Setbacks in Regulatory Data Protection Confront Innovative Drug Developers in the Russian Federation

• Author: Bruce McDonald - Vladislav Ugryumov - Denis Kolesnikov
• Position: Partner, Gowling WLG, 11 Gogolevsky Boulevard, Moscow, 119019 Russia, tel. +7 495 787 2073, vladislav.ugryumov@gowlingwlg.com. - Associate, Gowling WLG, 11 Gogolevsky Boulevard, Moscow, 119019 Russia, tel. + 7 495 787 2073.
• Pages: 171-194

Setbacks in Regulatory Data Protection Confront

Innovative Drug Developers in the Russian

Federation

B

RUCE

M

C

D

ONALD

,* V

LADISLAV

U

GRYUMOV

**

AND

D

ENIS

K

OLESNIKOV

***

A December 2015 court decision by the Intellectual Property Court (IPC)

of the Russian Federation, affirmed by the Russian Supreme Court on May

26, 2016, has introduced significant legal uncertainty for innovative drug

developers in the Russian Federation.

1

In Novartis AG v. BioIntegrator, the

IPC limited the scope of regulatory protection for investigative data filed in

support of an application for marketing approval of a new drug, holding that

such protection is limited to undisclosed data, and does not include data that

was filed by the developer in support of its application and published in

medical journals.

2

The IPC holding significantly curtailed the ability of

drug developers to prohibit the manufacturers of a generic or biosimilar

copy of the innovative drug from using their data to support its own

competing application. In October 2016, the Russian Ministry of Health

proposed amendments to the Law on Circulation of Medicines that would

codify the ruling,

3

and in January 2018, the Government of the Russian

Federation released a comprehensive “Roadmap for Competition in

Healthcare” that will accelerate such initiatives.

4

* Partner, Smith, Gambrell & Russell, LLP, 1055 Thomas Jefferson St., N.W., Suite 400,

Washington, D.C. 20007, tel. (202) 263-4362, bmcdonald@sgrlaw.com. The authors of this

Article received partial research funding from the Pharmaceutical Research and Manufacturers

of America, which represents the innovative biopharmaceutical industry. The views expressed

in this Article are solely those of the authors.

** Partner, Gowling WLG, 11 Gogolevsky Boulevard, Moscow, 119019 Russia, tel. +7 495

787 2073, vladislav.ugryumov@gowlingwlg.com.

*** Associate, Gowling WLG, 11 Gogolevsky Boulevard, Moscow, 119019 Russia, tel. + 7 495

787 2073.

1. See Lisa L. Mueller, Current State of Data Protection and Exclusivity in Russia,

T

HE

N

ATIONAL

L

AW

R

EVIEW

(Dec. 30, 2015), https://www.natlawreview.com/article/current-state-

data-protection-and-exclusivity-russia.

2. Id.

3. Anna McDonald, Changes in the Regulatory Control of the Pharmaceutical Market – Q1 2016

Review,

L

EXOLOGY

(May 11, 2016), https://www.lexology.com/library/detail.aspx?g=809cb41f-

401c-4e26-912a-835ba6540ed8.

4. Government of the Russian Federation, Roadmap for Development of Competition in

Healthcare, January 12, 2018, No. 9-r, http://static.government.ru/media/files/vyoWQD6EZY

QkBaqKfKFKAPZqqgtmcHDH.pdf (last accessed 02/14/2018).

THE INTERNATIONAL LAWYER

A TRIANNUAL PUBLICATION OF THE ABA/SECTION OF INTERNATIONAL LAW

PUBLISHED IN COOPERATION WITH

SMU DEDMAN SCHOOL OF LAW

172 THE INTERNATIONAL LAWYER [VOL. 51, NO. 2

This Article examines the statutory protection of data submitted by drug

developers to obtain regulatory approval in the United States and the

European Union, the protection afforded under the Agreement of the

World Trade Organization on Trade-Related Aspects of Intellectual

Property (TRIPS),

5

and explains why the Novartis decision is in conflict with

TRIPS and damaging to the prospects of innovation in the Russian

pharmaceutical market.

I. Vulnerability of Innovative Drug Developers to Curtailment

of the Patent Term

All of the developed countries and most of the developing countries in the

world regulate the approval and registration of pharmaceutical products and

have statutory requirements to ensure the quality, safety, and effectiveness of

medicines.

6

Of these, the majority provide innovative drug developers with

a statutory period of exclusive rights to the use of the data that they submit

to the government in support of such registration.

7

The reason for protecting such data for a limited period of time is that the

development of innovative medicines is exceptionally lengthy, expensive, and

risky.

8

A developer seeking approval of a new drug must begin with an

investigational new drug application,

9

including detailed data and reports of

all animal and non-clinical testing performed on the drug.

10

Physicians,

pharmacologists, chemists, microbiologists, and statisticians must review all

laboratory testing, including pharmacology and toxicology reports.

11

Only

after the government has seen and approved these reports can clinical trials

5. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994,

Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S.

299.

6. See generally Litovkina, Rezhim eksklyuzivnosti issledovatel’nikh dannikh: mezhdunarodnyi opit i

rosiiskoe zakonodatel’stvo [Modes of Exclusivity for Research Data: International Experience and

Russian Law] 4

M

EDITZINSKOE

P

RAVO

(2011) (Russ.).

7. International Federation of Pharmaceutical Manufacturers & Associations, Data

Exclusivity: Encouraging Development of New Medicines (2011), https://www.ifpma.org/wp-

content/uploads/2016/01/IFPMA_2011_Data_Exclusivity__En_Web.pdf.

8. See Henry Grabowski et al., Updated Trends in U.S. Brand-Name and Generic Drug

Competition, 19

J. M

ED

. E

CON

.

836 (2016).

9. The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective,

U.S. F

OOD

& D

RUG

A

DMIN

.

, https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm (last

visited Nov. 6, 2014).

10. 21 U.S.C. § 355(b)(1) (2016); Investigational New Drug (IND) Application,

U.S. F

OOD

&

D

RUG

A

DMIN

.

, https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevel

opedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm (last

visited Oct. 5, 2017).

11. 21 U.S.C. § 355(n)(3)(b); 21 C.F.R. § 56.107;

S

USAN

T

HAUL

, C

ONG

. R

ESEARCH

S

ERV

.,

R41983, H

OW

FDA A

PPROVES

D

RUGS AND

R

EGULATES

T

HEIR

S

AFETY AND

E

FFECTIVENESS

5

(2012).

THE INTERNATIONAL LAWYER

A TRIANNUAL PUBLICATION OF THE ABA/SECTION OF INTERNATIONAL LAW

PUBLISHED IN COOPERATION WITH

SMU DEDMAN SCHOOL OF LAW