The latest of international trade deals, the TPP, signed October 5^th, 2015, produced about seven pages of patent provisions that, under Canadian law, leave little impact. The Federal government’s is that Canadian law is already in compliance with these provisions. While this might be true, a more objective analysis of the text could support the argument that the TPP does in fact require some legal reform. However, legal reform would not create new legal obligations, as Canada has already committed to that reform under the newly minted Comprehensive Economic and Trade Agreement ()

Of all the TPP’s patent provisions, three concerning pharmaceutical drug patents are most notable. The first is patent term restoration, which extends patent terms in response to administrative delays. And the third is extended data protection specifically for biologics, a new form of prescription drug.

The first of the TPP’s notable provisions, concerning patent term restoration, can be found in articles and . Both provisions offer patent extensions in response to administrative delays. Article 18.46 grants extensions for patent office delays, and extends pharmaceutical patent terms by a time equal to any “unreasonable” delay in a drug's regulatory approval. Article 18.48 is not currently found in Canadian law, nor under .

The purpose of the provision is to recognize that patent enabled drug monopolies are of little value when drugs cannot be legally sold. This is welcome news for those who believe current patent terms successfully , as lost monopoly time would hinder pharmaceutical development. Also, everyone can appreciate how the provision detaches patent terms from flexible regulatory approval processes, adding certainty to IP investments and assurances against regulatory favouritism. Yet some argue term restoration is a tool for IP owners, used to extend an already sufficient monopoly.

The second notable provision is article , patent linkage. of patent linkage argue that tying marketing approval to previous patents creates space for tactical litigation, which can be used to delay generic competition and, in effect, extend patent terms. Although this was a debated topic during and after TPP negotiations, Canada has already employed for some time, and has also committed to linkage rules similar to the TPP since signing CETA.

The last of the TPP’s notable provisions can be found in articles and , which offer . This type of research is necessary for marketing approval and is an expensive cost of drug development. Supporters of data protection argue these provisions shield drug developers from free-riders, thus incentivizing invention. Though opponents might take issue with adding protecting of information on top of invention.

However, these provisions do not create monopolies on information, the way patents create monopolies on invention. Generic companies are free to rely on the same safety and efficacy data as the patent owners, so long as it is reproduced at their own expense.

The TPP grants a five-year protection on drug efficacy and safety data, and an additional three-year protection on research concerning biologic drugs, so-called large molecule drugs. Biologics are an emerging field of pharmaceuticals, and the extended protection is meant to recognize the often high risk and cost associated with exploratory research.

However, some suggests that a longer term of twelve years would be ideal, even considering this advantage. The TPP's compromise is eight years, which reflects Canada's current .

It is difficult to determine whether the provisions presented in the TPP’s patent chapter will help or harm Canadian interests. This determination will depend in no small part on which perspective the analysis is based. The TPP’s patent provisions are likely not immediately useful for consumers of patented drugs. Patent term restoration, patent linkage, and data protection all serve to strengthen patents.

However, these are welcome provisions from the perspective of drug developers, as they increase the value of existing and new patents. In this sense, perhaps the rules are also good for Canada. For example, biologics were given special protection to encourage investment. Canada’s pharmaceutical research and development sector, one of its largest, would likely benefit from this improvement in market conditions, especially since investment in that sector has recently suffered steady .

Matt Wallace is an IPilogue Editor, JD Candidate at University of New Brunswick, and writes on technology law.

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Invented in the 1980’s, 3D printers can create three-dimensional objects using malleable materials, often a liquid resin. Until about the last , the cost to purchase this new technology was well above what average consumers and business owners could afford. But a string of recent innovations — in part thanks to fierce following the expiration of — has made the commercialization of cheap 3D printers seemingly a matter of time. Quality printers can now be bought for .

Transferring manufacturing from the factory to the home is no small cultural shift, and IP stakeholders are understandably concerned (IP lawyer has written a nice overview). Generally their worry is that cheap 3D printers in combination with information technology — the same that has allowed the widespread pirating of music and movies since the internet’s commercialization — will unleash a torrent of new IP infringement.

These fears are not unfounded. Three-dimensional objects find IP value in their design, which can be stored in digital files. Like music or movie files, these designs are easy to share online, but until now have not been thanks to the high costs of manufacturing. That is to say, until now three-dimensional designs have been protected not by the threat of IP laws, but by the inability to make cheap copies. This will soon change.

Historically, when new technology threatens the security of existing intellectual works, there is a tendency to react with legal reform. And not without reason, as IP law has proven a useful weapon against piracy in the past — IP law itself was originally developed in reaction to the printing press.[1]

But the law is not always a useful tool in these fights. The most recent example of this is the entertainment industry’s response to the digital pirating of copyrighted materials in the late 1990’s, which consisted of legal reform campaigns and publicized lawsuits against file sharing services (such as the case that shut down Napster,[2] one of the first successful file sharing services). Neither accomplished their desired effect, however, and despite the time and money put into these strategies, digital piracy remains an issue today.

This example demonstrates the limit of IP law: enforcement. Without a practical regime for enforcing IP rights, there is little to dissuade all digital copying. For example, in the case of the entertainment industry, the law was useful when attacking centralized services, like Napster, which stored files on internal servers, but it has failed to stop new decentralized services, which store files on the computers of individual users.

These decentralized services, rather than providing pirated files, provide the ability for users to connect with one another and share the files they already hold. Because these services are easy to replace and the files difficult to replace, for a legal injunction to efficiently prevent this sharing it would need to somehow target every individual user. An attempt to shut down one of these services would only result in the quick launching of a replacement— one of the largest file-sharing websites has symbolized this dynamic by displaying on their homepage an image of the multi-headed Hydra.

Given that IP law is unable to fully control digital piracy, and that valuable 3D designs are easily shared, to meet the challenge of 3D printers IP owners should use strategies other than legal reform. Some alternatives have already been explored, such as Digital Rights Management, which attempts to protect IP through technological security measures. However, pirates have largely been able to circumvent this approach.[3] If IP owners want to protect themselves from cheap 3D printers, they should focus their resources on a strategy that pirates cannot corrupt: creating new ways to monetize IP.

Some of the biggest IP success stories of the digital age came from this strategy. For example,a partnership with Apple revitalized the music industry, who made easier than downloading; Hollywood by revamping their international strategy, creating bigger theatre audiences around the world for their big-budget action movies; and both the music and movie industry have seen success using new subscription-fee models that licence IP in bulk, most notably used by Spotify and Netflix. 3D designers could use the same strategies. For example, rather than designing one object for mass-production, they could create subscription-based software that produces multiple custom-tailored objects.

Whichever new business model works best to preserve 3D IP will likely be found only after extensive trial and error. But one thing is clear, when 3D printers permit mass pirating, IP owners should respond by offering a product that cannot be copied.

Matt Wallace is an IPilogue Editor, JD Candidate at University of New Brunswick, and writes on technology law.

1. Adrian Johns,��Piracy: the Intellectual Property Wars from Gutenberg to Gates (Chicago: University of Chicago Press, 2009) at 8.

2. E.g. A&M Records, Inc. v. Napster, Inc., 239 F.3d 1004 (9th Cir. 2001).

3. Hasshi Sudler, "Effectiveness of anti-piracy technology: Finding appropriate solutions for evolving online piracy" (2013) 56 Bus Horizons 149.

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�ճ���� IP chapter includes several rules that indirectly extend patent terms for pharmaceutical drugs, such as ,��, and . However, the actual benefit these provisions provide is 

Take patent term restoration for example, which extends patent terms by a time equal to any “unreasonable” delay in a drug's regulatory approval. This provision's purpose recognizes that patent enabled drug monopolies are of little value when drugs cannot be sold legally. And the TPP considers any five-year delay unreasonable.

Patent restoration is welcome news for those who believe current patent terms successfully ,��because lost monopoly time would hinder pharmaceutical development. This provision also detaches patent terms from flexible regulatory approval processes, adding certainty to IP investments. And it adds assurances against regulatory favouritism. However, some critics argue term restoration is a tool for IP owners used to extend an already sufficient monopoly.

Another debated policy found in the TPP is patent linkage. This rule requires generic drug companies to prove their products do not infringe any existing patents before they can be granted marketing approval.  of patent linkage believe tying marketing approval to previous patents creates space for tactical litigation that can be used to delay generic competition and in effect extend patent terms. However, Canada already employs patent linkage, and has already committed to linkage rules similar to the TPP by signing .

In addition to patent restoration and patent linkage, the TPP includes two controversial pro-patent provisions that provide data protection to pharmaceutical efficacy and safety research. This research is necessary for marketing approval and is an expensive cost of drug development. Supporters of the data provisions argue that these protections incentivize invention by shielding drug developers from free-riders.

Opponents of these provisions might take issue with protecting information on top of invention. However,��this is not a monopoly on information, and generic companies are free to use the same data so long as it is reproduce at their own expense.

The TTP grants five year's protection on drug efficacy and safety data, and an additional three year's protection to research concerning biologic drugs, so called large molecule drugs. Biologics are an emerging field of pharmaceuticals, and the extended protection is meant to recognize how exploratory research is often more risky and thus more expensive.

One compelling  against special protection concerns the nature of biologic drugs. Whereas traditional small molecule drugs are chemically synthesized and easily reproduced, biologics often have genetic and cellular components that are not as simple, or cheap, to replicate. Critics think this creates a natural barrier to entry, giving biologic developers a first-mover advantage that sufficiently returns the risky cost of research, eliminating any need for data protection.

However,��some  suggests, even considering this advantage,��that a longer term of twelve years would be ideal. The TPP's compromise is eight years, which reflects Canada's current .

As is usually the case with trade deals, the TPP’s patent provisions fall short of both advocates' highest hopes and critics' worst fears. For Canadian law, the TPP will have little effect. But this is not necessarily a good thing. Current patent rules may not be best for incentivizing drug development, as the  over patent policy suggests. Meaning,��this failure to change might successfully impede innovation.

All that can be said with certainty is the TPP will not reduce the price of today's life-saving drugs. Whether innovation properly compensates this cost is for posterity to judge.

Matt Wallace is an IPilogue Editor, JD Candidate at University of New Brunswick, and writes on technology law.

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