Funding for your invention and small business

By Debby Winters

 
I have people ask me quite frequently how they can get funding for their invention or their small business. Here are a few sources for you to consider.

Source 1 – Grants (local, state, federal, and non-profit)

If you have a small business, then consider the SBIR/STTR program. I have worked with dozens of startup companies that have received $150,000 SBIR grant from the federal government. Using grants as sources of funding are ideal because they are essentially free money. You don’t have to pay that money back and you don’t have to give up any equity in your startup. Of course they are also very competitive and hard to get. For more information go to http://www.sbir.gov/

The best (and free) source to find small business grants from the federal government for a new technology related company is: http://www.zyn.com/sbir/. Did you know you can get free help finding and writing these types of grants? Most states have local developmental centers that know of these types of grants and they can help you find them and apply for free. You don’t have to pay for their services (your tax dollars fund these groups). To find them, Google your state name plus small business or your state name plus SBIR.

Source 2 – Business Plan Competitions
Another great source for small businesses is a business plan competition. There are not only a good source of free money, they often allow you to network and connect with people in your area who can help you with your new business or in bringing your ideas to market. There are local business plan completions as well as ones that you can compete for outside of your area. Besides the money and the networking, these competitions usually offer free mentoring and seminars to help you build your business and develop a commercialization plan. You can find these by searching for your closest city name and business plan competition, or you can try calling your local university technology transfer office and they should know of any competitions on your area. If you don’t mind traveling to compete, there are many in other areas as well. Check out http://www.bizplancompetitions.com/ for ones that might interest you.

Source 3 – Angel Investor Networks
Angel investors are usually wealthy individuals who are willing to invest in very early stage companies or even people with a good idea and a good business plan. The usual amount of their investment is $50,000-$100,000. Unlike the two sources mentioned above, this type of money is not “free”. You will have to give up equity (stock) in your company in exchange for this type of investment. Most cities and large towns will have an angel investment group. The groups meet and the inventors and entrepreneurs come to pitch their ideas. Even if you don’t get funded it’s a good learning experience and most of the angels will try to help you out and maybe put you in touch with people who they think can help you with your new venture. You can search Google or call your closest university technology transfer office and they should be able to tell you if there are any angel networks nearby.

Source 4 – Crowd Funding
Most crowd funding sites allow you to post details about your idea and anyone who likes it can either donate money or pre-order your product or service.  This may be a great source of income because it does not make you give up any equity in your company.  A popular crowd funding site is kickstarter but there are lots of other sites as well.  To learn more, you can go here:  http://www.kickstarter.com/help/school/defining_your_project.

Source 5 – State Matching Funds

Many states provide matching funds for investments or tax incentive funds. Google you state and “matching funds for small businesses” to find a list. I’m in Arkansas and we have a number you can apply for. Among these are:

http://www.arkansas.gov/adfa/programs/ARCMF.htm

http://www.arkansas.gov/adfa/SSBCI/SSBCI.htm

http://www.arkansasedc.com/

One word of caution is that you should make sure your patent application is filed before you post any details about your invention online.  If you need help filing a patent application, contact me.

What Effect Does Passing The Affordable Care Act Have On Biosimilars?

By Debby Winters

Last week, the Supreme Court upheld the Patient Protection and Affordable Care Act (PPACA), termed by some as ObamaCare, as constitutional under the taxation clause of the Constitution.  Most look at this for its requirement that Americans secure “minimum essential” health insurance, but the impact of the decision on U.S. regulatory and patent law goes much farther than just that.  It has a huge impact on the world of Biosimilars.

Biosimilars is the term used to describe officially-approved subsequent versions of innovator biopharmaceutical products, which are made by a different company once the patent holder no longer has exclusivity for making the innovator product. The concern is that differences in impurities and/or breakdown products from the different process to achieve a biosimilar product can have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the product. For this reason, the US has lagged behind other countries around the world in producing Biosimilars.

The Supreme Court decision in the case of Mayo v. Prometheus earlier this year, dealt a hug blow to this line of products. This case looked at the survival of the Biologics Price Competition and Innovation Act (BPCIA), which created a new approval pathway in the U.S. for biosimilar products.

Mayo originally bought and used Prometheus test kits that employed a patented method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, but Mayo then decided to sell and market its own test, which was similar, but not identical to that of Prometheus.  Prometheus sued for patent infringement.  The court found that Mayo’s test would infringe the Prometheus patents, but it held the patent invalid as essentially claiming unpatentable laws of nature. This dealt a huge blow to the BPCIA.

Following the Supreme Court’s decision in Mayo v. Prometheus, the general feeling was that the PPACA would be substantially modified by the Supreme Court, and because the PPACA lacks a severability clause, the bill in its entirety was at risk of being struck down.  Should that have occurred, biosimilar producer had indicated that they would lobby the President and Congress to move quickly to pass new Biosimilars legislation.  The U.S. would then fall farther behind the rest of the world with Biosimilars.

That’s why the recent Supreme Court decision in PPACA erases any hesitation biosimilar producers may have had in using the BPCIA due to the uncertainty of its survival.  With the Biosimilars framework intact, efforts to shape the implementation of the pathway will certainly surge biosimilar producers to move forward full steam with their biosimilar products without fear of legislative overhaul and potential disruption of their FDA approval progress.  The result is certainly a relief for biosimilar producers who have already invested resources in seeking Biosimilar approval from the FDA.  The survival of the BPCIA is welcome news for biologics patient consumers as well, who hope to see lower prices in the near future on these important and typically costly drugs.