| In the pharmaceutical industry, a lot of research, | | | | to drug products, medical devices, food additives, |
| time, manpower and money goes into R&D for | | | | and color additives are eligible for patent extension. |
| the development of novel drugs and bringing them | | | | The maximum of patent term that may be restored |
| into market. If the innovations are not protected | | | | is five years. |
| with a proper fence of integrated technologies then | | | | 3) Interim term extensions |
| generic companies would exploit the invention without | | | | If the term of the patent expires before the |
| giving much benefit to the innovator company. | | | | certificate of extension is given to the application, |
| Hence, it is mandatory for the innovator company to | | | | then the Director extends the term of the patent up |
| apply for patent protection at least in those | | | | to one year under Interim term extension. This |
| geographical areas where the innovator company | | | | extension is only possible if the director feels that the |
| wishes to market their product, retain monopoly and | | | | patent should be considered for extension. |
| refrain their competitors entering into the market till | | | | Apart from patent term extensions, market |
| the patent term for the innovation expires. This | | | | exclusivities can be gained separately. Exclusivity |
| article discusses various strategies employed by the | | | | gives FDA approved drugs market exclusivity which |
| innovator companies in US to extend the life of the | | | | does not allow the generic competitors to enter into |
| patent and gaining market exclusivity for the | | | | the market till the exclusivity is valid. |
| pharmaceutical product. | | | | Following are the market exclusivities offered by |
| It is estimated that around 7 to 12 years of | | | | FDA: |
| extensive research is involved to bring the innovation | | | | 1) New Chemical Entity (NCE) exclusivity |
| into a shape, which can be marketed. Apart from | | | | NCE exclusivity is awarded for 5 years to NDA |
| product development there are hassles regarding | | | | applicant who receives the first approval for a drug |
| approval of the pharmaceutical product by respective | | | | product. No salt or ester of the novel chemical entity |
| drug authorities. Considering the patent term or the | | | | should have ever received FDA approval. During this |
| protection offered by the patent to be 20 years | | | | 5-year period, the FDA is stopped from accepting an |
| from the filing date of the patent, effectively a | | | | Abbreviated New Drug Application (ANDA) for |
| period of 8 to 10 years would be available with the | | | | review. The only exception is that if a patent is also |
| innovator company to get benefits of their | | | | listed on the NDA product subject to NCE exclusivity, |
| developed product. Innovator companies execute | | | | the FDA may accept an ANDA after 4 of the 5-year |
| various strategies to extend the life of the patent as | | | | period has expired, if the ANDA contains a Paragraph |
| well as the product. | | | | IV certification challenging the patent. NCE exclusivity |
| On grant of patent for the invented drug and regular | | | | can be considered as a total exclusivity as generic |
| payment of maintenance fees gives the patent | | | | competitors cannot submit or approve their product |
| holder monopoly over the drug and rights to exclude | | | | while the exclusivity is valid. |
| other from manufacturing, using and selling the | | | | 2) New Use / New Clinical Studies exclusivity |
| patented invention for a stipulated time. On expiration | | | | This kind of exclusivity is granted for a period of |
| of the patent, generic competitors would exploit the | | | | three years to NDA holder who applies for new use |
| market, which would lead to reduction of market | | | | of approved drug. New clinical studies are to be |
| share and revenue loss for the innovator company. | | | | carried out to get approval from FDA for use of the |
| Hence, additional patents are filed in order to fence | | | | approved drug for its use for new indication. |
| the invented drug or product. These additional | | | | Exclusivity can be granted for new dosage form |
| patents for the extension of invention / product | | | | (Sustained release dosage form, Controlled release |
| protection could comprise of method of preparation, | | | | dosage form), a new use or indication, a new salt or |
| new formulation, method of preparation of | | | | ester of a drug product, change in concentration, |
| formulation, drug derivatives and its metabolites, | | | | novel drug delivery etc. The 3-year exclusivity may |
| polymorphs, stereo-selective enantiomers etc. | | | | block FDA approval of a generic version until after |
| Additional patents filed could also cover | | | | the exclusivity expires. It is also possible that the |
| improvements to the invention or new uses, which | | | | FDA approves generic version if approval does not |
| are not mentioned in the initial granted patent. | | | | infringe on the protected change. |
| We will discuss in brief various strategies employed | | | | 3) Orphan Drug exclusivity |
| by the innovator companies in US to extend the life | | | | Seven-year orphan drug exclusivity is granted to |
| of the patent and reap maximum fruits for an | | | | promote research and marketing for the |
| extended period of time. | | | | development of drugs to treat rare diseases. US FDA |
| The Hatch-Waxman Act provides a system wherein | | | | had defined Orphan drug / rare diseases as those |
| the New Drug Applicant (NDA) holder could apply to | | | | diseases affecting 200,000 or fewer patients in the |
| have extension of its patent. The extension was | | | | US. This exclusivity period can block the FDA from |
| meant to compensate the applicant for a portion of | | | | approving competing generics of a drug product for |
| any time lost after the issuance of a patent during | | | | the orphan use. Applicant may request orphan drug |
| which the testing and approval phases of the FDA's | | | | designation for a previously unapproved drug or for |
| regulatory review process commenced. | | | | an already marketed drug. One or more applicants |
| Following are the paths by which patent term can be | | | | may receive orphan drug status for the same drug |
| extended: | | | | for the same orphan disease. |
| 1) Patent term adjustments - delay during patent | | | | 4) Pediatric exclusivity |
| prosecution | | | | Pediatric exclusivity gives an incremental 6 months |
| The patent term adjustment is provided in case of | | | | exclusivity to an existing marketing exclusivity that |
| United States Patent and Trademark Office (USPTO) | | | | has been earlier granted or to a patent protection. |
| fails to act to patent application from patent filing or | | | | This type of exclusivity is granted to clinical studies |
| fail to reply to applicant's appeal in a stipulated time. | | | | of drugs for pediatric population. This type of |
| The purpose of the patent term adjustment | | | | exclusivity ensures an incentive for an NDA applicant |
| provision was to guarantee that patent applicants | | | | for the clinical studies carried out specifically for |
| would still have a patent term of at least seventeen | | | | pediatric patients. Products with no patent life or |
| years from grant under the twenty-year patent term | | | | exclusivity remaining cannot qualify for pediatric |
| system. | | | | exclusivity. |
| 2) Patent extensions - delays due to regulatory | | | | Hence, it is seen that various methods are adopted |
| approval | | | | by the innovator companies to extend the term of |
| USPTO can restore the term of a patent that is lost | | | | their patent to extend their monopoly in the filed of |
| due to delays during regulatory approval by Federal | | | | pharmaceuticals. |
| Food and Drug Administration (FDA). Patents relating | | | | |