Aus­tralian Sen­ate Com­mit­tee rejects Bill that seeks to pre­vent the patent­ing of human genes

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In Brief

The Aus­tralian Sen­ate Com­mit­tee Report on pro­pos­als to amend the Patents Act to pro­hib­it patent­ing of human genes and oth­er bio­log­i­cal mate­ri­als exist­ing in nature has made a sin­gle rec­om­men­da­tion ​“that the Sen­ate should not pass the Bill”.

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On 26 Novem­ber 2010, the Sen­ate referred the Patent Amend­ment (Human Genes and Bio­log­i­cal Mate­ri­als) Bill (Bill) to the Legal and Con­sti­tu­tion­al Affairs Leg­is­la­tion Com­mit­tee for inquiry and report.

As part of the inquiry, the Com­mit­tee held two pub­lic hear­ings and received 122 submissions.

The Com­mit­tee iden­ti­fied the fol­low­ing key issues to be addressed:

• the dis­tinc­tion between dis­cov­er­ies and inventions;
• the scope of the Bil­l’s exclu­sion for bio­log­i­cal materials;
• access to treat­ments, diag­nos­tics and meth­ods for healthcare;
• the free­dom to con­duct research;
• invest­ment in research and development;
• access to new prod­ucts and knowledge;
• eth­i­cal issues with respect to the patent­ing of human genes and bio­log­i­cal materials;
• the Crown use and com­pul­so­ry licens­ing pro­vi­sions of the Patents Act; and
• inter­na­tion­al considerations.

The Com­mit­tee con­clud­ed that:

• the amend­ments pro­posed in the Bill will not assist to clar­i­fy the dis­tinc­tion between dis­cov­ery and inven­tion in the patent sys­tem and may make the dis­tinc­tion more obscure
• the pro­posed exclu­sion for bio­log­i­cal mate­ri­als which are iden­ti­cal or sub­stan­tial­ly iden­ti­cal to such mate­ri­als ​“as they exist in nature” is like­ly to have sig­nif­i­cant impli­ca­tion on broad range of sec­tors and indus­tries, includ­ing health­care, phar­ma­ceu­ti­cals, agri­cul­ture, food man­u­fac­tur­ing and biotechnology
• the pro­posed exclu­sion for bio­log­i­cal mate­ri­als would also have sig­nif­i­cant adverse con­se­quences for health­care in Aus­tralia because it could poten­tial­ly include long delays for patients to access new diag­nos­tic tests, med­i­cines and treat­ments, reduced access for Aus­tralian patients to clin­i­cal tri­als and a reduc­tion in invest­ment for med­ical research and devel­op­ment in Australia
• the pro­posed exclu­sion for bio­log­i­cal mate­ri­als does not pro­vide any cer­tain­ty for researchers seek­ing an exemp­tion from infringe­ment for research and exper­i­men­tal activ­i­ties relat­ing to patent­ed inventions
• the evi­dence the Com­mit­tee received indi­cates that patents over human genes and bio­log­i­cal mate­ri­als have not hin­dered research, par­tic­u­lar­ly med­ical research and that the ambigu­ous nature of the Bil­l’s pro­vi­sions could neg­a­tive­ly affect invest­ment in research and devel­op­ment in Australia
• there is a risk that, with­out cer­tain­ty in rela­tion patent pro­tec­tion for bio­log­i­cal mate­ri­als, com­pa­nies will have less incen­tive to devel­op and com­mer­cialise new prod­ucts for the Aus­tralian market
• there are eth­i­cal dimen­sions to the issue of patent­ing human genes and bio­log­i­cal materials
• the enact­ment of the Bill could breach Aus­trali­a’s inter­na­tion­al oblig­a­tions under the TRIPS Agree­ment and the US Free Trade Agree­ment to allow for the patent­ing of inven­tions in ​“all fields of tech­nol­o­gy” with­out discrimination
• the Crown Use and com­pul­so­ry licens­ing pro­vi­sions in the Patents Act can effec­tive­ly influ­ence patent-hold­er behaviour.

In the end, the com­mit­tee did not agree that the Bill rep­re­sents ​“an effec­tive solu­tion to the prob­lems which may be caused by patents over human genes and bio­log­i­cal mate­ri­als. In par­tic­u­lar, the com­mit­tee is con­cerned that pro­posed amend­ments in the Bill, which are focused on address­ing a spe­cif­ic issue, could have a large num­ber of unin­tend­ed con­se­quences across the entire patent sys­tem with inde­ter­mi­nate impacts on a range of indus­tries and sec­tors … Despite the need for fur­ther reform to the patent sys­tem, the com­mit­tee agrees that remov­ing an area of patentable sub­ject mat­ter, as pro­posed by the Bill, is not an appro­pri­ate solu­tion to this com­plex set of issues.”

See the full report — Aus­tralian Sen­ate Com­mit­tee Report