Final ruling on the Multidistrict Litigation Update
The Periphery Settlement Funding and Policy Review, published by the Active Group, is a new update on the litigation that is filed in the United States Patent and Trademark Office’s Electronic Processing Branch, or EPO. According to the press release, “EPO’s recent changes have caused confusion among inventors and businesses who need legal advice regarding their rights and obligations when engaging with EPO’s implants and bellwether trials.” What the statement fails to mention is that, for years, EPO has received hundreds of patent applications that were rejected due to lack of clear patentable subject matter. The changes in EPO’s processing guidelines were not designed to increase the number of patent applications approved; rather, they were designed to improve the quality of the patent review process, and make it more difficult to file fraudulent patent claims. The result was a noticeable decrease in the number of patent rejections for pending patents. However, the new updates affect every application filed with the EPO, regardless of whether it was previously rejected.
If an application is rejected under the new guidelines, it will now be required to go before a multidistrict litigation team that has been formed under the supervision of a United States District Court judge in Washington, DC.
The changes affect all applicants, whether the claims are founded on original or operative patentable subject matter. The basis for the changes was to ensure that patentable subject matter does not exist in two different states, or in two different EPO locations. The result will be that if an applicant’s application is approved in one state, it will have to compete with those of applicants in other states.
The new litigation requirements are part of the multidistrict litigation rule change implemented by the EPO.
According to the rule, all lawsuits that involve more than two parties and seek to resolve the same claim in a relatively short period of time must now be filed in federal court. Prior to the implementation of the rule, all such lawsuits were filed in state court. The new ruling was supposedly done in an effort to make patent law more uniform across the states and eliminate what many see as an abuse of the patent system. Proponents of the change say that it will allow litigants to better address the issues raised in their lawsuits, while opponents argue that it will create a one-size-fits-all lawsuit process that will favor large patent holding companies at the expense of small businesses and innovators.
One of the major reasons that the Multidistrict Litigation Rule has been implemented is to combat “microwave innovation.”
This is a reference to the efforts of certain pharmaceutical companies, like AstraZeneca, to get the US Patent Office to allow them to patent certain conduct related to their drug discovery process without going through the same process required of all other companies that do not employ the use of the process. For example, AstraZeneca sought to have the FDA declare that drugs that are administered to patients under a continuous-cycle therapy are allowed to treat any disease that occurs after the last dose of the drug. This would seem to be a logical step, because there is a very strong correlation between the duration of time that a drug is taken and the effectiveness of that drug. While there is no hard data to suggest that this is an effective treatment method, drug companies have sought to patent their drugs in order to control the quality of the drugs available to patients. Even if this is a valid argument, it should be noted that the Multidistrict Litigation Rule was applied in this case as well.
Another reason behind the Multidistrict Litigation Rule being implemented by the FDA is the implementation of technological advancements within the realm of medicine.
The development of metal-on-metal implant technologies has allowed for innovative designs in orthopedics. Previously, when an orthopedic patient went to a surgeon for the relief of pain from her back problem, there was only one option: An invasive procedure known as arthroscopic surgery. The advent of metal-on-metal implants has opened up the possibilities for less intrusive surgical treatments. Some of these devices have even been approved for use by the FDA. This means that the same technology that can help reduce pain in the back region now has the potential to provide relief from a variety of ailments.
The Multidistrict Litigation Update is not the final ruling in the lawsuit, nor is it the final word on the value of the claims that were originally filed against Biogenesis.
This is not intended to change the landscape of patient advocacy in the U.S., nor does it intend to put any restrictions on physicians seeking to provide alternative treatments to their patients who may be suffering from back pain. However, it is important for patients and doctors to understand that as long as the claims in this case are upheld by the courts, other medical professionals may use similar technology to resolve similar cases in the future. It is important for both sides to come to an agreement about the ultimate outcome of this case and to respect the will of the federal district court.