kate_sept2004 / iStockphoto.com
With several major drugs set to face generic or biosimilar competition as patent protection expires, LSIPR analyses how well prepared their manufacturers are and how badly their sales may be affected.
For consumers, the prospect of drugs going off-patent may well be a blessing. But for the pharmaceutical companies behind the branded medication, the onslaught of generic competition is seemingly far from positive.
One study suggested that the overall cost of developing a prescription drug is $2.6 billion, from research to marketing approval (“Innovation in the pharmaceutical industry: new estimates of R&D costs”, Tufts Center for the Study of Drug Development, published in the Journal of Health Economics, 2016).
Sanya Sukduang, partner at Finnegan Henderson Farabow Garrett & Dunner, says that America’s Hatch-Waxman Act recognises the significant investment that pharmaceuticals inject into developing new drugs and provide an incentive, through a range of regulatory and statutory provisions (such as market exclusivity and patent grants), for companies to continue developing novel therapies.
Life Sciences Intellectual Property Review (LSIPR) tracks the increasing challenges for intellectual property specialists in the rapidly evolving world of life sciences. From gene patents to stem cell research, we provide the very best news and analysis.
To continue reading this article and to access 4,500+ articles, our digital magazines and special reports published for LSIPR subscribers only then you will need a subscription.
If you are already subscribed please login.
Official LSIPR subscribers include:
Allen & Overy
Arnold & Siedsma
Birch, Stewart, Kolasch & Birch LLP (BSKB)
Carpmaels & Ransford
European Patent Office
George Washington Law School
Kirkland & Ellis International LLP
Marks & Clerk
NiKang Therapeutics Inc.
Powell Gilbert LLP
Procopio, Cory, Hargreaves & Savitch LLP
The United States Patent and Trademark Office (USPTO)
World Intellectual Property Office
Generic competition, Lyrica, Pfizer, Cialis, Eli Lilly, Neulasta, Amgen, Rituxan, Roche, pharmaceutical sales, research and development, patent protection