The anti-intellectual effects of intellectual property
Introduction
Currently, there is a shortage of new tools at the stages of both drug discovery and clinical development. For the latter, a recent FDA critical path document [1] states:
“Not enough applied scientific work has been done to create new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster time frames, with more certainty, and at lower costs.”
I propose that the problem at the development stage has some of its origins at a far earlier stage. Specifically, problems start at the earliest discovery stages where there is a commonly held opinion that the vast resources of academic biology have been insufficiently assisted by the testing of chemical tools and probes to interrogate biological pathways. The NIH Roadmap Molecular Libraries Screening Center Network and associated Molecular Library Repository of screening compounds exemplify important efforts to address this deficit [2]. The anti-intellectual effects of intellectual property (IP) considerations are the topics broadly covered by this commentary. Too often, this type of topic is treated as if it were only a technical, legal or factual issue and the very important effects of people's attitudes are ignored. This commentary deals with some of the softer, people issues. Hence, it is unapologetically subjective and very much an opinion piece by this author.
Section snippets
Profitability limits the number of oral drug targets
IP considerations have always been a core value of pharmaceutical and biotech companies. These organizations exist to make a profit for shareholders and investors by developing and selling chemical compounds (drugs) to fill a medical need. In this process, a profit is made and patients are helped. Profit-making organizations by definition cannot expend a significant portion of their resources on unprofitable activities. With very few exceptions, the work product of a drug discovery organization
Conclusions
In conclusion, I hope I have illustrated some of the indirect and largely hidden anti-intellectual effects of intellectual property and, in particular, the people issues involving biologists and chemists. On the people issue side there is good news and bad news. The bad news is that, in general, people issues are more difficult to solve than technical issues. The good news is that disconnects between biologists and chemists are eminently solvable as exemplified by the history of years of
Acknowledgements
The author acknowledges helpful conversations with academic faculty in the USA and UK.
References (14)
- et al.
The druggable genome: an update
Drug Discov Today
(2005) - et al.
Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings
Advanced Drug Delivery Rev
(1997) - et al.
Defining and maintaining a high quality screening collection: the GSK experience
Drug Discov Today
(2006) - FDA: Challenge and Opportunity on the Critical Path to New Medical Products. 2004;...
- et al.
Molecular biology: NIH molecular libraries initiative
Science
(2004) - et al.
Knockouts model the 100 best-selling drugs-will they model the next 100?
Nature Rev Drug Discov
(2003) - et al.
Navigating chemical space for biology and medicine
Nature
(2004)
Cited by (9)
Predicting Target and Chemical Druggability
2017, Comprehensive Medicinal Chemistry IIIWhat makes a good drug target?
2012, Drug Discovery TodayCitation Excerpt :This allows for broadening of the therapeutic landscape of a drug or to shift a target if, in later phases of development, difficulties arise for the anticipated indication. As described by others [43,44], the contribution of a pharmaceutical company to the value chain is a patentable chemical compound (or BIOL) that becomes a drug rather than the target itself. The ideal – but often not achievable – is the combination of both: a patent-protected compound (be it a BIOL or a SMOL) and a patent for the use of modulators against a target for the treatment of specified diseases.
What makes a good drug target?
2011, Drug Discovery TodayCitation Excerpt :This allows for broadening of the therapeutic landscape of a drug or to shift a target if, in later phases of development, difficulties arise for the anticipated indication. As described by others [43,44], the contribution of a pharmaceutical company to the value chain is a patentable chemical compound (or BIOL) that becomes a drug rather than the target itself. The ideal – but often not achievable – is the combination of both: a patent-protected compound (be it a BIOL or a SMOL) and a patent for the use of modulators against a target for the treatment of specified diseases.
Physicochemical properties of the amorphous drug, cast films, and spray dried powders to predict formulation probability of success for solid dispersions: Etravirine
2011, Journal of Pharmaceutical SciencesCitation Excerpt :As reviewed by Lipinski,1, 3 high throughput screening has tended to select for compounds with lower water-solubilities, higher lipophilicities and higher molecular weights. Furthermore, many drug targets have structure-activity relationship (SAR) requirements that do not overlap with properties known to provide for good oral bioavailability resulting in poor develop-ability and high attrition.4, 5 While expanding the chemical space of the target is the purview of medicinal chemistry, pharmaceutical scientists can contribute to enlarging the oral drug bioavailability space through the use of technologies that increase apparent solubility and dissolution rate.
New approaches to rewarding pharmaceutical innovation
2011, CMAJ. Canadian Medical Association JournalAchieving Proof of Concept in Drug Discovery and Development: The Role of Competition Law in Collaborations between Public Research Organizations and Industry
2016, Achieving Proof of Concept in Drug Discovery and Development: The Role of Competition Law in Collaborations between Public Research Organizations and Industry