was running for re-election and already had a primary opponent and a general opponent and we didn’t think it was going to be a particularly tough election. I got a call from a headhunter asking me if I would be interested in BIO and my first reaction was, “Certainly not, I am a Congressman, and that is a pretty cool job.” Then I started to talk to some folks and started to think about it and I had made a commitment to myself; a serious one, when I was in college that I was going to devote my life to public service. I actually started out as a house parent and then was a social worker, and working with kids led me to the Legislature to work on children’s issues, so I really had to make a decision whether going into the private sector — where I really had not spent much time — and particularly working for BIO was consistent with that pledge. I concluded that it was because if this association is effective, we accelerate the arrival of new drugs to fight disease, accelerate the arrival of new crops that can expand agricultural activity and feed more people and expand the development of new fuels and materials that make our human existence on this planet more sustainable from an environmental point of view. It seemed to me to be among the most exciting stuff going on in the world, and I took the leap.
Quinn: Do you think your time serving in the House of Representatives provided you with some insights in how to approach your job with BIO?
Greenwood: Of course. The Board of Directors of BIO wanted us to become a world class advocacy organization and obviously the two dozen years I had spent as a legislator familiarized me with the processes of government, particularly the federal government and the State government as well, and gave me a familiarity with dealing with the media and interest groups. That has well prepared me fortalking to members of the House and Senate, knowing what they are looking for. They are looking for a clear idea of what it is that you want of them, as opposed to beating around the bush, and a presentation that is clear, accurate and concise to support your position. Of course, that experience helped me to do the kind of work I am doing now.
Quinn: That leads me to a couple different questions. One is some have called BIO an industry lobbying group, but it seems to me thatBIO is so much more than that, although I know you meet with Members of Congress and so forth, but how would you characterize BIO?
Greenwood: We are an advocacy organization. Our job is to make sure the scientists and the entrepreneurs who build these biotechnology companies and try and develop products have a public policy environment in which they can succeed. I often say that no matter how good the science is and no matter how good the business acumen is, if the public policy environment is not conducive to success you cannot succeed. So particularly because biotechnology is such a complex field it requires an organization that can explain the science and explain the business to policy makers so they can develop policy that helps us to succeed in serving patients, in serving farmers and making a cleaner environment.
Quinn: Now I know that…
Greenwood: Let me elaborate, back to your question. The role of advocacy is important, but we are also a convener of meetings. An important role that BIO plays is that we have partnering and investor conferences in New York City, San Francisco, two a year in Europe, in Japan and this year we will start in India and next year we will start an annual meeting in China. Our BIO International Convention attracts about 13,000 people depending upon the year and the city. Those become opportunities for collaboration, for investors to understand what companies are doing in terms of the science and vice-versa, so that the companies can attract investment. It enables us to educate all kinds of folks in the biotech community. It enables us to give States, localities and countries opportunities to exhibit and show companies what they offer in terms of inducements to develop their companies in those locales. We are a multi-faceted operation.
Quinn: It seems critical for you to stay on top of the science involved and I was wondering how do you manage to stay fluent in the finer details of the science?
Greenwood: Keeping up with the science is challenging but it is also one of the fun aspects of the job. Obviously, from the day I arrived here, going on 5 ½ years ago, I have spent time visiting and touring companies and I ask a lot of questions. You have to ask a lot of questions, even the dumb questions, so you can begin to understand it –so I can get my head around what this thing called DNA is and how it works and how it controls, the repository of all of the intelligence in the universe as we know it. Being able to understand the science as a layman, and I think it helps that I am not a scientist, enables me to translate that information to policy makers on a level that they can understand. And I enjoy it. I enjoy it because it is incredibly fascinating.
Quinn: Is there some kind of biotech primer that is available for individuals or even reporters so they can get clued in on the finer details of the science?
Greenwood: Yes. We publish a biotech primer every year that gives the basics of the industry and the basics of the science. Another thing we do is biotech boot camps for the media and we do them around the country. Again, it is difficult for reporters and bloggers to keep up with the science and understand the basics of it, yet they still have to report on a very complex subject. So by bringing some of the scientists to the media and walking them through the basics of cell biology and DNA and RNA, and having them do some hands on experiments, we make sure the people who cover what we do are more informed than they would otherwise be.
Quinn: I am going to be attending the 2010 BIO International Convention in Chicago. In looking at what you have planned for the Convention the thing that jumps out at me is not only the number of interesting sessions, but you have President Clinton, President Bush, Vice-President Gore, Surgeon General Dr. Regina Benjamin, USPTO Director David Kappos all on the program. So I was wondering, is that a typical BIO International Convention, and how do you get such star power at your Conventions?
Greenwood: I can’t say that having President Bush and President Clinton on the stage at the same time is typical for one of our Conventions, but we have been pretty successful over the years. President Bush spoke one year. This is President Clinton’s second time at our Convention. We have had people like Colin Powell in the past. We have had famous entertainers from the world of television and movies. We have had Heads of State. I think part of the attraction is when you have thousands of people from all over the world convening to talk about one of the fastest changing and most transformational endeavors in human history, powerful and smart people like to be there. It is an unusually large audience.
Quinn: Just following up on the Convention with one additional question. Do you have any advice for those people who might be attending and see that you have so many good sessions going on, some of which overlap and conflict with one another? Is there a way that they might be able to still obtain that information? Are there going to be recordings available for later viewing, or transcripts made available?
Greenwood: We do record a number of our sessions, which can be purchased through BIO’s website at the end of May.
Quinn: Now, some questions about the BIO organization itself. I see you have 1,200 biotech companies, academic institutions, State biotechnology centers and related organizations from around the world that make up your membership. Is there any kind of core focus, or what can you tell us, if anything, about exiting innovations your membership is researching presently?
Greenwood: Let me drill down a little bit on our membership. Yes, we have 1,200 members and about 900 of them are what we call core members, that is for-profit companies in the biotech field. The others include State affiliates , tech transfer offices at universities, cancer research centers, etc. If you look at our core members, about 90% of them are in the healthcare sector and are basically involved in drug and diagnostic discovery and development. About 90% of them are small companies that have yet to develop, or at least yet to have FDA approval of, their first product. We are overwhelmingly composed of emerging companies. Of course, the membership also includes the large biotech companies like Amgen, Genetech, Biogen Idec, Genzyme and Gilead. Virtually every one of the large pharmaceutical companies is a member of BIO. Then we have food and agricultural section which includes companies like Dow, DuPont and Monsanto that engage in the development of genetically enhanced crops and companies that do animal cloning/transgenic species. Finally we have our industrial and environmental section, which includes companies that among other things engineer enzymes that can break down cellulose into sugars to make biofuels and companies that make bioplastics. Our organization is composed of a broad variety of companies engaged in the forefront of biotechnology.
Quinn: With that number of diverse interests, how do you and your leadership team decide what you focus your energies on?
Greenwood: We are really a member driven organization. Each of our sections (emerging companies section, health section, food and agriculture section, industrial and environmental section) has a governing body. Those are composed largely of the CEOs of the companies. They, along with our staff, develop the policies and priorities that become our work plan and our agenda.
Quinn: With all this, if you were going to give someone an elevator speech, you had them on your elbow from maybe the first floor to maybe the fifth floor, how would you describe BIO in that time frame?
Greenwood: I would say that we are the national trade association for the biotechnology industry. Our job is to assist these companies in succeeding and developing the cutting edge of science that is trying to heal, to feed and to fuel the world.
Quinn: What would you characterize as your biggest challenge since taking over at BIO?
Greenwood: Biotechnology is complex, so not everyone understands it, and as often is the case with things that are not easily understood and that are new and represent change, we develop opposition. So there are those who don’t like embryonic stem cell research, there are those who don’t like genetically enhanced crops, there are those who fear animal cloning. There is a great deal of misinformation and there is a great deal of animosity that can be generated against the science. All the while, we feel that we are trying to do nothing but good things to thwart disease, feed hungry people and clean the environment. So a big part of the challenge is overcoming ignorance, frankly, overcoming fear. In some cases we suffer also from the fact that there are those who just don’t like the capitalistic system. They don’t like companies that make profit.
Quinn: I know that all too well as a patent attorney myself. There does seem to be unfounded animosity toward biotech.
What would you characterize as your most proud accomplishment with BIO so far?
Greenwood: In the healthcare debate there were a couple of issues that were terribly, terribly critical to the future of this industry. The first was the biosimilars issue, which is the statutory pathway for generics companies to make complex biologics. We are in favor of that; we favor competition, but we are also very, very keen on making sure that the legislation protects patient safety and that it also maintains the incentives; the financial incentives to investors to invest in our companies so that we can make these miracle medicines. It was a very tough fight. We had the generics industry arrayed against us, the AARP, powerful leaders in Congress all working in the opposite direction if you will, and we prevailed. We prevailed because we had the facts on our side, we talked straight, we were honest with Members of Congress. So that was a big success for us and one we are very, very proud of.
The second thing we are very proud of is that we were able to get some relief for small companies in the midst of this economic recession. We have witnessed literally dozens of companies go out of business for lack of access to capital. That is tragic because a lot of these companies have been on the verge of great and important discoveries that would relieve a lot of human suffering. We were able to get into this healthcare legislation $1 billion of refundable tax credits for small biotech companies that are working on novel therapeutic products. For those companies that don’t have revenue and take that credit they will receive a check from the Treasury Department. Those checks will in many instances be the difference between the ability of those companies to stay in business or not, the ability of those companies to maintain employees or lay them off. At the end of the day, again it goes to the hope that patients will have that these companies will someday develop drugs that will end their suffering.
Quinn: The investment was one thing I wanted to talk about too. What kind of capital investment is typically required for start-up biotech companies to really get off the ground and have a serious chance of surviving and innovating?
Greenwood: The story of a lot of small biotech companies begins with NIH-sponsored research done in academic institutions. Not in every instance but in many instances, you will see those academics then get to a point in the development of their research where they think they have a product that can be patented and that intellectual property might be the basis of a company. They will spin out a company, fill a patent claim and then they are off to the business of trying to attract investors. It was much easier 10 years ago when the human genome was first sequenced, there was a biotech bubble not unlike the dot-com bubble, but as the years have gone by and we all realize that it going to be a little bit more complicated to develop these cures than was first thought, investors are more inclined to wait and see companies achieve milestones before they will invest serious dollars. In many instances government programs, like the Small Business Innovation Research Grant Program at NIH that provides seed capital, provide seed capital to start-up companies and incubators to enable them to get far enough along in the science and the business to attract venture capital. Once that begins to happen, many of these companies go on a very, very long and protracted journey that can be 10 or 12 years or longer in which they may have to attract hundreds of millions, if not as much as $1 billion dollars if they are fortunate enough to go public before they actually get to the point where the FDA has actually approved their product and they start generating their first dollar of revenue. So it is a long and risky process.
Quinn: Would it be fair to say then that exclusive rights for biologics and patent protection is critical for these companies?
Greenwood: Absolutely. For most of these companies the only thing that they have is intellectual property. They may have a folder with their IP portfolio in it and not a place to file it. They start off with that and then they have to raise money to even begin to have microscopes and bricks and mortar and staff. It is on the strength of that intellectual property that they have to raise all of those dollars for a very long time. So for that reason, whether it is in the arena of biosimilars legislation or overall patent reform, we devote a lot our attention to making sure that patents and intellectual property are well protected and isn’t going to be readily infringed.
Quinn: One of the big issues circulating now relates to gene patenting. I sense that people are really entrenched in their opinions and it is hard to really have a constructive dialogue. When that happens how do you approach those types of thorny issues to attempt to speak on behalf of the industry?
Greenwood: I think in an issue like gene patenting, and frankly from my years in government and politics, the first thing you do if you want to succeed in a discussion or debate is to acknowledge the other person’s point of view. I think it is important to acknowledge that it is a bit counter-intuitive to think about gene patenting. It is natural for people to at first recoil at the idea: “You mean you can patent a gene that is inside my body? That is like patenting my wrist bone or something.” So the first thing we need to note and let people become aware of is that you don’t actually patent a gene in anyone’s body. What is patented is an isolated and purified version of a gene that gives it a different structure, a different nature and a different utility and only in that form can it be valuable for developing diagnostic or therapeutic products. If you can’t do that, then what would happen is that no one could afford to invest in those diagnostic and therapeutic products because they would too readily be copied by others and, of course, that is the whole basis for patenting in the first place.
Quinn: In and around the gene patenting debate there are those who think the government and universities should fund those types of innovations, so there would really be no exclusive rights attached. What do you say to that when people raise that as an issue?
Greenwood: Again, I think it is important to acknowledge there is another side to this debate. It is sort of natural for people to think that if companines couldn’t patent these kinds of things, then all kinds of research could be more readily accomplished and more products could be developed. If all it took were thought power and research to develop products that might be the case, but that is not what it takes. The patenting of a molecule is really just the very beginning of the process and, as I’ve said before, it is a process that requires hundreds of millions of dollars, payrolls for scientists and technicians. Why would anyone put up that kind of money, which is very much at risk because most of these products don’t turn out to work. Many of these companies go bankrupt even with the current patent system. So why would anyone take that chance if after spending all that money and developing these products a generic company or anyone else could just walk in and say thank you, I think I’ll do the same thing. Why would anyone make a movie or write a book if someone could just immediately make copies and start selling them? The patent system is the basis for innovation. It has been the basis for innovation for a very long time. It works and there really are no ultimately persuasive arguments against the current patent system.
Quinn: Now I just have a few things in my feeble attempt to emulate James Lipton of Inside the Actors Studio where he asks some interesting questions to get to know you a little bit. I did this with Judge Rader when I interviewed him and I think it went pretty well. Everyone reading had a lot of fun.
So if you will indulge me — favorite hobby or pastime?
Greenwood: I am a birder. I spend a lot of time watching birds, observing birds. I actually participate in two bird counts a year with the Audubon Society. One called the Christmas bird count and in the next couple weeks we will do the Spring migratory count. I am also a pretty avid fisherman. I like to fish for bass in my little boat in the Delaware River and I also love to fly fish for trout in good trout streams.
Quinn: Do you have a favorite fly fishing spot that you want to share with us?
Greenwood: There is a private club that if I am lucky my friend takes me to in the Poconos. The North branch of the Delaware River has got some great fly fishing, and there are a couple places in West Virginia I go to.
Quinn: Favorite sport?
Greenwood: My favorite sport is tennis, but I am too busy to play much tennis anymore. So my athletic activities consist of the fact that I have a trainer who beats me up twice a week, along with working out with my 24 year old daughter. I am becoming a bit of a gym rat. I am in the gym several days a week.
Quinn: Favorite movie?
Greenwood: I don’t know about a favorite movie, but I just saw a great movie this weekend called Saint Ralph. It is about a 15 year old boy in the early 1950’s whose mother goes into a coma and he becomes convinced that if he can win the Boston Marathon that would be a miracle and that miracle would result in his mother coming out of the coma. It’s sweet and fun movie and I recommend it.
Quinn: Who would you most like to meet? Benjamin Franklin, Thomas Edison or the Wright Brothers.
Greenwood: As a Pennsylvania boy, I would probably go with Ben Franklin. He was such a brilliant and diverse guy, from inventing everything from spectacles to printing newspapers to fire houses. Then his diplomatic career took him to France. I think that would be a pretty fascinating guy to spend some time with.
Quinn: Coolest invention of all time?
Greenwood: Probably the GPS system in my car because I have no idea how I got along without it. My kids tease me because I still use it to get from my house to the grocery store. (laughter) I love that you can set it for the fastest route or the shortest route and find all kinds of new ways to get from point A to point B.
Quinn: Best fictional inventor. Emmett Brown from Back to the Future, Q from James Bond, Tony Stark from Iron Man or the Professor from Gilligan’s Island.
Greenwood: (laughter) I would probably have to go with Emmett Brown. That was pretty far out.
Quinn: Favorite sci-fi visionary. Jules Verne, Gene Roddenberry, George Lucas, Isaac Asimov or H.G. Wells?
Greenwood: I think I would probably have to go with Jules Verne because his vision was, I think at least in retrospect, not only very long sighted but a lot of what he predicted has come to pass.
Quinn: Star Trek or Star Wars?
Greenwood: Not so much of either. I am a Baby Boomer so Star Trek was around a lot sooner, so instead of doing my homework I was watching Star Trek. I went to the first Star Wars movie but haven’t been to one for a while.
Quinn: Captain Kirk or Captain Picard?
Greenwood: I probably have to go with Kirk, again more of my generation.
Quinn: OK. Great. That’s all I have. I really appreciate you taking the time. Please keep up the good work. I am a big fan of what you have going on at BIO.
Greenwood: Thank you. I appreciate that. It’s nice of you to say.