When is Conception… and Are You Sure?
It’s probably not what you are thinking...
In the U.S., inventorship is determined by who conceives (not reduces to practice) the invention as claimed in the issued patent. Naming the wrong inventors, either by omission or inclusion, while correctable, can render a patent unenforceable. More importantly, when multiple owners are involved, disputes regarding inventorship can more readily arise.
The test for conception is whether the inventor(s) had an idea that was sufficiently definite and permanent that one skilled in the art could understand the invention. In a joint invention, each inventor must contribute to the joint arrival at a definite and permanent idea of the invention as it will be used in practice.
In Univ. of Pittsburgh v. Hedrick, the district court sided with Pitt—removing co-listed scientists from REBAR (Regenerative Bioengineering and Research) laboratory of UCLA from U.S. Patent No. 6,777,231, a patent directed to adult human mesenchymal stem cells from adipose tissue and their transdifferentiation to various tissue types, including neurons. The district court established that the two Pitt researchers, prior to Hedrick’s fellowship in their lab, had notebooks that described media and protocols that differentiated the cells into bone, muscle, fat, cartilage, and nerve cells. Furthermore, they had e-mailed a colleague noting that some of the cells seemed to resemble neurons. Even though the scientists were not “scientifically certain” that they had observed transdifferentiation to neural tissue, the district court held that they had conceived the claimed invention before Hedrick’s arrival. Therefore, the district court held that neither Hedrick nor the other REBAR scientists had contributed to the conception of the invention – even though their subsequent experiments scientifically proved the earlier speculation correct.
The Court of Appeals for the Federal Circuit agreed with the lower court. The unanimous opinion stated that knowledge means possession, not proof to scientific certainty – proof is reduction to practice. The Pitt researchers had sufficiently described the invention (via their notebooks and other indicia), thereby showing possession of a firm and definite idea of the claimed properties of the cells and, therefore, of the invention.
Note that this case addresses only inventorship. Whether the invention as claimed was enabled… is a story for another day (in court).
Inventorship is not the same as authorship—it takes cooperative communication between the scientists and the patent professional to get it right. Not doing so can lead to expensive entanglements. This case also shows that scientific hurdles are different from those for patentability – be careful about who you are relying on to determine what is patentable.
Submitted by BIOCOM's Intellectual Property Committee, by Les Overman with Stephen Reiter and Bernie Greenspan. The opinions expressed herein are those of the contributors and not their respective employers.
Please send your comments or suggestions to BiocomIP@gmail.com
Senate HELP and House Committee Back Data Exclusivity for Biologics
The first week of July, BIOCOM President and CEO Joe Panetta visited with members of the House and Senate in Washington DC. Joining him, were International Stem Cell's Jeffrey Janus, Mpex Pharma's Dan Burgess, Amylin Pharmaceutical's Senior Director of Government and Policy Bill Franco, and Vice President of Public Policy Todd Gillenwater of CHI.
Together, the group explained to members of the House and Senate how the industry was up against efforts to reduce the terms of a follow on biologic's pathway to as low as zero to nine years of non-patent data exclusivity in the healthcare reform mark-up that was underway at HELP. They also worked to recruit members of Congress to sign onto the Eshoo, Insley, and Barton biosimilars amendment and help fend off attempts by Rep. Henry Waxman to reduce exclusivity to just a few years.
On Monday, July 13, the Senate health committee voted to add to its health reform bill a follow-on biologics provision that would grant brand-name biologics 12 years of non-patent data exclusivity (which BIOCOM supports). Two weeks later the House Energy and Commerce followed with a 47-11 vote in favor of an Eshoo amendment which embodies the bipartisan HELP compromise with 12 years of data exclusivity, while also retaining the important provisions in H.R. 1548 aimed at avoiding patient and provider confusion over biosimilar products and ensuring patent disputes will be resolved prior to the expiration of data exclusivity. Although the passage of these two amendments are good news for the industry, BIOCOM will continue to work with partners at BIO, PhRMA, CHI, AdvaMed and MDMA in facing the future battle in the House and on the Senate floor. Click here to view BIOCOM's support letter for the Biosimilars Amendment Rep. Eshoo has Proposed.
Click here for WSJ story on biologics
Increased SBIR Funding for Small VC-backed Firms in the Works
On July 8, 2009 the House of Representatives approved thereauthorization of the Small Business Innovation Research (SBIR)program via the Enhancing Small Business Research and Innovation Act of2009 - H.R. 2965 witha 368-41 vote. On July 13, 2009, the Senate voted unanimously toreauthorize their version of the SBIR and Small Business TechnologyTransfer (SBTT) programs by approving the same bill, but only afterinserting amendments reflective of S. 1233.
The House version of H.R. 2965 reauthorizesSBIR/STTR through 2011 and would open the door to allow VC-backed smallbusinesses to compete and apply for SBIR and STTR grants if no morethan 50 percent of the company is owned by one venture firm and nosingle venture capital company constitutes a majority of the firm'sboard. The legislation also increases early stage Phase I grant funding$150,000 capping it at $250,000 and Phase II funding would be increasedfrom $750,000 to $2 million.
The Senate’s approved versionof the same bill number reauthorizes SBIR and STTR through 2023 andwould let the NIH award up to 18 percent of its SBIR dollars tocompanies that are not majority owned or controlled by a single venturefirm, while the remaining ten (10) federal agencies participating inthe program could apply 8 percent of SBIR grant money to those smallbusinesses. Furthermore, the Senate legislation only increases Phase Ifunding $50,000, capping early stage funding at $150,000. Later stagePhase II funding would be increased from $750,000 to $1 million.
Thelegislation will now go to a conference committee of the House andSenate, where the differences between the House and Senate versions ofthe bills will be negotiated and a consensus can hopefully be reached.We at BIOCOM are pleased this issue may finally be close to resolutionin a way that will return fairness to the SBIR program.