Greenblum & Bernstein, P.L.C. PHARMA/BIOTECH NEWSLETTER Recent News in Intellectual Property
	January 2019
In This Issue: · FDA Guidance Encourages Biosimilar Development · IP Groups Push for Patent Eligibility · USPTO Remains Open During Partial Government Shutdown Contact Us: Walter Schlapkohl, Ph.D., Esq. wschlapkohl@gbpatent.com 703-716-1191 (phone) 703-716-1180 (fax)	FDA Advances Guidance Documents to Encourage Development of Biosimilars -- by Shawn Hamidinia In December, the US Food and Drug Administration (FDA) announced the release of four guidance documents to advance biosimilar development in an effort to implement the Biologics Price Competition and Innovation Act (BPCIA). The first two Q&A guidance documents provide greater clarity on regulatory considerations for the development of biosimilar products. Notably, the FDA outlined regulatory strategies to combat anti-competitive behavior, including: (1) identifying on a website instances where generic sponsors had difficulty accessing doses of a reference drug needed to conduct studies for generic approval; and (2) evaluating how the agency can make it easier for biosimilar manufacturers to use reference products outside the U.S. for greater accessibility. The FDA also released two guidance documents that describe the transition of certain biological products, such as insulin and human growth hormone, from the Orange Book to the Purple Book. This means that a subset of biological products will face greater competition through the biologics pathway starting in March 2020. FDA Commissioner, Scott Gottlieb, explained that the intent of these policies is two-fold. The first aim is to ensure that the anti-evergreening provisions under the BPCIA (i.e., to prevent sponsors from gaming the exclusivity provisions to obstruct biosimilar entry) will apply to the biological products. The second aim is to ensure that the biological products will not receive any additional exclusivity during the transition as approved drugs under the Food Drug & Cosmetic Act to licensed biologics under the Public Health Service Act. To date, the FDA has approved fifteen biosimilar products although some have not launched due to what Director Gottlieb characterizes as “patent issues” governing these products. IP Groups Push for Patent Eligibility Law Change -- by Jonathan Miller and Walter Schlapkohl The call for clearer rules about what inventions can obtain patent protection is gaining support of regional intellectual property groups. In May, the Intellectual Property Owners Association (IPO) and the American Intellectual Property Law Association (AIPLA) together proposed language to “fix” what many inventors, biotech companies, practitioners and judges have found to be lack of clarity in the law regarding patent eligible subject matter. The proposal includes language, which among other things, would amend 35 U.S.C. §101 to render subject matter ineligible “if and only if the claimed invention as a whole (i) exists in nature independently of and prior to any human activity or (ii) is performed solely in the human mind.” The intellectual property law associations of New York, New Jersey and Boston, the National Association of Patent Practitioners, and other groups have indicated support the IPO/AIPLA proposal. The Director of the USPTO, Andrei Iancu, is also on board. In a speech delivered to the IPO’s annual meeting in September, he stated: “Whether through legislation or otherwise, there is a growing consensus that the issue must be promptly addressed.”   In the meantime, Director Iancu is also working on revised patent eligibility guidelines to assist the USPTO’s examining corps in determining what is and what is not eligible for patenting. Uncertainty with regard to what inventions are patentable have arisen largely from four relatively recent Supreme Court rulings, which created tough standards for overcoming judicially recognized exceptions to patent eligibility. Inventions covering laws of nature, physical phenomenon, or an abstract idea cannot be patented. Critics indicate that the recent Supreme Court cases are poorly defined and leave uncertainty, and that uncertainty undermines the U.S. patent system and discourages research and innovation. Proponents of the change believe, however, that the change would restore a broad scope of inventions eligible for patenting, including medical diagnostics and software. Additionally, emerging technologies (including, for example, blockchain, AI, and machine learning) will require patent protection. As such, certainty and clarity about what is patent eligible is needed.
	USPTO Remains Open During Partial Government Shutdown -- by Walter Schlapkohl As of January 9, 2019, the United States Patent and Trademark Office (USPTO) remains open for business as normal. According to the USPTO website, the USPTO is able to remain open for a “few weeks” because the agency has access to prior-year fee collections. Should the agency have to shut down after such funds run out, a small staff would continue to work to accept new applications and perform certain other functions.