Secondary Pharmaceutical Patents: A Global Perspective

Kenneth C. Shadlen (LSE)

[Bhaven N. Sampat (Columbia)]

WHO-WIPO-WTO Trilateral Symposium Panel 3

26 February 2018

Primary vs. Secondary Patents

Compounds Alternative structural forms; formulations, compositions, dosages, combinations; uses • Not processes

Primary Patents are applied for earlier and are usually stronger legally

Why File for Secondary Patents?

Sequential accumulation of patents on alternative dimensions of existing molecules and drugs can extend periods of market exclusivity.

Love it or Hate it

Responding to the Challenges of Secondary Patents

Litigation Examination

Responding to the Challenges via Examination: National Responses

India • Allows product patents in 2005 • Section 3(d) • Explicit: No secondary patent unless enhanced efficacy

Brazil • Allows product (and process) patents in 1997 • Dual examination system, INPI and ANVISA (2012 change) • De facto restriction on secondary patents

Argentina • Allows product patents in 2000 • Revisions to examination guidelines • Second uses not patentable (2001-- ); highly restrictive (2012 --)

National Policies in the Spotlight

India, Brazil, and Argentina • Different designs; functional equivalents • Grant pharma patents, as per WTO/TRIPS, but curb secondary Intelligent Compliance or Mock Compliance? • “Counter-hegemonic” approach to meeting obligations • Violating spirit – if not letter – of TRIPS

– Especially IN/BR, less attention to AR

Heat vs. Light… • What do measures to curb secondary patents achieve? Research!

1. International applications (PCT) that may be filed nationally – 2000-2002; filings in EU/JP/US; Jan-July – N=5,193

2. Code primary vs. secondary – Coding guide; expert consultant; coding individual claims but

classification at patent level (any “primary” claim = “primary”) – Primary 38%, Secondary 62%

3. Identify national applications and outcomes in 6 “countries” – 3 with systems to address secondary patents (IN, BR, AR) – 3 developed (EU, Japan, US)

4. Brazil, India, Argentina: Detailed outcomes, prosecution histories, fieldwork

Data

Grant Rates by Country

overall

“twins”

Detailed Outcomes for Secondary Applications

Backlog as Filter? Backlog as de facto “Deferred Examination” System?

Possible Indirect Effects

On Filing

• Deterrent?

– but these applications filed before systems fully in place

On Granting

• India: Changes how examiners approach applications, in general (new world view)?

• Brazil: INPI examiners act differently because of ANVISA (second set of eyes)?

• Argentina: Codification of pre-existing practices?

Conclusions

Restrictions on secondary patents per se having minimal direct effects on secondary patenting outcomes • Secondary grant rates (relative to primary) not less in

countries with restrictions than without restrictions • Argentina different, but even there a small part

Why so much attention to 3(d) and Prior Consent? • Possibilities of emulation (fear/hope) • Appreciation and abhorrence of deviation from norm • Symbolism: not what they do but what they mean • Indirect effects

Thank you

Ken Shadlen

• k.shadlen@lse.ac.uk

Bhaven N. Sampat and Kenneth C. Shadlen, “Secondary pharmaceutical patenting: A global perspective,” Research Policy, Vol. 46, No. 3 (April 2017), pp. 693-707.

Extra slides

Grant rates for secondary applications by family size

Grant rates for secondary applications by US status