Washington, D.C. (June 21, 2012) – BIO commends the House of Representatives for its unanimous approval of S. 3187, the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).
We appreciate the leadership of Senate Health, Education, Labor and Pensions Committee Chair Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) as well as of House Energy and Commerce Committee Chair Fred Upton (R-MI) and Ranking Member Henry Waxman (D-CA) in reconciling the differences between the user fee packages adopted by the two Chambers and for securing unanimous approval in the House.
Washington, D.C. (May 24, 2012) – BIO commends the bipartisan Senate approval of FDASIA, which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA).
In particular, we appreciate the leadership shown by Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) to craft a bipartisan measure which will continue to ensure patient safety, access to the newest cures and therapies, and job growth in America. FDASIA reflects the enhancements to PDUFA agreed upon by industry and the U.S. Food and Drug Administration (FDA). 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.
The statement of Senator Patrick Leahy in the Congressional Record sums it all up nicely: “After dozens of congressional hearings, markup sessions, and briefings, and countless hours of Member and staff meetings, through two Presidential administrations, and three Congresses, patent reform is finally a reality.”
On September 16, 2011 President Barack Obama signed into law the America Invents Act, which constituted the most significant overhaul to the U.S. patent system since the Patent Act of 1952. Some of the most pronounced amendments to Title 35 of the United States Code include replacing interference proceedings with derivative proceedings, initiation of inter partes review, eliminating failure to disclose the best mode as a challenge to a claim, the addition of post grant review process and various changes to the fee setting authority by the USPTO. But that was just the beginning.
A frenzy of protest activity was recently unleashed and directed at two bills that sought to prevent online piracy of copyrighted materials. These two bills being considered by Congress would have assisted intellectual property owners who so frequently have their rights infringed online. The PROTECT-IP Act (PIPA) was the Senate version of the bill; The Stop Online Piracy ACT (SOPA) was its counterpart in the House of Representatives. Protests led to many leaders withdrawing support and the bills were scrapped. Further consideration of the issues is, however, ongoing in alternative forms so it is likely useful to substantively address some of the key criticisms of PIPA and SOPA, which are virtually certain to resurface.
The essence of the bills was to enable U.S. law enforcement or a private party to shut down websites that are “dedicated to infringing activities.” Such websites are defined in the bills as those whose primary purpose is infringement.The accuser must show that the website has “no significant use” other than engaging in, facilitating, or enabling any of the following:
Copyright infringement; or
Infringement or violation of any of the protections contained in the DMCA (Digital Millennium Copyright Act) including its anti-circumvention provisions; or
Yesterday the United States Supreme Court issued a truly regrettable decision in the much anticipated copyright case Golan v. Holder. At issue in this case was nothing short of whether the United States Congress has the authority to restore copyrights in works that were in the public domain, or in other words whether Congress has the authority to strip works from the public domain and grant copyright protection. In one of the more intellectual dishonest decisions I have ever read, the U.S. Supreme Court, per Justice Ginsburg, determined that Congress can pretty much do whatever it is that they want with respect to copyrights. Removing works from the public domain and restoring copyright protection is said to be a power granted to the Congress under the Constitution, and there are no legitimate First Amendment concerns.
To all those who can read the Constitution it has to be clear that the Supreme Court’s decision in Golan v. Holder is absurd. It is a ridiculous decision that lacks intellectual honesty and defies common sense. Further, the facts of this case provide ample ground for the suspicions of many who wonder why it is that the United States is so interested in losing its identity and compromising Constitutional principles in order to facilitate some ill conceived plan to join the world community. Simply stated, treaties and international law cannot trump the Constitution. With all due respect to the six Justices who ruled in favor of stripping works from the public domain, the Constitution does not support this decision and any attempts to argue to the contrary are insulting and show a contemptuous understanding of the history and role of intellectual property in America.
The Wall Street Journal is reporting that President Obama will today announce a proposal that would merge six agencies that focus on trade and commerce into one new department. Apparently the belief is that the restructuring will make it easier for businesses to navigate government bureaucracy. Notwithstanding, the proposed restructuring may better be thought of as a reshuffling since it seems that the plan would only save several billion dollars over 10 years. Thus, the real savings and streamlining may be minimal and likely won’t make the bureaucracy any more friendly unless regulations are minimized, but that is another topic for another day.
The Obama government restructuring plan is of particular importance within the patent community because it will affect the Commerce Department as well as five smaller agencies. As soon as I heard that my Spidey-senses started tingling. Wasn’t there something in the the Leahy-Smith America Invents Act (AIA) that applied only so long as the United States Patent and Trademark Office remained an agency within the Department of Commerce? Sure enough, there is. The new fee setting authority vested in the USPTO is contingent upon the Patent and Trademark Office remaining within the Department of Commerce.
News broke several days ago that Senator Jon Kyl (R-AZ) has raised the issue of funding for the United States Patent and Trademark Office in his role as a member of the so-called Super Committee, which is charged with finding $1.2 trillion in budget cuts over the next 10 years. See Super Committee Considering an End to USPTO Fee Diversion. This means the patent community has another chance to urge Congress to do the right thing and adequately fund the USPTO. Everyone in the patent community can and should get involved and be heard — patent attorneys, patent agents, patent bar groups, patent bloggers, corporations, inventor groups, inventors and industry organizations such as the ABA IP Section, the AIPLA and IPO. It is time to get involved!
Many will recall that recently we came up to the doorstep of putting an end to fee diversion through the creation of a revolving fund for the USPTO. The revolving fund proposed by Senator Tom Coburn (R-OK), would have tied a revolving fund together with taking the USPTO out of the appropriations process. This would have meant that the USPTO would be guaranteed to keep 100% of the user fees collected without Congress being able to divert fees over and above what they specifically appropriated. The revolving fund made it into the enacted America Invents Act, but not the part about taking the USPTO out of the regular appropriations process, which essentially just kept the status quo.
Today the U.S. patent community sits perilously in the path of an oncoming train. The Leahy-Smith America Invents Act (AIA) Act mandates – but fails to fund – a wholesale conversion of the USPTO from an expert examining agency to one that not only examines patents but also adjudicates patent disputes in ways that promise to be faster and cheaper than patent litigation in our courts.
Senator Kyl is raising PTO funding on the Super Committee.
Without predictable funding, the Congressionally mandated reforms of the AIA will likely turn out like the agency’s “fast track” and Detroit office initiatives: announced, planned, but then delayed by the lack of one essential element – money. Indeed, without predictable funding, the reforms mandated by the AIA will likely result in a greater patent backlog, significant additional delay in finalizing the value of disputed patents, and a confused and discouraged agency workforce, all of which will significantly delay the recovery of our national innovation-based economy.
The coming train wreck would have been avoided if the 95 Senators who voted for ending fee diversion (with the support of every significant stakeholder in the otherwise-divided patent community) had had their way. It can still be avoided at no cost to taxpayers. And it can be avoided quickly, before Thanksgiving’s leftovers are gone, via the Super Committee. Let me explain.