Pharmaceutical Patents Research Articles

Non-patent protection of pharmaceuticals in the USA

The Obama administration’s recent health care reform legislation resulted from intense and divisive deliberations over public health policy in the USA. The existence of a fundamental right to health care, the role of the government in health care commerce, and the fiscal sustainability of existing service models were among the issues that were subject to spirited discussion. Widespread recognition that a significant number of individuals in the USA cannot readily afford the medications they require played a central role in the debate. 1 Manyofthe concernsthatpromptedhealth care reformlegislationin 2010hadearlier motivatedthe enactmentof the DrugPrice Competitionand Patent TermRestoration Act of 1984. 2 Congress intended that this legislation, commonly known as the Hatch-WaxmanAct,wouldbalancethe needforinnovativenewpharmaceuticalswith the availability of less expensive generic drugs. The statute includes elaborate provisions governing the mechanisms through which a potential generic manufacturer may obtain marketing approval on a drug that was originally sponsored by another. Among these measures were an exemption from patent infringement for activities associated with regulatory marketing approval, 3 unique litigation mechanisms for managing patent disputes, 4 and a government-sponsored clearing house of pharmaceutical patents. 5 This contribution focuses upon two additional aspects of the Hatch-Waxman Act and related legislation.In Part II, this essay considers patent term extension provisions – at first blush an odd choice given its title. The patent term extension rules

Patent Execution Strategies

Patents are considered to be enticements for innovation and thereby expected to benefit humanity by making available to the society. Pharmaceutical patents cover products that take a very long time to develop and the patent life is actually closer to 11 or 12 years since federal law requires a company to test its product for safety and efficacy and secure regulatory approval before marketing. Developing countries experience shows that such incentives focus on the market demand rather than the need of the society. This is more obvious in the health related innovation. Therefore, a strong IP protections safeguard should be held against counterfeit, illegitimate and fake pharmaceutical products.

Patent Quality

Against a backdrop of a rising generics market and increasing patent expiries, the 'quality' of patents has become an ever more significant topic of debate. Pharmaceutical Patent Analyst has brought together a group of leading attorneys and IP specialists to disentangle the issue of patent quality, including its definition and importance to the field of pharmaceutical and medical science, and what steps could be taken to improve understanding of this important yet fluid concept. Interviews conducted by Alexandra Sklan, Commissioning Editor.

The Many Means to an End: Training Methods in Pharmaceutical and Medical IP Law

Pharmaceutical Patent AnalystVol. 3, No. 1 Hot TopicThe many means to an end: training methods in pharmaceutical and medical IP lawNikolas S PurcellNikolas S PurcellDimock Stratton LLP, 20 Queen Street West, 32nd Floor, Toronto, Ontario, M5H 3R3, Canada. Search for more papers by this authorEmail the corresponding author at npurcell@dimock.comPublished Online:20 Dec 2013https://doi.org/10.4155/ppa.13.71AboutSectionsView ArticleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInReddit View articleReferences1 Patented Medicines (Notice of Compliance) Regulations, SOR/93–133. Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. §301 (Hatch–Waxman Act).Google Scholar2 Drug Price Competition and Patent Term Restoration Act, 21 U.S.C. §301 (Hatch–Waxman Act).Google Scholar101 Canadian IPO. www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/HomeGoogle Scholar102 USPTO. www.uspto.govGoogle Scholar103 Harold G Fox Moot. http://ipmootcanada.caGoogle Scholar104 Oxford IP Moot. www.oiprc.ox.ac.uk/moot.phpGoogle ScholarFiguresReferencesRelatedDetails Vol. 3, No. 1 Follow us on social media for the latest updates Metrics Downloaded 43 times History Published online 20 December 2013 Published in print January 2014 Information© Future Science LtdAcknowledgementThe author would like to thank R Sindelar for his thoughtful contributions to the article.Financial & competing interests disclosureThe author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.PDF download

Index to Volume 38

Index to Volume 38

Anticipating industry convergence: semantic analyses vs IPC co-classification analyses of patents

Purpose – The convergence of industries exposes the involved firms to various challenges. In such a setting, a firm's response time becomes key to its future success. Hence, different approaches to anticipating convergence have been developed in the recent past. So far, especially IPC co-classification patent analyses have been successfully applied in different industry settings to anticipate convergence on a broader industry/technology level. Here, the aim is to develop a concept to anticipate convergence even in small samples, simultaneously providing more detailed information on its origin and direction. Design/methodology/approach – The authors assigned 326 US-patents on phytosterols to four different technological fields and measured the semantic similarity of the patents from the different technological fields. Finally, they compared these results to those of an IPC co-classification analysis of the same patent sample. Findings – An increasing semantic similarity of food and pharmaceutical patents and personal care and pharmaceutical patents over time could be regarded as an indicator of convergence. The IPC co-classification analyses proved to be unsuitable for finding evidence for convergence here. Originality/value – Semantic analyses provide the opportunity to analyze convergence processes in greater detail, even if only limited data are available. However, IPC co-classification analyses are still relevant in analyzing large amounts of data. The appropriateness of the semantic similarity approach requires verification, e.g. by applying it to other convergence settings.

The Skilled Person: an Evolving Concept

The skilled person is a concept central to patent law, underpinning the analysis of obviousness, sufficiency, claim construction, novelty, added matter and priority. Identifying such a person correctly, particularly the level of skill and the common general knowledge that they should possess, is critical to determining whether a patent is valid and/or infringed and has significant implications for the pharmaceutical industry. However, the concept can be difficult to define. Once referred to as 'The man on the Clapham omnibus' of patent law, the skilled person is a technician who is skilled in the art yet wholly devoid of imagination. Nevertheless, his attributes and knowledge, which are context-dependent and vary from art to art, are continually evolving. This article will look at the evolution of the skilled person, focusing on the implications for the future of pharmaceutical patents and patent litigation.

Compulsory Pharmaceutical Patent Licensing in Brazil: the Controversy of Public Interest

Avenida Rio Branco no. 1, sala 1709, Centro, Rio de Janeiro, 20090 003, Brazil *Author for correspondence: E-mail: leonor.galvao@ murtagoyanes.com.br Compulsory license cases worldwide indicate that every exception rule brings controversy, even when foreseen in international agreements and supported by national laws, especially when the terms and conditions are not consistently defined, leaving gaps for subjective interpretations, which dangerously affect legal security and may favor arbitrary decisions. Compulsory licenses have become a controversial issue in Brazil since the Federal Government, through the Health Ministry, issued decrees stating public interest on certain antiretroviral medicines in order to justify the compulsory licensing thereof during price negotiations with the patentees [201].

Insights Into the Role of Patents in R&D

Pharmaceutical Patent Analyst has called on a group of international experts to explore key themes relating to intellectual property within the context of the fields of medical and pharmaceutical science. Topics include a reflection on how worrying the patent cliff really is, and adapting to life beyond it; to the ways in which social media is affecting how lawyers share information, and steps for protecting IP against the risks posed by hacking and cybersurveillance. We hope you enjoy these insightful contributions. Commissioned and edited by Gino D'Oca, Head of Commissioning.

The Politics of Pharmaceutical Product Patenting seen in the Light of the Supreme Court's Balancing Act in Novartis AG v Union of India (2013) 6 SCC 1

India is the world’s largest producer (and exporter) of generic drugs. Indian companies are known for their cheap products which are obtained by reverse-engineering and sell at a fraction of the prices most Western pharmaceutical majors command. This has led to India exporting drugs to a lot of other LDCs, and the industry has generated millions of jobs and billions of dollars in foreign exchange.So when a major Western drug-maker served a legal notice on an Indian generic manufacturer for patent infringement, which would lead to prolonged years of litigation reaching its crescendo with the judgment I am to comment on, the politics of patent protection unfolds to narrate what is known as the 'Novartis saga', which touches not just patent laws but also public policy with respect to healthcare and pricing of lifesaving drugs. In Novartis v. Union of India, which is rather detailed and well laid-out, Hon’ble Justices Aftab Alam and Ranjana Desai ruled against the Appellant, that section 3(d) of the Patents Act 1970 cannot be struck down under an Article 14 challenge. In the process of upholding its constitutionality, the Court pretty much summarized India’s laws with relation to patentability, especially with regards to product patents. The larger picture though, is that of the judgment’s role in determining the future of the world’s generic drug manufacturing industry. It is this larger picture I intend to focus this project research on. I see the Court’s judgment as a balancing act, a commendably intricate order which holds up India’s role in the pharmaceutical industry and reads the law succinctly to include it within the confines of this case; by repeatedly clarifying its stance, it is taking care to not spill adverse conclusions that could misinterpret this judgment.

Tracking 20 Years of Compound-to-Target Output from Literature and Patents

The statistics of drug development output and declining yield of approved medicines has been the subject of many recent reviews. However, assessing research productivity that feeds development is more difficult. Here we utilise an extensive database of structure-activity relationships extracted from papers and patents. We have used this database to analyse published compounds cumulatively linked to nearly 4000 protein target identifiers from multiple species over the last 20 years. The compound output increases up to 2005 followed by a decline that parallels a fall in pharmaceutical patenting. Counts of protein targets have plateaued but not fallen. We extended these results by exploring compounds and targets for one large pharmaceutical company. In addition, we examined collective time course data for six individual protease targets, including average molecular weight of the compounds. We also tracked the PubMed profile of these targets to detect signals related to changes in compound output. Our results show that research compound output had decreased 35% by 2012. The major causative factor is likely to be a contraction in the global research base due to mergers and acquisitions across the pharmaceutical industry. However, this does not rule out an increasing stringency of compound quality filtration and/or patenting cost control. The number of proteins mapped to compounds on a yearly basis shows less decline, indicating the cumulative published target capacity of global research is being sustained in the region of 300 proteins for large companies. The tracking of six individual targets shows uniquely detailed patterns not discernible from cumulative snapshots. These are interpretable in terms of events related to validation and de-risking of targets that produce detectable follow-on surges in patenting. Further analysis of the type we present here can provide unique insights into the process of drug discovery based on the data it actually generates.

Implications of TRIPS Flexibilities for Access to Non-communicable Disease Medicines in Lower and Middle Income Countries

Over 60% of deaths in the world are due to noncommunicable diseases (NCDs), principally referring to cardiovascular diseases, diabetes, cancer and chronic respiratory disease. Nearly 80% of these NCD deaths occur in low- and middle-income (LMIC) countries, where it is difficult for people to access essential medicine for treatment. The problem of effective access results in part from the exorbitantly high prices that arise from the negative effects of global patent protection. The WTO Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) offers flexibilities, such as compulsory licenses and parallel importing, to remedy those negative effects. Hence, two fundamental questions arise. To what extent do LMIC countries benefit from these safeguards when it comes to providing essential medicines for their populations? What options and political barriers do these countries have when making the case for being able to make NCD essential medicines accessible to their populations, and what lessons can be learned from the successes of increased and affordable access to AIDS/HIV medicines from the early 2000s? Through introspection of emerging case studies, this article explores ways to reduce barriers to essential medicines for NCDs under the WTO TRIPS frameworks and other relevant regulations related to pharmaceutical trade and patents.

Law on Pharmaceutical Patents

India is known as the global pharmaceutical capital because of the ever growing generic drug manufacturing industry. With the growth of such an industry the issue of protection to pharmaceutical patents is also gaining importance. Pharmaceutical patent protection is of prime importance to pharma companies because of the huge amount of money invested in the RD access to cheaper medicines; the issue of compulsory licensing and the patent infringement of pharma patents. It analyses the future of pharmaceutical patents through case studies of some of the most latest and landmark judgments passed in the history of pharmaceutical patents.

Drugged Out: How Cognitive Bias Hurts Drug Innovation

In recent years, legal scholars have begun to identify and evaluate how the cognitive biases held by all individuals impact law and policy. Thus far, however, scholars have not recognized the existence or impact of biases that impact pharmaceutical innovation and patent policy. This Article fills that gap at a key juncture. Currently, the industry mostly produces drugs that do not provide significant clinical benefits over existing drugs. Further, even the number of new drugs produced every year is modest compared with exponentially increasing pharmaceutical expenditures. This Article shows that there are significant cognitive biases that play a key, but thus far unrecognized, role in promoting modest innovation. In particular, there are views of pharmaceutical innovation and patent policy that have been broadly accepted amongst not only the industry, but by policy makers and some scholars that are not soundly supported. These views, referred to as “schemas,” are perpetuated because of well-established cognitive biases explained in the Article. Recognizing these schemas is critical because scholars and policy makers are vulnerable to accept these mistaken assumptions as fact, and create and recommend misguided policies. Although these schemas revealed here are broadly consistent with cognitive science studies, this is the first Article to not only document schemas in the realm of pharmaceutical innovation, but also show how they are perpetuated despite contrary evidence. After revealing these schemas, this Article proposes concrete steps to counteract them, including possible steps to modify patent policy in light of this new understanding.

Parallel Imports in the Enlarged EU: the Specific Mechanism

*Arnold & Porter (UK) LLP, Tower 42, 25 Old Broad Street, London, EC2N 1HQ, UK E-mail: christopher.stothers@ aporter.com This Hot Topic considers the implications of Merck v. Sigma [1], where the English Court of Appeal referred to the European Court of Justice (ECJ) questions on the application of the specific mechanism. The specific mechanism permits pharmaceutical patents and Supplementary Protection Certificates (SPC) to be enforced against parallel imports from 11 of the new EU Member States if such protection was not available in the new Member State at the relevant time. The ECJ carefully protects the ‘internal market’ required by the Treaty on the Functioning of the EU [2]. Since the 1970s, the ECJ has made it clear that patents cannot be enforced against parallel imports of pharmaceuticals within the EU, on the basis of the Treaty provisions on the free movement of goods (now Articles 34–36). That is the case even where the underlying price differentials that fuel the trade are caused by divergent pricing policies of national healthcare systems or by limitations in patent protection, which mean the product faces generic competition in the exporting country. That is a particular problem where the exporting country refused to grant patent protection for pharmaceutical products in the recent past. This problem has been recognized as the EU has expanded, and patent owners have therefore been given transitional rights to enforce their patents against imports from new Member States. In the case of 11 of the 13 newest joiners from Central and Eastern Europe (Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia and Slovenia), a ‘specific mechanism’ was applied since 1 May 2004 (1 January 2007 for Bulgaria and Romania, and 1 July 2013 for Croatia) [3] that permits the enforcement of patents and SPC against imports if such rights could not be obtained in the exporting Member State when they were filed in the importing Member State. It also requires an importer to notify the patent or SPC owner 1 month before applying to the regulatory authorities for authorization to import such products. This is in addition to any notification of the parallel import authorization by the regulatory authority and to the notification of repackaging, which must be made to the trademark owner before trade begins.

Book Reviews

Nicoli Nattrass of Centre for Social Science Research, University of Cape Town reviews, “Patenting of Pharmaceuticals and Development in Sub-Saharan Africa: Laws, Institutions, Practices, and Politics” by Poku Adusei. The Econlit abstract of this book begins: “xamines the need to reconstruct the globalized patent regime to address public health and development challenges that confront the citizens of countries in sub-Saharan Africa, focusing on the threats posed by HIV/AIDS, malaria, and tuberculosis epidemics. Discusses exploring the conceptual domains for patent discourse in global trade relations; evolutionary trajectories of patents and the politics of exclusion in sub-Saharan Africa; the ““myth” of patent justifications—triumph and failure dichotomy in the North and South; patent regulatory and institutional mechanisms in sub-Saharan Africa; pharmaceutical patents, the right to health, and constitutional supremacy in sub-Saharan Africa; and pharmaceutical patents and human development in sub-Saharan Africa. Adusei is Lecturer in Intellectual Property Law, Land Law, Company Law, and Private International Law at the University of Ghana, Legon.”

The Right to Health and Constitutional Imperatives for Regulating the Exercise of Pharmaceutical Patent Rights in Sub-Saharan Africa

The Right to Health and Constitutional Imperatives for Regulating the Exercise of Pharmaceutical Patent Rights in Sub-Saharan Africa

Esomeprazole in the Australian courts: The acid test

A number of decisions have already been handed down this year by the Australian Federal Court in a series of pharmaceutical patent challenges. The most recent of them is the decision in the esomeprazole case. At issue was the validity and infringement of three patents: the so-called purity patent claiming an optically pure salt of the (−)- enantiomer of omeprazole, including the magnesium salt; the so-called multiple unit tableted dosage form patent claiming, amongst other things, omeprazole or one of its single enantiomers or an alkaline salt thereof in a tablet form with defined characteristics; and the so-called 774 patent claiming an oral pharmaceutical dosage form comprising, amongst other things, a proton pump inhibitor including omeprazole or the (−)- enantiomer of omeprazole. This case is another example of the Federal Court complying with the parties’ express desire for a prompt delivery of reasons for judgement. After a hearing of some weeks, which concluded on 28 March 2013, there were final written submissions filed on 12 April 2013. The parties (and in particular Ranbaxy) requested a determination preferably by no later than 23 April 2013. That gave Justice Middleton just under one month from the conclusion of the hearing and only 10 days after the final written submissions to deliver a judgement with respect to the validity of three separate patents, each of which was attacked on numerous bases including lack of novelty, a lack of inventive step and manner of manufacture. His Honour’s judgement extends to 1017 separate paragraphs over 148 pages. Although the decision does not traverse any astoundingly new ground or offer any particularly insightful new approach to the conventional validity attacks that were mounted, some general observations may be of interest.

The Need for a Patent-Centric Standard of Antitrust Review to Evaluate Reverse Payment Settlements

Reverse payment settlements have ignited a firestorm debate among all affected parties: consumer groups, brand-name pharmaceutical companies, generic manufacturers, pharmaceutical wholesalers and retailers, lawmakers, executive agencies, and the federal courts. The Federal Trade Commission (“FTC”) has waged a decade-long battle against such private settlements of pharmaceutical patent litigation as illegal market-sharing agreements, with skirmishes among the circuits trending in favor of the settling parties until recently. The Third Circuit’s recent decision in In re K-Dur Antitrust Litigation unsettled this trend, and the Supreme Court granted the FTC’s petition for a writ of certiorari in a separate case on the issue on December 7, 2012.A reverse payment settlement is an agreement ending a pharmaceutical patent infringement suit under which a putative patent holder agrees to compensate an alleged infringer, typically a generic firm, to settle a patent infringement case. In exchange, the alleged infringer agrees not to challenge the patent holder’s patent or sell a generic version of the drug for a stated term. Because the payment flows from the plaintiff to the defendant, it has been called a “reverse” payment.This Note argues that any standard of antitrust review for reverse payment settlements must involve an evaluation of the patent’s strength at the time the patent holder and generic firm enter into a settlement. The Court of Appeals for the Federal Circuit is the court of competent jurisdiction to review a district court’s evaluation of a patent’s strength. Part I reviews reverse payment settlements generally and the statutory schemes that promote their emergence. Part II presents three approaches the circuit courts have adopted to review reverse payment settlements: per se illegality, a rebuttable presumption of illegality, and the scope of the patent test. Part III argues that any standard of antitrust scrutiny must consider the patent’s strength at the time of the settlement — an approach no circuit has yet adopted — and that the Federal Circuit is the proper appellate court to review patent strength.

How Do Public Health Safeguards in Indian Patent Law Affect Pharmaceutical Patenting in Practice?

The 1995 Trade Related Intellectual Property Rights (TRIPS) agreement required developing countries to grant product patents in pharmaceuticals. Developing countries have since explored various measures to ameliorate potential negative effects of the new laws on public health. A prominent example is India, whose post-TRIPS patent laws include a provision, section 3(d), that restricts patents on incremental pharmaceutical innovations. Its critics and supporters alike suggest that this provision makes Indian patent law very different from that in other jurisdictions. Yet there are concerns that given resource constraints facing the Indian patent office, this novel feature of Indian patent laws on the books may not have an effect on Indian patent prosecution in practice. We test this by examining the prosecution outcomes of 2,803 applications filed in both India and Europe, coded by whether they include claims that trigger 3(d) considerations. We find that having the 3(d) provision on the books does not translate into very different patent outcomes in practice in India, relative to Europe, a jurisdiction without this provision.