Origiin IP Solutions LLP insists on the need to file Abbreviated New Drug Application (ANDA) to prevent patent infringement risk during the approval of generic drugs.

ANDA application is filed at FDA for approval of generics where the innovator drug is already accepted. Typically, generic drug is equivalent to an innovator drug in terms of dosage, form, strength, route of administration, quality, performance, characteristics and intended use. Orange book contains therapeutic equivalence evaluations of all approved products that include innovator and generic drugs. The objective of ANDA is to reduce drug price because a generic drug is developed as an alternative to the patented drug. The main aim of manufacturing and marketing generic drug is to make available the same branded drug at a lesser cost.
 
Generic drug applications are termed ‘abbreviated’ because, it is generally not required to include preclinical & clinical trial data to establish safety and effectiveness unlike innovator New Drug Application. Once ANDA is approved, generic drug may be manufactured and marketed to provide a safe, equivalent, effective, low cost alternative to the patients provided generic applicants are successful in establishing that the drug is bioequivalent & performs in the same manner as the innovator drug, Bindu Sharma, founder-CEO and patent attorney, Origiin IP Solutions LLP told Pharmabiz.

ANDA application could be classified into one of the 4 classes, and paragraph IV certification is very critical. It requires applicant to establish that the generic drug for which ANDA is filed does not infringe any existing patent rights of the third parties.
 
To understand patent infringement, it is important to know rights of a patent holder. In a given jurisdiction where patent is granted, a patent holder has the right to prevent third parties from making, using, selling, offering for sale and even importing the patented product. Violation of any of the rights of the patent holder or patentee is called as infringement, said Tanu Singh, patent analyst & business development manager, Origiin IP Solutions LLP.
 
Providing examples of patent infringement, Origiin said that in 2009, Galderma, an international dermatology company, sued Mylan Pharmaceuticals for allegedly infringing 4 of its patents related to sub-antimicrobiotic dose doxycycline product Oracea, which is used to treat a certain type of skin condition called rosacea. Mylan filed an ANDA with FDA for a generic doxycycline delayed-release capsule. Mylan claimed in its ANDA that specific claims of the four patents were invalid and would not be infringed by manufacture or sale of the generic product. However, Galderma said that they would be irreparably harmed if Mylan were allowed to manufacture or market the generic product. It was found by the Court that such patent claims were both valid and infringed. The judge also ruled that two of the patents were valid but not infringed, and that another two were invalid and not infringed. FDA was directed to withdraw approval of Mylan's ANDA and that the effective date of approval of Mylan's ANDA would be a date not earlier than December 19, 2027, the expiration date of the patent.
 
To avoid such infringement of valid patent claims, it is extremely important to perform freedom-to-operate search to clearly understand patent infringement risk at the time of ANDA. However, mere ANDA filing does not actually infringe any patent but to evaluate future infringement, evaluation of product specifications is important. Patent infringement risk analysis along with invalidation search performed in advance could be of immense use to handle such complex situations, stated Sharma and Singh.