America Invents Act Expected To Be Signed Into Law Next Week

The America Invents Act of 2011 has been approved by the U.S. Senate and is expected to be signed into law within the next week. Once enacted, the Act will dramatically change current U.S. patent law and likely affect patent portfolio planning and strategy as well as patent disputes and litigation, in both the near and far term.

Some of the patent law changes will be implemented immediately upon signing by the President, while other changes will be implemented over the next 18 months. How and when these changes will affect current and future patent rights are highlighted below.

Within 10 Days of Enactment

Availability of Prioritized Examination Procedure. A prioritized examination of U.S. patent applications will be available 10 days after enactment. A prioritized examination fee of $4,800 will be required in addition to regular fees. No special examination support document is required, and any patent subject matter will qualify. This procedure will accelerate prosecution and the possible issuance of a patent application. Under prioritized examination, a final disposition (such as a notice of allowance or final office action) will be provided 12 months from the grant of prioritized status. Patent applicants may wish to take advantage of this program where some certainty on obtaining patent rights is important in the near term. Lack of Best Mode Cannot Invalidate a Patent. For actions commenced on or after the date of enactment, failure to include the "best mode" of practicing the claimed invention in a patent application cannot be used as the basis for invalidating the patent. Including the best mode is still a requirement for U.S. patent applications. Human Organisms Will Remain Unpatentable. Cloned humans, including human embryos, have not been historically patentable. The Act codifies this upon enactment. Man-made and novel human cells (including stem cells), tissue, organs, non-human organisms (e.g., genetically modified mice), isolated human genes, proteins and antibodies still generally remain patentable. Increased Fees. A 15% increase in U.S. Patent Office fees will be effective 10 days after the date of enactment. Modification of the Time Period to Apply for Patent Term Extension. Upon enactment, the 60-day time period to apply for patent term extension upon FDA approval of a product will begin on the next business day if the approval was transmitted after 4:30 pm ET. This codifies the judicial decision in The Medicines Company v...