Patent strategy in the life sciences Flashcards
patents are limited in what they offer
– The ability to (threaten to) sue
– The ability to promise not to sue
– The ability to sell the right to sue
true or false: a patent does not allow you to do anything with your invention
true
why is the right to sue uncertain with a patent
– 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
your ability to sue depends on what when you have a patent
-how much activity your patent covers
-if narrow, you may not succeed in preventing others from using slighlty different technology
-resources
why is your ability to sue also constrained by resources
patent litigation costs 3.5 million$ per side
Patents work by helping organizations bridge gap between….
invention and innovation
what is invention
the process of coming up with a concrete new idea
what is innovation
an actual change in the products/services available to end-users
While patents provide rights over inventions their purpose is to keep ….
others away so that the organization can invest in
the process leading to innovation
why is innovation difficult and complex
- 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.)
what is most likely to make a patent sucessful
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
Public Research and Patents:
Ebola vaccine
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
Ebola vaccine: patent
- 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
ebola vaccine part 2 patents
- 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
Universities and Patents
They do poorly on the former – 52% of universities lose money on just running a tech transfer office
which are the unis that make most money from patents
-northwestern
-nyu
-princeton
-columbia
pharma industry faces a decline in its level of productivity, what is the result?
industry has moved to collaborations with public and private sector partners
what are the 3 main collaboration driverss
-people
-data and materials
-tools
collaboration drivers: people
- Takes longer to graduate
- Increased specialization
- Cultural change toward sharing
collaboration drivers: data and materials
- 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
collaboration drivers: tools
-New tools (e.g. CRISPR)
- Artificial intelligence
- Cloud/diffuse storage
- Databanks and biobanks
Forms of Regulatory Exclusivity
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:
new chemical entity
-5 years in US (practically 6)
* Prevents competitors
from using original data to
seek approval
orphan drug
- 7 years protection
- Protects against any approval of same drug for same
indication
pediatric
Extends other exclusivity by 6
months if conduct pediatric
studies
new uses
3 years protection for new indication, dosage, or to switch to over-thecounter
antimicrobial
Extends exclusivity by 5 years for drugs “intended to treat a serious or lifethreatening
infection”
new biologics
12 years of exclusivity (4 before an application can be submitted & 8 more before approval)
Patents and Trade Secrets: negotiating partnership
- Existing patents and secrets
- Future inventions and derivative research
- Long delays in negotiating with universities
- Value sharing
patents and trade secrets: governing partnership
- Identifying/applying for patents and secrets
- Monitoring infringement and litigation
- Assigning rights/value
Regulatory Exclusivities: negotiating partnership
- Value sharing
- Assignment of data
- Standard agreements possible
Regulatory Exclusivities: Governing partnership
- No patent management or trade secrecy monitoring
- No litigation
leukemia: which countries worked on the probe
australia, us and austria
Signed agreement with Cellgene for….
US$40 million upfront, up to US $1 billion if successful
what is Medicines 4 Kids
is a spinout from the SGC dedicated to developing drugs without patents
what does m4k do
-developing a drug to treat diffuse intrinsic pontine glioma (DIPG), an extremely rare brain
cancer
-Developed thesis that inhibition of ALK2 kinase would kill tumour cells
