Patent linkage system serves as a crucial tool in the pharmaceutical industry, strategically aligning the approval process of generic drugs with the patent status of their branded counterparts. This intricate system acts as a preemptive measure, ensuring that generic medications undergo thorough scrutiny before entering the market, thereby averting potential patent infringement disputes. By intertwining the marketing approval of generic pharmaceuticals with the patent status of branded drugs, this system effectively safeguards intellectual property rights and fosters a balanced marketplace.

In essence, the patent linkage system operates by synchronizing the marketing clearance of generic drugs with the expiration of patents associated with their branded equivalents. This synchronized approach not only facilitates the identification of potential patent infringements but also streamlines the resolution process, minimizing legal entanglements between generic manufacturers and brand owners. Consequently, generic drug producers are compelled to await the expiration of patents on branded medications before obtaining marketing authorization for their products, ensuring fair competition, and protecting the interests of innovators.

While the concept of patent linkage is not explicitly outlined in trade-related segments of intellectual property rights agreements such as TRIPS (Trade-Related Aspects of Intellectual Property Rights), certain bilateral and multilateral trade agreements incorporate clauses addressing this mechanism. Notably, the inception of the patent linkage system can be traced back to the United States, where it was introduced under the Hatch-Waxman Act, also known as the Drug Price Competition and Patent Term Restoration Act of 1984. As the pioneering country to implement such a system, the United States established a prototype comprising four key components: the patent register, notification mechanisms, stay of approval provisions, and initial generic exclusivity rights.

The patent linkage system not only serves as a regulatory framework but also plays a pivotal role in shaping pharmaceutical innovation and market dynamics. By aligning the approval process of generic drugs with patent expiry dates, this mechanism incentivizes research and development efforts while promoting a conducive environment for generic competition. Moreover, it fosters transparency and efficiency in the pharmaceutical supply chain, ensuring that consumers have access to safe, affordable, and high-quality medications.

In recent years, the global pharmaceutical landscape has witnessed an increasing adoption of patent linkage systems, reflecting the growing emphasis on intellectual property protection and regulatory harmonization. Countries worldwide are recognizing the significance of integrating patent linkage mechanisms into their regulatory frameworks to address emerging challenges and foster sustainable healthcare ecosystems.

Patent linkage systems in Asia-Pacific countries:

Australia:

In Australia, the patent linkage system operates under the Therapeutic Goods Act 1989 and the Patents Act 1990. In Australia, similar to other Asia-Pacific nations, a stringent process governs the disclosure of potential patent infringements by product applicants seeking marketing approval. Health authorities withhold approval for generic replicas that infringe upon existing patents, ensuring robust intellectual property protection within the pharmaceutical sector. Proposed amendments to the Therapeutic Goods Act 1989 mandate that applicants for first generic and biosimilar medicines notify the patent holder upon acceptance of their application for TGA evaluation. This notification, as per Section 26B of the Act, will occur earlier in the process after preliminary assessment and must be sent to both the patent holder and the TGA. It applies when the applicant does not intend to market the medicine before the patent term ends or plans to do so before the term concludes. For all other generic and biosimilar medicine applications, the existing notification scheme under Section 26B will remain in place until registration on the ARTG.

China:

The State Food and Drug Administration (SFDA) in China plays a pivotal role in evaluating new products for marketing approval, necessitating thorough assessments to ascertain the absence of patent infringements. The SFDA refrains from intervening in patent disputes until the completion of the appeals procedure, maintaining a fair and impartial approach to intellectual property enforcement.

Singapore:

Singapore’s patent linkage system mirrors that of the United States, requiring applicants to disclose relevant patents and serve notices to rights owners during the marketing approval process. A 30-month stay is imposed if legal action is initiated by a patent owner within 45 days of receiving notice, ensuring a period of stability for market participants.

Brunei, Malaysia, Vietnam, Indonesia, Thailand:

Patent linkage systems remain absent in these nations, presenting opportunities for further exploration and potential adoption to enhance intellectual property protection and regulatory coherence within the pharmaceutical industry.

Philippines:

A Government Administrative order in the Philippines has revoked the authority of the Food and Drugs Authority of the Philippines (FDAP) over the patent linkage system and intellectual property protection in general, signaling a shift in regulatory oversight within the country.

South Korea:

In 2015, South Korea implemented a patent linkage system in accordance with its free trade agreements with the United States. While the introduction of this system has led to a noticeable increase in patent challenges for generic medications, South Korea has effectively managed such challenges, maintaining a stable market supply of generic products.

Japan:

The Ministry of Health, Labour, and Welfare (MHLW) in Japan introduced a “patent linkage” system to prevent post-sale patent infringement claims from disrupting the market supply of generic products. Although the system reduces the likelihood of frivolous lawsuits, its operational clarity and transparency are subject to scrutiny, contrasting with the more explicit regulations and information disclosure practices of the US and China.

Patent Linkage system in Europe:

The European Commission has consistently opposed patent linkage within the EU, arguing that marketing approval decisions should prioritize public health over patent issues, which fall under the jurisdiction of courts. Despite this stance, patent linkage has been implemented in some EU member states. However, the Bolar provision in the EU allows generic drug manufacturers to commence development before patent expiry, facilitating quicker market entry post-patent expiration.

Unlike patent linkage, which protects patent holders, the Bolar exception expedites the entry of generic and biosimilar drugs into the EU market after patent expiry. Exceptions exist within the EU where patent linkage systems operate. Italy allows pricing and reimbursement patent linkage, while Hungary mandates generic manufacturers to declare non-infringement and specify distribution plans. In Germany, generic products cannot be sold through pharmacies until listed on the Laurer-Taxe, a reimbursed products list, delaying prescription notification post-patent expiry if databases aren’t promptly updated. France delays generic reimbursement listing until six months before patent expiry unless non-infringement statements are provided, often leading to injunction requests from patent holders.

Patent linkage system in India:

In India, there is no patent linkage system, and attempts by major pharmaceutical companies to establish one have been rejected by the courts. The legislative intent is to maintain separate patent and drug regulation systems under distinct laws. Despite efforts by multinational pharmaceutical firms to introduce patent linkage, including lobbying through free trade agreements and legal actions, recent developments in cases like Bayer v. Cipla and Union of India shed light on the evolving landscape of patent linking in India.

In the Bayer v. Cipla case involving Cipla’s generic version of Sorafenib tosylate and Bayer’s patented medication, Bayer filed a writ petition to prevent the Drug Controller General of India (DCGI) from granting Cipla a license to produce and sell a similar medication. Bayer also demanded assurance from Cipla that their product did not infringe on Bayer’s patents. Bayer argued that DCGI should not approve Cipla’s product under the Drug and Cosmetics Act (DCA), claiming it could be considered a counterfeit drug.

The court deliberated on whether DCGI could use the DCA to approve generic versions of branded drugs, if such approval would violate the Patents Act, and if the DCA could classify generic drugs as counterfeit. The court ruled against Bayer, emphasizing that patent linkage is not regulated in India and highlighting the need for specific legislation. It affirmed that courts, not DCGI, have sole authority to determine patent infringement, upholding DCGI’s right to approve generic versions of branded drugs for sale. The court also dismissed Bayer’s argument that Cipla’s generic drug should be labeled as counterfeit, as it would have implications for all generic drugs. Consequently, the court upheld DCGI’s authority to approve the marketing of generic drugs under the DCA.

Drawbacks of Patent Linkage Systems:

• Complications can arise from linking patents with regulatory approval processes.
• Patentees are usually responsible for enforcing their rights against low-quality patents granted by national patent offices.
• Regulatory agencies tasked with patent linkage may lack the expertise to assess patent validity, increasing their workload.
• Generic medications under compulsory licenses may face registration delays until patent expiration due to patent linkage.

Complexity of Implementing Patent Linkage Legislation in India:

India’s pharmaceutical industry, global corporations, and health concerns add complexity to the decision. Balancing the interests of generic and innovator businesses is essential. An alternative approach, such as a notification method, has been proposed. Under this method, the Drug Controller General of India (DCGI) can list all new applications on its website. Pharmaceutical companies can monitor the database and bring lawsuits if a generic product infringes on their patent. However, the court exclusively decides patent infringement disputes, and DCGI is not involved in the decision-making process.

Conclusion:

Patent linkage systems regulate the marketing approval of generic drugs, ensuring compliance with existing patents. However, they pose challenges such as complications and increased workload for regulatory agencies. Balancing the interests of all stakeholders remains a challenge, requiring a systemic equilibrium to be established.