Vicissitudes of a patent

Hepatitis C is a widespread disease with an incidence rate of 32 per 100,000. In 2008, Gilead Pharmasset LLC. filed a patent application for Sofosbuvir, one of the drugs used to treat Hepatitis C. It obtained patent No. 2478104 for Sofosbuvir in 2013.

Sofosbuvir has faced several attacks by various companies. It is rare that a single patent experiences so many attacks.

The charitable organization, “Humanitarian Action,” appealed against the patent in 2015 because the patent allegedly did not comply with the patentability criteria of industrial applicability, novelty, and inventive level. The Chamber of Patent Disputes examined the appeal but refused it.

Farmasynthez, a pharmaceutical company, appealed against the patent in 2016 for the same reasons, but again, the Chamber of Patent Disputes dismissed the appeal.

In 2017, Farmasynthez challenged the patent again and succeeded in partial invalidation of the patent. A new patent (No. 2651892) was granted with the claims amended by the patent owner. 

The patent was due to expire in 2028, so Gilead applied for an extension of the patent in 2018. However, the patent office refused it because claim one of the patent did not tally with the drug to be sold. Gilead appealed this decision at the IP Court, arguing that the patent office incorrectly opined that the scope of protection according to claim one of the patent was not correlated with the registration certificate for Sofosbuvir. The court carefully examined the appeal and concluded that the decision of the patent office had not complied with Article 1363(2) of the Civil Code and ordered it to extend the duration of patent No. 2651892. The patent office examined the extension request and, on January 21, 2020, extended the duration of the patent to March 25, 2031.

However, this was not the end of the story.

In anticipation of the extension of patent No. 2651892, Farmasynthez appealed against it, but the patent office dismissed the appeal on October 30, 2020, and kept the patent in force.

Later, another public organization came into play. The National Centre of Public Health appealed against the patent on October 18, 2023. It objected to the extension of the patent, arguing that it was made against the law. It claimed that the extension should be canceled because:

1. The combination of features of the invention did not tally with the active ingredient of the drug according to its registration certificate, and
2. The term for filing the extension request was not observed.

The appellant argued that the basic patent was No. 2478104, from which the term for filing the request should have been calculated, and not patent No. 2651892. In fact, according to the appellant, the grant of patent No. 2651892 was a correction of the mistake made during the examination of the application and could not have led to the grant of another patent. Hence, patent No. 2651892 could not be regarded as the “first” patent, and there should be no extension made twice in relation to the same product.

The appellant also recalled the previous argument refuted by the IP Court regarding the inconsistency between the claims and the registration certificate. The Chamber of Patent Disputes rehashed all the details of the case and confirmed that supplemental (extension) patent No. 2651892 had been issued based on the basic patent No. 2651892 and recounted basic details about the details and procedure of extension.

The Chamber noted that claim one of the patent covers any stereoisomer, including Sofosbuvir, while the extension request had not been filed in respect of all alternatives but only in respect of Sofosbuvir. So, the combination of features defining the scope of protection is identical to the chemical formula of Sofosbuvir shown in the Registration Certificate. The same conclusion was made by the IP Court, and the administrative body could not challenge its conclusion.

To sum up, patent No. 2651892 is an independent patent, meaning the request for an extension was timely filed, and there should be no reference made to an earlier patent. The Chamber confirmed the validity of the extension and published its decision in March 2025.

The number of attacks this patent has faced only confirms the value of the medicine. Hepatitis C is indeed a serious disease that should be treated by a drug that is specifically directed at that particular virus.