AsherAMiller+-+Logs

Log Patent Protection Strategies Journal of Pharmacy and BioAllied Sciences http://dx.doi.org/10.4103/0975-7406.62694

Abstract
This review is about the need to find ways to extend patent protection. Many top-selling drugs have been going generic and biological drugs have come into the mainstream, cutting into research and development funding.

Main Article
The pharmaceutical industry is complicated and high stakes. Lawyers and scientists have become inextricably linked where new drug development is successfully occurring.

More commonly, however, scientists and lawyers do not work closely together.

=Market Exclusivity=

Market exclusivity occurs for a set period of time and is the holy grail of drug development. Manufacturers of new drugs depend on exclusivity to recoup their investments in research and development.

=Rising costs of Drug Development=

There are a few examples of how much revenue can be generated while a drug is on-patent and how much revenue is lost once the exclusivity expires. Coupled with this is the fact that the cost of developing new drugs has gone up dramatically.

Patent rights last for 20 years and allow a monopoly temporarily. They are filed for as early as possible in the drug development process.

=Strategies for Extending Drug Commercial Lifecycle=

If a generic manufacturer is going to make a drug that has been patented they must provide documents explaining why they claim they will not be infringing upon the patent, even if the patent is expired.

Drug manufacturers planning to extend their patents have to build in secret weaknesses that will allow them to reference their patent as prior art, but still improve upon it without actually changing much.

New formulations
There is a shorter FDA approval route for new formulations. They are more likely to be granted a new patent if the changes create clinical improvements.

One common trick is to resubmit patents as patents for extended release medications.

New routes of administration for known drugs
Another trick is reformulating the drug with an alternative delivery system, for example intranasal Imitrex.

Stereoselectivity/chiral switches
Two thirds of drugs marketed currently are chiral and in 2002 enantiomer pharmaceutical sales were $160 billion. Chiral switching is when a racemic mixture is patented again as only the eutomer.

Potential advantages of single enantiomer products
AstraZeneca started searching for a better replacement for omeprazole years before their patent was going to expire. Of all the compounds they tried the eutomer of omeprazole alone was actually significantly better than omeprazole.

New uses
Patents can be created for the same compound if a new use has been discovered through research.

Lilly at one time patented a drug called Atomoxetine for depression, but later discovered it was effective enough at treating attention deficit disorder to patent market and sell it as Strattera. There are other examples.

Combinations
Drug companies may also obtain a patent for simple combinations if they can be proven to have novelty and non obviousness.

Although drug companies typically have an aversion to combinations, they have been successful before.

Recent combinations have been effective at combining drugs for the treatment of bipolar disorder and HIV/AIDS.

Polymorphism
The various crystal structures of a drug can be patented, but if an effective polymorph is not described in the patent, the patent holder may be unprotected.

=Conclusion=

It is important for lawyers and scientists to collaborate early on in the patent application process.

http://cococo.unibo.it/cococo/screening-libraries http://zinc.docking.org/ http://cactus.nci.nih.gov/chemical/structure http://www.daylight.com/dayhtml/doc/theory/theory.smarts.html

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