From I.P to N.P A Call for a New Paradigm Dr A. Schwartz
The Innovative Pharmaceutical business model Big Pharma identifies unmet clinical need Innovator loses Revenue on Older Products, Necessitating development of new products Through R&D new breakthrough therapies are brought to the market Innovator rewarded through IP exclusivity 2 all rights reserved Aharon Schwartz 19/11/2013
Tzures in Paradise o The Innovative Pharmaceutical business model faces multiple challenges: Innovation draught Innovation quality & value Shorter effective patent life I.P. uncertainty 3 all rights reserved Aharon Schwartz 19/11/2013
Innovation draught o 4 all rights reserved Aharon Schwartz 19/11/2013
Innovation draught? Yes In 2012 FDA Approved 39 products. However: only 35 of the 39 were drugs Only 15/35 targeted new MOA. The rest offering, for the most part, minor benefits over already-approved therapeutic options. Only 7/35 offer treatment for conditions where there was no real previous options 5/7 were in indications that are not just orphan but ultratiny. 2/7 ( Belviq & Fulyzaq ) have the potential to treat more than a few thousand patients. 5 all rights reserved Aharon Schwartz 19/11/2013
Value for Money? Prescrire (1981-2003) Rating # % Bravo 7 0.2% A real advance 77 2.7% Offers an advantage 217 7.6% Possibly helpful 455 15.8% Nothing new 1,913 66.6% Not acceptable 80 2.8% Judgment reserved 122 4.2% Total 2,871 100 6 all rights reserved Aharon Schwartz 19/11/2013
I.P.- "From here to eternity"? "Filing numerous patent applications for the same medicine [ ] is a common practice. [ ] an important objective of this approach is to delay or block the market entry of generic medicines - לטיפול ביל"דXמולקולה Xתהליךסינתזה 1 של Xתהליךסינתזה 2 של X של Mesylateמלח X שלI פולימורף Xפסוידופולימורף אנהידראט של X שלSuccinateמלח באי ספיקת לבXטיפול ב- 1980 1990 2000 2010 2020 7 all rights reserved Aharon Schwartz 19/11/2013
I.P Stifles Competition o individual medicines are protected by up to nearly 100 product-specific patent families [ ] this can lead to uncertainty for generic competitors affecting their ability to enter the market. o "Enforcing patent rights in court is legitimate and a fundamental right [ ] however, that litigation can also be an efficient means of creating obstacles for generic companies, in particular for smaller ones. In certain instances originator companies may consider litigation not so much on its merits, but rather as a signal to deter generic entrants. 8 all rights reserved Aharon Schwartz 19/11/2013
I.P. Uncertainties o Of ca. 2000 patent opposition lodged during 2008 to the European Patent Office: Only 28.6% have been rejected 31.6% were partially accepted 39.8% accepted o In the U.S 75% of patent infringement prosecution denied In 45% of the patent infringement cases the patents were found in-valid. 9 all rights reserved Aharon Schwartz 19/11/2013
Insufficient exclusivity period? o Drug developments eats over 50% of the 20 years patent life. o Additional (however insufficient) exclusivity periods are granted: Orphan drugs Patent term extensions NME & New Formulations o The need to provide pharmacoeconomic price justification creates additional hurdles. 10 all rights reserved Aharon Schwartz 19/11/2013
In summary o The current I.P. system does not provide an adequate basis for the business model of the innovative drug ecosystem: It does not provide enough support for innovation It does not encourage value creation It does not encourage competition It does not provide high level of certainty It does not provide adequate return on the risky investemnts in drug R&D 11 all rights reserved Aharon Schwartz 19/11/2013
From I.P. to N.P- A new Paradigm Patent Exclusivity Based on innovation priority Based on marketing approval priority 12 all rights reserved Aharon Schwartz 19/11/2013
Patents & Innovation o Patents will be granted according to current practices o Patents will be examined and approved by only a few major authorities. i.e. US, Europe, Japan o Drug development and commercialization exploiting inventions covered by pending or valid patents will be allowed through compulsory licenses to holders of marketing approval for predetermined royalties on net sales 13 all rights reserved Aharon Schwartz 19/11/2013
Standard Marketing Exclusivity Periods o Marketing exclusivity will be granted to the first developer achieving marketing authorization in a territory. o Standard Marketing exclusivity periods will be granted: 12 year for drugs providing significant improvement over currently marketed products 10 years for NME, orphan indications etc. 6 years for NME 3 years for new non patented formulation 14 all rights reserved Aharon Schwartz 19/11/2013
Advantages along the Value Chain o Academic institutions conducting basic & applied research will benefit as: Simpler and cheaper mechanism providing IP protection No need to conduct inefficient marketing activities Increased chances for commercialization No loss of economic benefits 15 all rights reserved Aharon Schwartz 19/11/2013
Advantages along the Value Chain o Drug companies will benefit as: Compulsory license mechanism ensure IP availability Drug companies can focus on their core competences of drug development & marketing Clear, transparent & high certainty mechanism for obtaining marketing exclusivity 16 all rights reserved Aharon Schwartz 19/11/2013
Advantages along the Value Chain o National health systems will benefit from: Rational, predicable and clear time limited marketing exclusivity granted according to product added value Competition encouraged Companies will be pushed to race to the market IP will not limit companies from utilizing best technologies 17 all rights reserved Aharon Schwartz 19/11/2013
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