Guest post by Konstantin Linnik, Ph.D., a partner in the Boston office of Nutter McClennen & Fish LLP, and Marc Chateney-LaPointe, Ph.D. a summer associate with the firm.
On July 17, 2014, MassBio will host an expert panel “Best Practices in Protecting and Exploiting Intellectual Property.” Among other topics, the panel will discuss the new US patent system, the first inventor to file (“FITF”) regime that took effect a little over a year ago as part of the patent reform law known as American Invents Act (AIA). Under the new law, the first inventor to file at the Patent Office wins.
Before AIA, our patent system operated under “first-to-invent” rules for well over two centuries. Under the old system the initial inventor had rights to the patent regardless of whether he was the person first to file an application with the Patent Office. If a subsequent inventor happened to submit a patent application before the first inventor, the latter could bring an interference proceeding at the Patent Office. Here, the first inventor must show that he was the first to conceive of the claimed invention and that he worked diligently to reduce the invention to practice. Both of these facts can be proven by evidence from a laboratory. Therefore, it was standard practice for each inventor to keep a laboratory notebook that provides a permanent record of every planned and executed experiment. Notebooks that were regularly dated, reviewed, signed, and then countersigned by a non-inventor witness, served as evidence of prior conception under the old system.
Many scientists assume that recent changes to our patent system rendered the signing of lab notebooks unnecessary. Not so! Even after the AIA lab notebooks remain as important as ever. Here is why.
Where the invention is allegedly disclosed to a third party, for example, in the course of a scientific collaboration, the third party might file a separate patent application on that invention before the original inventor. The inventor may be able to establish that the later filing applicant derived the invention from his disclosure by instituting a so-called derivation proceeding at the Patent Office, as defined in 35 U.S.C. § 135. A petition under this section must “set forth with particularity the basis for finding that an inventor named in an earlier application derived the claimed invention” as well as state that this earlier application was filed without authorization. Additionally, this petition “shall be supported by substantial evidence” showing that the earlier-filed application was derived from the petitioner. (A further limitation is that the derivation petition must be filed within one year from the date of the first publication of a claim to the allegedly derived invention.)
By Brian Malkin, Partner at Frommer Lawrence & Haug LLP in Washington, D.C. and an editor of the FDA Lawyers Blog
On September 26, the Massachusetts Biotechnology Council (“MassBio”) hosted the fourth part of its “Adventures in Biotech” Forum series entitled, “Executing the Dream II: Eyes on the Price – Strategic Science Tactics & the Pursuit of Business Objectives.” The purpose of this Forum was to discuss ways that scientific strategy may be worked into the philosophy of a new company, how the scientific strategy can propel the growth of the company, and how the scientific strategy may change over time as a result of that growth. The speakers included Birgit Schoeberl, Vice President, Early Stage Discovery, Merrimack Pharmaceuticals (“Merrimack”); Muthiah Manoharan, Ph.D., Senior Vice President Drug Discovery, Alnylam Pharmaceuticals (“Alnylam”); Laurence Reid, Ph.D., Senior Vice President, Chief Business Officer, Alnylam; and Steven Tregay, Ph.D., Founder, President and Chief Executive Officer, Forma Therapeutics (“Forma”).
Each of the speakers had a different approach as to how they incorporated their scientific strategy into their business. Tregay, for example, described Forma as a “sustainable research and development discovery engine” focused on oncology therapies that can screen 30-40 individual (not combinational) targets a year using an iterative process that includes: computational and medicinal chemistry, parallel synthesis, X-ray crystallography and relevant biology studies. According to Tregay, Forma’s science permits it to mitigate risk by running in parallel a large number of discovery programs while continuously assessing the molecules, prioritizing targets for their pipeline at the appropriate scale, and maintaining communication between all scientists, and project teams. As part of its strategy, Forma first goes broad to investigate a cancer target technology and then more specific as aspects of that technology are validated and ready for candidate screening. Integral in Forma’s strategy is forming partnerships with companies interested in screening many potential cancer candidates quickly rather than few candidates exhaustively, where it already has formed partnerships with Celgene, Boehringer Ingelheim, Genentech, and Johnson & Johnson, as well as some research universities.