Category Archives: Public Policy

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Stopped at the Threshold: A New Study Reports on PTO Patent Examinations in the wake of Mayo and Myriad

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Biotech patent applicants are finding themselves in uncharted waters. After the Supreme Court’s decisions in Mayo Collaborative Svs. v. Prometheus Labs and Ass’n for Molecular Pathology v. Myriad Genetics, companies have been trying to understand how these decisions will impact the industry. A recent study supported by BIO, in collaboration with Bloomberg BNA and the law firm of Robins, Kaplan, Miller & Ciresi analyzed how Mayo and Myriad have changed patent eligibility for biotechnology. The Read More >

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Forbes: Faster FDA Approvals Have Not Caused More Drug Safety Problems

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In 1992, Congress, industry, and the FDA worked together to create the Prescription Drug User Fee Act (PDUFA). This program ensures that FDA has the ability to hire additional reviewers to expedite the drug review process by having industry pay “user fees.” Recently, attention has been given to a flawed study in the August 2014 issue of Health Affairs, which has some critics claiming that PDUFA fees are biasing FDA review decisions. The study looked at Read More >

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Delivering on Biotech’s Promise to Treat Anthrax, Smallpox, Ebola

Jim Greenwood

Thanks to federal biodefense programs that partner with industry to develop and stockpile medical countermeasures, each year America is better equipped to respond to potential biological, chemical, nuclear and radiological threats, BIO president and CEO Jim Greenwood says in a Roll Call op-ed published today. With recent anthrax and smallpox incidents at CDC and NIH labs,  which fortunately did not lead to any human exposure,  it’s worth taking a look at how we might respond Read More >

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BIO Submits Comments on “Myriad” PTO Patent Guidance

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On July 31st, BIO, alongside a group of international bioindustry trade associations submitted comments to the United States Patent and Trademark Office regarding their March 4, 2014 Guidance on patent subject matter eligibility. Representing associations from Japan, Australia, Canada, the UK, Germany, Spain, Portugal Belgium, the Netherlands and others, the comments reflect a deep concern among the international community regarding how the PTO is interpreting the Supreme Court’s recent decisions in Mayo v. Prometheus and Read More >

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Partners for Healthy Dialogues: Letter to CMS

Partners for Health Dialogues

BIO, a member of Partners for Healthy Dialogues (P4HD), joined 25 medical societies and manufacturers in a letter to the Center for Medicare and Medicaid Services highlighting both their shared commitment to sunshine and the importance of context in the upcoming data release.  As BIO CEO Jim Greenwood said in a Q&A with P4HD: “We believe that part of CMS’s public service function in this area should be to help improve the public’s understanding of the need for Read More >

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