VC-backed biotechs will get shot at $1M-plus SBIR awards

Posted under Biotech Venture Capital, Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, small business, Small Business Innovation Research, Startups, Universities, Videos by John Carroll

For the past 8 years, the prohibition against giving companies majority-owned by venture groups access to the government's Small Business Innovation Research awards has been one of the most painful thorns in the side of the biotech industry. But after intense lobbying on the part of BIO and venture groups, lawmakers are about to have it legislatively removed. Legislators negotiating on behalf of the House and Senate have hammered out a new agreement to amend the program, opening its SBIR doors once again to the VC-backed companies.

Now the NIH and the National Science Foundation can reserve up to 25% of their SBIR funds for the VC-backed biotechs, a common sight in an industry that relies heavily on venture groups to fund early- and midstage development work. Biotechs can get SBIR awards of up to $150,000 in Phase I, up from $100,000, and a million dollars-plus for Phase II programs.

BIO chief Jim Greenwood cheered the announcement, highlighting a few key players who helped provide the bipartisan support needed to make it all happen.

"In particular, BIO applauds House and Senate leadership, including Rep. Sam Graves (R-MO), Rep. Nydia Velazquez (D-NY), Rep. Ralph Hall (R-TX), Rep. Eddie Bernice Johnson (D-TX) and Sen. Mary Landrieu (D-LA) and Sen. Olympia Snowe (R-ME) for their efforts in moving this measure forward," said Greenwood.

- check out the release from BIO
- here's the story from Portfolio

Related Article:
Bill offers small developers shot at R&D funds

BIO Supports SBIR Reauthorization in Senate

Posted under Blog, Companies, congress, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Public Policy, sbir, Senate, small business, Startups, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

Last week, the Senate passed the National Defense Authorization Act (S. 1867), which included SBIR reauthorization through Senate Amendment 1115.

This is a critical step toward ensuring that all innovative companies can compete for SBIR grants – based on the promise of their science rather than the structure of their capital.  Reauthorizing the program to allow small companies that receive the majority of their financing from venture capital to once again be eligible to compete for SBIR grants is imperative.  This change will allow more small biotechnology start-ups to continue critical research and development of medical advancements and breakthroughs.

A compromise on a longer term reauthorization is critical. BIO will work with Congress to ultimately reauthorize the SBIR program to reflect the realities facing small companies in capital-intensive industries such as biotechnology. SBIR should be an aggressively competitive program that fulfills federal research and development goals of bringing breakthrough public health discoveries to the public.

Senate amendment 1115 was offered by Sens. Mary Landrieu (D-LA) and Olympia Snowe (R-ME), with the following co-sponsors: Sens. Jeanne Shaheen (D-NH), Scott Brown (R-MA), John Kerry (D-MA), Kelly Ayotte (R-NH), Christopher Coons (D-DE), Carl Levin (D-MI), Benjamin Cardin (D-MD), and Robert Casey (D-PA).

Recent news stories:

Senate OKs SBIR funding, but full passage remains a question mark, New Hampshire Business Review, December 6

BIO Applauds Small Business Innovation Measure in Senate Defense Bill – Inside Health Policy, December 2

Senate Passes SBIR Reauthorization – BioCentury, December 2

BIO Praises Senate Passage of SBIR Reauthorization – BioMedReports, December 2

Senate OKs Changes to High Tech Start Ups – Science, December 2

The Critical Importance of International Patent Protection for Small Businesses

Posted under Blog, Companies, Diagnostics, Emerging Companies, Funding, Intellectual Property, Medical Devices, Medical Supply, patent, patent protection, Patently BIOtech, Pharmaceuticals, Public Policy, small business, Startups, U.S. Patent and Trademark Office, Universities, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

As part of the implementation of the Leahy-Smith America Invents Act, the U.S. Patent and Trademark Office (PTO) recently held two public hearing on international patent protection.  Stanley C. Erck, President and CEO of Novavax, Inc., testified on behalf of BIO in support of an initiative to reduce filing and prosecution costs for international patent protection of biotech inventions.

In his testimony, Mr. Erck explained the important role patents play in the biotechnology industry. The vast majority of BIO members do not yet have a product on the market and must raise the funds necessary to finance the long and expensive process to bring a new vaccine or therapy to market (an average of $1.2 billion over ten years, according to the Tufts Center for the Study of Drug Development).   Intellectual property, in the form of U.S. and international patents, is often the main assets of these small biotech companies.

The importance of international intellectual property protection has increased as biotech companies seek to expand the markets for their products.   Small biotechnology companies face unique challenges in securing international IP protection as biotechnology patent prosecution in foreign jurisdictions can be more expensive and complicated and subject to greater non-uniformity of the law than many other technologies.  The scope of patent claims and what is allowed can differ significantly from country to country, which further complicates and increases the cost of international patent filing for biotech inventions.  Without procedural or substantive harmonization, these problems are likely to increase costs for small biotechnology companies.

“For our small biotechnology businesses, securing IP protection can be as important as obtaining laboratory equipment, leasing space, or hiring creative, dedicated employees.  There is no reason, therefore, to exclude efforts to secure patent rights from publicly funded small business assistance programs that are available for more tangible assets such as capital equipment, hiring, or leasing space,” Mr. Erck testified.  “Securing international patent rights, a necessary protection for even the smallest biotech companies, can be an expensive proposition, so permitting public assistance programs to defray such expenses would give these companies greater flexibility to focus resources on important development efforts.”

BIO has urged the U.S. PTO to consider ways it can help small biotechnology companies file and prosecute patents internationally more efficiently, so that these companies can dedicate more resources to research, job creation, and product commercialization for the benefit of patients, farmers and other consumers.

A webcast of the hearing is available on the PTO website.