Biotechnology - Genomic and Proteomics/IP in BGP

Biotech And Software

Patents are primary means of protecting innovation in Biotech, not so with software. Unsurprisingly then, the two industries will differ on how to approach patent reform

• Biotech products can often be covered under one or more patents. Software development is generally cumulative, and so may require obtaining or licensing many patents.
• Very hard to patent software methods, not so with biotech.
• Software generally uses patents to leverage or control existing products, not necessarily to encourage the creation of new ones (Schacht p. 10)

Further question: in software industry, secrecy and lead time play more important roles in protecting innovation than do patents? Why are these not so important for biotech?

• Hypothesis: reverse engineering and FDA approval process makes secrecy difficult. And lead time is in fact enormously important for biotech, but only as a subsidiary to patents

Biotech and Pharma

• Biotech and Pharma industries basically aligned in their attitudes towards IP
  • Both support S3464, which would allow the justice department to enforce civil IP laws, and S3325, which would require US trade representatives to take more steps to stop piracy in foreign countries (Biotech, Pharma Industries To Target IP Protection Legislation)
• Possible sources of disagreement:
  • Follow-on biologics (http://www.bio.org/healthcare/followonbkg/Principles.asp). These are similar versions of approved innovative drugs. Two ways to increase speed of bio-similar productions. (1) shorten patent breadth, (2) allow biosimilars to go through same approval process as generic drugs. Unsurprisingly biotech industry is opposed to both moves. But generic pharma companies want both

Old Guiding Notes

• Define the main legal tools of protection (privatization) available for the field (patents, copyright, trademark, trade secrets, contracts, public domain) (remember the exercise done in genomics and proteomics).
  • (note to R.A. - try to create a matrix that cross references the previous two questions - let's try several ways to visualize how the narratives either hit barriers based on protection or can be synergistic via open licensing approaches - an example is the table in the Case Analysis Framework)

Our hypothesis is that because R&D costs are so high, and because once developed, a biotech product if (relatively) easy to produce, profitability in the industry rests on patents. In general firms that develop these new products will either bring them to market themselves, or license them out to larger pharmaceutical companies.

In this way, Biotech is not so different from the traditional drug industry. However, the key difference is that it is possible to patent not just products but basic scientific processes, such as the Cohen-Boyer process of manipulating rDNA. While these patents may be extremely lucrative (the Cohen-Boyer process brought Stanford and the UC system US$255m), it almost certainly imposes a cost on future innovation. (Feldman pp. 1797)

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Bibliography for Item 4 in BGP
Biotechnology_-_Genomic_and_Proteomics