There’s a famous Chinese curse “May you live in interesting times” which certainly applies now. It seems that every cornerstone we’ve relied on has slipped, creating instability in all aspects of modern life. As humorist Ogden Nash remarked: “Progress might have been all right once, but it has gone on too long.”
We live in a world where seemingly everyone has a cell phone —and a rifle. Every day we learn of breathtaking scientific discoveries and atrocities straight from the Dark Ages. Thanks to technology images of beheadings travel instantly around the world.
Debates rage over hot button topics widening divisions in society. One is over the merits (or demerits) of the patent system. That’s really a subset of a larger question: does innovation lead to prosperity for most people or does it merely widen the gap between the haves and have not’s?
What, if anything, should be done to correct “income inequality” is a point of contention in our political system. President Obama says that growing income inequality and a lack of upward mobility is “the defining challenge of our time.” Sen. Elizabeth Warren (D-MA) ads: “Trickle down (economics) doesn’t work. Never did.”
The pharmaceutical industry is widely criticized for wasteful spending on duplicative research to develop “me too” drugs, and focusing their efforts on “evergreening” patents. Those who argue that incremental innovation and follow on improvements to existing therapies aren’t worthy of patent protection need to look more deeply at the reality of what subsequent innovation provides. The case for protecting incremental innovation is laid out in a new publication by the Fraser Institute (released 19 June 2014), in which a thorough exploration of the therapeutic and economic value of follow-on pharmaceutical innovation is provided.
Pharmaceutical innovation is an inherently dynamic process; one innovation builds on another and improvements draw from a long history of earlier technological advances. Sir Isaac Newton once stated, “If I have seen far, it is by standing on the shoulders of giants.” In her classic paper on innovation, Scotchmer cites this quote and emphasizes that virtually all technical progress builds on a foundation provided by earlier innovators. Innovation is an undeniably cumulative event, and progress happens both in leaps and bounds (radical innovation) and in small steps (incremental innovation). In the context of the pharmaceutical industry, radical innovations encompass breakthrough discoveries of the ‘first-in-class’ medicine with a new mechanism of action. In contrast, incremental innovations may expand an existing therapeutic class through the development of a new drug based on differences in adverse effects, delivery systems, dosing schedules, or heat stability. In 2012, 45 new drugs gained regulatory approval from the US FDA, the highest number since 1997. Currently there are 907 biologics, medicines and vaccines in development, targeting more than 100 diseases. Much of this innovation can be considered incremental, resulting in so-called ‘me-too’ or follow-on drugs. These are therapies that largely replicate the action of existing drugs. All indicators suggest that a significant share of medical progress is happening through incremental innovation.
Pat Choate and Hank Nothhaft, at the Met Club, June 14, 2011.
I was lucky enough to receive a review copy of Great Again several months before it became available. I have also had the pleasure of getting to know Hank Nothhaft and his co-author David Kline over the past year or so, frequently exchanging e-mails discussing a variety of innovation and patent related issues. It has been exceptionally difficult to keep quiet knowing what Hank and David were writing about, and then reading the nearly finished manuscript. Simply put, everyone in the innovation industry and patent community needs to read Great Again. Every Staffer on Capitol Hill and everyone working in the White House needs to read Great Again. While Members of Congress are no doubt busy with a great many things, they too should read Great Again, but at the very least Members of Congress and those in the Executive Branch, including President Obama, should at a minimum read the Introduction, which is just 12 pages long.
I seem to have started a firestorm by writing a post openly questioning how a patent attorney (i.e., Stephan Kinsella) could be of the opinion that it is preferable to have weak patent rights. I openly questioned how and why any individual or corporation would hire a patent attorney who does not believe in the patent system and seems to think that patents are bad, perhaps even evil, and certainly the preferable model would be to have exceptionally limited rights. I appreciate the debate that is ongoing in the comments to that article, but I remain extremely confused regarding the irrational arguments being made. It seems facts are largely being ignored, and when they are being used they are distort reality, history and truth. When I make direct statements about facts and history off handed non-responsive and dismissive statements are made along the lines of “if you hold that belief it is obvious you don’t understand.” Saying that is fine, but that needs to be backed up with facts and argument, which is not happening. We all know why that isn’t happening, namely because there are no facts or legitimate arguments that can be made to counter what I am saying, so rather than addressing them an artificially zen approach to deflecting and recasting, even ridiculing, is preferred. Notwithstanding, below are my thoughts regarding some of what is being said.
Let me set the record straight from the start. I do not agree with President Obama on much, and I voted for and supported John McCain dating all the way back to his first run for President. Having said this, it is impossible to ignore the fact that so far President Obama and his Administration is saying all the right things with respect to innovation and patents, and there is real cause for optimism, at least if you believe that innovation and strong patent rights will lead to a better economy and leverage what Americans do best, which is solve problems with ingenuity and innovation. Not only has President Obama appointed a patent attorney to run the Patent Office, which is sadly revolutionary, but when he speaks of innovation his words sound Reaganesque. This has never been more apparent than in his speech on innovation and sustainable growth delivered at Hudson Valley Community College in Troy, New York, on Monday, September 21, 2009.
Several weeks ago, as summer was winding down and most of us were enjoying some slow times and gearing up for back-to-school, preparing for Labor Day festivities, on vacation or studiously studying fantasy football player projections, Law.com published a very interesting piece titled Slot Opens on Federal Circuit Bench, More Vacancies to Come? The article started out by discussing how Judge Alvin Schall recently informed the White House that he would be exercising his option to take senior status come October 2009. When Judge Schall takes senior status that will raise the number of judges on the Federal Circuit with senior status to five. So come October 2009 there will be five out of sixteen Federal Circuit judges on senior status, with another eight qualifying for senior status, should they choose, within the next two years. Times are definitely changing at the Federal Circuit and whether all those judges who qualify for senior status take senior status or not, even if President Obama winds up spending only one term in Office, which is far from a foregone conclusion, his legacy may well wind up being defined by the impact he will have on innovation policy and patent law.