Do I have to use a patent attorney?


Not always, but it helps as the drafting and filing of a patent application (including specification, claims, drawings and abstract) can be technically complex and should not be embarked upon by an inexperienced person. An application for a patent should include a specification comprising a full description of the invention (including any drawings), a set of claims defining your invention and short abstract summarising the technical features of your invention. You do not need prototypes, samples and a background of research activities.


I think I might be infringing a patented invention. What should I do?


Infringing a patent means manufacturing, using, selling or importing a patented product or process without the patent owner's permission. If you are doing any of these things, you should obtain professional legal advice quickly, because the owner of the patent can sue you.


What if I just want to register a URL to support my findings?


When buying website URLs it may be perfectly possible to buy a URL which contains the registered trade mark belonging to a third party, but if you attempted to trade using that URL you could be deemed to be breaching registered trade mark rights and forced to cease and even offer up a proportion of any revenues. Only the owner of a valid trademark registration has exclusive rights in the relevant country/territory to use that mark in relation to the products and/or services for which it is registered.


How long do trade marks last?


Registered trademarks last for an initial 10-year period and can be renewed indefinitely for additional 10-year periods subject to paying renewal fees. There is no such thing as a global trademark, but it is possible to apply for registration of a European Community Trade Mark, which covers all EU member states. Outside Europe, trademarks can be registered in all major trading countries although registration costs vary.


After steady growth in the 1990s, the number of biotechnology patent applications filed under the Patent Cooperation Treaty (PCT) has actually declined. This is because the surge in 1990s was due to patent applications relating to the human genome. The recent decrease can also be explained by stringent material for granting patents on genetic material. On average, in 2006 biotechnology patents represent 6.5% of European countries’ patent portfolios, compared to 10.3% in the mid 1990s.


Investors are well aware of patents and will generally conduct a thorough search before taking a decision to invest. Questions they will ask include: does a company fully own its intellectual property and if not, does it have a licensing agreement? Secondly have patents been granted and how broad is its protection.


Source for statistics - http://www.oecd.org/dataoecd/4/23/42833898.pdf


About the Author


Dr David Martin is senior European and UK patent attorney at Mathys & Squire LLP. He prepares and prosecutes patent applications for clients that include universities, associated spin-out companies and large multinationals. David has extensive patent law experience across the biotechnology field, including antibodies, protein therapeutics, genetic tests, stem cells, cell culture extraction and GM plants.


With a Degree in Biological Sciences from the University of Edinburgh and following completion of a PhD for research carried out on transposable element mutagenesis, David conducted postdoctoral research at the University of California (Berkeley) on the molecular genetics of plant form and transition to flowering. He then moved back to the UK and carried out further research at the University of Oxford into the molecular genetics of cell identity and leaf shape. David moved into the patent profession in 2002, qualifying as a Chartered and European Patent Attorney in 2007. For further information contact: Mathys & Squire LLP (www.mathys-squire.com).


Dr David Martin


BIA responds to European Court ruling


In response to the Court of Justice of the European Union judgement in case C-34/10 (Oliver Brüstle v Greenpeace e.V.) Glyn Edwards, BIA Interim Chief Executive, said: “It is unwelcome that the Court of Justice of the European Union (CJEU) has followed the Advocate General’s Opinion which applies a broad definition regarding what constitutes a human embryo. The BIA believes that this view could lead to a period of uncertainty for those operating within the field seeking to protect their research. It could also result in future challenges before the courts. Such uncertainty could hinder a company’s ability to attract investment, and as stem cells offer hugely promising research to treat some of the most incurable and devastating conditions the decision ultimately could affect the speed at which new products and therapies will be developed for patients and to treat areas of unmet need. Companies around the world will be affected in the same way, however, human embryonic stem cell research will continue in the UK. What is crucial is to get some clarity on how to protect the intellectual property related to this important research in the near future.”


Imminent Patent Expiry of Key Blockbuster Drugs to Benefit Generics Manufacturers, Anticipates Frost & Sullivan


The global generic pharmaceuticals market is likely to witness strong growth in the next few years owing to the patent expiration of key blockbuster drugs and the judicious cost containment efforts of governments and healthcare service providers worldwide. At the same time, the balance in terms of healthcare expenditure and sales revenue is poised to shift from developed to emerging markets such as India, China, Brazil, Russia, Turkey and South Korea, as huge potential still remains untapped in these countries. New analysis from Frost & Sullivan, ‘Generic Pharmaceuticals Market – A Global Analysis’, finds that the market earned revenues of $123.85 billion in 2010 and estimates this to reach $ 231.00 billion in 2017 at a compound annual growth rate (CAGR) of 9.29% from 2011-2018. Regions covered in the research include the United States, Europe (Germany, the United Kingdom, France, Spain, and Italy) and Asia (India and China).


“The patent expiry of several major blockbuster drugs worth $150 billion between 2010 and 2017 will fuel the growth of the global generic pharmaceuticals market,” noted Frost & Sullivan Research Analyst Aiswariya Chidambaram. “The trend is shifting towards less competitive, yet commercially attractive segments such as difficult-to-produce generics, specialty generics and biosimilars.”


Leading global generic pharmaceutical manufacturers have been proactive in forging strategic alliances with branded pharmaceutical companies for marketing rights and exclusivity in producing generic versions of blockbuster drugs such as LIPITOR, Cozaar and Crestor, among others. Market leaders such as Teva, Sandoz and Mylan are increasingly focused on biosimilars, as this segment provides a competitive edge and presents huge profit margins. While these are positive signs for market participants, a potential dampener is the progressively stringent regulations and price control measures being imposed by governments. These have tended to squeeze profit margins for generic manufacturers.


“The increase in the prevalence of chronic disorders, newly reported diseases and ageing populations have resulted in tremendous pressure being placed on governments to implement cost containment measures and curb rampant healthcare expenditure,” added Aiswariya.


As competition intensifies, generic drug manufacturers will have to make careful choices about the product segments that they wish to compete in and the appropriate time of entry into the market. “Large multinational generic firms need to adopt a differentiated approach by opting for products with technologically challenging formulations, products which require significant regulatory support and products with limited availability of active pharmaceutical ingredients (APIs),” advised Aiswariya. “Small and medium-sized firms should focus on products with relatively higher profit margins.”


If you are interested in more information on this study, please send an e-mail with your contact details to: Janique Morvan, Corporate Communications, at janique.morvan@frost.com.


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