Zachary Hiller Law Pharmaceutical Law and Patents

shutterstock_300979292A recent New York Times article discussed in depth how pharmaceutical law  and patents could block lifesaving drugs from hitting the market. The patent system protects and promotes innovation, but when it comes to pharmaceuticals, this may prevent value of new and very important drugs.

The article took a look at the behavior of pharmaceutical firms and how many drug companies discard potentially good ideas because they’re not patentable. We all know drugs are expensive, and bringing a drug to market is very costly. Getting F.D.A. approval alone is very expensive and a drug cannot be marketed without that approval.

This could mean some of the drugs we need the most, that don’t have patents when they are made- they will cost the consumer a pretty penny.

So why do these companies only want dugs that have patents? A drug patent offers the patent holder a period of time during which it may market the drug without competition. During this time, no one else may use this patent to secure F.D.A. approval. By the time a drug reaches the market could have 13+ years still on its patent. So during this period without any completion, the manufactures can raise the price of that drug in order recoup costs and make a tidy profit.

The root of the issue is: patents are used so innovators can get back the cost of their investments that development requires. But the patent system was originally intended to encourage innovation. While it does encourage innovation and development in some ways, it can hold back from needed development as well.

Some say a solution to this catch-22 is to call for greater government funding for public-domain drugs. Another potential approach is to provide a period of market exclusivity to any organization addressing an unmet medical need with a drug that isn’t patentable.

There are other options being tossed around as well. Recently an analysis from the Congressional Budget Office (CBO) estimates that a patent law change requested by brand name pharmaceutical industry stakeholders would add over 1 billion in costs over 10 years to the US health care system. This coalition is asking Congress to consider relieving drug patents from facing challenges via the Inter Partes Review (IPR) process. Through IPR, judges employed by the US Patent and Trademark Office review patent challenges that would otherwise be heard in lengthier court proceedings.

Both the House of Representatives and Senate are considering bills that could include the drug patent exemption rule change. And as usual, the current presidential debates will speak in depth on what health care related to all this could look like in our future. As baby boomers get older these issues will become more and more important to American families, affecting everything from the accessibility of medications and the prices that we will have to pay to get these drugs. Either way, patent law will have an impact on everything from health care costs to presidential politics.

If you have questions about patent law trust the experts at Zachary Hiller law to help you navigate the legal system.

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