Is some form of patent term extension available?
Certain standard Australian patents for pharmaceutical substances are eligible for patent term extension of up to 5 years. The pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG) and there must be at least 5 years between the filing date of the patent application and the first approval of any product containing the pharmaceutical substance. The term extension can be opposed on the basis that the requirements are not met. The rights of the patentee are more limited during the term extension.
The term of patents for medicinal or plant protection products may be extended through Supplementary Protection Certificates (SPC) granted under the general EU SPC Regulations ((EC) no 469/2009), which provides for additional protection for a maximum of 5 years. This aims to offset the loss of patent protection for pharmaceutical and plant protection products that occurs due to the compulsory and lengthy testing and clinical trials these products require prior to regulatory approval.
An additional six-month extension is possible in accordance with the Pediatric Regulation ((EC) No 1901/2006) if the SPC relates to a medicinal product for children for which data has been submitted according to a Paediatric Investigation Plan (PIP). PIPs are required to support the authorisation of medicines for children and aim to ensure that enough data is collected on the effects of the medicine on children. The extension compensates for the additional clinical trials and testing that PIPs require.
An application for an SPC has to be filed within six months after the grant of an authorisation to place the product on the Austrian market as a medical product. If the authorisation to place the product on the market is granted before the basic patent, the application for the certificate has to be filed within six months after the patent was granted.
In the SPC registration procedure, the APO does not examine whether the marketing authorisation is really the first one or if an SPC for the product already exists.
PTE and PTA are not available in Brazil. However, the general patent term is 20 years from the filing date or 10 years from the granting date, whichever is longer.
A Canadian patent has a term of 20 years from its Canadian filing date. Pursuant to recent amendments, where specific criteria are met, certain pharmaceutical patents may be eligible for extensions of up to 2 years through obtaining a Certificate of Supplementary Protection.
In China, there is no term extension available for any form of patent
Supplementary protection certificates ‘SPCs’ are available for pharmaceuticals and plant protection products and extend the term of the patent by a maximum term of 5 years. (The SPC is granted for a period of time that passes between the 5th anniversary of the patent application filing date and the grant of the marketing authorisation for the product protected by the patent.)
An additional 6 month extension applies to pharmaceutical products where conditions for a paediatric extension have been met, i.e. the product has been tested in the paediatric population.
Apart from Supplementary Protection Certificates provided for medicinal products, there is no patent term extension in France.
No. The lifetime of a patent is 20 years starting from the date of the application. Slow prosecution or other reasons are not available for requesting a term extension. However, for pharmaceuticals, for example, a Supplementary Protection Certificate (SPC) is available.
Patent term extensions are allowable only by means of Supplementary Protection Certificates for medicinal and plant protection products to a maximum of 5 years in accordance with the provisions of Regulations (EC) 469/2009 and (EC) 1610/1996 respectively. Another 6-month extension of medicinal SPCs is available for pediatrics, in accordance with Regulation 1901/2006 on medicinal products for paediatric use.
It is not possible to extend the duration of a patent; however, a form of ‘extension’ is available in relation to patents for medicinal and plant protection products to which the Supplementary Protection Certificate (“SPC”) regime applies. An SPC does not extend the duration of the patent itself, but only the protection for the specific product which is the subject of the marketing authorisation. The SPC takes effect from the expiry of the basic patent covering the product for a maximum term of five years. An SPC for a medicinal active ingredient may also be extended for a further six months if it has undergone the appropriate paediatric testing.
It is possible to petition the Patent Office to grant patent term extension for patents covering pharmaceutical compounds, processes for their preparation, use thereof, pharmaceutical compositions containing them, processes for preparing such compositions or formulations, and medical devices.
A petition for patent term extension can be submitted no later than ninety days from the date of regulatory approval of the pharmaceutical preparation (non-extendable).
Patent term extension is only available with respect to the first regulatory approval permitting use of the active ingredient in Israel. It is not possible to obtain patent term extension if there were previous regulatory approvals for salts, esters, hydrates or different crystalline forms of the active ingredient. In accordance with Patent Office decisions, patent term extensions will not be available for a new combination of two previously registered active ingredients or a new single enantiomer of a previously registered racemic mixture.
If the pharmaceutical preparation is registered in the US, patent term extension will only be available if a US patent covering the pharmaceutical preparation was also extended in the US. Moreover, if the pharmaceutical preparation is registered in the EU-5 countries (Italy, Britain, Germany, Spain and France), patent term extension will only be available if a patent covering the pharmaceutical preparation was extended in at least one of the EU-5 countries.
The period of Patent Term Extension will be equal to the shortest period of extension granted to a patent covering the pharmaceutical preparation in the US or in any of the EU-5 countries. However, in any event, the period of extension will not exceed five years, and the overall period of the patent and the extension must end no later than fourteen years from the earliest date in which a regulatory approval was obtained in the US or in any of the EU-5 countries. Moreover, the period of extension will automatically expire when an extension granted to a patent covering the pharmaceutical preparation in the US or in any of the EU-5 countries is revoked or withdrawn.
Patent term extensions may be challenged similarly to basic patents. In recent years, most of the inter partes litigation in this area has revolved around the proper scope of the first regulatory approval principle.
The only form of patent term extension available are Supplementary Protection Certificates for medicinal products and for plant protection products.
Old national legislation governing the grant of certificates for medicinal products has since long been repealed. As of today, the rules governing the grant, duration and the protection ensuing from supplementary protection certificates are those set forth in EU Regulation 469/2009 (for medicinal products) and EU Regulation 1610/96 (for plant protection products).
A thick body of national case law revolving around the grant or validity requirements of SPCs for medicinal products has formed over the years, fostered by the continuous stream of referrals decided by the Court of Justice of the European Union (CJEU) ever since the ‘90s.
As of today, the most controversial requirement is arguably Art. 3 (a) of the SPC Regulation and in particular the interpretation of the actual meaning of the wording “protected by the basic patent” following the Medeva (C-322/10), Actavis (443/12) and Eli Lilly (493/12) CJEU judgments.
Recent case law from the Milan court has also engaged with the interpretation of the meaning of the expression “active ingredient” as used in the SPC Regulation, and eventually applied the principles set forth on the subject in the Forsgren (631/13) referral.
Some controversy has also arisen as to whether the SPC Regulation allows the grant of a certificate to a patent holder that is not, at the same time, the holder of the relevant Marketing Authorization. While we have knowledge of this ground being used in court proceedings (as part of broader invalidity claims encompassing other reasons for invalidity), Italian courts have yet to pronounce on the issue.
First, when a registration of patent rights is made after the later of the date falling five years from the filing date of the patent application and the date falling three years from the date of a request for examination of the patent application, the patent term may be extended if the patentee files for a patent term extension application. Further, if the working of a patented invention involves a period during which a person was unable to work the patented invention when such person needed to obtain permission under laws which are intended to, for example, ensure the safe working of the patented invention or to undergo any other disposition, the patent term may be extended for a maximum of five years by way of the patentee filing for a patent term extension. As for registration of a patent term extension, only an interested person may file a demand for trial for invalidation of registration of a patent term extension. The general reason given for such demand for trial is that the length of the extension period involved in the registration of the patent term extension exceeds the length of the period during which the patented invention was unable to be worked.
Patent term extensions for medicinal products are available under Norwegian Law. The codified Supplementary Protection Certificate (SPC) Regulation (469/2009(EC)) is incorporated in the Norwegian Patents Act and is applicable as Norwegian Law. This means that the total protection period for a medicinal product under a patent and a SPC may go up to 25 years and 6 months as a maximum (20 years under the patent and 5 years and 6 months under the SPC with the six months so-called paediatric extension of the SPC).
A patent term extension for plant protection products is also available in Norway under the Regulation concerning the SPC for plant protection products (1610/96/EC) which is incorporated in the Norwegian Patents Act and is applicable as Norwegian Law. This means that the total protection period for a plant protection product under a patent and a SPC may go up to 25 years (20 years under the patent and 5 years under the SPC).
The requirements for granting SPCs for medicinal products and plant protection products are the following (all of them has to be fulfilled):
a) the product must be protected by a patent that is in force;
(b) a valid authorization to place the product on the market must have been granted;
(c) the product must not already has been the subject of a SPC; and
(d) the authorization referred to in (b) is the first authorization to place the product on the market.
The duration of a SPC for medicinal products cannot exceed five and a half years and the duration of a SPC for plant protection products cannot exceed five years.
The validity of SPCs can be challenged both on the grounds that the underlying patent is invalid and that the requirements for granting a SPC were not fulfilled.
Poland is bound by the SPC (Supplementary Protection Certificate) regulations.
Apart from SPCs, there are no other patent term extensions available.
The duration of a patent is 20 years from the date of application. An extension may be granted to pharmaceutical and phytopharmaceutical products that have been authorised by regulatory authorities by means of a supplementary protection certificate (“SPC”), under the general applicable European law and case law (notably and respectively Regulation no. 469/2009 and Regulation no. 1610/96.
The SPC applications can be opposed before INPI and granted SPC can be judicially challenged on the same terms as patents, typically for not meeting the requirements of the corresponding SPC Regulations.
In accordance with clause 4 of Article 1363 of the RUCC patents for pharmaceuticals products or pesticide/agrochemicals can be extended for the period calculated as the time from the filing date till obtaining of the first marketing authorization, deducted by 5 years, but not more than for 5 years. The extension request should be filed within 6 months from the patent grant date, or the first marketing authorization date (which is later). RUPTO issues an additional patent for the established time of extension. The decision of extension can be challenged within 3 months with the IP Court, arguing violations of the procedure. This term can be reinstated if opponent shows that he appealed within 3 months after receiving knowledge on the extension.
A patent’s term is 20 years beginning on the date the application for the patent was filed.
The term of a patent may be extended on the following grounds:
(a) There was an unreasonable delay by the Registrar in granting the patent. There is unreasonable delay only when, excluding any delays caused by the applicant:
(i) more than 4 years have passed between the date of filing of the application for the patent and the date of issue of the grant; or
(ii) more than 2 years have passed between the date on which the applicant filed a request for a search and examination report, or an examination report (as the case may be) and the date of issue of grant.
(b) Where an applicant relies on the prescribed information of a corresponding application to obtain the grant of a patent in Singapore, there was an unreasonable delay in the issue of the corresponding patent or related national phase patent (as the case may be) and the patent office which granted that patent has extended its term on the basis of such delay.
(c) Where the subject of the patent includes a substance which is the active ingredient of any pharmaceutical product and this is the first pharmaceutical product containing the patented active ingredient to obtain marketing approval, that there was an unreasonable curtailment of the opportunity to exploit the patent caused by the process of obtaining marketing approval of that product. There is unreasonable curtailment only when:
(i) the marketing approval was obtained after the patent grant; and
(ii) excluding any delays caused by the applicant, more than 2 years have passed between the date of the application of marketing approval for the pharmaceutical product was made and the date such approval was granted.
Yes. If permission or registration is required under the laws to practice a patented invention and it takes a long time to undergo necessary tests for validity, safety, etc. for obtaining such permission or registration, the term of the patent may be extended only once for an additional period of up to five years to compensate for the period during which the invention cannot be practiced, unless the delay is attributable to the patentee. See KPA at Article 89(1). This rule applies to inventions for pharmaceutical products or finished or raw agrochemical products.
Supplementary protection certificates (“SPC”) in accordance with EU regulations for medicinal products and plant protection products are available and extends the patent by up to five years and, with regard to medicinal products, another six months if the medicinal product has been tested to be suitable for children.
The SPC can be challenged on the same basis as the basic patent which the SPC is based on. In addition, an action can also be based on that any of the requirements to obtain a SPC are not fulfilled. The most common grounds for challenge are that the basic patent was invalid or the marketing authorisation relied on was not the first.
Swiss law provides for supplementary protection certificates (“SPCs”) for medicinal and plant protection products. An SPC’s maximum term is five years. Further, since 2019, paediatric extensions of SPC’s and paediatric SPCs can be obtained, which grant the benefit of an additional six months’ exclusivity.
SPCs may be challenged, for instance, on the grounds that the requirements for the grant were not met or that the base patent is invalid.
Because of the characteristic of a pharmaceutical or agrichemical invention patent, Taiwan’s Patent Act regulates the system of patent term extensions for these kinds of patents. The Patent Act stipulates that where regulatory approval must be obtained in accordance with other laws and regulations for the exploitation of a pharmaceutical or agrichemical invention patent or the manufacturing process thereof, if such regulatory approval is obtained after the publication of the relevant invention patent, the patentee may apply for one and only extension for the patent term of said invention patent based on the first regulatory approval. Said regulatory approval can be used only once to seek a patent term extension.
There are also some restrictions on patent term extension. The extension period shall not exceed the length of time during which the patent cannot be exercised because the patentee due to the patentees r the regulatory approval with the central competent authorities in charge of the business. If the time needed to obtain said regulatory approval exceeds five (5) years, the granted patent term extension shall be five (5) years. For an object that is applicable to the extension, the abovesaid term "pharmaceutical" does not include any veterinary drug. Furthermore, when requesting a patent term extension, the request form and supporting documents must be submitted to TIPO within three (3) months after obtaining the first regulatory approval, and the request for patent term extension will not be granted if the application is not filed within six (6) months prior to the expiry of the original patent term.
Patent term extension is not available in Thailand.
There is no patent term extension (“PTE”) under Turkish Law.
The time taken to obtain a marketing authorisation (“MA”) for a medicinal product in the EU can often be lengthy due to the volume of clinical and safety data that must be submitted and verified. In some cases, this regulatory delay may serve to significantly reduce the period during which the patentee can derive a commercial benefit from its patent rights covering the relevant medicinal product. SPCs (as defined above) can serve to compensate for this regulatory delay by providing an additional period of patent protection of up to five years in respect of certain medicinal products.
>Under Article 7 of Regulation (EC) No 469/2009 (the “SPC Regulation”), a patentee must apply for an SPC within six months of the grant of the MA or the grant of the patent, if later. Under Article 3, a product must meet the following requirements in order to qualify for an SPC:
- The product is protected by a basic patent in force;
- A valid MA has been granted;
- The product has not already been the subject of an SPC; and
- The MA that has been granted is the first to place the product on the market as a medicinal product.
Whilst SPCs are provided for by EU regulation, they are not granted centrally. Instead, the patentee must apply to the relevant intellectual property office of each Member State. In the UK, this is the UK IPO, i.e. before the Comptroller.
The SPC Regulation provides that the duration of an SPC is the amount of time between the patent filing and the grant of the first marketing authorisation for the product, less five years. However this is subject to a maximum extension under an SPC of five years. Under the Paediatric Regulation, SPCs may also be extended by a further six months where products have undergone trials for use in paediatric medicine, provided that the application for extension is filed no later than two years before expiry of the SPC. The SPC period is often the most valuable period of protection for a product: for instance Eli Lilly’s antidepressant Prozac achieved 80% of its sales under IP protection during the SPC period.
The right of the UK IPO to grant SPCs is provided for in Section 128B and Schedule 4A of the Patents Act.
A UK-granted SPC may be challenged in the Patents Court on the basis that it is invalid under Article 15 of the SPC Regulation. The grounds of revocation are:
- That the certificate was granted contrary to Article 3;
- The basic patent has lapsed before the term of the certificate expires;
- The basic patent was amended so that it no longer protects the product; and
- After the basic patent has expired, it would have been invalid.
Many proceedings relating to SPCs therefore involve the same patent invalidity arguments outlined above relating to the underlying basic patent. There is also a large body of case law (both in the Patents Court and the Court of Justice of the European Union (“CJEU”)) considering whether certain SPCs were properly granted pursuant to Article 3.
There have been a number of noteworthy recent decisions on the interpretation of Article 3 under the SPC Regulation, such as in Teva UK Ltd v Gilead Sciences Inc (C-121/17), in which the CJEU devised a two-part test for the interpretation of Article 3(a).
A number of other important questions as to the interpretation of the SPC Regulation have recently been referred to the CJEU, for which decisions are expected in the near term:
- Joint referrals in Sandoz v Searle (UK) (C-114/18) and Royalty Pharma (DE) (C-650/17), which seek clarification on the level of specificity required when an active ingredient is covered only by a class-based claim in the basic patent.
- Novartis (SE) (C-354/19), which asks whether Article 3(c) prevents the grant of a second SPC for a second medical use based on the same active ingredient, where that new use is specifically protected by a separate basic patent.
- Santen (FR) (C-673/18), which seeks further clarity on the precise scope of the well-known decision in Neurim (C-130/11) on the availability of SPCs for second medical uses.
Patent term extensions may be granted as a result of delays in prosecution which are the fault of the USPTO. These extensions will be granted at issuance and are not typically subject to challenge without a civil action.
Patent owners can also apply for term extensions due to delays by other regulatory agencies. A typical example is a patent for a drug which needs FDA approval in order to be sold. These extensions are governed by 35 U.S.C. § 156.
No, Vietnamese patents are currently not extendable.