Business and Science for BD & others
#63, September 2011
Patent reform creates first-to-file system in the US
President Obama signed the patent reform bill, moving the US from a first-to-invent to a first-to-file system, expected to be effective September 2013. Patent fees are increased 15% for most filers, but decreased for “micro entities”. There is a new Prioritized Examination 12 month review for up to 10,000 patent reviews per year (initially) for an extra cost of $4800 (half that for small firms). There are new challenge mechanisms, including a Pre-issuance Submission where third parties can submit publications or patents before patent applications are published or allowed, and a Post-Grant Review where 3rd parties can challenge via the patent office a patent validity within 9 months of patent granting. The invalidation of a patent for failure to divulge the “best mode” of the invention was eliminated. http://www.skgf.com/patentreform
Antibodies and payloads
Antibodies have become a standard modality for therapeutics. Now with the recent approval of Seattle Genetics anti-CD30 antibody drug conjugate with the cytotoxic tubulin-binder monomethyl auristatin E, following by many years the approval of the calicheamycin loaded Mylotarg from Pfizer (Wyeth), antibody payloads are becoming accepted as a means to add efficacy to antibodies. Payloads can be diverse:
The newer technologies are not dependent on rapidly proliferating cells, and avoid the cross-resistance with chemotherapy from the pgp pumps. but rather exploit the biology of the payload proteins.
Big company to get funding for development from small company
Must be more to this than meets the eye, but here is the latest dramatic example of big pharma seeking to offset risk. Under the agreement, the multi-kinase inhibitor cancer drug’s late-stage studies will be conducted by Eisai and wholly funded by SFJ, with Eisai paying SFJ milestone payments only if E7080 obtains regulatory approval. If and when the compound is approved, all commercial rights shall remain with Eisai. http://www.eisai.com/news/news201166.html
Gamers solve tough protein folding problem
Online gamers, work cooperatively in groups, competing with other groups, to achieve the lowest energy folding conformation of proteins in “Fold.It”, an online game. Now, as reported in Nature,http://www.nature.com/nsmb/journal/vaop/ncurrent/full/nsmb.2119.html, they solved in 3 weeks the structure of a protein (a retroviral protease that causes an AIDS disease in monkeys) that had been worked on by scientists for years. The gamers together built upon each other’s intermediate solutions, and used intuition and 3-D pattern matching in ways that are not yet in computer program algorithms. They were not scientists but did it for the joy of contributing to science, even staying individually anonymous, with the publication in the name of the winning group. Other folding and design challenges such as a potential flu therapeutic are already posted for the gamers. http://fold.it/portal/blog
Richard Hsu’s blog and my “10 Considerations in a Life Science License”
Check out Richard Hsu’s imaginative blog with lots of interesting, quick read postings. I gave him one. http://hsutube.com/life-science-license/ But there are lots of good posts.
Great ideas for spurring biotech
Bruce Booth of Atlas Ventures suggests a government policy could provide much needed capital for young biotechs, if small biotechs could sell their net-loss carry-forward tax deductions to big pharmas who want to repatriate some of their foreign earnings. He also suggests a new lower rate of capital gains tax for very patient investors willing to hold on for all the time it takes to develop a drug. http://lifescivc.com/. Our industry organization, BIO, has a longer set of proposals to spur innovation, including tax credits for angel investors, lower capital gains on investments in small businesses, tax holidays on repatriated investments in small biotech, and including innovation in the mission of the FDA. http://www.bio.org/sites/default/files/PromiseofBiotech.pdf
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