“We have concerns that some of the ideas proposed today could, if adopted, hurt patient access to the medicines they need …”

Washington, D.C. (May 9, 2018) – Biotechnology Innovation Organization President for Advocacy, Law & Public Policy Tom DiLenge today issued the following statement in response to the U.S. Patent and Trademark Office’s (PTO) proposed change to claim construction standards used by the Patent Trial and Appeal Board (PTAB):“BIO applauds Director Iancu and the PTO for proposing regulations that would change how the office interprets claims in administrative patent challenge proceedings.“BIO has long advocated for this particular rule change, and for more balance and fairness in the Inter Partes Review (IPR) system generally.  This rule brings us closer to that reality, and we urge the Director to continue down this path with additional changes to improve the system further.“Under the agency’s current proposal, IPRs and related post-issuance proceedings would use the same claim interpretation standard that is being used by federal courts in patent litigation. This approach will improve predictability in the post-issuance review process and help mitigate against inconsistent results that can occur when the same patent is adjudicated in different fora.“BIO urges the PTO to quickly finalize this rule to strengthen intellectual property protections and improve the ability of patent owners to defend their inventions and businesses against infringement.”About BIOBIO is the premier biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. BIO members range from biotech start-ups to some of the world’s largest biopharmaceutical companies – all united by the same goal: to develop medical and scientific breakthroughs that prevent and fight disease, restore health, and improve patients’ lives. BIO also organizes the BIO International Convention and a series of annual conferences that drive partnerships, investment, and progress within the sector…

BIO thanked President Trump and Senators Charles Grassley (R-IA) and Joni Ernst (R-IA) for rejecting a price cap on Renewable Identification Numbers (RINs) and working to provide regulatory relief to enable year-round sales of E15.

BIO's new “Renewable Chemical Platforms Building the Biobased Economy” report documents the rapid expansion of renewable chemical platforms and applications around the world, profiling 100 companies from 16 countries that are commercializing renewable chemical applications.

Washington, D.C. (April 10, 2018) – The Biotechnology Innovation Organization (BIO) and BioForward Wisconsin commend Governor Scott Walker for signing critical legislation to create a pathway for the substitution of interchangeable biologic medicines, with appropriate communication to patients and physicians.Governor Walker signed Senate Bill 575, following broad bipartisan support in both the Wisconsin Senate and Assembly. The policies outlined in the bill align with BIO’s principles on biologic substitution and garnered our support.  BIO and BioForward are grateful to the Wisconsin legislature and Governor Walker for their leadership on this issue.“Senate Bill 575 enjoys the support of physicians across Wisconsin and the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes provisions to ensure appropriate communication on all biologic medicines dispensed, in order to maintain a consistent and complete medical record,” said Jim Greenwood, BIO’s President and Chief Executive Officer. "By signing this bill into law, Governor Walker has added Wisconsin to the list of states that allow retail pharmacies to substitute interchangeable biologic medicines."While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law. Senate Bill 575 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote a competitive market for biologic therapies, while maintaining critical communication to patients and physicians. BIO supports full communication in the substitution process, as patients and their physicians should know what biologic medicine the patient receives from the pharmacy.“We…

Washington, DC (April 27, 2018) – BIO President and CEO Jim Greenwood issued the following statement regarding the Opioid Addiction Action Plan Act, introduced yesterday in the Senate by Senators Heller (R-NV), Isakson (R-GA), and Menendez (D-NJ). A companion bill in the House, sponsored by Representatives Yvette Clarke (D-NY) and Adam Kinzinger (R-IL), was advanced by the House Energy and Commerce Health Subcommittee earlier this week.

WASHINGTON, D.C. (April 26, 2018) – The Biotechnology Innovation Organization (BIO) today announced programming information for gene editing and synthetic biology at the 2018 World Congress on Industrial Biotechnology. Programming around these topics will kick off on Tuesday, July 17, with a plenary panel of experts to discuss how gene editing tools like CRISPR are revolutionizing the production of everyday products. Programming will continue with breakout sessions throughout the week, featuring executives from biotechnology companies, consumer goods producers and the government to explore the various applications for gene editing and synthetic biology in the field of industrial biotechnology.

Washington, DC (April 24, 2018) – BIO President and CEO Jim Greenwood issued the following statement today regarding S. 2680, the Opioid Crisis Response Act of 2018: