NK Patent Law is committed to sharing the experience, enthusiasm, and high level of technology expertise of its attorneys with the innovation community. In this Q&A, attorney and firm co-founder Laura Kiefer, Ph.D., discusses changes and issues affecting intellectual property (IP) law.
Q: How has IP law for life science businesses changed over the past several years?
A: There has been an interesting combination of increased access to capital, but tightening regulations and negatively trending caselaw have tampered outlook somewhat. For example, the United States Patent & Trademark Office has instituted rules on what is “eligible” for patenting based on the recent caselaw that are making it more difficult to patent biological therapeutics, diagnostic tests, and agricultural microorganisms. These include peptide and protein based therapeutics, diagnostic tests based on biomarkers including for the early detection and treatment of cancer, and beneficial microorganisms to reduce the use of chemical pesticides in agriculture. Historically a company could expect an easier time obtaining a patent for these types of technologies in the US than in Europe, but this has reversed in the last several years.
Q: The life science industry reaches across a wide spectrum of agriculture, medical devices, biotech, pharmaceuticals, medical devices, digital health, diagnostics and drug delivery. How are businesses with these particular focuses alike in terms of intellectual property needs, and how do they differ?
A: They are alike in that they likely need IP in order to progress the business. But the return on investment is very industry specific, and the portion of total budget dedicated for IP is very different. Take a pharmaceutical company for example: the IP is crucial, but also likely a small portion of the overall budget if clinical trials are required. A digital health company may have significant IP and a shorter time to takeoff due to lessened regulations, so securing IP in the form of granted patents quickly can be crucial for that company.
Q: NK Patent Law has worked with hundreds of young up-and-coming companies in the life sciences; is there any one particular technology or market sector that is growing faster in terms of popularity or need?
A: Computer enabled technology is taking off. Wearables, while not as popular just a few years ago, still form a large part of many medical and life sciences systems, particularly as adherence and compliance become important factors in insurance reimbursement.
Q: What changes at the USPTO level have had the most impact on life science startups over the past several years? Are there any new USPTO changes on the horizon?
A: The changes at the USPTO have reflected recent caselaw from the Supreme Court and the Federal Circuit, which hears all patent appeals. And the caselaw has been, frankly, disastrous for life sciences companies in recent years. The changes in what is even considered eligible for patenting as described above has inserted a new level of uncertainty for life sciences companies. Many companies had significant value attributed to their intellectual property, and some of those companies have had a significant or near total loss of that same value in large part due to recent caselaw. One example is a company called Sequenom that obtained a patent on a method of analyzing DNA from a mother’s blood sample to test for fetal abnormalities. The great thing about Sequenom’s blood test method is that it can be used instead of a riskier amniocentesis test. The Federal Circuit invalidated Sequenom’s patent in 2015 as being patent ineligible subject matter. The Supreme Court declined to review the decision.
The USPTO director from the Obama administration has stayed on for the Trump administration, and there have been no clear indications that changes are on the horizon. However, several major intellectual property groups have recently called for new legislation to address the drastically heightened standard for what is considered patent eligible subject matter. The barriers to obtaining patent protection for life saving diagnostic tests have garnered the attention of a least a few members of congress.
Q: President Trump has met with representatives from the pharmaceutical industry and indicated he was going to work to loosen regulations on the industry. What does this mean for your average startup in terms of opportunities and challenges in terms of getting their patent house in order?
A: That may or may not be a positive for the average startup. It will certainly create new opportunities, which some will capitalize on to introduce some new product that wasn’t available because of previous regulations. At the same time, the regulations themselves bring about innovation, so a reduction in regulations may see a corresponding reduction in innovation.
Ultimately, increased regulations usually mean more cost and red tape, and reducing these burdens will make life sciences products more appealing to investors and entrepreneurs.
Q: How can life science companies leverage their IP to achieve success in attracting investors and other aspects of growing their business?
A: Companies need to be selectively aggressive with their IP strategy. Not filing on valuable IP is largely a kiss of death for a life sciences company, but so can be destroying your budget by over-filing. Companies need to work with IP counsel that really understands the technology and the market.
About Laura Kiefer, Ph.D.
Dr. Kiefer’s practice focuses on patent prosecution before the United States Patent and Trademark Office and in foreign countries. Before obtaining her law degree, Dr. Kiefer worked as a research scientist in both large and start-up pharmaceutical companies and is co-author on numerous scientific articles published in peer-reviewed journals. Previously, Dr. Kiefer worked in private practice at a North Carolina intellectual property law specialty firm and as in-house corporate counsel for an entrepreneurial medical device development company spun out of Duke University.
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