Patent strategy in the life sciences

– The ability to (threaten to) sue – The ability to promise not to sue – The ability to sell the right to sue

true

– A patent may be successfully attacked if you try to use it – In US, between 43% and 46% of contested patents (those that make it to court) were held invalid for the last few decades

-how much activity your patent covers -if narrow, you may not succeed in preventing others from using slighlty different technology -resources

patent litigation costs 3.5 million$ per side

invention and innovation

the process of coming up with a concrete new idea

an actual change in the products/services available to end-users

others away so that the organization can invest in the process leading to innovation

• it usually fails for reasons other than the value/usefulness of the idea -Poor business strategy • Unreasonable expectations re value • Failure to partner • Failure to address risk (time, liability, etc.)

A so-so idea with good management, marketing and reasonable expectations likely to have more success than a great idea with one of these missing

Researchers at Canada’s National Microbiology Laboratory a recombinant virus to prevent Ebola * NML patented vaccine and licensed it to small US corporation * US firm did nothing to advance vaccine development

• NML was going to cut funding to the vaccine except one lone researcher, Judie Alimonti, on a short-term contract kept working to ensure production of clinical grade vaccines • When 2014 Ebola outbreak erupted in West Africa, Canada was able to contribute the vials that Alimonti had produced • These had close to 100% efficacy and saved lives

• Meanwhile, small US firm sold to larger firm that gave rights to Merck • None of these did anything up to 2014 except reap financial rewards that followed • Merck was 2 years late on getting FDA approval • If not for Alimonti, there would not have been clinical trials and lives would have been lost • Patents were distraction, almost dangerously so

They do poorly on the former – 52% of universities lose money on just running a tech transfer office

-northwestern -nyu -princeton -columbia

industry has moved to collaborations with public and private sector partners

-people -data and materials -tools

• Takes longer to graduate • Increased specialization • Cultural change toward sharing

• Lots and lots of data & materials • Yet, standardization and interoperability not common • Quality of data & materials/reproducibility of results • Cost of uploading/curating data and materials • Cost of integrating data • Managing data and material resources

-New tools (e.g. CRISPR) - Artificial intelligence - Cloud/diffuse storage - Databanks and biobanks

Regulatory exclusivity refers to the protection granted to pharmaceutical products by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe. This protection prevents generic manufacturers from obtaining marketing approval for a certain period, allowing the original developer to recoup their investment in research and development. Here are some common forms of regulatory exclusivity:

-5 years in US (practically 6) * Prevents competitors from using original data to seek approval

• 7 years protection • Protects against any approval of same drug for same indication