Extension Of Patents Research Articles

What explains patenting behaviour during Britain’s Industrial Revolution?

A recent re-evaluation of patenting during the British Industrial Revolution argues patentees were responsive to demand-side conditions. This view does not consider supply-side factors, such as a patentee’s skill or access to financial resources, as an alternative mechanism. I exploit a rich dataset of patentee occupations to investigate the role a patentee’s economic or social background played in their patenting behaviour. I find skilled patentees were intensive users of the patent system and frequently patented more economically valuable inventions. I also find patent value mattered more than patentee skill for patent extension, which likely indicates the existence of financiers willing to back the acquisition of patents for valuable inventions. The composition of Britain’s patentees, and their use of the system, reasonably relates to the value of the inventions they sought to protect.

The Effects of Patent Extension and Take-Back Regulation on Green Pharmacy

Problem definition: The eco-toxicity arising from unused pharmaceuticals has regulators advocating the benign design concept of “green pharmacy,” but high research and development expenses can be prohibitive. We therefore examine the impacts of two regulatory mechanisms, patent extension and take-back regulation, on inducing drug manufacturers to go green. Academic/practical relevance: One incentive suggested by the European Environmental Agency is a patent extension for a company that redesigns its already patented pharmaceutical to be more environmentally friendly. This incentive can encourage both the development of degradable drugs and the disclosure of technical information. Yet, it is unclear how effective the extension would be in inducing green pharmacy and in maximizing social welfare. Methodology: We develop a game-theoretic model in which an innovative company collects monopoly profits for a patented pharmaceutical but faces competition from a generic rival after the patent expires. A social-welfare-maximizing regulator is the Stackelberg leader. The regulator leads by offering a patent extension to the innovative company while also imposing take-back regulation on the pharmaceutical industry. Then the two-profit maximizing companies respond by setting drug prices and choosing whether to invest in green pharmacy. Results: The regulator’s optimal patent extension offer can induce green pharmacy but only if the offer exceeds a threshold length that depends on the degree of product differentiation present in the pharmaceutical industry. The regulator’s correspondingly optimal take-back regulation generally prescribes a required collection rate that decreases as its optimal patent extension offer increases, and vice versa. Managerial implications: By isolating green pharmacy as a potential target to address pharmaceutical eco-toxicity at its source, the regulatory policy that we consider, which combines the incentive inherent in earning a patent extension on the one hand with the penalty inherent in complying with take-back regulation on the other hand, serves as a useful starting point for policymakers to optimally balance economic welfare considerations with environmental stewardship considerations.

The anatomy of CUSMA’s patent: Does it still reflect an equipoise?

The Protocol of Amendment to the Agreement between the United States of America, Canada and the United Mexican States erased many of the TRIPS-plus provisions inserted earlier into the Canada- United States of America-Mexico Agreement (hereafter, CUSMA) signed on 30 November 2018. While the erasure of the provisions shows the contributions made to promote access to medicines, the Agreement still retains TRIPS-plus provisions, including the provisions on patent term extensions. Thus seen, irrespective of the changes introduced by the Protocol of Amendment, patent term extensions may have a negative implication on access to cost-cutting medicines (biosimilars and generics). Against this backdrop, this paper focuses on patent term extensions, as contained in the CUSMA’s Intellectual Property Rights (IPRs) chapter. The paper investigates if & how the patent term extension has the potential to impede access to affordable medicines (biologics and chemically synthesized medicines). In so doing, the paper provides possible responses to the question, do the provisions on patent term extensions hinder the timely access to affordable medicines? As such, the first part of the paper succinctly looks at CUSMA. Section “Patent protection under the TRIPS agreement” examines the TRIPS patent regime. While “The CUSMA’s rules on patent term extension” section discusses the nature of obligations included in the CUSMA’s IPRs chapter, the Section “The CUSMA’s rules on patent term extension vis-à-vis access to medicines” analyzes the potential implications of patent term extensions on access to affordable medicines. The final section concludes the paper.

Changing paradigm of supplementary protection of inventions in the national legislation of Ukraine

Key words: patent term extension, supplementary protection, supplementary protectioncertificate, drug patents, patent legislation reform
 The article is mainly aimed at distinguishingtwo mechanism: patent term extension which used to be applied inUkraine before the patent reform, and supplementary protection certificates whichwere introduced to national legislation in 2020.Patent term extension in the way it was provided in the Ukrainian Patent Law is arather simple mechanism that didn’t require much regulations. It used to provide additionalperiod of patent monopolies which was equal to the period which elapsed betweenthe date on which the patent application was filed and the date of the marketingauthorisation, not more than 5 years. Since there were no limitation on the type ofpatent (basic patent) or requirement of the first marketing authorization, this regimeprovided an opportunity to extend not only basic patent term, but also all secondarypatents related to one drug. This created a situation when duration of patent monopolyfor one drug exceeded 35 years.Provided that national pharmaceutical industry is oriented on manufacturing ofgeneric drugs, supplementary protection certificates are more appropriate forUkraine. Firstly, this is due to the limitation of effective patent life to 15 years whichis more feasible considering the national context. Another positive thing about SPCsis some uncertainty in relation to definition of the subject matter and scope of SPCprotection. That means that the country can have some freedom in determining theways of its interpretation. However, it should be noted that such indeterminacy is agrey zone. Thus, it is necessary to consider how the country can benefit from the supplementaryprotection regimen. Since the pharmaceutical sphere is very sensitive,the SPC issues have direct effect on public health and access to treatment. So, the articlejustifies the general idea that implementation of new legislation provisions shallbe aligned with both ensuring pharmaceutical innovations and guaranteeing that thepublic health needs are still a priority. Therefore, considering the long-term negativeeffect of the patent term extension regimen, the new SPC approach should be as balancedas possible.

Amend Patent Legislation to Expand Access to Pharmaceuticals during National Emergencies

As of February 2021, the COVID-19 pandemic has led to almost 109 million cases worldwide and over 486,000 American deaths (Johns Hopkins University 2021). With the federal government pouring more than $9 billion in taxpayer money to develop vaccines and treatments for COVID-19, accessibility to these taxpayer-funded products is a public concern (Witters 2020). Under current U.S. law, private entities of any size are allowed to keep patents funded by taxpayer dollars (Stevens 2004). Although government use of taxpayer funded patents exist in limited circumstances, there is little incentive beyond public and political pressure for pharmaceutical companies to forgo patent enforcement for public good. We recommend that Congress amend Title 35 of United States Code to allow patent term extensions when a patent holder agrees to forgo patent enforcement in times of presidentially declared public health national emergencies under the National Emergency Act.

Pandemic, Patents and Public Health

The COVID-19 pandemic has compelled a relook at public healthcare and the patent systems. It has brought to halt livelihoods with devastating consequences to people’s lives national economies. Global health security is at stake as there is a need to develop and deploy more vaccines, repurpose medicines and increase medical infrastructure support. Collaboration and collective response is imperative at international and national levels. IPR access is crucial in relation to public health. Many countries have issued new policies and enacted laws to make it easier for them to supply medicines to their population during the pandemic. Compulsory licensing has been used as an important mechanism to open up IP without the permission of patent holders. The present study analyses amendments to patent law and IP legislations that are effected from a cross country perspective during the pandemic time. It also examines international cooperation in the context of public health and IP under the TRIPS Agreement in view of the on-going consultation at the WTO. The study reveals differences in approaches to ‘governmental use’ of patents and access to know-how under the statutory framework. Improving the scope of use of products and process patents, suspension of patent term extension, consolidating the compulsory licensing mechanism, removal of inequity are the predominant aspects that are part of the amendments to patent law in the countries. Pandemics like COVID-19 need legislative initiatives to secure healthcare system access for all citizens. Healthcare access includes ready availability of basic vaccines, drugs, medical devices and medical infrastructure. There is often a clash between access to healthcare as a fundamental right on one hand and the need to award monopolies in the form of IP rights as an incentive for innovations from the pharmaceutical industry on the other. Hence, obstacles arise in decision-making to balance innovation incentives and ensuring rights to access healthcare. Judicial decision-making and public policy-making have been always at the centre stage in earlier epidemics and now in the current pandemic making it imperative for countries to protect the health interests of their citizens.

Changes in PBM Business Practices in 2019: True Innovation or More of the Same?

In 2019, pharmacy benefit managers (PBMs) responded to intense public criticism with business model changes described as movements toward full transparency and innovation to reduce costs for benefit plan sponsors. We critically analyze these changes in light of key challenges in specialty drug management: pharmaceutical manufacturer practices (price increases driven by coverage mandates and lack of price control, intensive and sometimes misleading advertising, patent extensions), FDA changes (increased reliance on manufacturer funding, weakened evidentiary base for drug approvals), and provider prescribing patterns (lag from evidence to routine practice, manufacturer influences on the knowledge base, direct manufacturer payments to frequent prescribers). The persistence of controversial PBM practices suggests that business model changes were mostly cosmetic, without altering key marketplace dysfunctions. Examples include "spread" pricing, in which PBMs pay pharmacies less than employer-paid amounts; rebate-influenced formulary development; and shifting of prescription volume to PBM-owned pharmacies. Spread in Medicaid was estimated at $224.8 million in Ohio and $123.5 million in Kentucky in 1-year periods and is the subject of an ongoing federal investigation. Rebate influence on formulary development is suggested by slow biosimilar adoption and a study documenting little association between brand exclusions and clinical or cost-effectiveness. Even in 100% passthrough arrangements, the price differential between rebated products and lower-cost alternatives may far exceed revenues returned to the payer. Shifting of business to PBM-owned pharmacies was identified in Florida managed Medicaid in 2018, where the state's 5 largest specialty pharmacies, all owned by managed care organizations or PBMs, collected 28% of prescription drug profit despite dispensing only 0.4% of claims. Finally, contract provisions and terms typically limit the ability of plan sponsors to monitor PBM performance. These include "offsetting," changes in definitions (e.g., "single-source generic") during the contract term, restrictions on audit rights, and exclusion of some pharmaceutical manufacturer revenues from "100%" passthroughs. We conclude that ostensibly positive changes in PBM practices have been offset by undisclosed business arrangements, shifts to alternative revenue sources, and opaque contractual terms. Establishing and maintaining a sustainable benefit will require fundamental alterations to this dysfunctional market DISCLOSURES: This work was funded solely by Archimedes, with no external funding. Motheral is the CEO of Archimedes, a specialty drug management company, and EpiphanyRx, a PBM that provides alternatives to the business models described in this article. Fairman is a consultant to Archimedes.

Formulation, Development and Evaluation of Uncoated Bilayer Tablet of Anti-Hypertensive Agents

The present research work was carried out to Formulate and evaluation of bilayer tablet dosage form for the treatment of Hypertension.The objective of this study to compare the specific characteristics of Metoprolol [beta selective (cardio selective) adrenoreceptor blocking agent] and Hydrochlorothiazide (Thiazide Diuretics]) in order to design stable formulation. It can be concluded that bilayer tablet were successfully formulated to achieve immediate release of Hydrochlorothiazide (HCTZ) and tailored release of Metoprolol (MPL)by using Dual Release Drug Absorption System(DUREDAS technology).Both drugs were found to be stable in Bilayer tablet formulation and were found to be stable for few months. This bilayer tablet dosage form increases the stability which may reduce loss and cost of formulation. It improves the benefits of producer, retailer, and patients. Recently, greater attention has been focused on development of bilayer tablet formulations. Over the past 30 years, the expenses and complications involved in marketing new drug entities have increased with concomitant recognition of therapeutic advantages of conventional drug delivery system. Several pharmaceutical companies are currently developing bi-layer tablets, for a variety of reasons: patent extension, efficient pharmacological effect, better patient compliance, etc. Bilayer tablet is becoming new approach for the successful drug delivery system and for better stability in combination. Bilayer tablets can be primary option to avoid chemical incompatibilities between APIs by physical separation.
 Keywords: Bilayer tablet, DUREDAS Technology, Antihypertensive, Metoprolol, Hydrochlorthiazide

Development Time and Patent Extension for Prescription Drugs in Canada: A Cohort Study.

The Comprehensive Economic and Trade Agreement between Canada and the European Union provides for an extension of Canadian patents for prescription drugs by up to 2 years. One of the arguments advanced for longer patent time is to compensate companies for the length of the overall drug development time (the time between patent application and market approval). This study investigates overall development time in Canada for different groups of drugs approved between January 1, 2009 and December 31, 2018 and how many of these drugs are eligible for up to 2 years of patent term extension. Based on a list of patents and dates of market approval, the change in overall development time for all drugs was calculated along with whether there were differences in development time between different groups of drugs. Using Canadian patent filing dates, overall development time for all drugs went from a mean of 2240 days (95% CI: 1832, 2648) in 2009 to 4197 days (95% CI: 3728, 4665) in 2018 (analysis of variance [ANOVA], P<.0001). Using first global patent filing dates, overall development time went from a mean of 4481 days (95% CI: 3053, 5908) in 2009 to 6298 days (95% CI: 4839, 7756) in 2018 (ANOVA, P=.0118). There was a statistically significant difference in the overall development mean time between small molecule drugs (3553, 95% CI: 3361, 3746) and biologics (3903, 95% CI: 3595, 4212), (t test, P=.0487) when using Canadian patent filing dates but not when first global patent filing dates were used. There was no statistically significant change in overall development time among drugs that were substantial, moderate or little to none additional therapeutic value compared to existing drugs. Out of 238 drugs, 218 (91.6%) would have been eligible for patent term extension with 195 (80.7%) eligible for the full 2 years. Patent term extension does not appear to be justified based on changes in overall development time, except possibly in the case of biologics. There are also trade offs in terms of increased expenditures that need to be considered if patent terms are lengthened.

Federal circuit addresses impact of the Uruguay Rounds Agreement Act and patent term extension on obviousness-type double patenting

Federal circuit addresses impact of the Uruguay Rounds Agreement Act and patent term extension on obviousness-type double patenting

Patent method for the extraction and determination of micro- and nano- plastics in organic and inorganic matrix samples: An application on vegetals

The uncontrolled introduction into the environment of plastic polymers have caused the dispersion of plastic debries, known as microplastics (MPs), that represent an important topic for environmental and human health threats. So far, the absence of effective and efficient extraction methods of MPs (especially for plastic particles with diameters inferior than 10 µm) from complex matrices (water, food, etc.) did not allow to perform the risk estimation and, the consequent assessment of the health impact associated with the exposure to these emergent contaminants.In this paper, a new patented method for the extraction and determination of micro- and nano-plastics in organic and inorganic matrix samples is reported. The method applied in the study has been nationally and internationally protected. The code of the submitted request of international patent's extension in several country of world is PCT/IB2019/051,838 of 7 March 2019, coupled with the accepted Italian patent n. 102,018,000,003,337 of March 7 of 2018 entitled “Method for extraction and determination of microplastics in samples with organic and inorganic matrices”. The method applied to our study is based on sedimentation of the particles with density higher than 1 g/cm3. The method can be applied to organic and inorganic samples as water, food, soil, waste, air, biological sample (blood, urine, tissues, etc.).After acid digestion of sample matrix, MPs are recovered by sedimentation in dichloromethane and then they are dispersed in metallic stub. Analysis is performed by SEM-EDX.•New method for the extraction and determination of total microplastics <10 µm.•The method is based on the sedimentation of particles with density higher than 1 g/cm3.•The method can be applied to organic (food, soil, biological sample, etc..) and inorganic samples.•Total micro- and nano-plastics quantification is performed by SEM-EDX.

The Meanings of "Pediatric Drug Development".

Pediatric drug development (PDD) became an industry goal when the Food and Drug Administration (FDA) granted patent extensions. This was later expanded to obligations for pediatric studies and to the European Medicines Agency's (EMA's) strict pediatric investigation plans (PIPs). Industry now sponsors many often international studies in young patients that are difficult or impossible to recruit. PDD's intellectual foundations characterize children as "therapeutic orphans," allegedly discriminated in drug treatment and development. While toxicities occured in newborns, demanding separate efficacy and safety (E&S) studies in all age groups is wasteful and reflects hidden conflicts of interest. The American Academy of Pediatrics (AAP) successfully procured pediatric research funds; the FDA dislikes pediatric off-label use and envisions labels as instructions for physicians. Pediatricians have continuously improved child health care by careful use of available drugs. Instead of physiologically defining children vis-à-vis drug treatment, the FDA defines children as ≤16 years old, offering convincing pretense for the need for mostly senseless "pediatric" studies in young adults, adolescents, and children. Although these studies may help advance pediatric academic careers, they do not improve pediatric health care. The EMA defines children as <18 years old and demands even more senseless and potentially harmful "pediatric" studies. Young patients need pharmacokinetic/pharmacodynamic and dose finding, but not separate E&S, studies. Institutional review boards and ethics committees should suspend or reject questionable FDA/EMA-demanded "pediatric" studies. Industry and science need repositioning towards "PDD"; US/EU pediatric laws need revision. We hope this will not take decades.

Lies don't travel far: Article 3(c) of the SPC Regulation from a German perspective

Germany, Higher Regional Court of Düsseldorf, I-2 U 63/18, 15 March 2019 According to the Court of Justice of the European Union, Article 3(c) of the SPC Regulation precludes the holder of a patent on the basis of which a first SPC has been granted for an active ingredient thereby claimed from obtaining a second SPC for a combination if that active ingredient constitutes the sole ‘subject-matter of the invention’ (Case C-577/13) and the other active substance is not protected as such by the patent (Case C-443/12). However, this case law has raised questions that remain unanswered. In a recent decision, the Higher Regional Court of Düsseldorf sought to address the problem of how the ‘subject-matter of the invention’ is determined in case the patent is objectively incorrect. Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate (SPC) for medicinal products is a European piece of legislation in the larger context of patent term extensions. However, it is not a patent per se whose term is open for extension but rather a ‘part’ of it. This ‘part’ must be protected by the patent (Article 3(a) of Regulation No 469/2009) and relate to a ‘product’, which is defined in Article 1(b) of Regulation No 469/2009 as an active ingredient or combination of active ingredients of a medicinal product. However, the Court of Justice of the European Union (CJEU) does not seem to apply this definition in a strict or literal sense. Judge Meier-Beck of the German Federal Court of Justice (Bundesgerichtshof), writing extra-judicially (Meier-Beck, GRUR Int 2018, 657, 661), has suggested that the term ‘product’ is subject to a ‘valuation … under SPC law’. Therefore, if an active ingredient and a combination of that active ingredient and another substance have the same ‘value’ for the invention covered by the basic patent, Article 3(c) of Regulation No 469/2009 precludes the grant of a second SPC whenever one of them (either the active ingredient or the combination) has already been the subject of a first SPC. Now, the Higher Regional Court of Düsseldorf has put flesh on this suggestion to give a better understanding of how to tackle Article 3(c) of Regulation No 469/2009.

Rational Use of Medicine in Children-The Conflict of Interests Story. A Review.

BackgroundUnited States (US) and European Union (EU) legislation attempts to counterbalance the presumed discrimination in pediatric drug treatment and development.MethodsWe analyzed the history of drug development, US/EU pediatric laws, and pediatric studies required by US/EU regulatory authorities and reviewed relevant literature.ResultsThe US and EU definitions of a child are defined administratively (rather than physiologically) as being aged <17 years and <18 years, respectively. However, children mature physiologically well before their seventeenth or eighteenth birthdays. The semantic blur for these differing definitions may indicate certain conflicts of interest.ConclusionsPediatric healthcare today is better than ever. Regulatory-related requirements for “pediatric” studies focus on labeling. Most of these studies lack medical usefulness and may even harm “pediatric” patients through administration of placebo and/or substandard treatment, despite the resultant publications, networking, patent extensions, and strengthened regulatory standing. Clinicians, parents, and ethics committees should be aware of these issues. New rules are needed to determine new pharmaceutical dose estimates in prepubescent patients, and when/how to clinically confirm them. Internet-based structures to divulge this information should be established between drug developers, clinicians, and regulatory authorities. A prerequisite for the rational use of pharmaceuticals in children would be to correct the flawed concept that children are discriminated against in drug treatment and development, and to abandon separate “pediatric” drug approval processes.

A Method for Approximating Future Entry of Generic Drugs.

To develop and test a method for approximating generic entry of top-selling drugs. The procedure involved 1) identifying products' key patents as those with a patent term restoration extension (whenever relevant) or otherwise as the first expiring patent listed in the US Food and Drug Administration's patent register, 2) determining whether the key patent had been extended through an associated pediatric extension, 3) identifying other regulatory exclusivities associated with the drug, and 4) categorizing key patents as active ingredient (or extended) patents versus secondary patents. The accuracy and precision of the procedure's predictions were then tested against a database containing the timing of generic entry for 170 top-selling drugs that lost market exclusivity between 2000 and 2012, on the basis of Medicaid data. Overall, the procedure predicted a median market exclusivity period of 12.5 years (interquartile range [IQR] 7.25-14.5) compared with the median actual period of 12.5 years (IQR 8.5-14.75 years). Among the 131 drugs (77%) with active ingredient patents, the median predicted market exclusivity was 12.25 years (IQR 7.5-14.5) compared with a median actual period of 13.0 years (IQR 10.0-14.75). Among the 38 (22%) drugs protected only by secondary patents, the median predicted market exclusivity was 16.0 years (IQR 6.75-19.5), but the median actual market exclusivity was only 8.25 years (IQR 6.25-13.5). The procedure approximated median actual exclusivity with reasonable accuracy and precision for drugs with active ingredient patents, but substantially overestimated exclusivity for drugs with only secondary patents.

The link between technology transfer and international extension of university patents: Evidence from Spain

The aim of this article is to shed light on the decision-making process at university technology transfer offices and show that the last steps in the process of international patent extension, when costs step up, tend to be only taken conditional on the existence of a licensing agreement. This information has so far been underexploited by policymakers and innovation scholars in search of innovation indicators. We argue that the number of international patent families filed by a university can be used as a rough indicator of technology transfer activity mediated through patents, especially in the context of tight public university budgets and national patent systems with fee reductions for universities. To support our argument, we review qualitative information from interviews at technology transfer offices, regulations, and internal statutes from a selection of Spanish universities and present a statistical analysis of the relation between patent internationalisation and licensing.

Improving Therapeutics to Better Care for Older Adults and the Young: Report From the American College of Clinical Pharmacology Workshop.

Improving Therapeutics to Better Care for Older Adults and the Young: Report From the American College of Clinical Pharmacology Workshop.

How much does the backlog on drug patents cost for health in Brazil?

The backlog in processing patent applications in Brazil has persisted since the enactment of Law 9,279/1996, when the country resumed granting patents on drugs. The agencies responsible for granting such patents, namely the Brazilian National Patent and Trademark Office (INPI) and the Brazilian National Health Surveillance Agency (Anvisa) cite technical and administrative reasons for the backlog. However, little research has focused on the economic impacts for health due to the inefficiency of the Brazilian patent system. The current study thus proposes a methodology to estimate the extent to which government procurement of medicines is burdened by the backlog in drug patent applications. According to the results, a total of more than BRL 14 million (USD 4.5 million) is spent unnecessarily per year by the Federal Government on just one antiretroviral drug due to the extension of the respective patent's life. Measures to resolve this situation are urgently needed in the three branches of government. These include hiring more staff for the INPI, analysis of bills of law under review in the two houses of the Brazilian Congress to amend the Industrial Property Law, and ruling on direct class action claims of unconstitutionality to suppress the legal mechanisms that allow extending the life of patents.

Trans-Pacific Partnership Agreement and Its Impact on Accessibility and Affordability of Medicines: A Meta-synthesis.

This article aims to discuss the main consequences of the implementation of the Trans-Pacific Partnership Agreement (TTPA) in the pharmaceutical sector in regard to public health, focusing on the accessibility and affordability of medicines. This paper also looks at the likely impact of the TPP agreement on access to affordable medicines. The potential effects of provisions in the final text are explored based on the context of developed and developing countries. A meta-synthesis study design was used. The thematic analysis technique was used to generate themes and a decision tree of the TTPA meta-synthesis. PubMed, EBSCOhost, Ovid, and Scopus databases from inception until the first week of January 2016 were used. Only peer-reviewed journals that discussed TPPA's impact on the pharmaceutical sector were included. Data were extracted by 2 reviewers and then verified by 3 senior researchers. The extracted data were imported into Excel spreadsheets and coded line by line. Codes were organized into descriptive themes. The identified themes were cross-checked against original articles to ensure consistency. A total of 85 full articles and reports were reviewed and, finally, 32 of them were used in the meta-synthesis. Two central themes to the TTPA emerged: intellectual property rights and transparency. Five subthemes were identified under intellectual property rights: patent subject matter (representing scope of patentability), patent term adjustment for patent office delays (representing patent term extension), protection of undisclosed test or other data (representing data exclusivity), protection of undisclosed test or other data (representing patent linkage), and compulsory licensing. Meanwhile, transparency and anti-corruption-procedural fairness, which presents restriction of coverage program and reimbursement, were identified as the subthemes of transparency. Findings indicate that the TPPA could potentially hinder the affordability and accessibility of medicine, which could increase risks to public health.

Sandoz & Hexal v Searle & Janssen Sciences Ireland: What is the formula for patent term extensions?

In Sandoz Ltd &amp; Hexal AG v G.D. Searle LLC &amp; Janssen Sciences Ireland UC [2017] EWHC 987 (Pat), the UK High Court held that an active ingredient in a pharmaceutical product that was claimed only by reference to a Markush formula and not expressly referred to in the patent was “protected” by a basic patent for the purposes of obtaining a patent term extension under the European Union Supplementary Protection Certificate Regulations. This decision will be welcomed by practitioners in adding some clarity to the interpretation of previous decisions of the Court of Justice of the European Union relating to the definition of what is protected by a basic patent in this extremely commercially important and fast-moving area of jurisprudence. The implication of this decision is discussed further in this report.