Abstract
New Zealand Relaxes Specification Requirement for Patent Amendments
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However, in the recent case of CNH Industrial Belgium NV, 1 the Patent Office concluded that this reading was unduly restrictive and that Reg. 58(d) was not intended to place substantive limits on patent amendments. Rather, the Patent Office sided with patent applicant, CNH Industrial Belgium NV, and concluded that an applicant seeking to amend their application need only provide support for the amendment from the original specification where such support was relevant or necessary. An example of where tying the amendment to the original specification would be relevant is to avoid post-dating an application. But where support from the original specification is not necessary, the applicant does not have to provide it. As the hearing officer in this case stated:
the process requirements … should not be read as imposing a substantive require that there must be specific support in the original specification for every proposed amendment. A better reading is that if the applicant relies on the amendment having support in the original specification, then Reg. 58(d) requires them to specify where the support is found. 2
The holding in CNH Industrial Belgium NV relaxes the requirements when amending New Zealand patent applications, making it easier to make such amendments.
Recent Paper Indicates That Patents On Marine Genetic Resources Are Overwhelmingly Held By a Handful of Companies
Robert Blasiak of Stockholm University's Resilience Center is the lead author of a recently published (in Science Advances) paper detailing ownership of patents over marine genetic resources. What this paper finds is that ownership of the oceans' genetic resources is overwhelmingly concentrated in a relatively few hands.
At a glance, this finding is counterintuitive: the oceans are vast, covering 70% of the Earth's surface, and numerous countries border them. There does not seem to be any inherent or structural reason why patents over marine genetic resources should not be well distributed. However, reality does not match this intuition: according to Blasiaks' paper, almost half of the 13,000 genetic patents held on marine species are held by a single corporation (BASF). Of the other half, they are overwhelmingly held by a relatively few private companies (not governments or public universities) based in only 10 countries.
Proponents of commercial exploitation of genetic patents say that companies that patent genetic resources are given a way to monetize them and, therefore, an incentive to invest in R&D which can lead to beneficial drugs and supplements. Opponents of widespread commercial patenting of genetic resources worry that the patents will actually restrict research by preventing anyone other than the patent holder from working with the gene sequence.
Right now, patenting maritime genetic resources is largely a wide-open “Wild West.” While the 2010 Nagoya Protocol regulates near-shore genetic resources (those found within 12 miles of a nation's coast), once you get beyond that distance, there is no regulation and anyone can patent anything. Since the unregulated area includes the deep-sea benthic areas, where many exotic species, including hydrothermal-vent-dwelling extremophiles, with potentially useful and unique genetic sequences live, the potential exists for valuable genetic resources to be tied up with little oversight over the process.
Uk Adopts New Trade Secrets Legislation
The United Kingdom recently introduced the Trade Secrets (Enforcement, etc.) Regulations 2018 on June 9, 2018. These regulations implement the EU Trade Secrets Directive 2016/943 (even though with Brexit, the UK is no longer part of the European Union). The new regulations also supplement, rather than replace, the United Kingdom's existing common law protection for trade secrets. The regulations strengthen trade secret protection by making it unlawful to acquire, use, or disclose trade secrets when doing so “constitutes a breach of confidence in confidential information.” The regulations allow for an injunction against the use of confidential information and financial compensation for its misappropriation.
The regulations do impose some obligations on the company claiming trade secret protection. They are obligated to take reasonable steps to keep the information secret or confidential. They also have to prove that the information had commercial value due to it being kept secret or confidential (i.e., that the breach of confidentiality diminished its value).
U.S. FDA Greenlighting Drugs Faster Than Ever—With Some Negative Consequences
The Food and Drug Administration (FDA) used to be derided as moving too slowly to approve new drugs, resulting in developers incurring delays before they could get a return on their investment and in patients experiencing delays in accessing new treatments.
No more: in 2017, for example, FDA approved 46 “novel” drugs (drugs whose chemical structure had not been previously approved)—the most in 15 years. Only 19.7% of applications for new drugs, biologics, and supplements were denied in 2017—a third of the rate (59.2%) of denials less than a decade ago, in 2010. FDA is also moving substantially faster than its European counterpart, which is currently taking an average of two months longer to approve drugs—and FDA is approving drugs which the European Medicines Agency has rejected for insufficient evidence of patient benefit, such as the blood cancer medicine Folotyn.
The faster approvals are coming at the urging of President Trump, who instructed his FDA commissioner, Dr. Scott Gottlieb, to “bring down” the time it takes to bring drugs to market. FDA has been accomplishing this by channeling more new drugs into expedited reviews which need only one clinical trial, not the traditional two, to show a benefit to patients before approval is granted. FDA is also letting drug makers use proxy, rather than direct, measurements to show successful outcomes. For example, a cancer drug might show successful patient outcomes by measuring how tumors shrank without any regard to whether patient health or survival—the real goals of any medicine—actually improved. Folotyn would have been approved from this use of proxy measures, since it has been shown to shrink tumors, but has not been shown yet to extend patients' lives.
The increased approval speed comes in the context of the pharmaceutical industry paying the FDA significant and increasing sums for drug review. In 2018, for example, the industry paid three-quarters (75%) of FDA's drug review budget—three times as much as it paid in 1993 (27%), the year after the industry was first allowed to contribute to the agency's budget in exchange for speeding up the review process.
The faster approvals mean, however, that drugs are now routinely being approved before safety can be adequately assessed. For example, FDA approved Nuplazid to treat hallucinations and delusions associated with Parkinson's. Nuplazid failed its first two trials, but then was approved on a third clinical trial which showed (using a new standard for success) a minimal benefit—even though more patients died or had significant side effects from using Nuplazid than did patients receiving no treatment. Since Nuplazid was approved for marketing in 2016, there have been almost 900 deaths and 5,700 other serious adverse events. Or take Uloric, a gout drug: FDA approved it despite evidence from two out of three clinical trials that patients taking it have suffered more heart attacks, heart failure, and strokes than patients not using it. Since Uloric's approval, its manufacturer has subsequently reported that patients taking Uloric are 34% more likely to die from heart disease than patients using another gout medicine.
Perhaps FDA was too slow before. There is evidence it may be too fast now—it may be that they have not quite gotten the balance right yet.