Market exclusivity refers to a situation where a particular company has exclusive rights to sell a specific product or service in a certain market for a specific period of time. This means that no other companies or competitors can offer the same product or service during that time, giving the company an advantage by being the only one in the market.
Full definition
Article 8 of Orphan Regulation provides for a ten - year period
of marketing exclusivity for an orphan medicinal product.
Orphan drug designation provides opportunities for grant funding towards clinical trial costs, tax advantages, FDA user - fee benefits, and seven years of
market exclusivity in the United States, if granted FDA approval.
Of course, funding clinical trials is often cost - prohibitive and pharmaceutical industry investors, with legally - binding fiduciary obligations to shareholder interests, have little fiscal incentive to devote resources to dietary protocols for
which market exclusivity is an impossibility.
That provision would have allowed approved drugs that win additional FDA clearances to treat rare disorders — i.e., those that affect 200,000 or fewer Americans —
extended market exclusivity in the hopes that biopharma companies would be more compelled to invest in difficult - to - treat spaces that involve costly follow - on clinical trials.
In the meantime, established pharmaceutical companies can replicate the product awaiting review and then file a special 180 -
day market exclusivity patent, which essentially steals the product and creates a temporary monopoly.
Considering Marvel studios recent joint venture with Sony in regards to its films, perhaps one of the clauses within the contract in regards to Sony's merch and
marketing exclusivity rights also entails them being able to produce video games exclusive to their platform.
Eileen's experience includes strategic advice on identifying and protecting intellectual property and regulatory assets; obtaining and
maintaining market exclusivity using intellectual property and regulatory laws; exploiting intellectual property assets; and enforcing intellectual property rights.
He is particularly interested in the interface of patent and regulatory protection and has advised clients on paediatric extension requests and
orphan market exclusivity.
And much of the reason its creators felt confident enough to invest all that time, money, and effort — given the small number of patients who might eventually use the medicine — can be traced to the Orphan Drug Act, a 1983 federal law that gave those who develop meds for uncommon diseases longer periods
of marketing exclusivity and other financial incentives.
And as members of The Enterprise Network by booj, the firm's «Gardner Ecosystem,» including websites, mobile apps, a CRM, and more, remains on the cutting - edge through its constantly evolving technology platform, which
includes market exclusivity.
Assuming that the patented compound even makes it to the market, the statement that they only have a few years of exclusivity is definitely true —
the market exclusivity for pharmaceuticals is almost always less than half of the patent exclusivity.
However, Gearbox boss Randy Pitchford took to Twitter to address these rumors of
marketing exclusivity and stated that they're false with «zero basis in reality».
While it has become more difficult to achieve this goal in today's era of expanding law firms and multiple offices, we will continue to make every effort to honor our commitment to
market exclusivity.
Counseling a large biologics company, providing an opinion on the eligibility of its new drug product for
marketing exclusivity and patent term extension.
This is a non-patent form of
market exclusivity that effectively prevents generic competition during the data protection period.
If you've been reading my blog for a while, you'll know that I'm convinced of a couple of things: (1) Fundamental shifts in the legal services environment will spawn a diverse population of new providers that will expand access to those services while destroying lawyers»
market exclusivity; and, (2) This is, on balance, a good thing.