On March 8th, the Senate approved the America Invents Act (S. 23) by an overwhelming vote of 95-5. BIO supports this bipartisan, consensus-oriented bill, formerly known as the Patent Reform Act of 2011. Once enacted into law, it will strengthen and improve our nation’s patent system, spurring innovation and job creation.
Patents are often the main assets of small biotech companies, and they rely on this intellectual property to attract investors to fund the lengthy and expensive research and development process necessary to bring breakthrough new therapies and other biotech products to patients and consumers. The improvements made by the America Invents Act would benefit the biotechnology industry, and indeed all sectors of the U.S. economy, by enhancing patent quality and the efficiency, objectivity, predictability, and transparency of the patent system.
Increased Resources for the PTO
The America Invents Act contains two provisions that would provide greater resources and operational flexibility for the Patent and Trademark Office (PTO). First, it would end the diversion of fees collected by the PTO in excess of its budget, and would permit the PTO to retain such fees for use in either the current or future budget years. It would also give the PTO the authority to set and adjust fees for patent applications, while requiring discounts in fees for small businesses. These measures will help the PTO improve its long-range budgeting and planning for capital and human resources, hire more examiners to process the more than 350,000 patent applications it receives annually, and reduce the current backlog of more than 700,000 pending applications.
Improvements to PTO Re-Examinations
The America Invents Act would create new and improved proceedings for interested members of the public and the patent owner to seek review of issued patents by the PTO. The new procedures would result in a more transparent and efficient system of patent quality review. Importantly, patent owners would have a new procedure under which they could go back to the PTO whenever they find new information that might affect the validity or scope of their patent claims without fear of later being accused of concealment or misrepresentation in court by an alleged infringer under the much-maligned inequitable conduct doctrine. These new procedures would create more business certainty, less risk in investment in biotechnology products, greater assurances in licensing rights, and greater enforceability of patents.
False Patent Marking Litigation
False patent marking litigation occurs when a manufacturer labels a product with an incorrect or expired patent number. Current law allows any member of the public to sue and sets the fine at $500 per falsely marked article, which has spawned a cottage industry of law firms using this law to shake down industry for settlements in return for promises to drop the lawsuits. Historically, this was not of great concern until 2009 when the number of these lawsuits greatly increased. The America Invests Act would require that, in order to sue, someone must have suffered a competitive injury. This utilizes a common legal principle to ensure that those actually injured are receiving compensation, while excluding those trying to take advantage of a statutory loophole for personal gain.
First Inventor to File
One of the most hotly debated provisions of the America Invents Act would change America’s first to invent system to a first inventor to file system. This system is embedded in international patent practice, with the United States as the only exception. While some argue that America’s first to invent system is superior, it is inherently fraught with uncertainties, and problems arise when biotechnology companies try to protect their inventions here and abroad. This bill would remove these uncertainties, while providing adequate protections against misappropriation of an invention by someone other than the true inventor.
The America Invents Act would provide several additional benefits for the biotechnology industry, including making it easier for the actual owners of the invention to file patent applications and eliminating the “best mode” requirement as a defense in infringement litigation. Generally, the removal of subjective elements of patent law helps to create a more equal playing field for all interested parties of an invention.
Senate Judiciary Chairman Patrick Leahy (D-VT), Ranking Member Charles Grassley (R-IA), and the other members of the Senate Judiciary Committee are to be commended for their tireless efforts to build bipartisan consensus on this legislation, which resulted in wide support of its passage in the Senate.
We look forward to working with the House Committee on the Judiciary as it continues its consideration of patent reform, and hope to see meaningful patent reform signed into law later this year.