A generic medicine is a safe, effective, and cost-efficient alternative to a branded drug. The “Hatch Waxman Act of 1984,” also known as the “Drug Price Control and Patent Term Restoration Act Of 1984,” governs the USFDA’s generic medicine approval procedure and has resulted in a plethora of generic drugs flooding the market.
Prior to the enactment of the Act, the pharmaceutical market was dominated by branded medicine manufacturers, also known as drug innovators. Generic medicine makers used to rarely compete with them and invest their funds in previously established brands on the market. There was no competition and the innovator benefited from his elite monopoly era, during which no other drug brand could join the market. This exclusive period also permitted the innovator to charge blatantly charge the consumers for their patented drugs. To put an end to these activities and make the drug market more user-friendly, the US Congress established the “Hatch Waxman Act” in 1984. It was regarded as one of the most successful segments of US law at that time. The statute was enacted keeping in mind the interests of both the inventor and the generic producer
The Hatch-Waxman Amendments introduced a generic drug approval process in which applicants could submit an ABBREVIATED NEW DRUG APPLICATION (ANDA) under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act). An Abbreviated New Drug Application contains information submitted to the FDA’s Center for Drug Evaluation and Research of Generic Drugs for examination and final approval of a generic drug product. Once an ANDA is granted, an applicant may manufacture and market the generic drug to provide the public with a safe, effective, low-cost alternative.
Abbreviated generic medication applications are so-called because they are not needed to provide preclinical and clinical data to show safety and effectiveness. Instead, the applicant must scientifically establish that their product is BIOEQUIVALENT, or performs in the same way as the innovator drug. The generic medicine must deliver the same amount of API into the patient’s bloodstream as the innovator drug within the same time frame.
The HATCH WAXMAN ACT established the use of bioequivalence as the basis for approving generic medicine products. Because of this statute, less expensive generic medications are now available in the market without the need for costly and redundant clinical trials. At the same time, the innovator company can request up to 5 years of additional patent protection for the new treatment that they developed to compensate for the time lost while their product was through FDA approval. The statute was enacted with the interests of both brand-name and generic medicine makers in mind.
The advantage gained by the branded drug manufacturer is that Regulatory delays in brand approval were deciphered. The exclusivity and effective patent life (the time left when the drug enters the market following drug development and FDA approval) was increased from 8.5 years to 13 years in the late 1980sand it is currently approximately 16-17 years.
The benefits received by generic manufacturers are as follows: –
-The generic manufacturer could challenge the validity of the innovator’s patent.
– The Act required the filing of an ANDA, and the omission of the expensive pre-clinical and clinical trials performed by the innovator, as well as the provision of relying on the innovator’s safety and efficacy data and performing a much cheaper substitutable study known as “bioequivalence” to establish equivalence.
– According to the statute, once approved, the generic has six months to dominate the market alongside the innovator, during which no other generic can be approved.
Every approved drug product’s information is published by the FDA in the “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the ORANGE BOOK. It includes the New Drug Application (NDA) and ANDA medications as well as the patent and generic exclusivity expiration dates. It is a ready reference of a branded drug product for generic companies, who utilize this information to identify the reference for developing their generic copies. Certain therapeutic equivalency codes are also included in the orange book. A-prefixing products are considered substitutable, whereas B-prefixing products are considered inequivalent and non-substitutable with the branded drug product.
Along with bioequivalence, the applicant is required to file one of the following four certifications about the reference brand name patent list in the Orange Book
Para I certification – there is no patent for the drug listed in the Orange Book.
Para II certification – The patent is listed in the Orange Book but has expired.
Para III certification – The patent is listed and is valid, but the generic manufacturer wants approval to market the drug once the pertinent patent expires.
Para IV certification – The generic manufacturer either challenges the validity of the brand name listed patent asserting it to be invalid or fake, or it affirms not to cross the boundaries of the patented claims. It is the most critical of all and gives rise to almost all the anti-competitive practices associated with the Hatch Waxman Act.
To comprehend patent infringement, it is necessary to first grasp the rights of the patent holder. A patent holder has the right in a specific country where a patent is awarded to ban other parties from making, using, selling, offering for sale, or even importing patented drugs. Infringement is defined as any violation of the patent holder’s or patentee’s rights.
Galderma, an international dermatological firm, sued Mylan Pharmaceuticals in 2009 for allegedly violating four of its patents relating to the sub-antimicrobic dosage doxycycline product ORACEA, which is used to treat rosacea. Mylan Pharmaceuticals submitted an ANDA to the Food and Drug Administration for a generic doxycycline delayed-release capsule. In its ANDA, Mylan asserted that certain claims of the four patents were invalid and would not be infringed by the production or sale of the generic product. However, Galderma stated that allowing Mylan to produce or sell the generic product would do irreparable harm to them. The judge determined that two of the patents were legitimate but not infringed and that two more were invalid but not infringed. The FDA was instructed to withdraw approval of Mylan’s ANDA and that the effective date of approval of Mylan’s ANDA be no sooner than December 19, 2027, the patent expiration date.
With 45% of all new ANDA (abbreviated new drug application) approvals during the previous nine months, according to India Ratings and Research, Indian pharmaceutical businesses will profit from an uptick in demand from the US market.
It’s extremely important to perform a Freedom-to-operate search or clearing search to clearly understand patent infringement risk at the time of ANDA. The Sloan Kettering Institute for Cancer Research and Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiary have filed a lawsuit against India’s Aurobindo Pharma for marketing an Erleada (apalutide) knockoff before five patents expire. According to the plaintiffs, Aurobindo told them in April that it had submitted an abbreviated new drug application (ANDA) to offer Erleada in generic form. The Indian business and its subsidiaries, Eugia Pharma and AuroMedics, claimed in their appeal that the generic did not breach J&J’s patents since it lacked the active component apalutamide.
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 an invalidation search performed in advance could be of immense use to handle such a complex situation.
It can be concluded from the judgment of Ferring B.V. v. Watson Laboratories, Inc., the Federal Circuit held that, After stating that Section 271(e) cannot be interpreted to mean that the act of filing an ANDA alone could establish infringement without considering the ANDA specification or amendments thereto, the Federal Circuit held that “an ANDA specification may resolve the infringement question when it “defines a proposed generic product in a manner that either meets the limitations of an asserted patent claim.”
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