As more companies and universities compete for shrinking government and investor funding in an already-crowded medical research field, it is important for those entities to protect their innovations (intellectual property).
“It’s important to counsel clients on how to best protect their innovations and inventions so they maximize their value and do not trespass on the rights of others,” says Alice Martin, a partner at Barnes & Thornburg and co-chair of its Life Sciences Practice Group. “Clients need assistance in determining what to protect and how to best accomplish that goal, which may mean writing patent applications, requesting trademarks and copyrights, and unfortunately litigating either offensively or defensively.”
Smart Business talked to Martin about the importance of obtaining patents, trademarks and copyrights; what kind of companies need protection; and how intellectual property relates to funding for medical research.
What kinds of medical field research results need to be patented?
Any composition, method or device made by the hand of man is potentially patentable as long as it’s novel, nonobvious and useful. However, patenting is not to be undertaken lightly; the process is time consuming and expensive, and protection is temporally limited. If the product, method or device is valuable and has a long-term life span, a patent may be worth considering.
Pharmaceutical patents are well known for medicines. Also patentable are new products made through molecular genetics, such as compositions to turn off disease-causing genes or to interfere with gene products, or molecules targeted to attack cancer cells. Diagnostic assays detect diseases by using various immunological techniques such as antibodies that react in the presence of the disease, or molecular genetic methods to determine the presence of a disease-related gene.
Medical devices such as replacements for damaged bone and cartilage incorporate mechanical and biological components, including stem cells, are considered as well.
Computer programs and methods for health care and medical reports are potentially patentable. Vaccines are patentable, such as the recently approved vaccine for HPV. Therapies for Alzheimer’s disease and other neurological developments such as multiple sclerosis are being developed.
Trademarks and copyrights should also be considered as protection. Sometimes these are more valuable than patents because they have longer terms. We also work quite a bit with universities because they are often at the forefront of early stage research
What are some common patent problems?
Because researchers often progress toward the same goals using the same research techniques, it may be difficult to obtain a patent due to public disclosures that the patent office considers not-novel or obvious. Or similar patent applications may reach the patent office at the same time, resulting in an ‘interference’ — litigation to decide who has the rights to the invention.
Another problem is improvement patents. One company may have a patent for a process or drug that includes A, B and C. Another company may find another step or element – step D — that improves performance. The second company could get a patent if it can prove that the step or element is not just a routine or obvious improvement over A, B or C. However, if you have to do steps A, B, C as well as D when practicing the improvement, or if you have to give the patient a drug including A, B or C, as well as D, that infringes on the first company’s patent.
A common way to overcome this problem is for the companies to enter into a cross-licensing agreement. The first company wants the improvement provided by the second company, which wants the benefit of its improvement. So a resolution is to negotiate so that either or both company can use steps A, B and C while adding Step D.
Some of the smaller companies that can’t afford to conduct the trials required for regulatory approval [through the U.S. Food and Drug Administration] or to commercialize their invention can license their patents to a bigger company that is able to move the invention from the bench to the marketplace.
Can an existing patent be used to prevent a competitor from making an improvement?Patents should not be able to prevent a competitor from making an improvement. However, patents must be enforced to exclude others from making, selling or using the already patented composition, method or apparatus.
No matter how altruistic a company, university or individual wants to be, funding is needed from somewhere. When a company has spent millions of dollars developing a drug, it wants to keep others from making, using or selling that drug device or method; otherwise the shareholders won’t be able to recoup their research and development losses and further investments are discouraged.
ALICE MARTIN is a partner at Barnes & Thornburg. Reach her (312) 214-8316 or [email protected].
