All Mixed Up Down Under: Why Australia Should Embrace Robust Regulatory Data Protection in the TPP

The nuances of intellectual property protection are admittedly difficult to understand, but we rely on our elected officials to get these details right, especially when the stakes are so high.  Given this, it is particularly distressing that Australia’s Trade Minister Andrew Robb has gotten it so wrong.

Australia’s Trade Minister recently claimed that Australia’s patent system is better for biologic medicines than the US system because of the US Supreme Court’s Myriad decision which narrowed patentable subject.[1],[2]  The Trade Minister further claims that since Australia has a stronger and better patent system, Australia does not need to alter their regulatory data protection (RDP) term or other components of their IP system for the Trans-Pacific Partnership (TPP).

Australia’s Trade Minister Robb is sorely mistaken and the flaws in his logic could have serious consequences for the TPP Agreement, the future of innovative medicine and global public health.  Australia has made the length of time available for RDP a sticking point in the TPP negotiations.  This intransigence threatens both the future of the TPP and the patients who are awaiting tomorrow’s biologic medicines.

Biologic medicines are inherently different from traditional “small molecule” therapies, which presents a number of new challenges in both the design and enforcement of the intellectual property (IP) architecture that will protect them.[3]  The precision with which biologic medicines must be produced greatly complicates the logistics of protecting their intellectual property.  As a result, patents alone are insufficient for protecting the IP they embody, necessitating RDP as well.  RDP provides a period of time following marketing approval during which competing firms may not use the innovative firm’s data to secure marketing authorization for a biosimilar version[4] of the drug.  The data in question, the safety and efficacy data from proprietary preclinical and clinical trials, is collected from the moment when the compound first shows medicinal promise, a process that is both expensive and time consuming.[5]  Through RDP the innovator firm is granted a period of protection for their investment in clinical trials and data collection, regardless of the length of time required to bring the drug to market.

Contrary to Trade Minister Robb’s assertions, patents and RDP are not substitutes and Australia’s patent protection – however good – does not preclude the need for sufficient RDP for biologic medicines.  Although complementary, patents and RDP incentivize innovation in different ways and serve distinct purposes.  It would serve Trade Minister Robb well to brush up on the distinction.  Patents provide protection for innovations meeting the standards of patentability, innovations that are novel, nonobvious, and useful.  Given the lengthy drug-development and patent-approval processes, effective patent terms rarely correspond to marketing approval.  In some cases innovative therapies may experience patent expiry shortly after making it to market, providing the innovator firm with little chance of recovering the investment that was required to develop the therapy.  Moreover, in the case of biologics, the fact that the subsequent product is only similar to the innovative product makes it potentially easier for a competing firm to design around the patent, while still relying on the innovator’s data to prove the safety and effectiveness of the product.

In contrast, RDP protects the tremendous investments of time, talent, and financial resources required to establish a new therapy as safe and effective and provide some certainty that a biologics manufacturer will have a sufficient period over which they can seek to recoup the significant investments required to bring an innovative biologic to market.  RDP safeguards the clinical trial data for a limited period of time, preventing biosimilar firms from free-riding on the data that was generated at great expense to the innovator.  That is, competing firms looking to obtain regulatory approval may either generate their own preclinical and clinical trial data to establish safety and efficacy, or wait the set period of time (12 years in the U.S.) after which they are able to freely utilize the innovator’s data and prior approval under an abbreviated regulatory approval pathway.

RDP is neither an extension of patent rights nor a substitute for them.  Though they work through different avenues, both serve to incentivize biopharmaceutical firms to invest in the research and development that bring us breakthrough therapies and cures.  If innovative therapies and improving global public health are important to Australia, they should protect biologic medicines with both robust patents and RDP. 

[1] Association for Molecular Pathology v. Myriad Genetics, 12-398.

[2] A description of the Myriad decision may be found here:  Stohr, Greg, Susan Decker, and Robert Langreth. “Gene Patents Limited by Court in Mixed Ruling for Myriad,” Bloomberg Business, online edition, 13 June 2013.  Available at:

[3] As I described in an earlier IPWatchDog post, historically, pharmaceuticals have been small, chemically manufactured molecules and these molecules still comprise more than ninety percent of drugs currently available. “Small molecule” therapies are synthesized by chemical reactions between different organic and/or inorganic compounds.  In comparison, biologics or large molecules are therapeutic proteins and are most often derived from living cells.  Biologics are produced from micro-organisms or animals by utilizing the metabolic processes of the organisms themselves.

[4] Given the complexity of a biologic and its manufacturing process, it is impossible to replicate the exact same drug in the same way that a generic manufacturer copies a traditional small molecule drug.  At most the subsequent product is “similar” to the innovative biologic, hence the term biosimilar.

[5] According to a recent article in Forbes, a single clinical trial can cost up to $100 million.  Please see:  Herper, Matthew. “The Truly Staggering Cost Of Inventing New Drugs”, Forbes, online edition, 10 February 2012.  Available at: