Here’s a copy of the talk I gave at the American Chemical Society meeting, on using patent information to track globalization:
Check out it. I think the findings will surprise you!
A new report from DrugPatentWatch.com profiles the leading researchers, US states, and countries responsible for drugs approved over the past ten years.
The report features:
Here is a short list of the top drug inventors:
|Inventor||US State / Country||Number of Patents|
|Wong, Patrick S.||California||24|
|Ebert, Charles D.||Utah||17|
|Chaudry, Imtiaz A.||New Jersey||17|
|Ayer, Atul D.||California||16|
|Mandeville, III, W. Harry||Massachusetts||16|
|Sequeira, Joel A.||New York||15|
|Rand, Paul K.||United Kingdom||15|
For more information, see http://www.DrugPatentWatch.com/reports/ .
This is a student paper from the 2010 final projects in the NIH Foundation for Advanced Education in the Sciences’ TECH 366 — Biotechnology Management. The students were asked to tell a story based on the course lectures, and to expand with general lessons on biotechnology company management.
Patent Analysis: A Tool for Making Strategic Business Decisions
It takes 10-15 years and over a billion dollars to develop a drug and get it to market. Once in the market, only 2 out 10 drugs generate revenues that match or exceed its research and development costs. Of the drugs reaching the commercial market less than a third become blockbusters, drugs that earn or exceed a billion dollars in revenues. These are the numbers for the success stories; in the pharmaceutical industry 1 out of 10,000 chemical compounds discovered are found beneficial and safe for commercialization. In the face of these numbers, can a company truly grow big enough and diversify enough through mergers and acquisitions to ensure stability and future profits? I believe that a change is needed and that change is minimization, focus, and partnerships. This idea is not new for it has been made in a 2004 Businessweek article. However, as with all big things, changing directions is slow and costly. In the eventual necessity of this change there will be a greater need for market analysis and strategic decision making for new drug development as a way of minimizing invested research and development dollars and subsequently, risk. Since innovation drives the market and innovation rests on intellectual property rights predominantly secured by patents, I believe that patent analysis can become the cornerstone for market analysis and strategic business decisions.
As a way of emphasizing patent analysis as a marketing and business strategy tool I have devised a flow chart comprising an integrative model of the resource base-view and Porter’s five forces, both of which are commonly used for assessing risk and potential value of new businesses and drug development. Although patent analysis does not address all issues that are encompassed by this business model, patent analysis serves as an economical approach to determine a focused marketing area, risk of new drug development, and potential value of a drug by addressing the following questions: What are my resources (IP)? How can I best use my IP? How does my innovation differ from that of my rivals? Who are my rivals? What are the potential markets? How crowded are these markets? Who are the innovators, leaders and laggards in these markets? Are there IP barriers to entry into this market? What is the likely direction of the market? What will it take to stay competitive in this market?
Patent analysis begins with a patentability and freedom to operate search. These two searches will provide relevant “prior art” that determines whether your innovation is patentable and has no IP impedance to commercialization. Next, based on the prior art a series of relevant patents can be collected and Patent Citation analysis can be done. Ocean Tomo, the leading Intellectual Capital Merchant Bank, has been innovators in patent analysis since 2003 and has devised various unique ways of using Patent Citation analysis[4,5]. In particular, Ocean Tomo has used Patent citation analysis as a way of determining the relatedness of patents for assessing potential litigation issues. However, modifications of this analysis can bring forth a list of potential markets that your innovation may have a use and potential partners to build collaborations to exploit those markets. In essence, through exploring the relationship between your patent and other patents there is a potential to generate additional revenues and/or diversification through: licensing part of your technologies to non-competitors, setting-up research partnerships to exploit an open market, or in-licensing a particular technology that would allow you to expand your market base or create additional IP barriers to prevent others from entering into the market. An additional use of Patent citation analysis, also utilized by Ocean Tomo, is to create categories of ‘hot topics’ and ‘next generation’ patents (figure 2). Hot topic patents are generally older patents that have a large number of citations by patents that expand a variety of technologies. They tend to be patents that lead to industry standards, disruptive technologies, and/or made a substantial impact across various industries. The ‘next generation’ of patents cites two or more of these ‘hot topic’ patents. The ‘next generation’ patents should represent patents that are improving and innovating upon an industry standard, suggesting that market adoption should be quicker with these technologies as oppose to the actual disruptive technology. Secondly, this analysis provides insight into potential market direction and who the innovators are for a particular technology group. These analyses should be substantiated through Patent Count Analysis. Patent count analysis adds up the number of published (public) patents pending, issued, and abandoned for a technology group to assess the market drive/pull in a given industry; The greater the number of patents being filed and maintained in a particular industry the greater the probability that there is a profitable and growing market to support the investments being made in those intellectual properties. Furthermore, subdividing patent counts by ownerships gives an idea of the market leaders and how aggressively they are in using patents to prevent others from entering into the market. Pending on the analysis, the best business strategy may be to license your technology to the more aggressive company or seek a partnership with one of the rival companies that have approximately equal market size. Opposite to this, a large number of abandoned patents suggest that there is not enough money being made in the industry to justify continuing with the patent process and incurring additional fees or paying patent maintenance fees. Under these circumstances it may be better to forgo the patenting of the technology and either license the technology cheaper than it would cost to replicate the technology or make the technology available to everyone as ‘good will’ expense.
A final benefit of patent analysis is the valuation of your intangible properties for merger and acquisition, litigation, and/or taxes. The analyses discussed above can also be used to address three issues that underlie the valuation of intellectual properties: potential litigation issues, potential value of the technology (substitutable, ‘next generation’ technology, hot market area, and potential to be implemented in multiple markets), and the potential value of the market (market competitors, competitor market size, and a growing market). By addressing these issues you can have a clear idea of risk involved in the drug development and/or business development and can better utilized a more appropriate discount rate for calculated values determined by traditional market-base, asset-base, or income-base approach for valuation. In summary, product value is influenced by its scarcity and alternative uses. Patent analysis reflects scarcity and alternative uses of a product by outlining market availability, market need, market size, and market competitors.
In conclusion, through regular use of patent analysis you will be able to bring your drug development, IP portfolio management, business strategy, and business development groups together, using an integrative approach to minimizing research and development spending through targeted research projects and/or partnerships. As a single group, they can collectively use patent analysis to better position the company for the future through innovation and innovative strategies.
1. (Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2010 (Washington, DC: PhRMA, March 2010)
2. (Davidson, L and Greblov G. The Pharmaceutical industry in the Global Economy (2005) Indiana University Kelley School of Business )
3. Arnst C, Barrett A, and Arndt M (2004) The Waning of The Blockbuster Drug. BussinessWeek Oct. 18 (http://www.businessweek.com/magazine/content/04_42/b3904034_mz011.htm)
4. Malackowski J.E., Barney J.A., Cardoza K, Walker M.D., and Gray C., (2006) Innovation Measurement: The Economic Impact of Patent Value: Business Submission at Ocean Tomo, LLC and Ocean Tomo Federal Services, LLC. Contact firstname.lastname@example.org or 312-327-4400.
5. Malackowski J.E. and Barney J (2009) Patent Attributions To Equity Returns. Business Submission at Ocean Tomo, LLC and Ocean Tomo Federal Services, LLC. Contact email@example.com or 312-327-4400.
6. Pohl M (2002) Patent Landscaping Studies: Their Use in Strategic Research Planning. Pharmaceutical Patent Attorneys, Pohl & Assoc. LLC. Contact: Mark.Pohl@LicensingLaw.net
7. Grant RM (1991) The Resource-based theory of competitive advantage. California Management Review 33:114-135
About the author
Eric Norman received his Ph.D. in neuroscience from the University of Pittsburgh. Eric has spent many years conducting scientific research and has gained a broad knowledge of neurophysiology that culminated in a series of scientific articles. Currently working at NIH’s Office of Technology Transfer (OTT), Eric brings his scientific knowledge and critical thinking skills to the development of marketing campaigns aimed at promoting early stage technologies available at NIH and FDA. As a strong interest and personal passion, Eric studies the use of patent analysis and how it may be used in business development.
This is a guest post from BiotechBlog reader Viren Konde. Do you have a response to Viren’s post? If so, you may respond in the comments section below.
The recent editorial on “Intellectual property and biotechnology innovation: To protect or not protect” by Dr Yali Friedman, Managing Editor of the Journal of Commercial Biotechnology was thought provoking and led to this write-up. The editorial emphasized on the intellectual property protection differences between the developing and developed countries, and their drug manufacturers on the issues of patents, price controls, and research & development investments in the biotechnology sector. The remarks indicate that, the developed countries, being the ‘technology producer’ have favored strong intellectual property protection to motive the innovation and apparently the trade; while the developing countries being the ‘technology consumers’ have exploited the benefits of it at much lower cost by building a weaker intellectual property protection system.
Although it is logical that all countries, whether, developing and developed, should offer the strongest intellectual property protection possible, it is believed that, there are no legal definitions of “developed” and “developing” countries. The WTO members have announced for themselves whether they are “developed” or “developing” countries, with an open option to challenge the decision of a member to make use of provisions available to the developing countries. It was also believed in the agreement that the developed countries need maximalist IP regimes, as they are highly innovative and strong IP regimes provide the requisite incentives in this regard. On the other hand, developing countries require minimalist IP regimes, as they are hardly innovative and are often net importers of technology. These norms have also formed the basis for the 1970’s Indian Patents Act for the ‘developing India’. The amendments to Indian Patent Act in a timely fashion [Indian Patent (Amendment) Acts of 1999, 2002, and 2005] have driven India to ‘innovative (Product Patents) regime’ in its intellectual property policy.
Today, although, India continues to remain a “developing” country; it is also considered a ‘technologically proficient’, and therefore as an innovative developing country. Therefore, in the present times, the older definitions of intellectual property based on the differences between developed versus developing countries can not relate to India. Some developing countries like India are more scientifically advanced than others as a result of decades of investments in education, medical infrastructure, and manufacturing capacity. India hosts more drug manufacturing facilities that have been approved by U.S Food and Drug Administration than any country other than the United States. India’s biotechnology industry is managing to position itself on the strength of contract research, clinical research and contract manufacturing services together with the sales of off-patent biologics in the local as well as lightly regulated markets in the Middle East, Africa and Asia.
Unfortunately, India’s patent regime does not appear to be satisfying to the developed world given that India, though “technologically competent” in certain technology sectors like software and pharmaceuticals have not yet witnessed any significant levels of “innovation” in the biomedical utility sectors like biotechnological products and processes. Recently, the US-based Biotechnology Industry Organization (BIO) criticized India’s patent law and the Office of the US Trade Representatives kept India (and some other countries) on the USTR’s “Priority Watch List” in order to bring India’s patent law more in line with Western IP protections. Clearly, there are some issues and concerns that need clarification and that will be discussed here, such as the patentability criteria under section 3(d), and the provision of compulsory licensing in the Indian Patent Act; the price control and the cost difference of the innovator verses generic biotechnology drugs; the TRIPS mandate on clinical data protection and exclusivity; and also the pre- and post-grant patent opposition provisions used by Indian biogeneric manufacturers.
– Viren Konde
With the issue of data exclusivity for novel biologics re-emerging in the news, I’d like to present two arguments that will be published in the upcoming issue of the Journal of Commercial Biotechnology:
Why data exclusivity is the new patent protection
Peter J Pitts, Center for medicine in the public interest
Follow-on biologic drug competition – No need for new marketing exclusivities
Michael S Wroblewski(a) and Elizabeth A Jex(b)
a) Office of Policy Planning, Federal Trade Commission
b) FTC Office of Policy Planning
This is a student paper from the 2009 final projects in the NIH Foundation for Advanced Education in the Sciences’ TECH 366 — Biotechnology Management. The students were asked to tell a story based on the course lectures, and to expand with general lessons on biotechnology company management.
Contract research organizations (CRO) have played significant roles in the research and development (R&D) of biotechnology industry ever since its first appearance in the late 1970s. CRO provide important services in clinical trial management, safety monitoring, formulating and manufacturing, laboratory services, data management, NDA writing and filing as well as other regulatory affaire support, etc. The CRO industry had shown stable and increasing revenue on the global scale in recent years despite the weak growth of global economy. For instances, CRO shared $15 billions of global biotechnology R&D market in 2007 and $18 billions in 2008. In the United States, approximately $9 billion, accountable for 15% of total of R&D funds flowed to CRO in 2007. Even under the impact of global financial crisis, CRO revenue increased to approximately $10 billion when the total U.S. R&D increased to $65 billion in 2008 (Fig 1).
In recent years, the biotech industry has generated several lines of biomedical products that are sold over billion dollars each year, giving more room for CRO industry to grow. In 2008, for instances, monoclonal antibodies sales reached $33 billion, TNT blockers reached $18 billion, and erythropoietin reached $9.5 billions. The global sales of biotech drugs jumped from $75 billion in 2007 to $125 billion, almost 16% of global drug sales, in 2008. This fast growth (Fig 1) of biotech revenue may encourage R&D expenditure in biotechnology and therefore expand the market size for CRO in the near future.
Fig 1. Global sales by CRO and Biotech industries. (data source: reference 1, 2, 3, 4.).
Today’s CROs may operate either as local niche services or on international scales. Several CROs, such as Quintiles translational corporation, Covance Incorporated, Pharmaceutical product development, Charles river labs and MDS incorporated, have generated over billion dollar revenues each in 2008. Out sourcing to CRO has become an attractive strategy for many biotech firms because CRO may provide services that are not available in-house for start-up firms. In some other cases, CRO may provide services with more competitive quality and better-targeted milestones than in-house research department for some large biotech firms. CROs are often used because their ability to reach out for regionalized patient populations and ability to efficiently manage international clinical studies. In any cases, however, the conventional role of CRO is to merely act as the “extra capacity” to facilitate R&D projects of the sponsors. By saving time, capital, labor, and/or space using specialized skills and/or research facilities of CRO, sponsors can focus more on the “core skills” and the growing regulatory demand that are relevant to their products.
Compared to other types of biotech firms, CROs have much better success rate as business entities either as small privately owned companies or as large international corporations. One of the important reasons is that CROs are less dependent on external funds such as VC than other biotech firms. CROs may survive on the service fees when external funds are not available for expansion. However, CROs usually do not request for the right of the potential intellectual property (IP) that may be generated from the services it provides. The matter of fact is that, most often, the part of the R&D project that CROs are involved are unlikely to generate any IP. The fact that the CRO is unable to claim for the right of the IP that may be generated through their own activities is probably the most obvious “downside” of the CRO business, especially when IP rights after Bay-dole act are usually claimed by research organizations even if the research might had been sponsored by the other parties. Therefore, CROs may be characterized as “low risk, low return” type of business and may be less attractive to investors who are looking for high return opportunities.
The global financial crisis may have created an opportunity for CROs to break the “low risk, low return” formula and enter the arena to compete for IP titles. As the financial support for start-up and early stage biotech companies quickly reduce to the very minimum, the so-called “valley of death” would become more “deadly” . As the result, new IPs are unlikely be developed to relatively maturation stages where the large and well-funded firms can see promising products and to invest further R&D efforts. Soon will see a shortage of relatively mature biotech drug candidates to supplement the inheritably insufficient in-house R&D of the established biotech firms. Having the infrastructures and funding in place for research and development, the profiting CRO may invest in early stage biotechnologies and seek for higher returns. CROs may not necessary become the replacement of small biotech firms, but an extra funding mechanisms for the desperate industry that is not on the “bail-out” list of the government.
Initiatives should be launched to invite CROs to invest in early biotechnologies. It is a risky idea for CROs to invest in early stage biotechnology. But the potential benefit of this initiative is not for CROs alone if “we” are seriously considering the challenges caused by lack of funds for early and small biotech firms. Here, I define “we” as the local government and established biotech firms because the pressure won’t be on the small and vanishing biotech firms’ shoulders alone if “we” are not going to do anything about the development pipelines that will soon be more broken in the “valley of death”.
Then the question comes to how to invite CRO to the IP hunting arena. The Maryland technology development corporation (TEDCO) had provided a good model by collaborating with Johnson & Johnson (J&J) to establish a co-managed funding agreement in 2005. This funding awards seed biotech companies with funds to develop technologies that are potentially of interest for J&J. TEDCO matches the J&J funds. J&J has opportunity for equity investment as the technologies mature (reference 5).
To invite CROs to joint collaborative research agreement, funding should be established by pooling money from government and sponsor companies to fund part (eg. 2/3) of a specific R&D project. CROs will identify and license the IP of interest and provide the rest (eg.1/3) of projected cost. Collaborations of the like will significantly increase the pipeline portfolio of early stage technologies for the sponsor with reduced risks without significant increase in R&D costs. CROs will obtain opportunities for generating IP assets without exhausting the profits earned from the contract works.
Local government, especially the state government, should take the initiative to invite CROs invest in early biotechnologies, not just to benefit CROs, but to stimulate the biotech industry and the economy of the state. Historical data showed that states that paid more attention to the biotech R&D received more returns from the industry. When the relative efforts in biotech R&D by states (national ranking of state expenditure in 2006) were plotted against the relative benefit received by states (national raking in patent number, VC investment, and NIH funding received), a clear positive correlation was seen between the state’s effort in R&D and the benefit the state received in a long run (Fig 2). For instance, California invested $6.5 billions (13.6% of total U.S. investment) in biotech R&D, ranking number one in the U.S. in 2006, indicating the involvement and focus of the state government. At the mean while, California received 24,293 patents between 2002-07 (nearly 20% of the national total), $20.7 Billion CV investment between 2002-07 (40.5% of national total), and $3.2 billion of NIH funding in 2007 (15% of national total), all ranked in number one on the national list.
State involvement and policy in biotech development play no doubt the most critical roles nurturing the growth of local biotech industry, including the CRO industry. Investing $1.7 billion in biotech R&D, North Carolina ranked in number eight on the national list in 2006, and now hosts two of the world-top-10 public-traded CRO companies, Quintiles transnational corporation and Pharmaceutical product development, making $3.57 billion of revenue in 2008. The state attracted capital investment from several internationally operating pharma/biotech companies. Recently, Novartis announced to build a $267.5 million vaccine manufacturing and Merk announced a $100 million expansion on its vaccine facility in the state. Constella Group, a private CRO company in Durham North Carolina grow from a statistical consulting service to a $200 million revenue-making bioinformatics firm in 2007 by assisting life-science clients.
In conclusion, encouraged and appropriately guided by the local government, CROs may deliver great value to the local economy. It’s important to recognize that the value of a CRO does not only exist in the revenue it generating, but also exists in its readiness to help the biotech industry overcome the current financial challenges.
Fig 2. The correlation between the state R&D expenditure and the returns (number of patents, VC investment, and NIH funding to the state). The colored trend lines are regression lines corresponding to the data points of the same color. The Y-axis is the national ranking of the state with smaller numbers indicating the top states. (data source: reference 6)
1. US Pharmaceutical Industry Report, 2008-2009: www.reportlinker.com/p0118600/US-Pharmaceutical-Industry-Report-
2. Business insights: www.globalbusinessinsights.com/content/rbcr0001m.pdf
3. Global market review: http://knol.google.com/k/krishan-maggon/global-biotechnology-market-review/3fy5eowy8suq3/16#
4. IMS health: http://www.imshealth.com/portal/site/imshealth/
5. Maryland TEDCO: http://www.marylandtedco.org/tedcoprograms/ fundingopportunities.cfm
6. Biotechnology Industry Organization: http://www.bio.org/speeches/pubs/er/statistics.asp
In 2005 India mostly strengthened their patent laws to meet international norms, with the distinct requirement that new drug products must “differ significantly in properties with regard to efficacy.” This requirement for a significant improvement in efficacy only applies to drugs — not to other patentable inventions like pens, car engines, etc., and is of concern for drug companies seeking to protect their inventions in India.
In 2007, Novartis received a first-hand demonstration of the limitations of patents under these new rules. They failed to receive patent protection for Glivec (sold as Gleevec in the U.S.). In response, Novartis opted to redirect hundreds of millions of dollars of R&D to other countries — essentially voting with their feet.
A recent partnership between Merck and India’s Nicholas Piramal (NPIL), potentially worth more than $300mm, suggests that Merck is unfazed. In this partnership, NPIL is responsible for essentially the entire drug discovery chain, from candidate identification through pre-clinical and early-stage clinical trials.So, one may ask the question: Have Novartis’ experiences affected other companies, and is Novartis actually redirecting their investments?
Pfizer is also investing strongly in India, announcing their intentions to develop drugs for conditions endemic to India.
Novartis, on the other hand, is keeping their word. Whie they did recently announce plans to dramatically increase the headcount at their India Development Centre, the company reiterated that these were not R&D jobs: “This is not a high-end work and the nature of job is similar to business process outsourcing. We will think of doing high-end R&D work in India only when the patent laws are made totally compatible with WTO norms”
So it appears that Novartis isn’t influencing the activities of others. The question remains: who will bend first? Novartis or the Indian Government?
I’ll be giving a talk at the Kogod School of Business on Tuesday February 24th on “Drug Development – Balancing National and Commercial Needs”. The basis of the talk is that countries need access to medicines, foreign currency, and tax revenues, while drug developers need profits (or else they will cease to exist). I’ll be covering strategies used by nations and drug companies to meet their respective needs, and describing case studies in which these needs are at odds with each other, and those in which they coexist in harmony.
Looking forward to a good discussion.
After months of effort, I’m pleased to announce the launch of Biotech U, a biotechnology education resource featuring web-based lessons on biotechnology business, law, IP, politics, regulations, and science.
Biotech U is based on Building Biotechnology, the leading text used in business-of-biotechnology courses. The online-learning structure is designed to meet the needs of busy professionals who seek a robust educational resource but lack the time to attend traditional classes. Feel free to try the sample course, an Introduction to Biotechnology, and I hope you enjoy this new resource.
By John Avellanet, Managing Director and Principal of Cerulean Associates LLC
Reprinted with permission from SMARTERCOMPLIANCE™ 2(9): p 1-2 (September 2008)
Nine out of ten companies do not have appropriate policies and controls in place to stop employees, contractors or partners from walking out the door with intellectual property and trade secrets.
For those of us who’ve spent much of our careers helping prevent corporate espionage, the July report by the not-for-profit IT Policy Compliance consortium comes as little surprise.
Passwords and patents do not make your company’s information and discoveries any more secure than locks and labels make your home and its belongings safe from theft.
Carnegie Mellon University’s CERT research think tank has followed information theft for decades and has come to two eye-opening conclusions:
Given all the security efforts around stopping outsiders when the real risk lies within, is it any wonder that 90% of businesses do not have any way to stop—much less even detect—intellectual property (IP) and trade secret theft?
Before we even get down to work on reasonable trade secret controls, I give my clients a brief set of “yes/no” questions to answer on their own.
These questions are straightforward and easily answered in less than 30 minutes. For instance, “Do you have a ‘clean desk’ policy for sensitive or confidential information?”
The goal of these questions is to help my clients quickly outline their weaknesses—and their strengths. In this way, we can quickly shift into discussing solutions.
And while many executives need the more detailed audit with its prioritized recommendations, keep in mind that a half-dozen quick-fixes implemented now can stop today’s disgruntled employee or frustrated contractor from sabotaging your work.
Ask yourself, What documented proof do we have that our policies are being followed?
For instance, a typical “clear desk” policy requires personnel to clear their desk and office area of confidential information before they leave for the day, locking it in a file cabinet, turning it back over to the document specialist for filing and so on.
When companies state they do this, my reaction is always to be skeptical. How do you know this is actually being followed?
If your people turn sensitive material over to an archivist, that individual should have log files that can be reviewed.
However, what proof do you have that people are clearing their desk and securing their office area?
A simple way to test this is to simply stay late one evening and walk around, from cubicle to cubicle, office to office. How many documents do you see labeled “confidential” or “private” or “trade secret” sitting out? How many documents do you quickly recognize that should be labeled “confidential” or “trade secret” (such as product drawings or formulations) but that aren’t labeled and aren’t put away?
Then, take the next step. Ask your internal auditors (or hire an outside independent auditor) to include this in their regular audit routine. Assuming no other extenuating circumstances, I usually suggest my clients audit this once or twice a year (perhaps more for habitual “offender” departments).
I’ve made a free version of my intellectual property and trade secret security checklist available for download. You can use this to quickly assess your strengths and opportunities for improvement.
You can get your free PDF copy here: http://www.ceruleanllc.com/biotechblog
Are you ready?
John Avellanet is a former Fortune 50 subsidiary C-level medical device and biotechnology executive where he created, developed and ran his firm’s Records Management and IT departments, and was directly accountable for trade secret protection. In 2006, he founded his independent consulting firm, Cerulean Associates LLC (www.ceruleanllc.com) and has since become one of the leading experts on trade secret and corporate espionage protection for biotech, pharmaceutical and device companies.