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Self-Defense: Expediting the Patenting Process to Meet Emergency Demand

Published onOct 19, 2014
Self-Defense: Expediting the Patenting Process to Meet Emergency Demand

The modern world faces many varied threats that require quick action.  Not the least of these are diseases like Ebola.  However, despite its media coverage and known mortality rates, many of the largest medical R&D groups have failed to act on Ebola until now.  A recent article in USA Today stated that although the threat of Ebola has been known since 1976, the monetary gain from the development of a cure has been so little that major drugmakers have ignored it.  Now that the threat is growing, several new treatments, from antiviral drugs to blood transfusion therapies, are being tested and readied for market.  However, they are not ready yet.

Why are these treatments not available?  One reason may be the lack of economic protection of the drugmaker’s final product through a patent.  The United States patent system, although useful in its protections of intellectual property, is notoriously slow.  In the face of anything other than a “sure deal”, a pharmaceutical company may be tentative to produce and subsequently patent an otherwise unneeded treatment.

So, how can a company expedite its protection so that new treatments for new illnesses can become economically available?  This article will use a broad hypothetical to follow a few options for such a process and find whether such a patent process may actually be effective in helping secure a company’s specific treatment.

The Hypothetical

Assume that a large, multi-national medical research company called Mediquip, Inc. has recently created a drug called Cavendex.  This drug can be administered to Ebola patients to shorten the virus’s life span in the body, giving time for other treatments to work effectively.  Alone, Cavendex is not useful and is expensive to produce.  Mediquip wants to get a patent, or some other protection, before it begins providing the drug to countries hit by Ebola.  Ideally, Cavendex would need to be on the market within the year to make itself useful.

The Normal Patent System

The first place Mediquip would likely look to get Cavendex patented is the normal patent application process.  The United States Patent and Trademark Office (USPTO) oversees all patent applications in the United States, including patents for medical treatments.  According to the USPTO’s own data, the full process for a utility (“invention”) patent, from filing to a board decision, could take on average 88.1 months (about 7 years and 4 months).  In contrast, the “traditional” total pendency route in the USPTO takes on average 37.7 months (a little over 3 years) to pass through its process.

In a situation like our hypothetical, time is of the essence.  If the full process for a new treatment could take over seven years, Mediquip will want other options.

Special Expedited Patent Processes

Apart from the traditional route, the USPTO boasts a few other ways to expedite the patent process for Mediquip.  The two most relevant here are (1) TrackOne and (2) Patents for Humanity. TrackOne allows a “fast track” approach for utility patents beginning in September 2011.  This process can allow a patent to be granted within 12 months, but requires a separate, narrower application process, charges higher fees, and sets annual limits on the number of patents accepted.  Considering that pharmaceutical patents may require more than one patent, this could cause problems for Mediquip, but it is still a viable option otherwise.

Another option is Patents for Humanity, which was renewed on February 20th, 2014 in order to further incentivize patents that are focused on humanitarian work. Applicants are judged in various categories, including medicine, and are granted “patent acceleration certificates” based on their impact on global problems.  Similar to TrackOne, this process could possibly grant Mediquip a patent for its drug within the year, but the patent is not guaranteed.  Patents for Humanity is a competition and its result is the award of a certificate to accelerate process, not a patent itself.  This being said, the program could still benefit Mediquip, if it is able to meet the separate application requirements and annual deadline, which is October 31st this year.  In fact, among last year’s winners were a few drug manufacturers.

Ebola virus particles

The FDA’s “Exclusivity” Rights

If the expedited options do not work for Mediquip, the company can always attempt to secure “exclusivity” rights under the FDA instead.  For new pharmaceuticals, the Food & Drug Administration (FDA) can grant drug manufacturers a special form of intellectual property protection separate from patent rights called “exclusivity” which allows a company to produce and market a drug exclusively for a period of 3 to 7 years.  Mediquip in particular may be able to file for “orphan drug” exclusivity which protects the production and marketing of drugs for rare diseases for 7 years.  The decision for orphan drug exclusivity can be made between 1 to 3 months, but applicants must meet separate statutory guidelines for the process and are not notified of the decision.  Instead, applicants must continue to monitor the Orange Bookwhich contains all FDA-approved drugs.  Note, too, that although having a patent is not required for exclusivity protection, the application process requires at least some sort of patent application or information for the new drug.  Mediquip, even if it does not expect a patent within the useful time frame, may have to file a patent application for its exclusivity rights.

The Results: Will It Help Here?

Under our proposed hypothetical, Mediquip has a few options to expedite the protection of its Ebola drug.  Although these options require a fraction of the time that the normal utility patent process takes, each also comes with its own set of challenges, whether they be applicant ceilings, uncertain contests, or further statutory requirements.  Mediquip is likely in need of a brand new, emergency process that has yet to be developed.  Until then, its best decision will likely be to try more than one of these expedited programs and begin production of Cavendex.  After all, Mediquip’s decision to allow Cavendex’s dissemination could lead to economic gains much larger than if it was the exclusive patent holder.

* Austin Griffin is a third-year law student at the Wake Forest School of Law. He holds a B.A. in English from the University of Florida in Gainesville, Florida, with foci in Medieval Literature and Rhetoric. Upon graduation, he plans on entering into a legal career centered on sustainability and renewable energy.

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