PHARMACEUTICAL PATENT CONCENTRATION, 1980-2019

ABSTRACT Drug patent litigation settlements specify a date for generic entry and typically include a so-called acceleration clause allowing the generic to enter earlier in certain circumstances. An agreed-upon date between a brand and a generic with “first-filer” status is particularly salient because this date also affects when other generics may enter. It has been unclear the degree to which acceleration clauses increase competition—by accelerating entry—or decrease competition, by deterring pursuit of entry by potential generic competitors. This paper documents the entry outcome after first-filer-brand settlements by tracking how often acceleration clauses in these settlements in fact accelerate entry. In no case was a first filer’s 180-day exclusivity period accelerated because of a later filing generic winning patent litigation or settling for an earlier entry date. In the cases where early entry occurred, the first filer had lost its right to the exclusivity period, typically by failing to receive tentative FDA approval within 30 months of its filing; or other generics shared first-filer status. An acceleration clause paired with the 180-day exclusivity period appears to effectively deter other generics and, at least in the instances we observed, never to have resulted in an actual “accelerated” entry.

Download Full-text

Global Spread of Pharmaceutical Patent Protection: Micro Evidence from the International Equivalents of Drug Patents in Japan

Millennial Asia ◽

10.1177/0976399616686864 ◽

2017 ◽

Vol 8 (1) ◽

pp. 26-47

Author(s):

Yoshimi Okada ◽

Sadao Nagaoka

Keyword(s):

Patent Protection ◽

Substantial Effect ◽

Chemical Substance ◽

European Patent ◽

Patent Laws ◽

Pharmaceutical Patent ◽

Global Spread ◽

Year 2000 ◽

Substantial Heterogeneity ◽

Drug Patents

We investigate the global spread of pharmaceutical patent protection as acquired by firms, based on a novel global patent database for all significant medical drugs, including biologics, introduced in Japan. It gives us the propensity of filing and grant rate for each country for patents granted in Japan. The major findings of the study are as following. Both the filing propensity to and the grant rate of major Asian countries approached those of the OECD economies by the early 2000s for chemical substance inventions. However, substantial heterogeneity with respect to other drug inventions still exists, specifically, crystal, use, formulation or combination, suggesting significant future room for international harmonization of patent granting standards. We found clear evidence of policy impact on the spread of protection for the two largest non-OECD economies. The amendments to Patent Laws in China in 1993 had an immediate and significant impact on patent filing propensity to China (30 percentage points increase), before accession to the WTO in late 2001. Furthermore, India’s ‘mailbox application system’ had a substantial effect as filing propensity reached 80 per cent of the number of corresponding European patent applications around year 2000, prior to implementing the Trade-Related Aspects of Intellectual Property Rights for drug patents in 2005. Subject classification codes: O34, O38, K29

Download Full-text