Facilitating generic drug manufacturing: Bolar exemptions worldwide

• Author: Anthony Tridico - Jeffrey Jacobstein - Leythem Wall
• Position: Partner - Associate - European Patent Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, USA
• Pages: 17-20

p. 17WIPO | MAGAZINE

As the global disease burd en expands, the need for new, more effec tive treatments

is greater than ever. Investing in drug research and d evelopment is, however, a costly,

high-risk endeavor. Patents are intended to offer some gu arantee of a return on in-

vestment, but the patent system is also desig ned to balance the interests of inventors

with those of the public. So, after a patent expires, a patented tec hnology may be

freely exploited by anyone; although c are should be taken to ensure that the re are

no other IP rights associated with th e technology that could imp ede practicing an

invention in this way. In the pharmaceutical indu stry, patents can hinder or prevent

manufacturers of gener ic drugs from entering the market. As with the makers of bra nd

name pharmaceutical products, generics manufacturers need to prove the efcacy

and safety of their products. Th ey can, in certain circu mstances, use eleme nts of

the original manufactu rer’s approval if they demonstrate that their generi c version is

bioequivalent to the approved medicine, but may have to conduct additional trials

on a protected product before its patents expire or are he ld invalid by a court. The

generic manufacture r, therefore, runs the risk of infringing a patent held by a bran d

name manufacturer even if it d oes not plan to enter the market until af ter the patent

expires or is found invalid. Gener ics manufacturers also have to set up and test man-

ufacturing and deliver y capacity before entering a market, creating add itional risks of

infringing a patent held by a brand n ame manufacturer. To overcome this problem,

many countries have put into place legal exemptions (or research exemptions) from

infringement for cer tain acts relating to the developm ent and submission of testing

data to a regulatory agency. These exemptions are of ten referred to as “Bolar” pro-

visions, in reference to a US law enacted to over turn a prior court ruling holding that

the US did not provide for a research exemption – R oche Products, Inc. v. Bolar

Pharmaceutical Co., Inc., 733 F.2d 858 (1984).

Many nations have put similar exemptions i n place, but their nature and scop e vary

signicantly from country to country.

NORTH AMERICA

In the US, the Hatch-Waxman Act establis hed a regulatory framework to encourage

the marketing of generic pha rmaceutical products. T he Act also created a research

exemption, indicating that “it shall not be an a ct of infringement to make, use, offer

to sell, or sell within the United States or imp ort into the United States a patented

invention… solely for uses reasonably related to the development and submission

of information under a Federa l law which regulates the manufa cture, use, or sale of

Facilitating generic drug

manufacturing:

BOLAR EXEMPTIONS

WORLDWIDE

By Anthony Tridico, Partner,

Jefrey Jacobstein, Associate, a nd

Leythem Wall, European Patent A ttorney,

Finnegan, He nderson, Farabow, Gar rett &

Dunner, LLP, USA