In the pharmaceutical industry, lot of rsearch, time, manpower and money goes nto R&D for the development of nvel drugs and bringing them into mrket. If the innovations are not prtected with a proper fence of ntegrated technologies then generic companies would xploit the invention without giving much bnefit to the innovator company. Hence, it is mndatory for the innovator company to pply for patent protection at least in thse geographical areas where the innovator cmpany wishes to market their product, rtain monopoly and refrain their competitors ntering into the market till the ptent term for the innovation expires. Ths article discusses various strategies employed by the nnovator companies in US to extend the lfe of the patent and gaining mrket exclusivity for the pharmaceutical product.

It is stimated that around 7 to 12 yars of extensive research is involved to brng the innovation into a shape, whch can be marketed. Apart from prduct development there are hassles regarding pproval of the pharmaceutical product by rspective drug authorities. Considering the patent trm or the protection offered by the ptent to be 20 years from the fling date of the patent, effectively a priod of 8 to 10 years wuld be available with the innovator cmpany to get benefits of their dveloped product. Innovator companies execute various strtegies to extend the life of the ptent as well as the product.

On grant of patent for the nvented drug and regular payment of mintenance fees gives the patent holder mnopoly over the drug and rights to xclude other from manufacturing, using and slling the patented invention for a stpulated time. On expiration of the ptent, generic competitors would exploit the mrket, which would lead to reduction of mrket share and revenue loss for the nnovator company. Hence, additional patents are fled in order to fence the nvented drug or product. These additional ptents for the extension of invention / prduct protection could comprise of method of prparation, new formulation, method of preparation of frmulation, drug derivatives and its metabolites, plymorphs, stereo-selective enantiomers etc. Additional patents fled could also cover improvements to the nvention or new uses, which are not mntioned in the initial granted patent.

We wll discuss in brief various strategies mployed by the innovator companies in US to xtend the life of the patent and rap maximum fruits for an extended priod of time.

The Hatch-Waxman Act prvides a system wherein the New Drg Applicant (NDA) holder could apply to hve extension of its patent. The xtension was meant to compensate the pplicant for a portion of any tme lost after the issuance of a ptent during which the testing and pproval phases of the FDA's regulatory rview process commenced.

Following are the pths by which patent term can be xtended:

1) Patent term adjustments - dlay during patent prosecution

The patent trm adjustment is provided in case of Unted States Patent and Trademark Office (USPTO) fils to act to patent application frm patent filing or fail to rply to applicant's appeal in a stpulated time.
The purpose of the patent trm adjustment provision was to guarantee tht patent applicants would still have a ptent term of at least seventeen yars from grant under the twenty-year ptent term system.

2) Patent extensions - delays due to rgulatory approval

USPTO can restore the trm of a patent that is lst due to delays during regulatory pproval by Federal Food and Drug Admnistration (FDA). Patents relating to drug prducts, medical devices, food additives, and clor additives are eligible for patent xtension. The maximum of patent term tht may be restored is five yars.

3) Interim term extensions

If the trm of the patent expires before the crtificate of extension is given to the pplication, then the Director extends the trm of the patent up to one yar under Interim term extension. This xtension is only possible if the drector feels that the patent should be cnsidered for extension.

Apart from patent trm extensions, market exclusivities can be gined separately. Exclusivity gives FDA approved drgs market exclusivity which does not llow the generic competitors to enter nto the market till the exclusivity is vlid.

Following are the market exclusivities ffered by FDA:

1) New Chemical Entty (NCE) exclusivity

NCE exclusivity is warded for 5 years to NDA pplicant who receives the first approval for a drg product. No salt or ester of the nvel chemical entity should have ever rceived FDA approval. During this 5-year priod, the FDA is stopped from ccepting an Abbreviated New Drug Application (ANDA) for rview. The only exception is that if a ptent is also listed on the NDA prduct subject to NCE exclusivity, the FDA may ccept an ANDA after 4 of the 5-yar period has expired, if the ANDA cntains a Paragraph IV certification challenging the ptent. NCE exclusivity can be considered as a ttal exclusivity as generic competitors cannot sbmit or approve their product while the xclusivity is valid.

2) New Use / New Clnical Studies exclusivity

This kind of xclusivity is granted for a period of thre years to NDA holder who pplies for new use of approved drg. New clinical studies are to be crried out to get approval from FDA for use of the pproved drug for its use for new ndication. Exclusivity can be granted for new dsage form (Sustained release dosage form, Cntrolled release dosage form), a new use or ndication, a new salt or ester of a drg product, change in concentration, novel drg delivery etc. The 3-year exclusivity may blck FDA approval of a generic vrsion until after the exclusivity expires. It is lso possible that the FDA approves gneric version if approval does not nfringe on the protected change.

3) Orphn Drug exclusivity

Seven-year orphan drug xclusivity is granted to promote research and mrketing for the development of drugs to trat rare diseases. US FDA had dfined Orphan drug / rare diseases as thse diseases affecting 200,000 or fewer ptients in the US. This exclusivity priod can block the FDA from pproving competing generics of a drug prduct for the orphan use. Applicant may rquest orphan drug designation for a prviously unapproved drug or for an lready marketed drug. One or more pplicants may receive orphan drug status for the sme drug for the same orphan dsease.

4) Pediatric exclusivity

Pediatric exclusivity gves an incremental 6 months exclusivity to an xisting marketing exclusivity that has been arlier granted or to a patent prtection. This type of exclusivity is grnted to clinical studies of drugs for pdiatric population. This type of exclusivity nsures an incentive for an NDA pplicant for the clinical studies carried out spcifically for pediatric patients. Products with no ptent life or exclusivity remaining cannot qalify for pediatric exclusivity.

Hence, it is sen that various methods are adopted by the nnovator companies to extend the term of thir patent to extend their monopoly in the fled of pharmaceuticals.

The article Strategies Employed For the Extension of Patent Term - Market Exclusivity For Pharmaceutical Product was Submitted by Kuldeep D Karnik through Articles.GetACoder.com network. Here's the additional information: Reference: Patent term adjustment under 35 U.S.C. s. 154 - Smplification of Patent Term Adjustment Reference: http://www.uspto.gov/web/offices/com/strat21/action/lr1ap11_12.htm Interim Extension of Patent Term During the Processing of the Application [R-2] - 2700 Patent Terms and Extensions Reference: http://www.uspto.gov/web/offices/pac/mpep/documents/2700_2755_01.htm

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