The decisions you make today about patents – what, when and where to file – could have implications tantamount to billions of dollars in R&D investment and sales over the next two decades.
The decisions you make today about patents – what, when and where to file – could have implications tantamount to billions of dollars in R&D investment and sales over the next two decades. Given the increasing importance of lifecycle management in the context of increasing generic usage rates, the entrance of biosimilars and the America Invents Act taking full effect in 2013, executives must have a smart global patent strategy to deliver their business objectives.
America Invents Act
In March 2013, the U.S. will move to a first-inventor-to-file patent system. US applications with a filing date on or after March 16, 2013 will be subject to this new law, which states that: 1) there will be more prior art to overcome to get a patent, and 2) patents granted on new law applications will be subject to a new Post-Grant Review (“PGR”) challenge in the US Patent and Trademark Office (“PTO”). Using PGR, a challenger can attack a patent for lack of novelty, obviousness, lack of utility, or failure to meet the enablement, written description or definiteness requirements. It will be easier to invalidate a patent in a PGR than in a US court action. The following three questions are important to ask, before filing:
1. What does a patent really protect and is it enough?
Life sciences patents include a specification, or a technical description of the invention and a list of claims that define what is “patented.” For enforcement purposes, it is important to have claims of varying scope and form, e.g., compound claims, pharmaceutical composition claims, and method of use claims. One patent may not be enough to ensure that new commercial products – such as new salts, crystalline forms or formulations – enjoy adequate patent protection.
2. Does the application meet the enablement and written description requirements?
A US patent must meet the enablement and written description requirements. Enablement requires that persons skilled in the art could make and use the invention without undue experimentation. In life sciences, inventions usually require working examples to support reasonably broad claims. If you have no working examples, think twice about filing an application. The written description is a separate requirement; the specification must describe an invention understandable to persons skilled in the art, and it must show that the inventor possessed the invention as of the filing date. Essentially, this means that you can’t claim what you didn’t invent, or haven’t yet invented. Life sciences patents can be vulnerable to attack based on lack of enablement or written description. Broad, speculative applications with limited technical work and few examples may not satisfy the enablement and written description requirements and may create prior art against your own later inventions.
3. What patent applications should be filed and where before March 16, 2013?
US applications having an “effective filing date” on or after March 16, 2013 will be subject to the new law. The effective filing date of a US application is the actual US filing date or the filing date of an earlier application from which the US application claims priority. To be entitled to an earlier effective filing date, the earlier application must meet the enablement and written description requirements. To avoid the increased prior art and risk of a PGR challenge, companies should consider filing new priority applications (in any country) before March 16, 2013. If a priority application was filed on or after March 16, 2012, and R&D has delivered additional results, consider filing a second priority application or a US or PCT application with these results before March 16, 2013. Going forward, companies should consider filing multiple priority applications, as R&D yields results, to get the earliest effective filing and prior art dates.
Life sciences companies should review their patent strategies to identify actions to be taken before March 16, 2013. In deciding what applications to file before this deadline, consider whether the proposed filings will satisfy the enablement and written description requirements and don’t let the new system force you to file applications before an invention is complete.
Michael Flibbert and Marian Flattery are attorneys at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.