Go­ing rogue at the patent of­fice

National Post (Latest Edition) - - FP COMMENT - Richard C. Owens Richard C. Owens is a se­nior Munk fel­low at the Macdon­ald- Lau­rier In­sti­tute and an ad­junct pro­fes­sor at the Univer­sity of Toronto Fac­ulty of Law.

Some­thing’s rot­ten in the Patent Of­fice, a divi­sion of the Cana­dian In­tel­lec­tual Prop­erty Of­fice (CIPO). The of­fice is run­ning roughshod over in­ven­tors’ rights, ar­bi­trar­ily deny­ing pa­tents to a whole class of in­ven­tions: the rapidly grow­ing break­throughs that are med­i­cal di­ag­nos­tic tests. This demon­strates, yet again, that with in­no­va­tion Canada can talk the talk but never walk the walk.

A patent is a 20-year mo­nop­oly to make, sell or use an in­ven­tion. A patent is is­sued by the com­mis­sioner of pa­tents ( cur­rently Jo­hanne Bélisle) in ex­change for the in­ven­tor pub­lish­ing a com­plete de­scrip­tion of the in­ven­tion and how best to im­ple­ment it. This way, so­ci­ety ben­e­fits from knowl­edge of the in­ven­tion and in­ven­tors have an in­cen­tive to in­vent. The Patent Of­fice is ob­li­gated to is­sue qual­i­fy­ing pa­tents. It is an in­ven­tor right. No ifs, ands, buts or pol­icy outs, the Patent Act states “The Com­mis­sioner shall grant a patent for an in­ven­tion … if an ap­pli­ca­tion for the patent in Canada is filed in ac­cor­dance with this Act and all other re­quire­ments for the is­suance of a patent un­der this Act are met.”

Per­haps no tech­nol­ogy is more heav­ily in­ves­ti­gated and hyped at the mo­ment than “per­son­al­ized” or “pre­ci­sion” medicine, the tai­lor­ing of med­i­cal treat­ments to an in­di­vid­ual’s spe­cific ge­netic at­tributes. In­ven­tions un­der­pin­ning per­son­al­ized medicine in­clude di­ag­nos­tic tests. And Cana­dian law is com­pletely clear: di­ag­nos­tic tests are patentable. That’s the l aw. But in prac­tice, they’re not get­ting pa­tents be­cause of a bo­gus Patent Of­fice pol­icy.

This pol­icy is ex­pressed in in­ter­nal “ex­am­i­na­tion guide­lines,” quasi- of­fi­cial, non­le­gal pol­icy state­ments. They avoid pa­tents on di­ag­nos­tics by mis- ap­ply­ing the law of in­ter­pre­ta­tion of patent claims. As guide­line 2015- 02 states “... a di­ag­nos­tic method claim con­strued as con­sist­ing solely of es­sen­tial el­e­ments that are dis­em­bod­ied (e.g., men­tal process, lack­ing phys­i­cal­ity, no prac­ti­cal ap­pli­ca­tion, etc.) will be iden­ti­fied as de­fec­tive for not com­ply­ing with sec­tion 2 of the Patent Act.” In other words, it’s es­sen­tially claim­ing that be­cause the in­ven­tion is a method, it’s not patentable. But this pol­icy breaks the law on in­ter­pre­ta­tion of patent claims as set out by the Supreme Court of Canada ( in a case re­cently brought, and won, by Ama­zon, and in ear­lier cases in­volv­ing Whirlpool and Free World Trust). It breaks the law of patentable sub­ject mat­ter, as up­held by the Supreme Court. It breaks the le­gal obli­ga­tion, again as­serted by the Supreme Court, of the Patent Of­fice not to make pol­icy. And it vi­o­lates statu­tory obli­ga­tions un­der the Patent Act ( un­der which, it might be noted, pe­nal pro­vi­sions may ap­ply against the patent com­mis­sioner and non-com­pli­ant ex­am­in­ers).

Quite a l oad to bear. Nev­er­the­less, the Patent Of­fice sol­diers on its merry way. In spite of the fact that pol­icy- mak­ing by the Patent Of­fice is clearly il­le­gal ac­cord­ing to the Supreme Court — which, along with f e de­ral a nd pro­vin­cial courts, are the ones solely re­spon­si­ble to make le­gal pro­nounce­ments on the Patent Act in Canada — the Patent Of­fice ac­tu­ally has a pol­icy that its ex­am­in­ers should obey pol­icy over law, a pol­icy to which even the Patent Appeal Board has been said to be sub­ject. An in­ven­tor would face years and years of lit­i­ga­tion to pos­si­bly get her due in Fed­eral Court.

But with­out pa­tents, who would in­vest in the dis­clo­sure, costly Health Canada ap­provals as a class- 4 med­i­cal de­vice, and com­mer­cial­iza­tion of a di­ag­nos­tic method? If in­ven­tions do not ad­vance, pa­tients suf­fer and die with­out them. Make no mis­take: ab­sent pa­tents, in­ven­tions stay in the lab. Health cost sav­ings and im- proved out­comes are lost. And Cana­di­ans pay not only for want of health ben­e­fits: it is usu­ally our tax dol­lars that funded the wasted re­search in the first place.

This must stop. In try­ing to get to the bot­tom of this mess, ac­cess- to- in­for­ma­tion re­quests have been made and the re­sults pub­lished on­line. They demon­strate that the over­whelm­ing ma­jor­ity of Patent Of­fice patent ex­am­in­ers in rel­e­vant fields op­pose the pol­icy. They know their le­gal obli­ga­tions. They are frus­trated. But high­erups or­der them to break the law. Why? Hard to say, since ab­so­lutely no good comes of it.

Maybe the Com­mis­sioner of Pa­tents, or other bu­reau­crats in the Min­istry of In­no­va­tion, Sci­ence and Eco­nomic De­vel­op­ment Canada ( to which CIPO re­ports) want to sti­fle di­ag­nos­tic pa­tents out of the com­pletely mis­taken be­lief that they would in­crease health- care costs, but that, with­out pa­tents, they would some­how mirac­u­lously turn into prod­ucts any­way. It wouldn’t be the first time that patent pol­icy has failed health-care re­search. Canada only re­cently over­ruled the prom­ise doc­trine, which was poi­sonous to phar­ma­ceu­ti­cal pa­tents, and has long re­stricted pa­tents on drugs and med­i­cal meth­ods. Any­way, there must be some­one in the Cana­dian gov­ern­ment to whom with­hold­ing the power of pa­tents from an area of sci­en­tific de­vel­op­ment that mat­ters most to peo­ple and their health makes sense.

Per­haps a frus­trated in­ven­tor will sue to make the CIPO obey the law, but Cana­di­ans are not par­tic­u­larly good at that sort of thing. Per­haps a class- ac­tion suit could be ar­ranged, or a man­damus ap­pli­ca­tion, where a court or­ders an agency to stop do­ing some­thing un­law­ful. If the Cana­dian gov­ern­ment were se­ri­ous about in­no­va­tion, it would bring the CIPO to heel. In­ter­nal pol­icy is eas­ily amended. It would also strengthen in­tel­lec­tual prop­erty rights in other ways and go ahead with the IP pro­vi­sions in the Trans- Pa­cific Part­ner­ship pro­pos­als, and ac­cept sim­i­lar pro­vi­sions in NAFTA. But it’s clear that, de­spite what the gov­ern­ment claims, Canada is not se­ri­ous about in­no­va­tion.

MED­I­CAL DI­AG­NOS­TIC TESTS AREN’T GET­TING PA­TENTS BE­CAUSE OF A BO­GUS POL­ICY.

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