Bio­phar­ma's Chi­na plan gets a boost from patent pro­tec­tions sealed in now of­fi­cial trade deal

As in­ter­na­tion­al re­la­tions ex­perts con­tin­ue to cast skep­ti­cism on the “phase one” US-Chi­na trade deal signed Wednes­day, multi­na­tion­al drug­mak­ers found much to be cheer­ful about.

Specif­i­cal­ly, the doc­u­ment in­cludes three pro­vi­sions re­lat­ed to phar­ma­ceu­ti­cal patent dis­pute res­o­lu­tion, patent term ex­ten­sion and coun­ter­feit med­i­cines, promis­ing to strength­en pro­tec­tion for drugs at a time Chi­na’s reg­u­la­to­ry agency has sped up re­views and short­ened the time gap be­tween over­seas and Chi­nese OKs.

“The trade agree­ment has re­solved many long-con­tro­ver­sial is­sues,” Chang Lee, VP of con­sult­ing for the Asia Pa­cif­ic re­gion at the CRO Parex­el, told End­points News. “These changes all re­flect the un­prece­dent­ed pro­tec­tion of drug patents of in­no­v­a­tive drugs, and they are not a small step for­ward.”

For in­stance, he not­ed, one of the key re­view cri­te­ria for biotech IPOs in ei­ther Hong Kong or Chi­nese mar­kets. Any bio­phar­ma look­ing to raise mon­ey via that av­enue could ben­e­fit from the new rules.

The first pro­vi­sion, Ar­ti­cle 1.11, stip­u­lates that Chi­na would set up a mech­a­nism com­mon­ly known as patent link­age in the US, as es­tab­lished in the Hatch-Wax­man Act of 1984. Ac­cord­ing to LEK Con­sult­ing, it func­tions “much like a traf­fic con­trol sys­tem” in­volv­ing the FDA, the USP­TO and the court.

To set it up, Chi­na would need to en­sure three things:

  1. A patent hold­er or li­censee would be no­ti­fied when some­one is look­ing to mar­ket a gener­ic or biosim­i­lar dur­ing the patent term of their ap­proved prod­uct
  2. There is enough time and op­por­tu­ni­ty for the patent hold­er to seek reme­dies be­fore the mar­ket­ing of the al­leged­ly in­fring­ing prod­uct
  3. Pro­ce­dures for ju­di­cial or ad­min­is­tra­tive pro­ceed­ings are in place to re­solve the dis­putes in a time­ly man­ner

Fur­ther­more, ac­cord­ing to Ar­ti­cle 1.12 of the trade deal, Chi­na has com­mit­ted to ex­tend­ing patent terms for un­rea­son­able, lengthy de­lays that aren’t the ap­pli­cant’s fault. The com­pen­sa­tion will not ex­ceed 5 years and the re­sult­ing ef­fec­tive patent term — count­ing from the date of mar­ket­ing ap­proval in Chi­na — will be no more than 14 years.

Last­ly, Ar­ti­cle 1.18 prods Chi­na to take quick ac­tion against coun­ter­feit phar­ma­ceu­ti­cal prod­ucts in­clud­ing API, bulk chem­i­cals or bi­o­log­i­cal sub­stances. Among them is a re­quire­ment to share in­spec­tion in­for­ma­tion with the US and pub­lish da­ta on en­force­ment mea­sures on­line every year, “in­clud­ing seizures, re­vo­ca­tions of busi­ness li­cens­es, fines, and oth­er ac­tions.”

The crack­down on coun­ter­feit med­i­cines come amid in­creased FDA scruti­ny on Chi­nese man­u­fac­tur­ers af­ter a car­cino­gen scare forced a re­call on some com­mon heart pres­sure pills with API from Chi­na.

Fur­ther­more, Lee point­ed out, the deal al­lows su­u­ple­men­tal ex­per­i­men­tal da­ta, which was for­bid­den in the past — mean­ing drug­mak­ers can now add new ev­i­dence to sup­port con­sid­er­a­tion of their patents af­ter they first filed for it.

“Lit­er­al­ly, Ar­ti­cle 1.10 of the Agree­ment is a ma­jor ad­just­ment to the pre­vi­ous sup­ple­men­tary da­ta pol­i­cy,” he said. “This means that no mat­ter whether it is the ex­am­i­na­tion pro­ce­dure of the In­tel­lec­tu­al Prop­er­ty Of­fice, the re­view pro­ce­dure of the Re­ex­am­i­na­tion Board, or the ad­min­is­tra­tive pro­ce­dure, the paten­tee can sup­ple­ment the da­ta.”

On the oth­er end of the spec­trum are ma­jor phar­ma play­ers such as As­traZeneca and Bay­er, for whom Chi­na has be­come a “CEO-lev­el pri­or­i­ty” both for its mas­sive mar­ket and fer­tile ground for drug de­vel­op­ment.

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