The recent ruling in the Myriad human gene case has created debate about what should be patentable. Raju Elangovan takes the opportunity to review the patent landscape in this controversial area.
The Judgment was delivered. But, the arguments are on in the public domain about the recent Myriad case. This case is related to human genes, the blue print of human life. So, every one of us is concerned about this case.
The laws are enacted at a particular period of time, based on the need. The need to modify the existing laws will depend upon the changing scenario or as a sequel to the courts’ judgments. The inventions in the scientific field are faster than the changes in the laws. On many occasions, the courts have to solve the unforeseen and newly emerging problems, with the old laws.
The verdict in the recent Myriad case was that the naturally occurring DNA segment is not patent eligible but that CDNA is a patent eligible because it is not a naturally occurring. It was quoted that Myriad said that only 5 claims of the patent are affected because of the verdict and there are more than 500 valid and enforceable claims in 24 different patents of Myriad.
Whenever there is a patent case which may impact the Pharma and Biotech industry, the voice of the industry is that, the judgment should not hamper the huge investments in R&D and should not discourage the risk taking attitude of the industry. Globally, the Myriad case has created a much heat for the Pharma and Biotech industries. This case has kindled the thinking of the governments, law firms, universities, research institutes and the corporate. Further, this case has created an opportunity for the gene patent holders to critically look at their portfolio, the claims of their patents, and area of research and the patent laws of different countries related to genes.
In this scenario, it is worth looking at the Human gene patents landscape. This article brings out a high level view of the landscape of Human gene patents.
This landscaping study is limited to only the last five year period from 2008 to till June 2013 and to the five Geographic areas US, EP, JP, China and India. The US.EP and JP geographies were taken as samples of active countries in biotech patents and China and India were taken as samples of emerging countries. The search strategy was formulated covering the classification codes as well as the Key words. Only the IPC codes C12N and C12Q which cover the gene patents were included in the search. To filter the Human gene patents, the keyword “Human” was included along with other appropriate related terms. The search covers both the applications and the granted patents. Hence, in this report the term patents cover the applications as well. The search was based on the title, abstract and the claims. Two commercial databases were used as needed and the search was restricted to the title, abstract and the claims.
The search threw 10,955 patents (family included). Obviously, the USA tops the list, followed by EP, JP, China and India in the order of 9573,7821,5685,3445 and 1510 patents (Figure 1).
Fig.1: Human Gene Patents across Five Geographies (2008 – 2013)
The high level IPC code wise search shows that more patents ( 9939) are under the code C12N which deals with gene mutations and genetic engineering and less (6551) under the code C12Q which deals with the processes.
Fig.2: IPC Spread of Human Gene Patents (2008 – 2013)
Assignee search for the same period, without assignee name standardization, threw 4840 assignees. But, among these 4840 only 15 assignees have more than 50 patents, during this period and only two assignees (Genentech and Merck Sharp & Dohme) have more than 100 patents. Interestingly, more than 3000 assignees have less than one patent each.
Fig. 3: Top Players in Human Gene Patents (2008 – 2013)
Obviously, only a few players can afford to be very active considering the time and the investments required. While the numbers signify the active players, the high value or path breaking invention may lie in the patent of the single patent owners.
With this panoramic view of the landscape, it is clear that the terrain is not flat. Further, at the backdrop of the Myriad case, there will be reassessment of the focus area of research, patent claim intelligence, patent risk assessment and the opportunities for amendment of existing patent laws.
Raju Elangovan, CEO, E-Merge tech Global Services
Raju is the founder and CEO of E-Merge tech, a premier Patent, Technology and Competitive Intelligent services company. E-Merge tech provides a range of services within these three areas, to global customers. He has more than 25 years of experience in various functions including legal from different industries and held “C” level positions in knowledge services companies.
Disclaimers: This article is just for continuous learning purpose. The data in this article are not based on authenticated research and so cannot be relied on. The rank list of players should not be taken as a guideline for any decision. The opinions in this article are not intended to be nor should be considered as strategic or legal opinion.