Showing posts with label Biotech. Show all posts
Showing posts with label Biotech. Show all posts

Tuesday, 12 January 2016

A not-so-odd trio: medical marijuana, fraud and patents?


Dr. Joe Wyse, a partner (and colleague of this blogger) at the Israel-based IP boutique, Dr. Eyal Bresler & Co., has provided us with an interesting way of how the
patent system may be used to prevent fraud in connection with the business of legal uses of cannabis.

One of the most dynamic new areas of patent activity has been medical uses for cannabis, as start-ups seem to be cropping up at a pace commensurate with the legal production of the plant itself. An interesting angle on the possible financial risks in entering the space was suggested by Jeffrey H. Kramer of Kroll Global Fraud Report 2015-2016, who focuses on what he claims are the particular risks of fraud in the field. Kramer writes as follows:

“The risks of fraud in the medical marijuana industry are clear and pervasive. States, banks, private equity firms, insurance companies and others could unknowingly enter into a financial relationship that could prove disastrous without thorough domestic and international due diligence investigations being completed on the dispensaries, growers and their sources of funds. Growers and dispensary owners could have significant financial or legal problems, ties to U.S. or international organized crime, or a host of other issues”.


While vigilance about the risk of fraud is always a good practice, the question remains, as a colleague asked, “Why all the fuss about fraud in the medical marijuana industry?” Is the industry being unfairly singled out? Is there a case of moral panic here? Is the Kroll company seeking to create a new business market by (over?)-stating the special risks connected with medical marijuana? To get a feel for how to properly address these questions, I ventured into cyberspace to see what experts in other industries were saying and writing about fraud. Even a modest bit of online searching throws up references to instances of serious fraud, sometimes on a massive scale, in so many established industries that one may well wonder if the marijuana business, in comparison, is as tainted as suggested in the Kroll article. What follows are some observations concerning several industries:

Food Industry According to a 2014 NSF White Paper, “a number of factors have come together to make food fraud a significant global threat for the food industry”. Indeed, "… it is estimated that it costs the world economy $49 billion annually and is growing”. The UK horsemeat scandal is just one example. Fraud is so rife in the food industry that many patented technologies are being introduced, especially in traceability and authentication, to identify the precise origins of food products.

Crowd Funding Let’s consider the world of crowdfunding, such as Kickstarter. During the last two to three years, numerous scams have been unearthed, ranging from falsifying the experience and qualifications of principals involved in order to attract investors to bogus inventions, false results data, dubious theft of images, misuse of donations, and outright lying about deliverables promised. In fact, according to Engadget web magazine, “the Federal Trade Commission now has your back when the host sites' safeguards aren't enough. The government body has taken its first action against a crowdfunding fraudster, reaching a settlement with Erik Chevalier after he cancelled a Kickstarter board game project and reneged on promised refunds”.

Biotech What about biotech? William Baine, at Rufus Scientific, has researched fraud in this area, and his report makes for sobering reading. He estimates that fully 50% of the fraud is financial, with the rest split between scientific and clinical trials misconduct, market rigging and the 'normal' corporate stories of theft, bribery and unethical business conduct.

Pharmaceuticals Pharmaceuticals provide a number of opportunities for specialized fraud, including good manufacturing practice (GMP) violations, off label marketing, best price fraud, continuing medical education fraud, Medicaid price reporting, manufactured compound drugs and various instances of kickbacks. Some examples include the three billion dollar settlement by GSK for illegal promotion and failure to report safety data, and false price reporting and Pfizer's settlements in the amount of $2.3 billion for multiple civil and criminal allegations in the largest case of pharmaceutical and health care fraud in US history.

It may be that the relatively new legal medical marijuana and cannabis industry, while subject to heightened attention and regulation, is actually relatively small in the amounts at issue. There (still?) may not be that much fraud to detect, in comparison with some of the other industries mentioned above. Still, investors in this nascent area do wish to have as much proof as possible of the bona fides, traceability and accountability of a business or individual in which they are being asked to invest. I would maintain that, apart from the usual due diligence of probity, registrable intellectual property associated with the principals can be enlisted to good effect.Note that the PTO practice in the United States requires providing it with details regarding ownership and provenance of the IP right sought to be registered, and a false declaration can trigger allegations of perjury and allied federal offences. It would make sense, therefore for any business seeking funds from outside investors in this new area, who are chary about the possibility that they may be getting involved in fraudulent activity, to be provided with the additional comfort of registering IPR’s.

Provisional patent applications may be particularly suitable for this purpose, since they must be applied for by a named individual, and then reassigned to other entities, as appropriate. The point here is that in an innovative industry, registrable IPR’s are easily created and filed, they provide an excellent paper trail, and, in cases of false identity, or improper personal information, may be readily exposed. Fraudulent abuse may lead directly to the enforcement at the federal level. Given this, perhaps potentially shady individuals seeking to enter this area may nevertheless be loath to perjure themselves in such an easily discoverable manner.

Saturday, 6 July 2013

Biotech Hopping at Wall Street and Biotech Patenting on an Upswing--More Patenting to Come?

The Wall Street Journal reports that there have been 16 biotech IPOs (it is unclear what is defined as biotech) since the beginning of this year raising over $1.1 billion.  (for more on venture capital backed IPOs generally see here)  To put that in context, in 2004 there were 25 IPOs bringing in close to $1.17 billion.  In the last ten years, at this point, this year would be tied for the second best year and the future looks bright for more biotech IPOs.  The Wall Street Journal also speculates that the rise in IPOs along with their general success is attributable to R&D and clinical trial successes.  For example, the article states that: “Last year, the Food and Drug Administration approved 39 new drugs, according to the agency, a figure not reached since 1997. This year, the agency has approved 13 new drugs.”  With the supposed dried up pipeline of Big Pharma, this is welcome news.  Also, the surge in IPOs with more funding may mean more money for patenting efforts in the biotech space with more investors looking to biotech.

On the patenting side, Nature Biotechnology’s Bioentreprenuer reports on statistics on biotech patenting provided by IP Checkups.  It is also unclear what is defined as “biotech,” but the numbers are interesting.  There is a general upswing in biotech patents granted since 2008 from 657 to 850 in 2012 in the United States.  Interestingly, the article also notes the average number of biotech patents by university.  (it is unclear whether these numbers are for granted patents or for patent applications—or full applications or provisional--but it is more likely applications or some of the other numbers don't add up).  If you add up the average number of patents per year between 2008 and 2012 for U.S. universities listed (not all U.S. universities apparently), you get around 880 patents in the United States per year.  The article also has the numbers for patenting at the EPO.  The patenting in the United States is quite a bit higher than the patenting at the EPO.  This could be, in part, because of cost.  Any opinions on the data?   

Saturday, 5 January 2013

OECD 2012 Updated Biotechnology Indicators: Funding for IP and Other Interesting Stats

The OECD recently released its updated 2012 Biotechnology Indicators here. Some of the statistics are updated and others are not. On the number of biotechnology firms in 2011: Germany, 678; United Kingdom, 488; Ireland, 237; New Zealand, 369; Sweden, 129; Poland, 91; Finland, 157. The latest numbers for the United States are from 2009 with 6,213 biotechnology firms. My guess is that this number has dropped. The Biotechnology Industry Organization has around 1,000 members (many of them universities) and most of those are based in the US. According to this 2011 BIO report, "the number of public biotech companies in the U.S. has decreased by 25% since January of 2008."

According to the OECD Biotechnology Indicators, the total biotechnology R&D expenditures in the business sector in 2011 includes (in millions of US dollars): Germany, 1,221; Sweden, 534.7; Ireland, 380; and the Russian Federation, 137. In 2009, the United States spent 22,030. The total public (Government and Higher Education sectors) biotechnology R&D expenditures in 2011 includes (in millions of US dollars): Russia, 763.4; Poland, 241.5; and the Czech Republic, 146.9. For 2010, Germany spent 5,972 and Korea spent 2,468. The percentage of share of biotechnology PCT patents from 2008-2010 included the United States at 40.76%, Japan at 11.49%, Germany at 6.77%, United Kingdom at 3.92%, Korea at 3.74% and China at 3.12%.

Friday, 8 May 2009

Technology and IP: Is There a Next Big Thing?

An issue that has occupied (some say "preoccupied") me for some time is whether we are entering into a period of technological stagnation. The concern has been expressed, as I recall, by no less an icon than Andrew Grove. While cast in various forms, the claim can be distilled to the following: the growth of the hardware/software revolution from roughly the 1950s to the begin of this decade was accompanied by the rise of new industries worthy of their name--e.g. Intel, Microsoft, IBM and HP. These companies can all be characterized by their success in monetizing technology and the IP rights therein, whereby IP protection is a basic component of commercial success.

By comparison, this decade can be best characterized by Web 2.0, networking, and online social communities. Whether My Space, Facebook, Wikipedia, or You Tube, their success in accumulating the eyeballs of their tens, if not hundreds of millions of user, has not been translated into the kind of monetization that we witnessed in the earlier period. Even the flagship company of this decade--Google-- is still more notable for its stock price than the absolute size of the gross revenue that it is generating. As soon as one leaves Google, the profitability of even the most notable Web 2.0 companies remains clouded. Moreover, from the IP perspective, Web 2.0 is not IP driven-- witness the internal struggle within You Tube, where the increasing adoption of professional contents (protected by copyright) will likely enhance You Tube's profitability, but may well diminish the social (and largely non-IP) experience of its users.

But can it be monetized like a Pentium chip?

Interestingly, when I raised these issues with a prominent Silicon Valley colleague who recently visited our offices, his eyebrows furrowed, and a certain unease was observed in his defense of the technological and commercial future of the Valley. Indeed, a week later my colleague sent me a thoughtful email in which he particularly pointed to biotech as the next new development that will push forward technological development in Silicon Valley and beyond. Maybe yes, maybe no--but even if "yes", somehow I don't see how this industry, with its long R&D and regulatory gestation, and the centrality, almost too much so, of patent protection, as taking the place of the computer and telecon industries, with its dynamic mix of copyright, trade secrets, and patents, as the new beacon of technology.

By "almost too much so, of patent protection", I mean that it appears that biotech, more than other tech industries, tends to rely on patent protection as a sine qua non of competitive advantage. Patent protection is exclusionary by nature, so it is not difficult to imagine a scenario where, if there is notable biotech profitability, and the public comes to view the industry as earning "excessive" profits, there could be a backlash against IP protection, in general, and patents, in particular. If that comes to pass, then the industry and the patent protection on which is relies might well find itself between the proverbial "rock and hard place". The more successful the industry, the greater the pressure to weaken patent protection; the weaker patent protection becomes, the less robust the industry will become.

Pushing the thought a bit further, let's assume nevertheless that the technological future will be a bi-polar world of biotech and Web. 2.0, alongside the commodification of more and more hardware and the increasing reliance on "software as a service" in place of fully integrated software products. How will IP fit into this new world? In my view, one possible answer is that IP will do so in an inverse way. That is to say, industries with a greater reliance on IP protection will likely enjoy greater profits than those industries for which IP is secondary, or the drift of opinion is in favor of weakened IP protection. There will be industries in both camps. If so, the next generation of technological development will be much more patchy from the point of view of commercial success and the level of IP protection.

However, I am not certain that issue has yet become a front and center agenda item. Fareed Zakaria is a leading fashioner of ideas, editor of the International Edition of Newsweek, prominent television commentator, and author of a world-wide best seller, "The Post American World". He was recently interviewed on Bloomberg radio, and a phrase at the end of the interview grabbed my attention. In conclusion, Zakaria expressed the belief that a renewed America will continue to maintain its technological leadership and generate a new era of world-beating developments such as "Google and the iPod."

Don't get me wrong. No one is a bigger fan of the information revolution spawned by Google than I am. As well, the iPod that my family gave me as a birthday present has literally changed my knowledge base, as I obsessively download and listen to podcasts on various topics on a daily basis (including the Zakaria interview itself). So what is it in Zakaria's comment that bothered me? Ironically, it is precisely his choice of examples. Somehow I don't see Google and the iPod as the future functional equivalents to Microsoft and Intel. Indeed, I don't recall any discussion in his interview about biotech and the like or intellectual property (in "The Post American World") more generally. Zakaria is not alone. We still seem far from that day.