SAUDI ARABIA Law and Practice Contributed by: Dr Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed Al Dhabaan & Partners Eversheds Sutherland
The Patent Law does not make any specific dis - tinctions regarding infringement rights between biologics and small molecules. 3.2 Data and Regulatory Exclusivity The key differences for biologics and biosimilars compared to small molecules are as follows. Price Impact According to Article 6 of the Pricing Rules, when the first biosimilar enters the market, the price of the reference biological product is reduced by 20% (compared to a 25% reduction for small molecule generics under Article 4). Pricing Structure According to Article 7 of the Pricing Rules, the pricing structure is as follows. • First biosimilar: maximum 75% of the refer - ence biological product’s pre-reduction price. • Second biosimilar: maximum 65% of the reference biological product’s pre-reduction price. • Third and subsequent biosimilars: maximum 55% of the reference biological product’s pre- reduction price. 3.3 Acceptable Pre-Launch Preparations There are no specific differences in pre-launch preparation exemptions between biologics or biosimilars and generics. Article 47 of the Patent Law provides the same limited “non-commercial activities relating to scientific research” exemp - tion without distinguishing between product types. 3.4 Publicly Available Drug and Patent Information There are no differences. Saudi Arabia does not have an Orange Book equivalent system. The
SFDA maintains public lists of approved drugs and products pending approval. 3.5 Reimbursement and Pricing/Linkage Markets The key difference is in the pricing rules, as outlined in Article 15 of the Pricing Rules. The price of biological products manufactured locally under licence from foreign companies can be fixed for up to seven years if all manufacturing phases are transferred to Saudi Arabia. Beyond the pricing differences noted in 3.2 Data and Regulatory Exclusivity , the same basic reim - bursement and pricing procedures apply to both biologics or biosimilars and small molecules. 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates Availability and Legal Framework In Saudi Arabia, supplementary protection cer - tificates (SPCs) or similar patent term extension instruments are available. These are governed by the Patent Law and its implementing regula - tions, which aim to extend the protection of pat - ents beyond their standard term to compensate for the time taken to obtain regulatory approval. Applicable Laws and Main Provisions The main provisions related to SPCs in Saudi Arabia are found in the Patent Law. This law provides the framework for extending the pat - ent term for pharmaceuticals and other regu - lated products to account for the time required for regulatory approval. Patents Eligible for SPCs Patents that can form the basis of an SPC include those covering:
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