Patent Term Extension in Patent Term Extension in Patent Term Extension in Patent Term Extension in

KoreaKoreaKoreaKorea

Yoon Suk ShinYoon Suk ShinYoon Suk ShinYoon Suk Shin

October 22, 2012October 22, 2012October 22, 2012October 22, 2012

11

Contents

• Patent Term Extension (PTE) System

• History of the PTE System

• Patents Eligible for PTE

• Requirements for Filing a PTE Application

• Scope of PTE

• PTE Cases

• Extendible Term

• Invalidation of PTE

• Statistics of PTE Applications and Grants

• Proposed Revisions to Patent Law and Implementing Decree Relating to PTE

• Case Law – First Approval

• Questions

Patent Term Extension (PTE) System

• Prior to working an invention relating to a medicine or an agrochemical, the patentee

who has acquired a patent for the invention must complete tests on efficacy and safety

of the invention and obtain approval or registration from the relevant authorities.

• Since these procedures require a period of time to complete, the term for working a

patent relating to a medicine or an agrochemical is inevitably shorter than that for other

patents.

• In order to compensate for this disadvantage, a PTE system was introduced.

• According to this system, the term of a patent relating to a medicine or an agrochemical

can be extended for up to five (5) years, so long as certain requirements are met.

Original Patent Term Extended Term Term for Working the Patented Invention

Patent Registration Approval Patent Term

Expiration

1

History of the PTE System

• The system came into effect as of July 1, 1987 upon

introduction of patents for chemical compounds.

– 1987: Approval-after-Petition

– 1990: Application for Patent Term Extension

• Korea is the second country in the world to have

adopted the PTE system.

(US: 1984; Japan: 1988; EU: 1993)

2

Patents Eligible for PTE

• Patents for which approval or registration under other

laws or regulations was obtained prior to working

• Patents for which a lengthy safety testing period is

required for obtaining approval or registration under

other laws or regulations

• Patents relating to medicines that require marketing

approval under Article 26(1) or Article 34(1) of the

Pharmaceutical Affairs Act

• Patents relating to agrochemicals or raw materials that

require registration under Article 8(1), Article 16(1) and

Article 17(1) of the Agrochemicals Management Act

• Patents for Substance, Process, Use, and Composition

3

Requirements for Filing a PTE Application

• Only a valid patent is eligible for PTE.

• A patentee can apply for PTE.

• Marketing Approval (MA) should be granted to the patentee

or to an exclusive or non-exclusive licensee.

• PTE can only be applied within 3 months from the date

approval or registration is obtained, but at least 6 months

before the expiry of the patent term.

[Example]

For the same effective ingredient contained in one patented product,

approvals for the final medicine and the raw material medicine were

obtained at different times. In such case, a PTE application must be

filed within 3 months from the date the first approval was obtained.

4

Requirements for Filing a PTE Application

• The claims of a patent subject to PTE must describe the effectiveingredients.– Where the claims are directed to a substance, the composition of the

claimed substance must be identical to the composition of the substancefor which approval has been obtained.

– Where the claims are directed to a process, the composition of asubstance that can be produced by the claimed process must be identicalto the composition of the approved substance.

– Where the claims include two or more inventions, the claimed inventionsmust contain the same substance as the approved substance, and theextended patent term will only be effective with respect to the approvedsubstance.

– Where the claims defines a use that is different from the use of theapproved substance, the claimed use must be identical to that of theapproved substance.

• PTE is granted based on the first MA with respect to the patent.

5

Scope of PTE

• Extended patent term will only be effective with respect to the approved substance and use.

• Only effective with claims directed to the approved substance and use

• Where the claims include two or more inventions, the extended patent term will only cover the invention relating to the approved substance.

• If the substance and use are the same, the scope of the PTE can be extended to a different formulation in terms of usage or dosage.

6

PTE Case 1

• Where a plurality of approvals were obtained for a plurality

of effective ingredients claimed in a patent,

PTE can only be granted once for only one of the approvals.

7

PTE Case 2

• Where a plurality of approvals were obtained for one

ingredient claimed in a patent,

PTE can only be granted for Approval A.

8

PTE Case 3

• Where one approval was obtained for a plurality of patents,

PTE can be granted for each of the Patents A, B and C relating

to Approval D.

9

Extendible Term

Where clinical tests (or bridging tests) were performed in Korea

10

Extendible Term

Where clinical tests (or bridging tests) for a new drug

developed outside of Korea were performed outside of Korea

• If approval or registration was obtained on or after June 17, 2005,

– The extendible term will only include the period for administrative procedures required

to obtain the approval or registration and not the period for supplementing the PTE

application.

• If approval or registration was obtained before June 17, 2005 or if approval

or registration has been requested but not yet obtained,

• The extendible term will include the period for phase III clinical trials conducted in a

foreign country after registration of a patent right and the period for administrative

procedures for obtaining the approval or registration.

• It will be necessary to submit evidence proving that the approval/registration

authorities of the country where the new drug was developed have acknowledged

receipt or approval of clinical data relating to the foreign phase III clinical trials.

• Bridging test result should be submitted.

11

Invalidation of PTE

• PTE can be revoked through an invalidation trial before IPT. – Interested party or examiner

– When revoked, the patent term is deemed never to have been extended.

• Grounds for Revocation– When MA is not necessary to practice the patent

– When the MA holder is not the patentee or the patentee’s exclusive licensee or registered non-exclusive licensee

– When the extended term is greater than the period that the patent could not have been practiced

– When the applicant of the patent term extension is not the patentee

– When an application is not filed by all the owners of the patent

12

Statistics of PTE Applications and Grants

’99 ’00 ’01 ’02 ’03 ’04 ‘05 ’06 ‘07 ’08 ’09 ‘10 ‘11 ‘12 Total

Applns 8 2 12 6 11 22 9 15 26 35 37 33 24 28 268

Grant 7 2 9 6 11 20 9 15 24 29 25 29 10 2 198

As of August 2012

13

Proposed Revisions to Patent Law and

Implementing Decree Relating to PTE

• Patents eligible for PTE (Article 7 of the Implementing Decree)

- Patents relating to a new substance having a novel chemical structure or

a novel composition for which approval or registration was first obtained

• A new dosage form of a known active ingredient is not eligible for PTE.

• A combination drug is eligible for PTE, but only if it contains a new activeingredient.

• The provision stating “a lengthy period has been taken to complete theactivity tests, safety tests, etc.“ was amended. Specifically, the term“lengthy” was deleted to comply with the practice of calculating theextendible term on a daily basis. (Article 89 of the Patent Act)

• The revisions are expected to be enacted in 2013.

14

Case Law – First Approval

• PTE can only be granted based on the first approval.– IPT Decisions (2009 Won 3927, 3928)

– A formulation comprising a hyaluronic acid and a human growthhormone

– Approvals• 1st: Diclase for treating diseases in adults resulting from a deficiency in

growth hormone

• 2nd: Eutropin Plus for treating growth deficiency in a child due to lack ofgrowth hormone from the pituitary glands

– The two medical uses in the first and second approvals, namely, fortreating diseases resulting from a deficiency in growth hormone, aresubstantially identical. Further, the claims of the patent subject to PTEdo not limit the application of the formulation to an adult or a child.

– New formulations for known ingredient

– PTE cannot be granted based on the second approval.

15

Question 1

• Combination Drugs

– Combination drugs comprising known active ingredients will not likely qualify for PTE according to the proposed revisions to the Implementing Decree of the Patent Act and the general position taken by the Korean Intellectual Property Office.

– MA for A+B combination: PTE can be granted for a claim for A, B or A+B, if it is the first MA.

– MA for A: PTE will not be granted for a claim for A + B.

16

Question 2

• Pediatric Extension

– No discussion yet

17

Question 3

• Biopharmaceutical Products

– PTE is based on the concept that a patented invention

could not be worked after patent registration for a

certain period of time due to time needed to

complete tests on efficacy and safety and to obtain

approval or registration from the relevant authorities.

– Where the investment in the development of

biopharmaceutical products was made before the

filing of a patent application, PTE may not be an

appropriate means to recoup the investment.

18

Question 4

• PTE based on 3rd party marketing approval

– Not allowed in Korea

– MA holder should be a patentee or a licensee of

the patent in Korea.

– No compensation is necessary unless the patentee

attempted to practice the patent and invested

resources to obtain MA.

19

Any Questions?

yshin@leeinternational.com