Patent Reform Act of 2007 – Impact on Regenerative Medicine

The author of CELLWISE, one of the newer bio-Blogs out there, asked a question related to the Patent Reform Act of 2007 in a comment on the Pfizer post. He asked:

cellwise-question-ii.png

The article that is cited is right; our patent system is not optimized for today’s innovations or our different industries. The patent office is overwhelmed by too many applications.  The applications are too broad and poorly thought out, making them difficult to review and it can take 2-3 years before your patent is reviewed for the first time. The patent office has a huge backlog, lawyers fight tooth and nail for their clients on every claim, and patent reviewers are evaluated by how many patents they get off their desk and not issuing high quality patents (it is easier to allow claims than to reject claims, as no one argues). As a result, a huge number of low quality patents are being issued. The Patent Reform Act of 2007 is trying to address several problems at once, and two of the primary stakeholders in the outcome of the reform, the info tech (IT) and pharma/biotech industries, have very different interests.

One major difference between IT and pharma is that pharma’s intellectual property is usually based on single patent products (drug compositions), while IT innovations are convergent technologies built from several different patented technologies. Thus, it is in pharma’s interest to have very strong patents that are difficult to infringe or challenge, with large penalties for infringement to keep generics out. On the other hand, it is in IT’s interest to have patents that are easier to challenge (and thus weaker), and minimize damages in case they miss a patent when assembling the next mobile device. The new Patent Reform Act definitely caters towards convergent devices, and not single patent products.

Regenerative medicine is very different than pharma’s one patent model. Most products, like the iPhone, will be based on a convergence of several different patented technologies (the cell composition, the culture conditions to differentiate the cell, the 3D scaffold material, the method of use, etc…), and I think RegenMed will actually benefit from the Patent Reform Act. Tissue engineered products, biomaterial-based medical devices, and cells delivered via specialty tools will all be dependent on reasonable costs to incorporate various technologies for these next generation therapies. Therefore, policies that benefit convergent innovations vs. single patent products will help the industry navigate through the ‘patent thickets’ that are developing.

As these changes are made, they will require different strategies and ways of thinking, and pharma has a horrible history of dealing with change. This resistance to change may be due to the culture that comes with such long product life cycles, and they will have a more difficult time transitioning than the IT industry. However, it should aid the development of the fledgeling RegenMed 2.0 industry.

Other links of interest:
Cutting through the patent thicket
Patent Reform Act of 2007: Innovation, Implications and the American Inventor
The global stem cell patent landscape: implications for efficient technology transfer and commercial development

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About jrowley

This blog is about the technology behind Regenerative Medicine - including, but not limited to, stem cells therapies, biomaterial-based devices, as well as tissue engineered products. My name is Jon Rowley. I have been in the Regenerative Medicine field since 1994 (undergraduate research), and have my PhD in Biomedical Engineering from the University of Michigan in Biomedical Engineering. I am currently an employee of Aastrom Biosciences, an adult autologous cell therapy company. You can see my professional creds at: http://www.linkedin.com/myprofile?trk=tab_pro Important Note: Absolutely everything posted in this blog is my personal opinion and is in no way the opinion of my employer, Aastrom Biosciences, or approved by anyone before it is posted. No warranties or other guarantees will be offered as to the quality of the opinions or anything else offered here.
This entry was posted in Big Pharma, Innovation, Intellectual Property, Regenerative Medicine and tagged , , , , . Bookmark the permalink.

One Response to Patent Reform Act of 2007 – Impact on Regenerative Medicine

  1. dbellbell says:

    please see http://www.piausa.org/ for a different/opposing view on patent reform

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