PETALING JAYA: The Health Ministry is drafting guidelines to ensure hospitals will have continued access to generic medicines even during legal disputes from the original brand names over patent issues.
Known as the patent linkage guideline, it is also to ensure generic drugs do not infringe on innovator drug patents.
It will allow access to generic drugs but at the same time ensure that the patent of innovator drugs is not infringed.
This guideline is meant to prevent any problem should there be a court case between the patent holder and the generic drug manufacturer.
The guidelines are necessary as Malaysia had ratified the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) in September 2022.
Article 18.53 of the agreement requires members to establish a notification mechanism to patent holders, provide adequate opportunity to seek legal remedies and establish procedures to resolve patent disputes before marketing.
According to the ministry in a public consultation document released recently, the guidelines would fulfil Malaysia’s CPTPP commitments, besides safeguarding access to medicines.
It also helps in preserving judicial determination of patent disputes and ensuring regulatory neutrality, it said.
Malaysia has four-and-a-half years from the date of the agreement coming into force to implement the patent linkage measures.
“This provision emphasises the importance of protecting intellectual property in the pharmaceutical industry while ensuring timely access to affordable medicines,” said the ministry’s document.
Patent linkage refers to a regulatory mechanism that links the approval of a generic pharmaceutical product to the patent status of the corresponding New Drug Product (NDP).
“It does not prevent generic entry. It introduces a transparent notification mechanism allowing patent disputes to be resolved through the courts,” the ministry said.
Patent linkage will apply to all pharmaceutical product registration applications intended for human use, except for biologics.
This includes pharmaceutical products originating from all countries and not limited to countries that are parties to the CPTPP.
Patent linkage will only apply to product patents claiming the active pharmaceutical ingredient (API), formulation, polymorphs, salts, esters, dosage form, dosing regimen; as well as patents claiming approved medical use under the NDP.
It will not apply to patents for manufacturing and packaging.
Patent linkage will not apply during public health emergency; products which requires a compulsory licence under the Patents Act, and those where the rights of the government is authorised under the Patents Act and other urgent national measures.
Those applying for patent linkage due to their patent status or with the intention of marketing their products must indicate whether the product is protected by a granted patent in Malaysia (MyIPO).
The National Pharmaceutical Regulatory Agency (NRPA) will verify procedural compliance, manage notification and suspension periods, and notify the generic product registration holder (PRH) when legal proceedings are initiated by PRH NDP, patent owner and patent licensee.
However, the NPRA will not determine patent validity, interpret patent scope and decide on patent infringement.
