Drake, partial part 2

Panel 2: Patent Law I  [my apologies; had to step out during this]

Prof. Joshua Sarnoff, DePaul University College of Law

Governmental Innovation Mechanism Choices (with reference to Climate Change)

Patents and IP rights are part of national choices for tech development, a decision set which also includes direct development and investment.  R&D can provide push (demonstration and stimulus for market development with reduction of risk of market entry); pull mechanisms can assure scale for private R&D investments and decrease market risks through contractual mechanisms, including terms about ownership of IP or nonrestrictive licensing of IP.  Trade concerns include discrimination favoring local industry.  But the basic issue is that we just don’t know whether and in what forms these mechanisms are effective.

Direct development: national labs; integovernmental collaborations.  Again, empirical knowledge is uncertain about comparative benefits.  Direct and indirect subsidies (tax treatment), production/market subsidies; foreign aid can be thought of as a subsidy.  Market distortions—oil and gas subsidies.  Again, trade concerns about preferential treatment.

What else encourages/discourages entry into a market?  Recognition and certification; disclosures; private industry measures compelled by threat of market intervention.  Other possibilities: nationalization; “crown use”; operational controls like provision of service mandates and interoperability mandates; entry and merger regulation; price controls; statutory and compulsory licensing.

Natural experiments?  Bayh-Dole replicating around the world, but it’s hard to compare because people aren’t trying alternatives.  Governments could explicitly try different options in different sectors or markets.

Prof. Shine Tu, West Virginia University College of Law

Unluck/Luck of the Draw: An Empirical Analysis of Examiner Allowance Rates

Anecdotally, some examiners are known to be tougher than others; saw an examiner take pride in 0% allowance rate.  Us v. them attitude.  Study attempted to quantify behavior by coding every issued patent over 10 years, about 1.7 million.  Backlog was nearly 700,000 as of Aug. 2011, and number of applications has grown to over 500,000 in 2010. First office action pendency is 27.2 months. 6775 examiners at PTO; $1.4 billion. Are we getting our money’s worth?

Primary examiners (more than 5 years experience) allow many more patents than secondary examiners (less experience/don’t have signatory authority); take less time to issue patents; a significant proportion of secondary examiners have a very low allowance rate, less than 5 patents/year.  Significant proportion of primary examiners have very high allowance rate, more than 50/year for 3 or more years.

Allowance rate 1993-1999 was 66%, and now 54% according to PTO. Adjusting for continuations, one study says 85%; other studies estimated 47% and 68-78%.  There is no “correct” allowance rate since the standard of patentability has to be met.  His rates match up with PTO’s; not corrected for divisions and continuations.  Examiners get less time to review patents as they gain experience.

Is the “add new examiners” strategy going to work?  Doesn’t seem like it from the data.

What about litigation analysis? Tried to match litigated patents with examiners, found about 2100.  Overwhelmingly, primary examiners were issuing patents that were litigated.  Weighting by # of patents, though, we see different results—primary examiners sometimes do better and secondary examiners sometimes do better. 

Prof. V.K. Unni, Indian Institute of Management Calcutta (India)

Evolution of a TRIPS Compliant Patent Regime: Learning from the Indian Experience

India initially had barriers to foreign trade and foreing investment, in the interest of self-reliance.  In 1991, India almost went bankrupt.  WTO/TRIPS entry followed.  The main effect was on patents, not copyright/TM/designs.  Many Indian pharmacos developed expertise in reverse engineering.  But with TRIPS becoming fully effective in 2005, Indian companies had to retool to survive. Many were active in the US market.  Explosion of patent litigation, including over the concept of inherent anticipation, which comes up in a lot of US/UK pharma cases as well. 

Some Indian companies are still aggressive believing they can strike down a pharma patent.  Voluntary licensing is less common because patent holders impose restrictive conditions. Recently, March 9 case, the patent controller issued India’s first compulsory license for a pharma product—an anti cancer drug.  Finally, Indian companies target the US market with ANDAs.

India has fully complied with TRIPS, demonstrating that full compliance can coexist with flexibility.