© 2009 Pharmaceutical Law Group PC Market Exclusivity Paradigm Gregory J. Glover, MD, JD...

© 2009 Pharmaceutical Law Group PC

Market Exclusivity Paradigm

Gregory J. Glover, MD, JD

Pharmaceutical Law Group

[email protected]

www.pharmalawgrp.com


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Market Exclusivity ParadigmOverview

These slides will provide a graphic presentation of the market protection paradigm using a hypothetical representative example.

Topics covered include:

A. the relative timing of patent protection and regulatory approval;

B. five-year and three-year new product exclusivity (often described as data exclusivity);

C. Orphan Drug Exclusivity;

D. Patent Term Restoration;

E. Pediatric Exclusivity; and

F. Hatch-Waxman Patent Litigation and the operation of the 30-month stay.


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Our example is a product with one patent.

In this example, a provisional application was filed, the utility (regular) application was filed within a year, and the patent was issued within three years.

The patent term is 20 years from the date of filing.

Note that the IND became effective – a requirement for the start of clinical trials – after the patent issued and many years after the patent filing. This scenario is often the case because companies file patent applications before knowing that a product will be suitable for clinical trials.

In this example, the NDA is filed four years after the IND became effective, and the NDA is approved one year after the NDA filing.


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Original Patent Term - 20 years

IND Effective

NDA Filed

NDAApproved

Patent Application

Filed Patent Issued

ProvisionalApplicationFiled

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


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IND Effective

NDA Filed

NDAApproved

Patent Application

Filed Patent Issued


Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


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8



IND Effective

NDA Filed

NDAApproved

Patent Application

Filed Patent Issued


Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


9


If our product is a “new chemical entity,” it will be eligible for 5 years of new product exclusivity.

For five years after NDA approval, FDA cannot accept for filing a generic application (ANDA or 505(b)(2)). However, FDA may accept for filing a generic application that contains a patent certification that the patent is invalid, not infringed, or not enforceable – a Paragraph IV certification.

5-year exclusivity is independent of any patent protection that might be available.


10



IND Effective

NDA Filed

NDAApproved

Patent Application

Filed Patent Issued


Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


11



IND Effective

NDA Filed

NDAApproved

Data Exclusivity, NCE

Patent Application

Filed Patent Issued


Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


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If our product is not a “new chemical entity,” it will be eligible for 3 years of new product exclusivity.

For three years, FDA may not approve a generic application for the same indication or condition of approval as the approved product.

3-year exclusivity is independent of any patent protection that might be available.

A product may be eligible for either 5-year or 3-year exclusivity – but not both.


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IND Effective

NDA Filed

NDAApproved


Patent Application

Filed Patent Issued


Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


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IND Effective

NDA Filed

NDAApproved


Patent Application

Filed Patent Issued

Data Exclusivity, Non-NCE


Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


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If our product also qualifies for Orphan Drug Exclusivity – generally, a product for treating fewer than 200,000 patients in the United States per year – then, our product is eligible for 7 years of market exclusivity following product approval.

During the 7-year period, FDA cannot approve the same drug for the same indication – even if the second applicant generates completely independent data.


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IND Effective

NDA Filed

NDAApproved


Patent Application

Filed Patent Issued



Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


17



IND Effective

NDA Filed

NDAApproved


Patent Application

Filed Patent Issued



Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26

Orphan Drug Market Exclusivity


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Patent term restoration is designed to restore to the patent term some of the time that was lost in the process of satisfying the requirements for regulatory approval.

If our patent and our product meet the requirements for patent term restoration, the duration of the restored is calculated as one-half the period in clinical trials – from the IND effective date to the filing of the NDA -- plus the entire period of FDA review.

The restored period cannot exceed 5 years, and the patent life following product approval cannot exceed 14 years.

For our product, the restored term is 3 years -- 2 years (one-half of the 4-year clinical trials period), plus one year of regulatory review.


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IND Effective

NDA Filed

NDAApproved


Patent Application

Filed Patent Issued



Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26



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IND Effective

NDA Filed

NDAApproved


Patent Application

Filed Patent Issued



Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


Patent Term Restoration


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If our product is eligible for Pediatric Exclusivity – because the drug sponsor completed studies in accordance with a Written Request from FDA – then, our product is eligible for an additional six-months of exclusivity added on to any other exclusivity that has not expired.

For example, 5-year exclusivity becomes 5 years and 6 months; 3-year exclusivity becomes 3-years and six-months; and 7-year Orphan Drug exclusivity becomes 7 years and 6 months.

With respect to patent protection, the generic applicant must certify that the expiration date of any patent is six months later than the actual expiration date. Accordingly, any generic applicant that is waiting for patent expiration before marketing its product will need to delay marketing for an additional six months.


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IND Effective

NDA Filed

NDAApproved


Patent Application

Filed Patent Issued



Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


PTR


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IND Effective

NDA Filed

NDAApproved


Patent Application

Filed Patent Issued



Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


PTR

Pediatric Drug Patent Certification


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IND EffectiveNDA

Approved

Pediatric Drug Exclusivity, NCEData Exclusivity,

NCE

Patent Application

Filed Patent Issued



PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


NDA Filed

Market Exclusivity


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IND EffectiveNDA

Approved


NCE

Patent Application

Filed Patent Issued

Pediatric Drug Exclusivity, Non-NCEData Exclusivity,

Non-NCE


PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


NDA Filed

Market Exclusivity


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IND EffectiveNDA

Approved


NCE

Patent Application

Filed Patent Issued

Pediatric Drug Exclusivity, Non-NCEData Exclusivity,

Non-NCE


PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26


Pediatric Drug Exclusivity

NDA Filed

Market Exclusivity


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The Effective Patent Life is the period of patent protection following product approval – after taking into consideration any applicable Patent Term Restoration and Pediatric Exclusivity. The Effective Patent Life is substantially shorter than the original 20-year patent term.


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IND Effective

NDA Filed

NDAApproved

Patent Application

Filed Patent Issued


PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26

Pediatric Exclusivity


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IND Effective

NDA Filed

NDAApproved

Effective Patent Life

Patent Application

Filed Patent Issued


PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26



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The product sponsor must file a patent listing for each patent that claims the product or a method of using the product. These patents are listed in the Orange Book.

A generic applicant must make one of four patent certifications: (i) no patent information was filed; (ii) the patent has expired; (iii) the patent will expire on a specific date, and the generic applicant does not intend to market its product before that date; and (iv) the patent is invalid, not infringed (by the generic product), or not enforceable.

If a generic applicant files an application containing a Paragraph IV certification that the patent is invalid, not infringed, or not enforceable, the generic applicant must provide notice to the patent owner and the sponsor of the original product.


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IND Effective

NDA FiledNDA

Approved

Patent Application

Filed Patent Issued



PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26



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IND Effective

NDA FiledNDA

Approved

Patent Application

Filed Patent Issued


ANDA filed, Notice


PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26



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The act of filing a generic application containing a Paragraph IV certification is deemed to be an act of patent infringement for the purpose of initiating patent litigation.

The patent owner has 45-days (from the notice of an application containing a Paragraph IV certification) to bring a patent infringement suit against the generic applicant.


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Original Patent Term - 20 yearsPediatric Exclusivity

IND Effective

NDA FiledNDA

Approved

Patent Application

Filed Patent Issued


ANDA filed, Notice


PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26



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IND Effective

NDA FiledNDA

Approved

Patent Application

Filed Patent Issued


ANDA filed, Notice

Patent Infringement Suit


PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26



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If the patent owner initiates a patent infringement suit within 45 days, then FDA cannot approve the generic application for 30-months, unless – before that time – the patent is deemed to be invalid, not infringed, or not enforceable.

The 30-month stay nearly always expires before the end of the Effective Patent Life. In most circumstances, a product is eligible for only one 30-month Stay regardless of the number of patents listed in the Orange Book.


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IND Effective

NDA FiledNDA

Approved

Patent Application

Filed Patent Issued


ANDA filed, Notice



PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26



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IND Effective

NDA FiledNDA

Approved

Patent Application

Filed Patent Issued


ANDA filed, Notice


30-monthStay


PTR

Years 1 3 5 7 9 11 13 15 17 19 21 23 25

2 4 6 8 10 12 14 16 18 20 22 24 26



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Summary

– relative timing of patent protection and regulatory approval

– five-year and three-year new product exclusivity

– Orphan Drug Exclusivity

– Patent Term Restoration

– Pediatric Exclusivity

– Hatch-Waxman Patent Litigation, including the 30-month stay


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Gregory J. Glover, MD, JD

Pharmaceutical Law Group PC

900 Seventh Street, NW

Suite 650

Washington, DC 20001

202-589-1780 (telephone)

202-318-2198 (facsimile)

[email protected]

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© 2009 Pharmaceutical Law Group PC Market Exclusivity Paradigm Gregory J. Glover, MD, JD...

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