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Update on Draft Amendments to Pharmaceutical Affairs Act



The Taiwan Food and Drug Administration (TFDA), the central competent health authority, previously proposed two bills of the Pharmaceutical Affairs Act (PAA) to introduce patent linkage and data exclusivity for new indication, respectively, in early 2016 but then combined them as one bill later this year (such combined bill is referred to as “draft bill” hereafter) with further revisions after gathering comments from the public.  The Executive Yuan has approved the draft bill on 4 August 2016, which was submitted to the Legislative Yuan (i.e., the legislation body in Taiwan) to undergo first to third readings of the draft bill.  The draft bill has passed the first reading in mid-September 2016 and it is resolved that the contents thereof should be further reviewed and discussed by the health committee within the Legislative Yuan.  As of today, said committee has not commenced the review and discussion yet.  Set forth below is a summary of the revised draft bill.

 

1.     Data and Market Exclusivity

(1)  New Active Ingredient (original Article 40-2 is revised)

The currently effective PAA provides 5-year data exclusivity and 5-year market exclusivity for the drug containing new active ingredient. However, to enjoy the 5-year data exclusivity, if the applicant applies for a market approval for a new active ingredient drug in a foreign country first, the applicant must file the application for the same drug with the new ingredient in Taiwan within three years after the issuance of the market approval in such foreign country.

In the draft bill of the PAA, the 5-year data exclusivity is shortened to 3 years.  However, the 5-year market exclusivity and the 3-year limitation to the data exclusivity remain unchanged.

(2)  New Indication (Article 40-3 is newly added)

Under current Article 40-2 of the PAA, a drug with new indication or with newly changed indication is not provided with any data or marketing exclusivity.

The draft bill of the PAA newly introduces 2-year data exclusivity and 3-year market exclusivity for the drug with new indication or with newly changed indication. If the applicant performs domestic clinical trial for such kind of drug, the applicant can enjoy 5-year market exclusivity to encourage and boost the conduct of clinical trial in Taiwan. 

Similar to the limitation to the data exclusivity for the drug new active ingredient, the draft bill sets a limitation to the data exclusivity for the drug with new indication or with newly changed indication. That is, to enjoy the 2-year data exclusivity, if the applicant applies for a market approval for such kind of drug in a foreign country first, the applicant must file the application for the same drug with the new indication or with newly changed indication in Taiwan within two years after the issuance of the market approval in such foreign country.

2.     Patent Linkage

Taiwan currently does not have a patent linkage system. A Chapter 4-1 (Articles 48-3 to 48-22) titled Patent Linkage and other relevant articles (Articles 92-1, 100, 100-1, and 106) are added to the draft bill of the PAA. These newly added articles concern patent listings, patent declarations certified by an applicant filing an Abbreviated New Drug Application (ANDA), notification of the ANDA filing to the New Drug Application (NDA) holder, stay of issuing market approval to the generics by the TFDA, and marketing exclusivity provision conferred to the first ANDA applicant who successfully defends a patent infringement suit.

(1)  Patent Listings

According to Article 48-3 of the draft bill, an NDA holder can list patents that cover the drug within 45 days from the day after collecting an NDA market approval.  Drug substance patents, composition or formulation patents, and medical use patents can be listed.  For medical use patents, the claim numbers should be indicated.  As clarified in Article 48-21, for the above patents that have not expired before the draft bill takes effect, the NDA holder can list the patents within three months after the bill takes effect.

a.      Article 48-4 provides that certain information (such as patent number, patent expiry date, patentee and exclusive licensee) on the above-mentioned patents should be submitted and that, if the NDA holder is different from the patentee, the NDA holder should obtain the patentee’s consent.  For those patents that are registered with exclusive license, the consent from the exclusive licensee would suffice.

b.     If a patent is granted after the issuance of market approval by the TFDA, Article 48-5 provides that the patent should be listed within 45 days after patent publication.

c.      According to Article 48-6, if there is a patent term extension, post-grant amendment, patent revocation, patent extinguishment, or change of patentee information or exclusive licensee information, such change should be submitted to the TFDA within 45 days after its occurrence.

d.     Article 48-7 of the draft bill provides that any third party who alleges that the listed patent information is incorrect can notify the TFDA with a written explanation and evidence attached.  The TFDA will notify the NDA holder of the third party’s notification and relevant documents within 20 days of receipt of the notification.  The NDA holder should submit a written reply within 45 days after receipt of the notification. 

e.      As required by Article 48-8, the TFDA should publish and/or update the patent information provided by the NDA holder and/or as updated pursuant to Articles 48-6 and 48-7 mentioned above.

(2)  Patent Certifications Certified by ANDA Filer

According to Article 48-9 of the draft bill, when an ANDA applicant submits an ANDA application, the ANDA applicant should simultaneously select the following as a declaration for each of the listed patents claimed by the NDA holder:

              i.          No patent information has been listed for the new drug;

            ii.          The patent corresponding to the new drug has extinguished;

          iii.          The TFDA will issue the generic market approval after the extinguishment of the patent(s) corresponding to the new drug; and

           iv.          The patent corresponding to the new drugs should be revoked or will not be infringed by the generic drugs for which market approval is sought.

(3)  Notifying NDA Holder and Staying Market Approval to Generics

According to Article 48-12 of the draft bill, the ANDA applicant having a declaration of Item (iv) of Article 48-8 shall inform the NDA holder and the TFDA in writing within 20 days after the day that all the required documents required for filing the market approval have been completed and well-prepared.  If the NDA holder is different from the patentee or exclusive licensee, the ANDA applicant should inform the patentee or exclusive licensee as well.  Under Article 48-13, after the NDA holder, patentee or patent exclusive licensee receives the notification, it can file a patent infringement suit within 45 days after the receipt of the notification under Article 48-12 of the draft bill.

Based on the same Article 48-13, the TFDA shall stay the issuance of the market approval within 15 months after the patentee or patent exclusive licensee receives the notification and files a patent infringement lawsuit.  However, the stay can be lifted if the ANDA applicant obtains a court judgment that the patent has not been infringed or a decision revoking the patent issued by the Intellectual Property Office, if there is a settlement between the parties or if the patent is extinguished.

(4)  Marketing Exclusivity to First Successful ANDA Applicant

According to Article 48-16 of the draft bill, the first ANDA holder who successfully defends a patent infringement suit is granted a twelve-month period of marketing exclusivity.  The TFDA shall not issue a market approval to other applicants for generic market approval until the expiration of the aforementioned 12-month period.  The generic should launch the generic drug within 6 months after receipt of the market approval under Article 48-17.

However, under Article 48-18 of the draft bill, if the first ANDA holder fails to market the drug within 6 months after issuance of market approval, it will forfeit the 12-month period of marketing exclusivity.

(5)  Competition Law Concerns

Article 48-19 of the draft bill also states that the TFDA should be notified of any settlement agreement on patent linkage-related arrangements between the NDA holder and the ANDA applicant or the first ANDA holder. The TFDA should establish guidelines on the details of such notification in the future. If the TFDA notices anypotential anti-competition arrangements in such agreements, it shall transfer the matter to the Taiwan Fair Trade Commission (TFTC) for handling.


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