Posts Tagged: "bio"

Calling the Innovation Act fast-tracked doesn’t do justice to what is really happening. The Innovation Act was only officially introduced on October 23, 2013, and the Committee has not heard from any independent inventors or small businesses. Even the innovator community that stands to lose big is just warming up, this past week with a substantial coalition of University groups and the Biotechnology Industry Organization (BIO) weighing in for the first time, with BIO concluding that the “proposals are not supportable without significant amendment.” The University groups weighing in against the Innovation Act are the Association of American Universities, American Council on Education, Association for American Medical Colleges, Association of Public and Land-grant Universities, Association of University Technology Managers and Council on Government Relations, collectively referred to in their position statement as “the Higher Education Community.”

So maybe the Federal Circuit won’t find “preemption” to be useful in deciding this appeal; we’ll know soon enough. I, for one, can’t make sense of the DOJ’s fixation on “tying up.” In Flook, the Supreme Court made clear that a claim’s patent-eligibility does not turn on the range of uses that are preempted versus those that remain in the public domain. Even in Mayo, the Supreme Court discussed preemption explicitly only as an underlying policy concern, as a justification for an outcome that, to the Court, seemed right and just – not as a test that distinguishes a “law of nature” from a man-made process. By elevating “tying up” to the status of an actual analytical tool, DOJ proposes an unworkable test that fails to distinguish “products of nature” from man-made inventions and leads to absurd outcomes. It asks the Federal Circuit to rely on asserted facts and unstated claim constructions. It requires strained interpretations of leading precedent. It is evasive and avoids the hard work of construing the claims and applying them to the activities believed to be “tied up” – lawyer work that, if undertaken, may or may not show that the preemptive scope of these claims isn’t all it’s trumped up to be.

It will enhance the development and review of innovative new therapies through increased transparency and scientific dialogue, advancements in regulatory science and strengthened post-market review. It will also increase FDA’s access to external expertise to improve the drug review process. FDASIA will foster timely interactive communication with sponsors during the drug development phase as a core Agency activity to facilitate the conduct of efficient and effective drug development programs and help make safe and effective drugs available to the American public in a timely manner.

Earlier in the week BIO also unveiled another report it commissioned and which was authored by Lori Pressman, David Roessner, Jennifer Bond, Sumiye Okubo, and Mark Planting. This report, titled Taking Stock: How Global Biotechnology Benefits from Intellectual Property Rights, discusses the role of intellectual property rights in encouraging upstream research and development as well as downstream commercialization of biotechnology. More specifically, the report outlines how intellectual property rights and technology transfer mechanisms encourage collaboration and lead to the research and development of new biotechnologies, particularly in emerging and developing economies.

The inclusion of an enhanced Accelerated Approval pathway, crafted by Senator Kay Hagan (D-NC), will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases while preserving the FDA’s robust standards for safety and effectiveness. Senator Hagan is to be congratulated for her hard work and leadership on this very important provision.

Just over three weeks ago the United States Supreme Court issued a decision in Mayo Collaborative Services v. Prometheus Laboratories, which sent much of the patent world into a whirlwind. In that decision the Supreme Court unanimously found that the claims at issue did not exhibit patent eligible subject matter because the additional steps that were added to the underlying law of nature were well known in the industry. A curious ruling for many reasons, and one that will have to be digested over many years as the United States Patent and Trademark Office and the Federal Circuit struggle to figure out how Diamond v. Diehr remains good law (it was not overruled) and remains consistent with a ruling that seems completely inapposite. To continue to provide a variety of perspectives on this landmark ruling what follows is the reactions of those in the industry.

While many people believe that alternative energy is at least several decades away, what is clear is that if we do not set out about making that future a reality it will never been the future we realize. There is tremendous research ongoing relative to battery technologies, solar energy, biofuels, geothermal energy, wind energy, hydroelectric energy and much more. In all likelihood no one, single solution will replace our dependence on fossil fuels, at least not in the foreseeable future, but there does seem to be a light at the end of the tunnel. We only need to choose the path to obtain that reality.

BIO has consistently praised House Judiciary Committee Chairman Lamar Smith (R-TX) for his introduction of a comprehensive patent reform bill similar to the bill adopted by the U.S. Senate earlier this month by a nearly unanimous vote. Unfortunately, given the addition of the Goodlatte supplemental examination amendment, added to the bill during Committee consideration, we have no choice but to oppose floor consideration of the bill until this issue is repaired.

In the situation where there is a joint research collaboration everything is fine, people are happy and hope springs eternal right up until that moment when everything falls apart. Then you have issues associated with a law firm representing inventors of a joint collaboration might be conflicted out of the representation altogether because downstream patent applications filed by one or more of the collaborators creates a situation where the collaborators no longer have jointly aligned interests, perhaps as the result of double patenting issues. Ware explained several cases arising out of a common set of facts whereby multiple joint collaborators were not consulted on the filing of a joint application (or at least not enough to their liking), which created a double patenting issue for an after filed application. The law firm representing the collective was sued for malpractice and breach of fiduciary duty; the case settled.