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This is a guest post from the BiotechBlog Intern, Fintan Burke. Fintan is a student at the School of Biotechnology at Dublin City University. Do you have a response to Fintan’s post? Respond in the comments section below.

In Europe the 1998 EU Biotechnology directive (98/44/EC) states that Totipotent stem cells (stem cells that develop into a foetus) are unpatentable on human dignity grounds. The issue of pluripotent stem cell (those that develop tissues and organs, and the focus of research) patentability is vague, and there have been no amendments or replacements since the directive was passed. A further obstacle for stem cell patenting comes from a 2008 decision made by the European Patent Office to disallow any patent that requires the disruption or destruction of human embryos.

This vague patent legislation was finally called into question in October 2011, when Greenpeace brought German researcher Dr. Oliver Brüstle to the Court of Justice of the European Union (CJEU) over his patent for specialised stem cells to treat neurological conditions. Dr. Brüstle, perhaps aware of the EU directive, did not mention that the stem cells used in the patent originated from embryonic cells. The case brought up vital questions about the directive that needed to be elucidated, such as a clear legal definition for the term “human embryo”, their use in industry and in Dr. Brüstle’s case the eligibility of a patent that does not explicitly mention the use of stem cells. The court, following the Advocate General’s opinion, ruled that any fertilised human ovum can be regarded as an embryo and thus any stem cells gathered from them cannot be protected by patent law.

The decision also highlights the differences between the US and EU stem cell patent laws. While the US Patent office allows patents for stem cell generation, the 1996 Dickey-Wicker Amendment banned government funding to programs where human embryos are created or destroyed for research. This amendment has been effectively muted by the executive orders issued by President Bush in 2001 and President Obama in 2009, both of which allowed federal funds to be spent on human embryo research under strict terms. These orders were in turn suspended by a preliminary injunction by US District Court Judge Royce Lamberth (which has since been overruled).

Before the ban on federally sponsored stem cell research, most funding came from private firms. Perhaps one of the most prolific patent applicants under this model was Dr. James Thompson of the University of Wisconsin, whose innovative stem cell patents were acquired for the Wisconsin Alumni Research Foundation (WARF) and funded for by the pharmaceutical company Geron. Over the years, however, WARF have had to revise and abandon their patents, due to pressure from consumer watchdogs who claimed that the patents detailed processes that were too obvious to be patented in the first place.

While EU and US legislation are in place to protect the origins of a human, the advent of induced Pluripotent Stem Cells (iPSCs) may cause a radical rethink of policy. iPSCs, which are derived from somatic cells, eliminate the concern of interfering or destroying the human embryo. Though many existing stem cell policies still apply to iPSCs, Timothy Caulfield et al outline existing laws that are hindering iPSC research.  In the paper, the authors note “the regulatory field in California is in a state of flux at present”, with researchers having to deal with three overlapping Californian stem cell research guidelines as well as the National Academy of Science guidelines. The paper also mentions that some of the state guidelines seem to deliberately exclude iPSC research in their guidelines, adding to the confusion. Legislation does not improve in the UK either. Since iPSCs are derived from somatic cells, they are covered by the broad UK Human Tissue Act instead of the 1990 Human Fertilisation and Embryology Act, which covers embryonic stem cells. Furthermore should iPSC go on from research, there are increasingly complex applications to multiple regulators before it can undergo clinical trials.

Stem cell patenting legislation is in a unique position; it is governed not only by commercial concerns, but ethical ones too.  The consequence of this is a potentially prolonged development time due to the myriad of regulatory bodies and ambiguous legislation that exist in the EU and US. It remains to be seen whether the EU’s ban on patents will stifle future competitiveness in this international market, though the development on iPSCs go a long way to quell many ethical concerns. In a review published in Nature this year Daisy Robinton and George Daley note that should a new, uniform guideline emerge for these more ethically agreeable stem cells researchers may be able to realise their full medical and commercial potential.

I’m back from the Filling the Pipeline conference in Boston, where I presented a talk on pharmaceutical globalization.

Maintaining control of pharmaceutical drug innovation is key for national security, public health, and economic development. We know that much of late-stage development has gone overseas, but the question remains: Where are drugs invented? Using the DrugPatentWatch database, I demonstrate a model to track pharmaceutical globalization using patents and reveal the locations of pharmaceutical innovation. For more, see the slide deck below:

I will be giving a talk on “Using patent information to track globalization” at the ACS conference in Anaheim next week. The talk is part of the ACS Division of Chemistry and Law session on What Can Patent Information Do For Scientists, and is based on analysis of data from DrugPatentWatch. I look forward to meeting BiotechBlog readers who may be in attendance. For those who cannot make the event, my talk will be based on my work on globalization of pharmaceutical innovation.

Fortune magazine recently published an article on the growing trend of generic companies challenging pharmaceutical drug patents. I enjoyed working with the writer to help layout the industry landscape, and share my knowledge of drug patents and trends from DrugPatentWatch.com. It’s a good read, and it does an excellent job of laying out the legal, regulatory, and economic mess that the pharmaceutical industry has become.

I’ve just had a paper published in Nature Reviews Drug Discovery, using data from DrugPatentWatch to profile the locations of drugPharmaceutical Globalization: Where are drugs invented? invention for the past decade.

The location of drug development is important for two reasons. Firstly, it is important to track the global spread of innovation. Much late stage drug development (e.g. clinical trials) and manufacturing have moved to lower wage-cost countries, but trends in the location of invention has not been clearly described. Knowing where drug invention is occurring can help streamline drug development by identifying ideal locations for research facilities. Secondly it is important to know where invention is occurring, because that may affect which drugs are developed. Early-stage research funding and, by extension, the research itself, is likely to be focused on conditions affecting the countries in which these activities are occurring. For example, research in the United States might focus on conditions such as heart disease and stroke, whereas research in Japan might emphasize stomach cancer.

By examining the patents covering drugs developed over the last decade, I was able to ascertain the locations of the inventors. Focusing on inventors is important because it gives a clear indication of where the control of the invention was located. Patents are required to list the names and locations of the individual(s) who maintained intellectual domination of the invention. Failure to list all inventors, or listing too many inventors, can yield an invalid patent. Whereas one might consider assessing globalization of invention by focusing on the location of the company funding the research, or the company listed on the patent, these strategies are flawed. The company funding the research may not be the same company which conducted the research (e.g. Japanese companies funded many of the early US biotechnology companies, but the inventions occurred in the US by US researchers, so focusing on the funder might produce the incorrect conclusion that the innovation was Japan-based), and many companies have facilities in multiple countries, making it impossible to determine in which of the countries an invention might have occurred. Looking at the company listed on a patent is also flawed. The company listed on a patent might not have been the company that housed the researchers or, even worse, it may be a tax shelter based in a country where no invention occurred. So, by focusing on the locations of the listed inventors it is possible to determine where the invention occurred. An additional benefit of this strategy is that it enables inclusion of patenters from numerous countries. For example for a patent listing one US-based and two Canadian inventors, the US would be given 1/3 credit for an invention, and Canada 2/3 credit.

So, what did I find? In short, the US and the legacy pharmaceutical countries in Europe (United Kingdom, Germany, Sweden, France and Switzerland) have been responsible for the bulk of new drugs invented over the past decade, and there is no indication that this dominance is waning. Emerging economies such as India and China were largely absent. For more details, please see the paper at Nature Reviews Drug Discovery: Location of pharmaceutical innovation: 2000–2009.

You can also get more detailed information on the complete set of drug inventors and where they live in my Global Drug Patent Inventor Report and Individual Country Drug Patent Inventor Reports.

What do you think of the findings? Are you surprised? Do you disagree? Sound off in the comments.

New Reports Based on Data-Mining the DrugPatentWatch database

Please contact us with any special data requirements beyond the existing report catalog

Orphan Drug Report


The Orphan Drug Report profiles pharmaceutical drugs with FDA Orphan Drug Exclusivity

The Report includes:

  • The tradename, applicant, ingredient, and Orphan exclusivity expiration dates for each Orphan Drug
  • Details on each NDA and product number, including Dosage, Strength, Approval Date, Therapeutic Equivalence (TE) code, Reference Listed Drug (RLD) indicator
  • All FDA-listed patents covering each Orphan Drug

Report highlights:

  • More than 100 pages
  • More than 80 drugs profiled

More information is available at http://www.thinkpharm.com/orphan-drug-report.html


Drug Patent Challenge Report


The Drug Patent Challenge Report profiles the companies that successfully challenged pharmaceutical drugs patents.

Using data on drugs approved from 2000 to 2009, this report provides complete lists of:

  • A list of the companies with the most successful patent challenges
  • A list of all the drugs for which each firm successfully challenged a patent
  • A list of all the companies that have received FDA approval for each listed drug

Report Highlights:

  • More than 60 companies profiled
  • More than 80 drugs profiled

More information is available at http://www.thinkpharm.com/drug-patent-challenge-report.html


Drug Patent Inventor Report


The Drug Patent Inventor Report profiles the individuals, US states, and countries leading pharmaceutical innovation.

Using data on drugs approved from 2000 to 2009, this report provides complete lists of:

  • Top Inventors
      Which inventors were granted the most patents?
  • Patents per Inventor
      The patents awarded to each inventor
  • Approved Drugs per Inventor
      The approved drugs protected by each inventor’s patents
  • Co-Inventors per Inventor
      The co-inventors listed on each inventor’s patents
  • Assignees per Inventor
      The assignees listed on each inventor’s patents
  • Inventors per US State
      A count of the number of inventors in each state, along with the number of patents awarded to each inventor
  • Inventors per Country
      A count of the number of inventors in each country, along with the number of patents awarded to each inventor

Data highlights

  • More than 3,000 pages
  • More than 4,000 inventors listed
  • More than 2,000 patents listed
  • 44 US states listed
  • 30 countries listed

More information is available at http://www.thinkpharm.com/drug-patent-inventor-report.html

I’ve posted a new Drug Patent Challenge Report at thinkPharm.com.

This new report complements the Drug Patent Inventor Report and Orphan Drug Report and profiles the companies that successfully challenged pharmaceutical drug patents.

The Drug Patent Challenge Report includes:

  • A list of the companies with the most successful patent challenges
  • A list of all the drugs for which each firm successfully challenged a patent
  • A list of all the companies that have received FDA approval for each listed drug

Report highlights:

  • More than 60 companies profiled
  • More than 80 drugs profiled

A preview of the report is also available.

Do you need any other pharmaceutical drug and patent reports? Let me know.

A new report from DrugPatentWatch.com profiles the leading researchers, US states, and countries responsible for drugs approved over the past ten years.Drug Patent Inventor Report

The report features:

  • Top Inventors
    • Which inventors were granted the most patents?
  • Patents per Inventor
    • The patents awarded to each inventor
  • Approved Drugs per Inventor
    • The approved drugs protected by each inventor’s patents
  • Co-Inventors per Inventor
    • The co-inventors listed on each inventor’s patents
  • Assignees per Inventor
    • The assignees listed on each inventor’s patents
  • Inventors per US State
    • A count of the number of inventors in each state, along with the number of patents awarded to each inventor
  • Inventors per Country
    • A count of the number of inventors in each country, along with the number of patents awarded to each inventor

Here is a short list of the top drug inventors:

InventorUS State / CountryNumber of Patents
Wong, Patrick S.California24
Theeuwes, FelixCalifornia17
Ebert, Charles D.Utah17
Chaudry, Imtiaz A.New Jersey17
Ayer, Atul D.California16
Mandeville, III, W. HarryMassachusetts16
Sequeira, Joel A.New York15
Ogawa, YasuakiJapan15
Rand, Paul K.United Kingdom15

For more information, see http://www.DrugPatentWatch.com/reports/ .

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