Exploring the Myth and the Reality of Linkage and Evergreening

Manisha A. Desai, Ph.D. Assistant General Patent Counsel Eli Lilly and Company

Patent Linkage
System to prevent approval of copy products until valid patent disputes are settled.
It requires action by patent-holder
Changes the timing, not the need, for litigation Allows generic applicants to avoid damages

Elements of an effective Patent Linkage system

Notice of a generic application for approval Identification of relevant patents

Preventing approval of infringing products

Opportunity to address patent issues before copy product is approved
Copyright 2012 Eli Lilly and Company 2

9 May 2012 Manisha A. Desai, Ph.D.

MYTH: Linkage Will Result in Compulsory Patent Litigation

REALITY:
Generic applicant largely controls whether there is litigation Linkage allows generic applicant to assess patent protection for a product before significant investments are made into manufacturing and marketing If the generic applicant believes patents preclude early launch of product, linkage actually prevents litigation
Public benefits from avoidance of wasted resources in unnecessary litigation

If generic applicant believes product is not infringing or patent is not valid, linkage only changes the timing of litigation
9 May 2012 Manisha A. Desai, Ph.D. Copyright 2012 Eli Lilly and Company 3

MYTH: Generic Market Entry Will Be Delayed or Eliminated

REALITY:
Review of generic application continues to proceed normally Innovator may choose to forgo litigation entirely
In the US, sanctions for frivolous lawsuits ensure a reasonable basis for litigation (Rule 11, Federal Rules of Civil Procedure)

Linkage provides legal certainty to generic applicant before launch

9 May 2012 Manisha A. Desai, Ph.D.

Copyright 2012 Eli Lilly and Company

Evergreening
MYTH:

Secondary or follow-on patents on improvements prevent generics from commercializing the original product, even after expiration of the original product patent.

REALITY:

Patent can be granted only for inventions that are new, useful and not obvious The secondary patent protects only the improved product, not the original product. Generic applicants are free to market the original product if its patent is expired. Patients benefit from improvements to pharmaceutical products

9 May 2012 Manisha A. Desai, Ph.D.

Copyright 2012 Eli Lilly and Company

Evergreening is a False Premise: A Real-World Example

PROZAC, a first-in-class therapy for major depressive disorder, launched in 1987
Daily dosage regimen, generally 20mg/day
Patent protection expired August 2001

PROZAC Weekly approved February 2001

TM

Separate patent protection for weekly dosing regimen

Generic applicants were free to launch fluoxetine for daily use after expiration of the compound patent

Patients decide whether the new product has value

9 May 2012 Manisha A. Desai, Ph.D.

Copyright 2012 Eli Lilly and Company

THANK YOU

Manisha A. Desai, Ph.D. Assistant General Patent Counsel Eli Lilly and Company www.lilly.com

9 May 2012 Manisha A. Desai, Ph.D.

Copyright 2012 Eli Lilly and Company