Newsletter
Update on Draft Amendments to Pharmaceutical Affairs Act
Update on Draft Amendments to Pharmaceutical Affairs Act
1. 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.
2. 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.
3. 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 any potential anti-competition arrangements in such agreements, it shall
transfer the matter to the Taiwan Fair Trade Commission (TFTC) for handling.