Patentability of Pharmaceutical Substances in Philippines
The main rule governing patentability is that, provided an invention meets the standard substantive requirements for patentability, which are novelty, inventive step, and industrial applicability, patents shall be available for any invention, whether a product or process, in all fields of technology without discrimination. Members must also condition the issuance of a patent on the innovation's appropriate disclosure and may request details on the most effective way to implement the invention. Since disclosure makes crucial technical information publicly available and ensures that the invention truly enters the public domain after the patent term has ended, it is an essential component of the social contract that the grant of a patent constitutes. This is because disclosure may help others advance technology in the field even while the patent is in effect.
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Three types of exclusion to the above rule on patentable subject-matter are allowed. These may be of interest from a public health perspective:
• inventions the prevention of whose commercial exploitation is necessary to protect ordre public or morality, including to protect animal or plant life or health;
• diagnostic, therapeutic, and surgical methods for the treatment of humans or animals; and
• certain plant and animal inventions.
The minimum rights that must be granted by a patent under the TRIPS Agreement closely resemble those that are found in the majority of patent laws, namely the right of the patent holder to bar unauthorised users from using the patented process and from producing, utilising, offering for sale, or importing the patented product or a product obtained directly through the patented process.
The TRIPS Agreement stipulates that the duration of the protection must not end before 20 years have passed since the patent application was filed. It should be noted that, although the issue of patent term extension to compensate for regulatory delays in the marketing of new pharmaceutical products was raised in the Uruguay Round negotiations, the TRIPS Agreement does not contain an obligation to introduce such a system.
In South-East Asia, the Philippines is a significant commercial partner for the EU. Pharmaceuticals will play a bigger part in this bilateral partnership as a fast-growing industry. A population that now pays 46% of its out-of-pocket medical costs will see an increase in pharmaceutical consumption in the future years as a result of rising population wealth and government healthcare programmes. According to some projections, out-of-pocket pharmaceutical spending in the Philippines increased from US$ 664 million to US$ 3.46 billion between 2010 and 2015. By 2023, it is expected that total healthcare spending will increase by 11.2% yearly and total US$38.6 billion. A large portion of these sales will occur at hospitals that are being renovated as part of new government healthcare initiatives as well as retail chain pharmacies, which are the present leading drug sales venue. The biggest market participants in the Philippines are local companies, and they maintain their market share through aggressive advertising and the creation of generic products.
To avoid the high energy costs associated with domestic production, many international pharmaceutical companies with operations in the Philippines opt to manufacture medications abroad and import them into the country. However, in order to stop local competitors from producing and selling phoney products, there are still significant IP risks associated with patenting, packaging, marketing, and sales of pharmaceuticals in the Philippines. Packaging and advertising which promote strong consumer trust and loyalty will prove especially valuable as Filipinos become increasingly accepting of generic drugs and brand name drugs face pressure to justify their high prices.
Some of the key laws addressing pharmaceuticals in the Philippines are the:
• Foods, Drugs, Medical Devices and Cosmetics Act
• Generics Act
• Act Prohibiting Counterfeit Drugs
• Consumers Act
• Reproductive Health Law
The Philippine constitution contains provisions for controlling food and drugs. The Food and Drug Administration of the Philippines (or FDA), more specifically the CDRR, is in charge of leading the enforcement of food and drug laws (Center for Drug Regulation and Research). According to FDA regulations, pharmaceutical companies must obtain an operating licence (LTO) from the FDA before beginning any commercial activity. The processing time for such applications is typically one to two months.
To comprehend the Philippines' drug IP regulating system, one must understand two fundamental ideas: First, there is a first-to-file system in the Philippines. According to this approach, the company that applies for rights to a certain piece of intellectual property has the best chance of having those rights registered if they are not successfully contested. Second, registration is necessary in the Philippines to enforce rights, with the exception of copyrights and well-known marks.
Patenting drug formulations enables businesses to benefit from protected periods during which they alone may profit from the drug in order to partially repay their significant development costs. Additionally, technology that is essential for making pharmaceuticals swiftly or inexpensively might be protected through patents.
In the Philippines, IPR-related complaints may be brought to the Intellectual Property Office, which may result in the cancellation of registrations or the rejection of pending applications. SMEs operating in the Philippines should frequently monitor the electronic gazette published by the Philippine IPO, which lists new patents, industrial design certificates, etc., in order to take advantage of this opportunity. Otherwise, SMEs might pursue legal action through channels other than the IPO, such as customs seizures, to have an immediate impact on the supply chains of counterfeiters. In the Philippines, Erleada, Ingrezza, Vosevi, Biktarvy, Epclusa, Harvoni, Lokelma, Ninlaro, Sovaldi, and Tibsovo are the firms with the broadest patent coverage.
Author:Tanya Saraswat and Narsee Monjee Institute of Management Studies (NMIMS). in case of any query, contact us at Global Patent Filing, or write back us via email at firstname.lastname@example.org.