Innovation and technology conversations are almost always oriented toward what comes next, what lies ahead, what will disrupt, or what will transform. Intellectual property law sits at the centre of these forward-looking debates, shaping how innovation is protected, disrupted, and governed. Yet the conversation at the launch of , hosted recently by IP Osgoode, suggested a more compelling perspective: looking towards IP futures does more than help us anticipate change; it helps us see the present more clearly. ��Artificial intelligence, digital globalization, and shifting economic models are not only reshaping innovation—they are also illuminating the blind spots embedded within todays IP structures. These blind spots surface in unresolved questions about originality and human authorship, the erosion of local normative priorities within global trade flows, and the largely invisible human labour underlying IP and information technologies.

, co-editor of the volume, opened the event by emphasizing the importance of emerging scholars in shaping the vitality of IP research. Reynolds, alongside co-editors and , has brought together an impressive collection of 18 chapters by 23 authors who participated in the 2023 workshop hosted at UBC's Allard School of Law. The resulting volume spans five thematic areas: the future of international IP treaties; evolving questions in Canadian law and artificial intelligence (AI); the relationship between Indigenous legal traditions and colonial IP frameworks; the future of IP in a digital and global environment; and the ways in which IP law can both reinforce and mitigate inequality. Together, these themes underscore that IP law is not merely a technical regulatory tool, it is a place where economic priorities, social justice concerns, and cultural values converge. Viewed through a future-oriented lens, each of these domains reveals pressures already reshaping the doctrinal foundations of IP.

Originality, Human Authorship, and the Limits of Existing Doctrine

Innovation debates are oriented toward what comes next, and questions of authorship reveal how unprepared existing doctrines may be. The rapid rise of AI-generated content forces copyright law to confront assumptions long taken for granted: that creativity is human, that authorship is identifiable, and that originality reflects individual intellectual effort. In his presentation, “Protection of AI-Generated Images in Canadian Copyright Law,” examined whether such works can satisfy the originality requirement, suggesting that protection may arise only where users provide sufficiently detailed inputs and where AI systems faithfully execute those executions -conditions that are rarely satisfied in practice. Most users do not invest the level of skill and judgment required to craft detailed prompts, and the outputs of AI black box systems often deviate from what the user intended. Dr. Rei-Anderson illustrated this point by referencing models’ tendency to hallucinate when asked to produce precise outputs or maintain specific spatial relationships.

[*The image below is Chat-GPT's output when asked, “What would it look like if I looked outside an acoustic guitar?” The fingerboard, strings, bridge, and saddle are all incorrectly positioned.]

Recognizing the gaps between expressive intention and AI-generated outputs highlights a deeper theme: the originality doctrine may have to adapt as technologies evolve if copyright law is to preserve a normative commitment human intellectual effort.

Viewed through a future-oriented lens, this is not simply a novel doctrinal puzzle. It exposes a present blind spot. When outputs emerge from opaque systems blending prompts, training data, and algorithmic processes, authorship becomes diffuse and originality difficult to anchor. The debate over AI-generated works therefore reveals an existing tension: doctrines built around individual human creativity struggle to accommodate collaborative, machine-mediated forms of production. The future of authorship, in this sense, illuminates the fragility of its present foundations.  

Globalization and the Disappearance of Local Normative Priorities

’s presentation shifted the discussion to the tension between the territorial nature of IP law and private international law (PIL), a dynamic that reveals another blind spot within IP law: the erosion of local normative priorities. Territoriality in IP law, she noted, is not merely technical, rather, it represents a manifestation of a state’s sovereign authority to protect fundamental national policies, including freedom of expression, education, and access to knowledge. These policies reflect deeply embedded social and economic values, and IP law often serves as a vehicle for their expression.

However, territoriality increasingly conflicts with the goals of PIL, which seeks to reduce multi-jurisdictional litigation and improve efficiency across borders. Daniel introduced the concept of “ICE Bias” (Initiative, Choice, and Enforcement) to describe the systemic imbalance between right holders and users in cross-border disputes. Right holders typically initiate proceedings, select favorable forums, and possess stronger incentives to enforce judgments, while users are often limited to seeking declaratory relief.

This imbalance encourages strategic litigation, where rights holders obtain judgments in restrictive jurisdictions and attempt to enforce them globally. Through cases such as and ., Daniel illustrated how global injunctions risk undermining domestic policy decisions. Her concern reflects a broader question about the future of IP in a globalized environment: how can law remain responsive to local values while operating within transnational networks?

In this manner, globalization does not merely generate efficiency, it risks flattening normative diversity. When enforcement mechanisms privilege scalability and uniformity, local concerns can be overshadowed by global market interests. Daniel proposed the development of specialized IP forums to complement general PIL venues, thereby preserving territorial policy choices while managing cross-border disputes.

Labor Exploitation in AI Training Processes

While AI is often framed as an autonomous technological force, Professor Teshager Dagne redirected attention to the human labor embedded within AI systems, emphasizing that data labeling, preprocessing, and model training depend on workers in economically vulnerable regions whose contributions remail largely invisible within IP frameworks.

Drawing on research conducted in Uganda and Ethiopia, Dagne described environments resembling digital “sweatshops,” where workers labeled data behind laptops rather than operating sewing machines. Although copyright doctrine recognizes human skill and contribution, data-labeling labor often falls outside traditional authorship frameworks. Dagne suggested joint ownership as a potential remedy, but acknowledged doctrinal and practical barriers, particularly where workers have signed away rights. This gap reflects a broader policy deficiency and highlights the need for statutory reform.

Dagne’s intervention emphasizes the socio-economic values embedded within legal systems: IP law does not merely regulate innovation; it shapes the distribution of benefits and burdens. A future-oriented IP perspective highlights that fairness in IP cannot be assessed only at the level of ownership or protection, it must account for the full technological pipeline and the conditions under which knowledge and data are produced.

Seeing the Present Through IP Futures

The launch of Intellectual Property Futures: Exploring the Global Landscape of IP Law and Policy does more than anticipate technological change; it provides an opportunity to identify and critically examine the blind spots embedded within the contemporary IP legal landscape. Looking ahead, in other words, becomes a way of more clearly seeing the problems with the present – and this wide-ranging, open-access collection provides us with an excellent vantage point to do just that. ��

Xiang Zhang is a doctoral student at Osgoode Hall Law School and a Senior IP Osgoode Research Fellow, with a strong interest in advancing open-source and open access to knowledge.

Dominic Rochon is a 2L J.D. student at Osgoode Hall Law School and an IP Osgoode Research Fellow, with an interest in music, copyright, and user-generated content.

16 April 2026

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British Telecommunications (BT) alleges that��on-line services offered by Valve infringe on four U.S. patents held by BT. The patents at trial are broadly worded and could implicate many popular video game, social networking, and video streaming services. If [BT v Valve]��were to succeed,��they would be granted legal authority allowing them police many of the services relied upon by the video game industry, as well as many other popular websites.

David versus Goliath

Valve, founded in 1996, owns and operates ��Steam, an industry-leading software distribution and social networking application for computer gaming.��Steam, released in 2003, commands a near-monopoly over the digital rights management (DRM) and computer game distribution. Despite massive support among developers and gamers alike, ���ٱ𲹳�—a�Ի� �ղ�������—h������ .

British Telecommunications (BT) group is the oldest telecommunications company on the planet, tracing its roots to the invention of the first telephone by Alexander Graham Bell. BT is a leading communications provider in the United Kingdom. According to court documents, BT “,”��in network telecommunications.

What the suit claims

BT argued that Valve continued to operate services at great cost to the patent holder, despite multiple communications asking Valve to stop. The following patents are alleged to have been infringed:

• Communications node for providing network based information service:��

• Method for automatic and periodic requests for messages to an e-mail server from the client:��

• Communications network and method having accessible directory of user profile data:��

• Multi-user display system:��

One can��see��how Valve's services are implicated in these patents. Steam��is a digital marketplace that distributes “”; provides chat services “”; stores “”��for its users; and allows these users to “.”

Valve is far from the only company implicated by the broad language of these patents (and certainly not the most financially successful). Messaging, video streaming, and web marketplaces are endemic to the internet and the tech world. As the patent holder, BT has a choice to enforce the patent against whomever they wish. Why go after Valve?

Possible reasons:

1. This is intended as the first of many similar suits

If the court were to rule in favour of BT in this case—however likely that may be—it would open the door for further enforcement of the strict language contained by the patents-in-suit. If the court accepted the language that “BT has been damaged and continues to be damaged by Valve’s infringement,” and applied retributive, pecuniary damages, this would set a precedent allowing BT to challenge industry leaders’ social media and networking IPs.

2. BT is looking to become involved in gaming, DRM, or streaming

Video games are a multibillion dollar industry. Leading publishers and distributors, like Valve, command the industry’s continually expanding value. Social and competitive gaming services, like Valve's��Steam are at the heart of a parallel, expanding market for “e-Sports”. Video game “sport” tournaments have exploded in popularity and now host regular tournaments each year. Cash prizes range in the tens of thousands of dollars. It is not improbable that major telecommunications companies would keep an eye on this growing market. If BT had any interest in permeating the market, the ability to enforce this patent against Valve could pay serious dividends.

3. A suit against Valve will allow BT to test public opinion

Most computer gamers must interact with ���ٱ𲹳�.��As a result,����news related to Steam and Valve receives a great deal of attention. The video game consumer base is very large. An accusation against Valve is sure to gain the attention of a large audience, including many people who would not otherwise follow tech news. This is a known tactic within the video game industry to��lobby public opinion.��Kotaku.com has gone so far as to develop a separate ��news page to cover all of the grievances--material and superficial--raised against Valve/Steam.��Targeting Valve is a��sure way to determine if public opinion will allow BT to go ofter other, higher-profile internet services with patent suits (e.g., Facebook, Amazon).

What does this mean?��

Perhaps this can be dismissed as a "patent troll" case. But, granting patent rights to BT in this case might lead to controversial effects. The Trans Pacific Partnership (TPP) (albeit, with rapidly diminishing support). The TPP would permit greater US-based regulation of the public internet. If this were ratified, a decision like that in BT v Valve would support and legitimize BT and the US government's policing of many of the most popular applications and resources on the internet.

Further news related to the suit will follow in the coming months.

Christopher McGoey is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.��

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The United States Patent and Trademarks Office (USPTO) has released an updated set of Eligibility Examination Guidelines to provide guidance to examiners on when to reject claimed inventions as ineligible abstract ideas. These guidelines give a sense of what computer-implemented subject matter the USPTO considers to be ineligible for patent protection.

Developing guidelines was difficult for the USPTO as the courts have provided little explanation of when patent claims are invalid for defining ineligible abstract ideas, or even what abstract idea means, and the USPTO lacks the authority to craft its own definitions. The USPTO is largely limited to telling examiners that patent claims cover abstract ideas if they cover subject matter that is similar to what the courts have determined to be abstract ideas. Given the absence of general concepts or principles for identifying the kinds of abstract ideas that are not eligible for patent protection, practitioners and applicants need to be aware of all of the Federal Circuit and Supreme Court case law on patent subject matter eligibility, and to craft patent claims with arguments in mind as to why the subject matter covered by the claims is materially different from subject matter determined to be ineligible in any of this case law.

The original 2014 Interim Guidance on Patent Subject Matter Eligibility¹ document (“the Guidance”) defines steps to be taken by an Examiner to assess subject matter eligibility.�� Steps 2A and 2B apply the two-part analysis from Alice² and Mayo³.��In step 2A the Examiner determines whether the claim is directed to a statutory exception to patent protection: a law of nature, natural phenomenon or an abstract idea.��If not, then the claim is eligible for protection (although the Examiner must still determine whether the claim meets the other requirements for patentability, such as novelty and non-obviousness).��If the claim is directed to a law of nature, natural phenomenon or an abstract idea, then step 2B applies and the Examiner determines whether the claim as a whole represents “significantly more”.�� Claims that do not cover significantly more than a law of nature, natural phenomenon or abstract idea are ineligible for patent protection and are to be rejected under 35 U.S.C. § 101.

The posting of the Guidance in 2014 provoked much comment and criticism, some critics alleging that under the Guidance virtually nothing was eligible for patent protection. The July 2015 Update on Subject Matter Eligibility⁴, (“the Update”) responds to these comments and criticism.

The Update provides an updated set of subject matter examples, and also divides the case law into different categories of abstract ideas, which are useful both as a credible attempt to organize the case law, and to provide insight into the USPTO’s perspective on this case law and arguments they may find persuasive.�� It also provides reassurance that the USPTO is addressing criticism that under the current rules post-Alice⁵ there is not a clear path forward for software patent applications because of the difficulties encountered with subject matter objections. The Update makes it clear that examiners should not determine a claimed concept to be an abstract idea unless the claimed concept is similar to at least one concept that either the Federal Circuit or the Supreme Court have identified as an abstract idea. In other words, applicants should be able to avoid having their claims rejected, at least in the USPTO, on subject matter eligibility grounds by defining concepts in the claims that differ sufficiently from claim concepts invalidated on these grounds by the Federal Circuit or the Supreme Court.

Of course, much will depend on how aggressive and creative examiners are in determining that claimed concepts they are considering are similar to a concept determined to be an abstract idea by the courts. Further, the Update makes it clear that this determination of similarity does not require evidence: examiners can ground such a rejection by merely explaining, clearly and specifically, why the claimed concepts are similar to concepts determined to be abstract ideas by the courts, and are thus ineligible for patent protection.

New Examples

In the Update, several new examples are provided in addition to those found in the original Guidance document and include:

21. ��Transmission of Stock Quote Data – modeled after the claims at issue in Google Inc. v. Simpleair, Inc.⁶, (Claim 1 ineligible, Claim 2 eligible).
22. ��Graphical User Interface for Meal Planning – based on Dietgoal Innovations LLC v. Bravo Media LLC⁷ (Claim 2 ineligible).
23. ��Graphical User Interface for Relocating Obscured Textual Information (Claims 1,4 eligible, Claims 2-3 ineligible).
24. ��Alerting System for a Catalytic Chemical Process --�� based on Parker v. Flook⁸ (Claim 1 ineligible).
25. ��Temperature Control of Rubber Molding --�� based on Diamond v. Diehr⁹ (Claims 1-2 eligible).�� Claim 1 is the actual claim 1 from Diamond v. Diehr, Claim 2 is a hypothetical claim in the form of computerized instructions.
26. ��Exhaust Gas Recirculation in an Internal Combustion Engine – based on technology from U.S. Pat. 5,533,489 (Claim 1 eligible).
27. ��A method of loading System Software (BIOS) into a computer – based on technology from U.S. Pat. 5,230,052 (Claim 15 eligible).

In each example, the Update evaluates the hypothetical claims based on steps 2A and 2B, and discusses how an Examiner might determine patent eligibility for patent claims covering an analogous technology.

Example #25 – Diamond v Diehr

An interesting example in the Update is #25, since it introduces hypothetical claims modeled after the technology in the 1981 case Diamond v. Diehr, 450 U.S. 175 (1981).�� This case dealt with a patent involving a computerized process controlling a rubber molding press.��The invention offered significant advantages over the prior art at the time, as it enabled in situ temperature monitoring and automatic recalculation of the optimal cure time.��This calculation involved using the temperature inputs and the Arrhenius equation, long used to calculate the cure time of rubber molding processes.

The reasoning in the Update for Diamond v Diehr differs from the reasoning provided by the Supreme Court. In the 1981 decision, the Supreme Court obliquely refers to the machine or transformation test in determining subject matter eligibility:

“A mathematical formula, as such, is not accorded the protection of our patent laws, Gottschalk v. Benson, 409 U. S. 63 (1972), and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological environment. Parker v. Flook, 437 U. S. 584 (1978). Similarly, insignificant post-solution activity will not transform an unpatentable principle into a patentable process. ��To hold otherwise would allow a competent draftsman to evade the recognized limitations on the type of subject matter eligible for patent protection. On the other hand, when a claim containing a mathematical formula implements or applies that formula in a structure or process which, when considered as a whole, is performing a function which the patent laws were designed to protect (e.g., transforming or reducing an article to a different state or thing), then the claim satisfies the requirements of § 101. Because we do not view respondents' claims as an attempt to patent a mathematical formula, but rather to be drawn to an industrial process for the molding of rubber products, we affirm the judgment of the Court of Customs and Patent Appeals.”¹⁰

In example #25, according to the Update, Claim 1 from Diamond v. Diehr involves a repeated calculation of the Arrhenius equation, a mathematical relationship held to be representative of a law of nature, and therefore Step 2A is met. Next, analyzing the claim as a whole using the Guidelines, the combination of steps taken together amount to significantly more than just the abstract idea of the Arrhenius equation (Step 2B). ��Thus, claim 1 in Diamond v Diehr is patent eligible, satisfying the “significantly more” step of the test.

The USPTO may have seen fit to rewrite the justification for this case to bring it into accord with the Alice framework.��The Court in Diamond v Diehr determined that the structure claimed, considered as a whole, was the kind of structure and performed the kind of function the patent laws were designed to protect. In making this determination, the Court refers to the machine or transformation test to establish the patentability of the claimed invention. However, after the decision of the Supreme Court in Bilski, the machine or transformation test is no longer the definitive test, although it remains a helpful indicator of subject matter eligibility.

Categories of abstract ideas outside the scope of patentable subject matter

The US courts have provided little explanation of when and why patent claims are invalid for covering abstract ideas.��Since the USPTO lacks the authority to create its own definitions, and it is difficult, perhaps impossible, to discern principles from the case law, the USPTO has instead focused its efforts on helping examiners to determine if the concepts defined in claims are similar to what the courts have determined to be abstract ideas, and are thus invalid.��The Guidelines and Update construct several different categories of ineligible abstract ideas based on the case law.�� Each category covers many different examples, taken from the case law, of concepts defined in patent claims that have been invalidated by either the Federal Circuit or the Supreme Court as abstract ideas. Clearly, patent applicants should do whatever they can to define their inventions using claim language and concepts that fall outside these categories.

These categories are the closest the USPTO gets to general concepts or principles for subject matter eligibility. These categories include the set of “judicial descriptors” associated with software based subject matter that has been identified by precedent in the Federal Circuit and the Supreme Court as patent ineligible, including

1. “Fundamental economic practices” including concepts dealing with the economy and commerce including contracts, legal obligations and business relations.
   1. Mitigating settlement risk -- Alice¹¹.
   2. Mitigating hedging risk -- Bilski¹².
2. “Certain methods of organizing human activity” including concepts dealing with personal and intrapersonal activities including relationships, transactions involving people, social activities and behaviour.
   1. Managing human behaviour, specifically meal planning -- Dietgoal¹³.
   2. Advertising, marketing and sales – Ultramercial¹⁴.
3. “An idea ‘of itself’” i.e. an idea standing on its own including a bare concept, plan or scheme, and
   1. Methods of comparing data that could be done mentally -- Cybersource¹⁵.
   2. Concepts relating to organizing, storing, and transmitting information – Cyberfone¹⁶.
4. “Mathematical relationships/formulas” including algorithms, mathematical relationships, formulae and calculations.
   1. Converting binary coded decimal values to pure binary values -- Benson¹⁷.
   2. A mathematical formula for hedging – Bilski¹⁸.

It is difficult to find recent cases where software related patents have survived subject matter eligibility analysis by the Federal Circuit or the Supreme Court. Given the numerous examples of ineligible subject matter in the Update and Guidelines combined with the rejection statistics¹⁹ from the USPTO and invalidation statistics²⁰ at the Federal Circuit, it is reasonable to ask whether any claims have recently survived challenge on subject matter eligibility grounds. ��One example outside of the scope of software subject matter is Myriad²¹, where the Supreme Court allowed claims for complementary DNA.

While the Supreme Court invalidated all of the claims in both Bilski and Alice; there is one case related to software subject matter that has survived scrutiny, at least at the level of the Federal Circuit:�� DDR Holdings v Hotels.com²².

DDR Holdings v Hotels.com²³

The Guidelines discuss this case. This is the first Court of Appeal for the Federal Circuit case to uphold the validity of a software subject matter patent since Alice.�� In this patent, the claims were directed to managing the look and feel of an e-commerce website to provide “store within a store” functionality.

The claims in DDR covered a software solution to a problem, which, according to the judgment but not the dissent, was unique to the internet.��The claims dealt with the problem of retaining website visitors at an ecommerce site and offered a solution anchored in software that addressed a challenge unique to the web.�� Specifically, in the prior art a user clicking on an advertisement would be taken away from the host website to the advertising merchant. The claimed invention involves presenting a hybrid page generated by the host website to include a composite of the host website and advertising merchant’s product information. The decision was based, at least in part, on the grounds that the claimed concept lacked a non-technological analog.

Takeaways

When drafting new applications for software-based inventions, it is important to keep in mind the judicial descriptors of ineligible subject matter, and to draft the claims to avoid categorization under any of these judicial descriptors if at all possible.��However, it is also important to keep in mind that this area of law is in flux, and will almost certainly see significant change over the next few years.��In particular, the categories of ineligible subject matter constructed by the USPTO may evolve or grow in number over the next few years as more cases are decided. Eventually, as the courts grapple with more and more cases, clear principles may start to emerge from the present chaos. One day, it may again be possible to rely on general principles to distinguish patent eligible subject matter from ineligible subject matter. At present, that day seems far distant, and for the foreseeable future it will be even more important to keep up-to-date on the latest Federal Circuit and Supreme Court precedent, mostly to know what kinds of subject matter to avoid claiming, but also to keep an eye out for the occasional beacons of hope, such as a DDR.

��is a partner,��lawyer and patent agent in��Bereskin & Parr's Patent Group in the Mississauga��Region. He��is active with the Intellectual Property Institute of Canada (IPIC) and has contributed extensively to patent education in Canada. is a JD candidate at Osgoode Hall School and was a summer student in��Bereskin & Parr's��in��Toronto.��Twitter: .

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In the intellectual property arena, Congress enacted the Leahy-Smith America Invents Act[4] in September 2011, providing a complete overhaul of the U.S. patent system. The next year, high-stakes patent trials resulted in three eye-popping verdicts, each exceeding $1 billion.[5]�� By the end of the 2012 Term, the United States Supreme Court has reviewed an unusually large number of patent cases.[6]�� As Timothy Holbrook reminded us:

Starting in around 2000, the Supreme Court became active, if not even hyperactive, in patent law. . . . Additionally, the Supreme Court’s intervention is no longer on the periphery of patent law. The cases they have decided go right to the substance of patent law: the doctrine of equivalents and prosecution history estoppel, subject matter eligibility, induced infringement, the statutory experimental use defense, to name but a few.[7]

Of great interest in the 2012 Term was Association for Molecular Pathology v. Myriad Genetics, Inc.[8]�� Lying at the intersection of intellectual property and public health, this case concerned the patentability of composition and method claims covering two isolated human genes associated with breast and ovarian cancers as well as their alterations and mutations. In a surprisingly short decision, Justice Clarence Thomas held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that [synthetically created DNA segment known as complementary DNA] is patent eligible because it is not naturally occurring.”[9]�� He further noted that the case did not involve patent claims in “an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes,” “patents on new applications of knowledge about the BRCA1 and BRCA2 genes,” and “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”[10]�� Although it is too early to assess the full implications of this narrowly written decision, it is not hard to appreciate the decision’s potential impact on U.S. biotechnology and life science industries. Myriad Genetics will also raise important questions about the appropriate level of patent protection in relation to the development of biologics[11] and diagnostic kits.[12]

At the international level, there has been a decade-long, but still vibrant, debate about the major impediments the Agreement on Trade-Related Aspects of Intellectual Property Rights[13] (“TRIPS Agreement”) has generated to access to essential medicines in less developed countries—a term used collectively to cover both developed and least developed countries as identified within the World Trade Organization (“WTO”).[14]�� Since the TRIPS Agreement entered into force in January 1995, it not only has taken away the wide policy space less developed countries once enjoyed at the international level,[15] but it has also resulted in needless deaths and suffering to patients that have acquired either the human immunodeficiency virus (“HIV”) or the Acquired Immune Deficiency Syndrome (“AIDS”).[16]�� The pandemic caused by HIV/AIDS, malaria, and tuberculosis has also greatly reduced the productivity of many countries in sub-Saharan Africa.[17]

In December 2013, WTO member states met in the Ninth Ministerial Conference in Bali, with the hope of reviving the Doha Development Round of Trade Negotiations (“Doha Round”).[18]�� This ministerial conference was held a few months after WTO members agreed at the Council for Trade-Related Aspects of Intellectual Property Rights (“TRIPS Council”) to extend the transition period for least developed countries.[19]�� Article 66 of the TRIPS Agreement initially set the period at ten years.[20]�� In November 2005, shortly before the Sixth Ministerial Conference in Hong Kong, WTO members agreed to extend the period for seven-and-a-half years until July 1, 2013, as long as the extension-seeking country has not yet met the TRIPS requirements or has not already offered protection in excess of those requirements.[21]�� Building on Haiti’s formal request for another extension on behalf of the Least Developed Countries Group,[22] the June 2013 TRIPS Council decision further extended the transition period for eight years until July 1, 2021 without the earlier “non-rollback” commitment.[23]

Notwithstanding this recent extension for least developed countries, there remains another deadline that is highly important to the global access to medicines debate. This deadline concerns the ratification of the protocol to amend the TRIPS Agreement, which WTO member states adopted also shortly before the Hong Kong Ministerial.[24]�� If ratified by two-thirds of the WTO membership, the new Article 31bis would allow countries with insufficient or no manufacturing capacity to import generic versions of patented pharmaceuticals. Although the initial deadline for ratification was December 1, 2007, that deadline has since been extended four times to December 31, 2015. As of this writing, slightly less than a third of the 159 WTO member states have ratified the proposed amendment.[25]�� If the amendment fails to attain the requisite ratifications by the new deadline, this deadline will have to be extended again.[26]

Sadly, with all the interrelated developments in the intellectual property and public health arenas both within and outside the United States, the domestic debate remains surprisingly disconnected from the international debate. Because of this disconnect, the laws and policies Congress and the administration adopt often do not synchronize with developments abroad. To help bridge this disconnect, this Article discusses the interrelationship between intellectual property and public health in the context of communicable diseases. This type of disease is intentionally picked to highlight how developments abroad could easily affect what happens at home, and vice versa.

Parts I to III of this Article recount three distinct “virostories”—stories about viruses responsible for AIDS, the Severe Acute Respiratory Syndrome (“SARS”),[27] and the avian influenza.[28]�� Part I discusses the ongoing developments within the WTO concerning efforts to address the access-to-medicines problems in relation to HIV/AIDS and other pandemics. Part II documents the unusual race among research and health institutions in Canada, Hong Kong, and the United States to patent technologies involving the isolated gene sequences of the SARS coronavirus. This Part also explores the use of patenting as a defensive measure and the development of patent pools as a solution to prevent the creation of a patent thicket. Part III examines the recent efforts by Indonesia, India, and other members of the Non-Aligned Movement to claim sovereignty over viruses found within their jurisdictions. This Part focuses on the H5N1 strain of the avian influenza virus in Indonesia.

To help illustrate the need to take a global, holistic, multidisciplinary socio-legal approach, which will be the focus of the second half of this Article, Parts I to III embrace the narrative technique. Such a technique enables the stories to be told in a way that would be meaningful to those participating in both the intellectual property and public health debates. The thick descriptions the article provides also highlight related issues on cross- border trade, global governance, human development, North-South relations, international sovereignty, human rights protection, and medical and biological ethics. With a wide range of characters, openings, plot twists, and endings, these virostories provide insight into the different facets of the international patent debate. By bringing together HIV/AIDS, SARS, and H5N1, this Article will further remind policymakers that the discussion on the TRIPS Agreement should not focus so much on the HIV/AIDS crisis in the less developed world to the point that they ignore other similar problems created by an out-of-balance intellectual property system.[29]

Part IV draws seven important lessons from the three earlier narratives to advance a new, integrated approach to setting international intellectual property norms. This new approach takes account of both the existing problems concerning the TRIPS Agreement and the new problems precipitated by the negotiation of the Anti-Counterfeiting Trade Agreement (“ACTA”),[30] the Trans-Pacific Partnership (“TPP”) Agreement,[31] and other nonmultilateral trade and investment agreements.[32]�� Tying domestic laws and policies to the international debate, this Part focuses on three sets of issues that often come up in the international intellectual property norm- setting process: negotiation gains, the negotiation process, and negotiated outcomes.

By bringing together both the descriptive and the prescriptive, this Article seeks to drive home the message that the international intellectual property and public health debates could easily spill over into the domestic debates, and vice versa. Just as viruses do not recognize national boundaries[33]—as health professionals have repeatedly warned us— policymakers and commentators should also think more holistically and globally about the connections between the domestic and international debates and between developments in the intellectual property and public health arenas. After all, there are non-altruistic reasons for developed countries to promote access to essential medicines in the less developed world.

Featured here is the Introduction of a paper by , IP Osgoode Research Affiliate, Kern Family Chair in Intellectual Property Law and Founding Director of the Intellectual Property Law Center at Drake University Law School. Born and raised in Hong Kong, Professor Yu is a leading expert in international intellectual property and communications law. He also writes and lectures extensively on international trade, international and comparative law, and the transition of the legal systems in China and Hong Kong. The full article was published in 45 Ariz.St. L. J. 1564 (2013) and can also be found .

[1] Pub. L. No. 111-148, 124 Stat. 119 (2010).

[2] Pub. L. No. 111-152, 124 Stat. 1029 (2010).

[3] Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566, 2608 (2012).

[4] Pub. L. No. 112-29, 125 Stat. 284 (2011).

[5] See Amanda Bronstad, IP Awards Dominate, NAT’L L.J., Mar. 4, 2013, http://www.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1202590587509&slreturn=20131006195123 (reporting the verdicts from the lawsuit Carnegie Mellon University filed against Marvell Technology, the lawsuit Apple filed against Samsung Electronics, and the lawsuit Monsanto filed against DuPont).

[6] For a discussion of the Court’s growing interest, see generally Timothy R. Holbrook, Explaining the Supreme Court’s Interest in Patent Law, 3 IP THEORY 62 (2013).

[7] Id. at 63–64 (footnotes omitted). 8. 133 S. Ct. 2107 (2013).

[8] 133 S. Ct. 2107 (2013).

[9] Id. at 2111.

[10] Id. at 2119–20.

[11] For discussions of intellectual property issues in relation to biologics, see generally Donna M. Gitter, Innovators and Imitators: An Analysis of Proposed Legislation Implementing an Abbreviated Approval Pathway for Follow-on Biologics in the United States, 35 FLA. ST. U. L. REV. 555 (2008); Christopher M. Holman, Maintaining Incentives for Healthcare Innovation: A Response to the FTC’s Report on Follow-on Biologics, 11 MINN. J.L. SCI. & TECH. 755 (2010); Gregory N. Mandel, The Generic Biologics Debate: Industry’s Unintended Admission that Biotech Patents Fail Enablement, 11 VA. J.L. & TECH. 8 (2006); Symposium, Follow-on Biologics: Implementation Challenges and Opportunities, 41 SETON HALL L. REV. 501 (2011).

[12] See, e.g., EDSON BEAS RODRIGUES JR., THE GENERAL EXCEPTION CLAUSES OF THE TRIPS AGREEMENT: PROMOTING SUSTAINABLE DEVELOPMENT 168–69 (2012) (discussing the impact of gene patents on the development of diagnostic kits); Rochelle C. Dreyfuss & James P. Evans, From Bilski Back to Benson: Preemption, Inventing Around, and the Case of Genetic Diagnostics, 63 STAN. L. REV. 1349, 1361–70 (2011) (providing a case study of patent-related issues arising in genetic diagnostics).

[13] Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh AgreementEstablishing the World Trade Organization, Annex 1C, 108 Stat. 4809, 869 U.N.T.S. 299 [hereinafter TRIPS Agreement].

[14] See Peter K. Yu, The International Enclosure Movement, 82 IND. L.J. 827, 858–62 (2007) (discussing these deleterious impacts). For book-length discussions of access-to- medicines problems in relation to the TRIPS Agreement, see generally SUDIP CHAUDHURI, THE WTO AND INDIA’S PHARMACEUTICALS INDUSTRY: PATENT PROTECTION, TRIPS, AND DEVELOPING COUNTRIES (2005); HOLGER HESTERMEYER, HUMAN RIGHTS AND THE WTO: THE CASE OF PATENTS AND ACCESS TO MEDICINES (2008); CYNTHIA M. HO, ACCESS TO MEDICINE IN THE GLOBAL ECONOMY: INTERNATIONAL AGREEMENTS ON PATENTS AND RELATED RIGHTS (2011); INTELLECTUAL PROPERTY, PHARMACEUTICALS, AND PUBLIC HEALTH: ACCESS TO DRUGS IN DEVELOPING COUNTRIES (Kenneth C. Shadlen et al. eds., 2012); VALBONA MUZAKA, THE POLITICS OF INTELLECTUAL PROPERTY RIGHTS AND ACCESS TO MEDICINES (2011); NEGOTIATING HEALTH: INTELLECTUAL PROPERTY AND ACCESS TO MEDICINES (Pedro Roffe et al. eds., 2006) [hereinafter NEGOTIATING HEALTH].

[15] See generally Yu, The International Enclosure Movement, supra note 14, at 855–72 (discussing the growing enclosure of the policy space of less developed countries at the international level).

[16] For discussions of access-to-medicines problems in relation to HIV/AIDS, see generally THE GLOBAL GOVERNANCE OF HIV/AIDS: INTELLECTUAL PROPERTY AND ACCESS TO ESSENTIAL MEDICINES (Obijiofor Aginam, John Harrington & Peter K. Yu eds., 2013) [hereinafter GLOBAL GOVERNANCE OF HIV/AIDS]; THE POLITICAL ECONOMY OF HIV/AIDS IN DEVELOPING COUNTRIES: TRIPS, PUBLIC HEALTH SYSTEMS AND FREE ACCESS (Benjamin Coriat ed., 2008) [hereinafter POLITICAL ECONOMY OF HIV/AIDS].

[17] See FRANKLYN LISK, GLOBAL INSTITUTIONS AND THE HIV/AIDS EPIDEMIC: RESPONDING TO AN INTERNATIONAL CRISIS 82–92 (2009) (discussing the impact of HIV/AIDS on human resource capacity); Wolfgang Hein et al., Introduction: Globalization, HIV/AIDS and the Rise of Global Health Governance, in GLOBAL HEALTH GOVERNANCE AND THE FIGHT AGAINST HIV/AIDS 1, 7 (Wolfgang Hein et al., eds., 2007) [hereinafter FIGHT AGAINST HIV/AIDS] (“HIV/AIDS and infectious diseases strike hardest at the productive parts of the population, at the pool of experienced individuals that would qualify for leading positions in society, leading to economic decline.”); Colin McInnes, National Security and Global Health Governance, in GLOBAL HEALTH GOVERNANCE: CRISIS, INSTITUTIONS AND POLITICAL ECONOMY 42, 48 (Adrian Kay & Owain David Williams eds., 2009) [hereinafter GLOBAL HEALTH GOVERNANCE] (noting the “disproportionate impact [of HIV/AIDS] upon workers in what should be the most productive period of their lives”); Geoff Tansey, Introduction: Legal Fictions and Public Health, in NEGOTIATING HEALTH, supra note 14, at 1, 2 (noting that, in rural Africa, “HIV/AIDS is devastating farming families and undermining their ability to farm”); Srividhya Ragavan, The Jekyll and Hyde Story of International Trade: The Supreme Court in PhRMA v. Walsh and the TRIPS Agreement, 38 U. RICH. L. REV. 777, 821 (2004) [hereinafter Ragavan, Jekyll and Hyde] (“An epidemic increase of AIDS reduced life expectancy and affected labor and economic output, as the younger casualties increase. Consequently, national productivity declined in several developing nations since the loss of labor from the loss of each life affected a proportionate value of output.” (footnotes omitted)); Yu, The International Enclosure Movement, supra note 14, at 855 (“At the macro level, health problems could also lower the productivity of a country—to the point that it will fall behind its trading partners in terms of economic development, technological innovation, industrial progress, and national competitiveness.”).

[18] Press Release, World Trade Org. [WTO], Bali Ministerial to Be Held 3–6 December 2013 (Dec. 11, 2012), http://www.wto.org/english/news_e/news12_e/gc_11dec12_e.htm.

[19] Press Release, WTO, The Least Developed Get Eight Years More Leeway on Protecting Intellectual Property (June 11, 2013), http://www.wto.org/english/news_e/ news13_e/trip_11jun13_e.htm.

[20] TRIPS Agreement art. 66.

[21] Press Release, WTO, Poorest Countries Given More Time to Apply Intellectual Property Rules (Nov. 29, 2005), http://www.wto.org/english/news_e/pres05_e/pr424_e.htm.

[22] Communication from Haiti on Behalf of the LDC Group, Request for an Extension of the Transitional Period Under Article 66.1 of the TRIPS Agreement, IP/C/W/583 (Nov. 5, 2012). Haiti initially proposed to extend the transition period “for as long as the WTO Member remains a least developed country.” That proposal, though eventually failed, earned the support of the Joint United Nations Programme on HIV/AIDS (UNAIDS), the United Nations Development Programme (UNDP), and more than 300 civil society organizations. See UNAIDS & UNDP, TRIPS Transition Period Extensions for Least-developed Countries 6 (UNAIDS, Issue Brief, 2013), http://www.unaids.org/en/media/unaids/contentassets/documents/ unaidspublication/2013/JC2474_TRIPS-transition-period-extensions_en.pdf [hereinafter UNAIDS/UNDP Issue Brief] (calling on the WTO members to give “close and immediate attention” to the extension request from least developed countries); Catherine Saez, WTO: LDCs to Press for Extension for TRIPS, Plain Packaging Back, INTELL. PROP. WATCH (Feb. 26, 2013, 2:15 PM), http://www.ip-watch.org/2013/02/26/wto-ldcs-to-press-for-extension-for-trips-plain- packaging-back (reporting the support least developed countries received from UNAIDS, UNDP, and civil society organizations).

[23] Council for Trade-Related Aspects of Intellectual Property [TRIPS Council], Extension of the Transition Period Under Article 66.1 for Least Developed Country Members: Decision of the Council for TRIPS of 11 June 2013, IP/C/64 (June 11, 2013). For discussions of this extension, see generally Frederick M. Abbott, Technical Note: The LDC TRIPS Transition Extension and the Question of Rollback (ICTSD Programme on Innovation, Technology and Intellectual Property, Policy Brief No. 15, 2013), available at http://ictsd.org/ downloads/2013/05/the-ldc-trips-transition-extension-and-the-question-of-rollback.pdf; Arno Hold & Bryan Christopher Mercurio, After the Second Extension of the Transition Period for LDCs: How Can the WTO Gradually Integrate the Poorest Countries into TRIPS? (NCCR Trade Regulation, World Trade Institute, University of Bern, Working Paper No. 2013/42, 2013), available at http://ssrn.com/abstract=2302335.

[24] General Council, Amendment of the TRIPS Agreement, WT/L/641 (Dec. 8, 2005) [hereinafter TRIPS Amendment], available at http://www.wto.org/english/ tratop_e/trips_e/wtl641_e.htm; see also Yu, The International Enclosure Movement, supra note 14, at 872–86 (tracing the development of Article 31bis of the TRIPS Agreement).

[25] Members Accepting Amendment of the TRIPS Agreement, WTO, http://www.wto.org/english/tratop_e/trips_e/amendment_e.htm (last updated Oct. 21, 2013) [hereinafter Members Accepting Amendment].

[26] See General Council, Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, ¶ 11, WT/L/540 (Sept. 1, 2003), 43 I.L.M. 509 (2004) [hereinafter August 30 Decision] (stating that the waivers granted in this decision “shall terminate for each Member on the date on which an amendment to the TRIPS Agreement replacing its provisions takes effect for that Member”).

[27] For discussions of SARS, see generally THOMAS ABRAHAM, TWENTY-FIRST CENTURY PLAGUE: THE STORY OF SARS (2007); TIM BROOKES, BEHIND THE MASK: HOW THE WORLD SURVIVED SARS, THE FIRST EPIDEMIC OF THE 21ST CENTURY (2004); DAVID P. FIDLER, SARS, GOVERNANCE AND THE GLOBALIZATION OF DISEASE (2004); KARL TARO GREENFELD, CHINA SYNDROME: THE TRUE STORY OF THE 21ST CENTURY’S FIRST GREAT EPIDEMIC (2006); WORLD HEALTH ORG. [WHO], SARS: HOW A GLOBAL EPIDEMIC WAS STOPPED (2006) [hereinafter HOW A GLOBAL EPIDEMIC WAS STOPPED].

[28] See generally AVIAN INFLUENZA: SCIENCE, POLICY AND POLITICS (Ian Scoones ed., 2010) [hereinafter AVIAN INFLUENZA] (discussing avian influenza).

[29] As the U.K. Commission on Intellectual Property Rights reminded us:

It is particularly important not to allow the debate in [the intellectual property] area to be influenced unduly by the HIV/AIDS experience, dramatic though it is. Apart from HIV/AIDS, which is the biggest single cause of mortality in developing countries, TB and malaria claim almost as many lives. Together all three diseases claimed nearly six million lives [in 2001], and led to debilitating illness for millions more. In addition, there are a number of less common diseases which are collectively important. These include, for instance, measles, sleeping sickness, leishmaniasis and Chagas disease.

COMM’N ON INTELLECTUAL PROP. RIGHTS, INTEGRATING INTELLECTUAL PROPERTY RIGHTS AND
DEVELOPMENT POLICY: REPORT OF THE COMMISSION ON INTELLECTUAL PROPERTY RIGHTS 30
(2002) [hereinafter IPR COMMISSION REPORT] (footnote omitted).

[30] Anti-Counterfeiting Trade Agreement, opened for signature May 1, 2011, 50 I.L.M. 243 (2011) [hereinafter ACTA].

[31] See Trans-Pacific Partnership, OFFICE OF THE U.S. TRADE REP., http://www.ustr.gov/tpp (last visited Nov. 7, 2013) (providing up-to-date information about the TPP).

[32] See, e.g., Central America–Dominican Republic–United States Free Trade Agreement, May 28, 2004 [hereinafter CAFTA-DR], available at http://www.ustr.gov/trade- agreements/free-trade-agreements/cafta-dr-dominican-republic-central-america-fta/final-text; United States–Australia Free Trade Agreement, U.S.-Austl., May 18, 2004 [hereinafter AUSFTA], available at http://www.ustr.gov/trade-agreements/free-trade-agreements/australian- fta/final-text; United States–Singapore Free Trade Agreement, U.S.-Sing., May 6, 2003 [hereinafter SUSFTA], available at http://www.ustr.gov/sites/default/files/ uploads/agreements/fta/singapore/asset_upload_file708_4036.pdf. For discussions of bilateral, plurilateral, and regional trade agreements, see sources cited in Peter K. Yu, Intellectual Property and Human Rights in the Nonmultilateral Era, 64 FLA. L. REV. 1045, 1046 n.1 (2012). For a discussion of intellectual property provisions in international investment agreements, see generally Bryan Mercurio, Awakening the Sleeping Giant: Intellectual Property Rights in International Investment Agreements, 15 J. INT’L ECON. L. 871 (2012).

[33] As Colin McInnes observed:

Health threats, the provision of health care services and the market for pharmaceuticals are increasingly transborder in nature. In terms of health security, this makes defence ‘at the border’ a near impossibility despite efforts by states to do just that. The state can no longer function as a self- contained vessel for health provision (and indeed health security), rather it has become permeable. This is most obliviously the case with infectious disease where the processes of globalization have enabled disease to spread more quickly.

McInnes, supra note 17, at 44 (citation omitted); accord FIDLER, supra note 27, at 13–16 (discussing the “germs do not recognize borders” mantra of public health); MARK W. ZACHER & TANIA J. KEEFE, THE POLITICS OF GLOBAL HEALTH GOVERNANCE: UNITED BY CONTAGION 1 (2008) (“[T]he world is becoming an ever smaller place, and microbes that cause devastating diseases do not stop for border guards.”).

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The Pharmaceutical Patent Regime

Several changes to Canada’s pharmaceutical patent regime were desired by Europe, and . Canada has agreed to allow a patent term extension (PTE) of up to two years. Additionally, the dual proceedings for patents – prohibition applications under the Patented Medicine (Notice Of Compliance) Regulations 1993 (as amended) for regulatory matters, followed by a court determination of patent validity or infringement – will likely be reformed. This second change is coupled with the newly acquired ability of brand companies to appeal an adverse PM(NOC) decision. However, the Canadian data and marketing exclusivity periods will , respectively, rather than move to the European period of 10 years. (To see past IPilogue coverage on this topic, click .)

These changes have predictably elicited polarized viewpoints. The Canadian Generic Pharmaceutical Association (CGPA) commended , but voiced their disappointment of others, including the PTE. The CGPA is pleased with the expected discontinuation of the dual litigation practice, the recognition of the generic pharmaceutical industry’s importance in Canada, and the limitations placed on the use of the PTE. Notably, a suggests that the PTE’s annual increased cost, even with the two year maximum, will range from $850 million to $1.65 billion.

By contrast, it was alleged in January 2013 that in Canada. Opinions nonetheless differ on whether brand companies have met previous promises to increase R&D in Canada in exchange for improved patent protection.

Whether these two changes are good for Canadians or not remains to be seen. Can the predicted annual cost of the PTE to Canadians be offset? The federal government’s will not help those paying for prescriptions out of their own pocket, and lacked any assurance that reimbursement will continue in the long term. Pharmaceutical companies may perhaps decrease their product costs in response to lower litigation costs, or may conduct more research in Canada – but probably not sufficient to offset the high PTE cost.

Geographical Indications

Protecting Geographical Indications (GIs) was another important aspect of CETA. Until now, the only GI protection in Canada has been for . Otherwise, GIs are protected under or as certification marks under the . These laws have not always protected European GI producers against prior Canadian users, as occurred with the Parma ham GI in . In Europe, GI protection is largely and is potentially available for any foodstuff or beverage, although some countries such as the UK have also long had a scheme like Canada’s and have also protected GIs under the law of unfair competition or false marketing.

Under CETA, Canada has agreed to increase the scope of GI protection to include . Areas that will remain unchanged in Canada include: words commonly used to describe items (Black Forest ham), generic plant names (kalamata olives), and components of longer terms, which can all still be used in association with wares. For other items, such as Asiago cheese, current users can continue to use the term, but future users are prohibited. It has not been indicated whether Canadian GIs can be protected in Europe. However, even if this protection is reciprocal, the limited use of GIs by Canadian producers suggests from the additional protection.

While existing Canadian trade-marks will , it seems that previously blocked European GIs, even if potentially confusing with Canadian trade-marks, may now be used in Canada. Thus, the European Commission has claimed that Prosciutto di Parma can in Canada. The possibility of harm to existing Canadian trade-mark owners and consumer confusion over the source of the two products becomes quite real. Consumer impact can of course be viewed as either a benefit (increased choice) or a detriment (confusion) but the potential harm to Canadian producers with valid trade-marks, coupled with the limited GI use by Canadian producers, suggests a clear victory for Europe in this sector.

Conclusion

In light of CETA’s impact on patent law and GIs, Canada appears to have lost the IP game to Europe. Whether this preliminary assessment holds true once the full text of CETA is released, and is applied in Canada, remains to be seen.

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The Ramifications of CETA on Pharmaceutical IP Laws: The Expected and The Unexpected

CETA has been in the making for many years, and the EU has made clear its desire for Canada to for pharmaceuticals - seen by many as . However, it was unknown how much Canada would end up changing��its intellectual property rights (IPR) regime in the��face of��intense pressure from both and resistant to strengthening IPR through CETA and other international trade deals.

In the end, although the full-text will not be available until it has been translated into all of the European languages, it has been widely accepted that the final agreement will have on pharmaceutical intellectual property laws in Canada:

1. Patent term restoration will provide innovative pharmaceutical companies the ability to restore up to two years of patent protection that have been lost by regulatory processes;
2. Innovative pharmaceutical companies will gain a “right of appeal” for decisions made under the -��a right��that is currently only available for patent challenges from a generic pharmaceutical company.

On its face, these changes are a boon to the innovative pharmaceutical industry in Canada and represent . These anticipated changes could be interpreted as Canada's unwillingness to fully compromise, as the EU ��up to 5 years of patent term restoration in addition to more extensive data protection provisions. Interestingly, the Canadian Generic Pharmaceutical Association (CGPA) has claimed to have from the Government of Canada that��the implementation of the “right of appeal” will serve to curb duplicative litigation from innovative pharmaceutical companies. Canada is currently the only country in which an innovative company can sue a generic producer more than once on the same patent.

Varied Reactions to the Report from Various Stakeholders

As expected, the reactions to the proposed changes to Canadian pharmaceutical intellectual property law have been mixed, with various organizations and stakeholders speaking for and against the CETA agreement.�� Canada's Research-Based Pharmaceutical Companies (Rx&D) applauding the agreement and��opining that��the agreement��will serve to increase pharmaceutical innovation and support the discovery of new medications. Interestingly enough, a Canadian patient group, The Mood Disorders Society of Canada, after the agreement was announced, which echoed the sentiments of Rx&D. The statement also��expressed the group’s belief that CETA will encourage more pharmaceutical research in Canada and��help develop effective interventions to improve the mental health of Canadians.

The CGPA also��, which��cites��its disappointment of the CETA agreement��and claims��the agreement's��potential to increase health care costs for provinces, health plans, and patients. The statement also outlined the CGPA's��concern that CETA will cause generic medications to be delayed on their way to the marketplace.���� The statement was not completely critical however, as the CGPA��commended the Canadian government’s efforts to limit the term of patent restoration to 2 years and allow for the potential for the new “right of appeal” regulations to curb litigation costs.�� The CGPA was also��appreciated that CETA will not impose any changes to the domestic data protection regime.

In my opinion, the biggest stakeholder that is likely to be affected by these proposed changes to��Canada's pharmaceutical IP law are the provinces, which bear most of Canada's health care costs. In anticipation of the agreement, many provinces, including Ontario (the largest medication provider in the country) cautioned the Canadian government that concessions to the EU on these points could greatly increase health care costs. ��that CETA could increase��its prescription drug expenses by $1.2 billion dollars annually. After the release of the agreement, however, provincial since the extent of the changes��is less drastic than predicted. In addition, the Federal Government has already announced that��it will , although no further details on this point have been released. The Ontario government responded to this statement quickly, and was the first province to make it known that��it�� for sectors that will be adversely affected by CETA. As provincial governments and the federal legislative branch����the changes CETA will bring, there are undoubtedly going to be further developments on this issue, and the ultimate acceptance and implementation of CETA will likely depend upon the details of the final agreement.

CETA: A Changing of the Guard?

Although CETA has only been agreed to “in principle” for now, it is clear that its ratification and implementation will have far-reaching consequences. It will undoubtedly have a significant impact��on Canada's health care and pharmaceutical sectors, and may change how Canada is . It seems clear to me that, at least in the intellectual property context, Canada is making the statement that it will not be left behind by its industrialized trading partners in the new knowledge-based economy.

Adam Falconi is an IPilogue Editor and a JD Candidate at Osgoode Hall Law School.

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To achieve this end, Abrams & Wagner looked to Canada’s shift from a “first-to-invent” (FTI) to “�ھ�������-�ٴ�-�ھ�����” (FTF) system for claiming priority. The study finds that the shift to FTF resulted in a reduction in the number of patents granted to individual Canadian inventors and small businesses and warns American law makers of similar consequences could result from the implementation of s3 of the AIA.

From First-To-Invent to First-To-File
Currently (and until March 16, 2013) the US follows an FTI-priority rule. ��This means that in a dispute between two applicants for a patent of the same invention, the party which had the inventive idea first is entitled to the patent.�� This is typically established by using lab notebooks, emails and other documentation that may have recorded the date of invention.�� Conversely, a system based on FTF-priority rules relies on the date when��a patent application was filed with the Patent Office for the determination of priority.

The Resulting Issues
This change is not without controversy (). argue that a shift away from FTI-priority rules reduces the inventive process to a “race to the patent office” --a race that ultimately favors large corporations over individual inventors given that large firms have the financial capacity to keep expensive legal teams on call. ��have argued that the AIA’s streamlining of the priority�� determination process is actually better for small businesses since it reduces overall legal costs in the event of a dispute (click ��to read about a constitutional challenge to the AIA). Still others have raised relevant concerns pertaining to protection of the ��and .

Contribution of the Abrams & Wagner Study
Abrams & Wagner lend an empirical perspective to this debate by considering a that occurred in Canada on .�� This study finds that: (1) the overall rate of patent applications experienced a sudden drop after the law change (from an average of 1700 applications/month to 1000 applications/month), (2) patents awarded to individual inventors dropped by 15% after the legislative change, and (3) there was no apparent change in the quality of the patents granted after the law change – but is not conclusive as to the cause of these phenomena.

Caveats of the Abrams & Wagner Study and Areas for Further Research
The authors submit that contemporaneous legal changes to the patent laws may have also affected the sudden drop in applications in 1989.�� These include: changing patent term from 17 to 20 years, the introduction of maintenance fees, and the introduction of deferred examination.

Additionally, socio-economic causes may have contributed to a reduction in the number of patent applications submitted by individual inventors.�� These include: fewer resources available to inventors, less invention by individuals, demoralization in the light of the legal changes and an increase in the number of individual
inventors that joined firms.�� Further academic research into these possible causes should be conducted to test the conclusion reached by Abrams and Wagner.

Regarding conclusion (3), Dr. Ron Bouchard wrote on this blog, describing a new way of incrementally grading the value, not only for patents in the life sciences and other technology-intensive sectors, but also for associated regulatory approvals, chemical components, patent characteristics (the “innovative index”).�� It would be interesting to see if the methodology developed by Dr. Bouchard could be used to expand upon the picture created by the Abrams & Wagner study.�� (For other IPilogue entries pertaining to patent valuation click ��and .)

Takeaway for Canadians
As alike watch our largest tech giant through , , and – the Abrams & Wagner study may raise some appropriate questions in this time of self-reflection.�� Does the Canadian patent system stifle true grassroots innovation in our tech sector? ��If so, is there room for reform?�� If not, what are the consequences of the American harmonization with��the rest of the world's��FTF priority laws?�� Could we be seeing��the levelling of a procedural playing field? Could we start to see a reduction in the traditional Canadian-to-US brain drain?

“Poisoning the Next Apple? How the America Invents Act Harms Inventors” can be viewed ��and is scheduled for publication in the current volume of the .

Beatrice Sze is a JD Candidate at Osgoode Hall Law School.

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When Apotex began distributing its drug in the United Kingdom, Servier sued it for infringing on Servier's European patent. The European patent covered the particular crystalline form of perindopril erbumine that Servier marketed under the trade mark COVERSYL, and that Apotex was marketing as a generic pharmaceutical. Servier managed to obtain an interim injunction against Apotex, which prevented Apotex from selling their drug in the UK from August 2006 until July 2007. As part of the application for an injunction, Servier submitted a cross-undertaking in damages, stating that it would compensate Apotex if the injunction improperly caused Apotex to lose profits. In July 2007, the English High Court held that , since it lacked novelty. One year later, as a result of Servier's cross-undertaking, since Apotex lost a year's worth of potential profits.

Servier also held a patent on perindopril erbumine in Canada, where Apotex was manufacturing its drug. However, the Federal Court of Appeal in Canada, unlike its counterpart overseas, , and held that Apotex was breaching Servier's patent by manufacturing its drug in Canada. Since the manufacture of the drug was illegal, Servier believed that Apotex should not benefit from its own wrongdoing by receiving damages from Servier. Servier appealed the damage award, citing the legal principle of ex turpi causa non oritur actio, which means that no legal claim shall arise from an illegal or immoral action.

Apotex made several arguments to combat Servier's ex turpi causa��claim, including the argument that the ex turpi causa��rule only applies to criminal offences, or acts of moral turpitude. The appeal judge rejected Apotex's arguments, and the $17.5 million in damages. However, Apotex appealed yet again, and added an important element to its claim. Apotex conceded that the damages it received should be reduced by an amount proportionate to what a Canadian court would have awarded Servier as a result of Apotex's breach of Servier's Canadian patent.

The case turned for the English Court of Appeal judges on both the application of the ex turpi causa��rule, and Apotex's acceptance of a proportionate reduction in the damage award it received. The judges believed that not every legal or moral wrong necessarily deprives the wrongdoer of the ability to apply for a remedy, while relying on the wrongdoing as an element of the claim. The definition of a patent is that the patent holder owns a monopoly on the patented material. Since Servier's European patent was held to be invalid, it turned out that they held an illegitimate monopoly on perindopril erbumine for a time; since that is the case, it seems as though Servier should have been disgorged for their ill-gotten gains, rather than Apotex. The Court of Appeal held that Apotex was merely attempting to challenge Servier's patent, and that Apotex had a reasonably held belief that Servier's patent was invalid. Although Apotex lost its litigation against Servier in Canada, the judges maintained that Apotex's actions fell on the low end of the scale of legal and moral culpability.

As well, the judges felt that Apotex's concession of a reduction in its damage award was a crucial reason to allow Apotex's appeal. By agreeing to reduce the quantum of damages by the amount that a Canadian court would have awarded to Servier, Apotex adequately remedied Servier for Apotex's wrongdoing. Therefore, if there were any damages left over after the reduction, Apotex would not be benefitting from its wrongdoing, so the ex turpi causa��rule would not apply. As a result, the .

This case is important for its consideration of conflicting international intellectual property rights, and its consideration of the proper test for the ex turpi causa��rule. With regard to both, the English courts appear to have a great deal of deference to Canadian law. It is encouraging to see that level of respect, especially since the Canadian court reached a decision which was the exact opposite of the English court with regard to the validity of Servier's patent. Hopefully, that level of mutual respect can continue between the two countries' judiciaries.

Evan Reinblatt is a JD candidate at Western University, Faculty of Law.

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Through innovation, patents are an important enabler of economic growth. Studies on patent activity are therefore often carried out. These studies have revealed that the European Union, the EU, lags seriously behind other major international players such as the US and Japan in patent activity. The explanation given is that the EU single market for patents is still not complete. Despite numerous calls from Heads of States and major efforts since the 1970’s the EU has not succeeded in making a unitary patent system: an EU patent valid in all EU Member States.

Currently two different patent systems are in effect across Europe; a national patent system governed by the national law of each state and a European patent system governed by the European Patent Convention (EPC). The EPC is not an EU convention, but an agreement between 38 European countries. Under the EPC a European patent can be granted to the inventor if applied for. However, the European patent is not a unitary right, but consists of 38 independent patents. Each patent is governed by national law and is therefore only nationally enforceable and nationally revocable. After a patent has been granted through the European Patent Office () it has to be approved by the national patent offices in each country in which the inventor wants his invention to be protected. This means that the patent application has to be translated to each of the languages used in these countries. Renewal fees have to be paid in each country and auxiliary provisions in the different national laws make the maintenance of the patents burdensome on the inventor.

The administrative complexity and high translation costs (studies have shown that the translation fees amounts to around 70% of the total cost of applying for the patent) of this system has serious consequences for the competitiveness of the EU in relation to other major international players and has led companies to voice a demand that costs be significantly reduced.

In April 2011, this led the European Commission to table a , consisting of two legislative proposals, aimed at creating a unitary patent protection system that will reduce costs of patents within the 25 participating EU countries by 80%. The new system has two main features: the creation of unitary EU patent protection and the creation of a unified patent court for the EU. If adopted, this system will significantly simplify the current system under the European Patent Convention.

As mentioned the Commission’s proposal firstly provides for a system under which a European patent granted by the EPO entails in each of the 25 countries without the need for further action. The patent will ensure the same level of protection in all 25 countries. The system still requires the application to be submitted to EPO. The application can be submitted in any language, but the EPO will continue to examine applications and grant patents in its three official languages: English, French and German. The cost of translation into one of these languages will be compensated. The unitary patent will practically be a European patent granted under the EPO and given unitary effect upon request. In relation to the unitary patents, the EPO will take on further tasks. The EPO will be responsible for collecting, administering and remitting renewal fees for unitary patents and for keeping a register of unitary patents, which would include legal-status information such as transfers, limitation or revocation – all of which are presently dealt with by national authorities under national law.

The second important aspect of the proposed system is a . This litigation system will consist of the Unified Patent Court (UPC). The UPC will comprise of a Registry, a Court of First Instance and a Court of Appeal. The Unified Patent Court will have exclusive jurisdiction in respect of litigation relating to the infringement and validity of a unitary EU patent.

As there is currently a strong political will to get rid of the expensive and complicated system currently in place, the EU is eager to push forward with the Commission’s proposals and significant progress has been made for the first time in several years. Discussions concerning the location of the Unified Patent Court are currently taking place with meetings in the Competitiveness Council that took place on 29-30 September 2011 and more meetings scheduled for 5-6 December 2011. The EU expects the first unitary patents to be granted in 2013 and hopes that the new system will significantly boost research and innovation within the EU. Further, it is anticipated that the new system will increase patent activity and make the EU able to compete with the US and Japan. From a Canadian perspective, the implementation of the unitary patent system will mean easier and less expensive access to EU-wide protection for Canadian inventions.

The post The EU Patent: European Union Seeks Unitary Patent System appeared first on IPOsgoode.

Due to the nature of “cloud” infrastructure, companies filing patents for cloud based innovations may not have the legal support they need to protect their perceived IP rights.

As discussed in a previous , the trend towards cloud computing has caused a frenzy of new entrants into the market delivering new and innovative solutions to meet consumer and business needs.�� For example, Apple has filed for a that uses to let a user pause a song or video on one device and then resume it from that same place on another device. For consumers, the attraction to cloud-based services lies in the ability to remotely access storage space, software applications, or server content.�� Moreover, it is a convenient, cost-effective way to share and manage documents and multimedia.

Simply put, cloud computing refers to the delivery of computing services by a provider, remotely over the internet, without ever having to install hardware at the user’s end.�� However, defining the nature of the services, products and rights in cloud-based applications is a difficult task considering the complexity of organizing infrastructure and the number of parties involved.�� Cloud computing service providers will often outsource server tasks to multiple players in several different locations, and therefore, the infrastructure may lie within several jurisdictions.�� Because of the nature of “cloud computing” itself, the data is not tied to any one clear location.���� While it is not necessary for the user of cloud-based technology to know where their data is, businesses, in particular those with a vested interest in the intellectual property of a cloud-based service, should be aware that their rights in the “cloud” could get lost in the haze.

Many have written about the multiplicity of legal issues inherent in “cloud” technology, some of which include .�� In a recent international survey of current outsourcing practice and trends, the Norton Rose group examined whether the with cloud computing were a deterrent to its widespread use.

Like those issues, the , namely patents rights to technology, are complicated by the territorial nature of those rights and how the law in different jurisdictions will apply.�� For example, unauthorized practice of a patented invention across national borders, is not actionable under the Canadian Patent Act.�� A patent issued by the Canadian Intellectual Property Office does not grant the patentee the right to enforce their rights in other countries, posing difficulties for patent holders and licensees trying to assert their rights against alleged infringers.

Similarly, infringing activity is problematic for patent holders.�� As mentioned above, the data and processing server may be situated in more than one location and are often outsourced to different parties.�� As such, a patent holder never has access to an alleged infringer’s complete system, making reverse engineering to impossible.�� Even when a patent holder does manage to detect infringing activity, determining what constitutes infringement must be considered under different patent law regimes.

Cloud computing is creating a in the way we access technology and services.�� As such, it is likely that we will see an increase in the number of disputes surrounding intellectual property rights in cloud computing services in the future.�� How will companies deal with the legal uncertainties that surround the already complex, time-consuming, cost-intensive and distracting litigation process?

One is to let these tech-savvy companies tackle their contract, patent and legal processes in the way they know best: design and develop cloud-based applications to solve their complex business problems.�� However, intellectual property interests may be so deeply rooted or financially motivated that resolution of the dispute may not be achieved through settlement.�� For example, failed attempts at negotiating a licensing agreement resulted in the launch of a recent against Apple and RIM by Openwave Systems for alleged infringement of five of its patents relating to mobile internet.

The general debate over the patent system necessity continues. Cloud computing is just another sub-category of subject matter over which parties are asking whether the patent system is necessary or beneficial, or whether it is a massive deterrent to innovation.�� Some feel that the system should be .

For now, companies considering filing patents for cloud-based innovations must rely on the business and patent claim approaches proposed by the experts.

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