Case Law: A Review of selected Pharmaceutical Patents in the UK Courts during 2020

Patentslie at the interface between technology and law. This article provides a criticalreview of four high profile cases from 2020 in which patents relating topharmaceuticals were litigated in the UK Courts. The selectedcases om this review involved ‘sufficiency’, ‘inventiveness’, ‘plausibility’and ‘equivalency’ issues. The first case is a dispute between Regeneron Pharmaceuticals and Kymab Ltd in relation to Regeneron’spatent for a transgenic mouse platform. The second case relates to Pfizer’s patent for their Prevnar®13pneumococcal vaccineand the alleged infringement of this patent by concerns the validity of apatent belonging to NeurimPharmaceuticals Ltd relating to a slow-release formulation of melatonin fortreating primary insomnia. The final case is a dispute between FibroGen Inc. and AkebiaTherapeutics concerning FibroGen’spatents for hypoxia-inducible factor prolyl hydroxylase enzyme inhibitors (“HIF-PHIs”) for use in treating anaemia. The article aims to focus onthe technology behind the patents and to provide an insight into how science interactswith law in the context of patent enforcement and infringement. 

An evaluation of community pharmacists' perception of e-cigarette: An English cross-sectional survey with geospatial analysis.

We wanted to establish prevalence of e-cigarette sale via Englishcommunity pharmacies. A cross-sectional survey of 500 retail-pharmacies was completed.Seventeen out of the 66respondents sold e-cigarettes, indicating a sales-prevalence of 25.76%. NRTwas widely available for sale (n=16, 94.1%), cessation services were lessfrequently available (n=7, 41.2%), or not available (n=9, 52.9%). ‘Dailysmokers’ were likely to use e-cigarette (n=8, 47.1%). Accessories were sold to0-2 people (n=13, 76.5%), χ² p=2.454 x 10-4. Young women purchasede-cigarettes (n=4, 23.5%), p=0.049, which were placed on top of the counter (n=7,41.2%), reflecting ‘impulse sales’ strategy. NRT was available forself-selection (n=14, 82.4%) (p=0.004), however staff-assistance was required(n=12, 70.6%), posing barriers. Costs for e-cigarette (£10.99-£29.99) versusNRT (£4.25-£35.99) represents value for money. Labelling and packaging werefound to be attractive, p=0.049, fashionable, colourful p=0.049, healthy,potentially breaching laws. All respondents provided NRT counselling, p<1x10-8.Less than half (n=8, 47.1%) provide e-cigarette’s counselling, while a majority(n=9, 52.9%) did not. Eight respondents describe 22 flavours, providing goodmouth feel. Aggregate ‘deprived’ versus ‘affluent’ analysis revels interestinginsights. We find some support of non-smokers initiating use. Pharmacists help patientsbut have limited support. We make recommendations to improve practice.

A mini-review of Nanocarriers in drug delivery systems Nanocarriers in drug delivery systems

The application of nanotechnology indrug delivery systems (DDS) has been researched widely and seen an advancementover the past three decades. Since the 1970s, nanoparticles were primarilyutilised in vaccine deliveries and cancer chemotherapy. In more recent years,they have been found to hold promises for broader applications such as inproteins and therapeutic gene delivery systems. To date, there have been only ahandful of nanocarrier-loaded drugs commercialised into the pharmaceuticalmarket. More research is thus needed to facilitate a breakthrough of theseproducts into the current market. This mini-review mainly focuses on four typesof commonly utilised organic nanocarriers including micelles, compactpolymerics, solid-lipid nanoparticles and liposomal vesicles and discusses theprogress and some challenges associated with these nanoparticles (NP). 

Formulation of floating metronidazole microbeads using Terminalia mantaly gum as polymer

The aim of the present study was to evaluate Terminalia mantaly gum as a polymer in the formulation of floating metronidazole microbeads. Terminalia gum was extracted and characterized using mateial, proximate and pasting properties. Terminalia gum in combination with sodium alginate at varying conccentrations (0-80 %w/w)was used in preparing the microbeads by ionotropic gelation using zinc chloride as the chelating agent. The microbeads were evaluated using shape, size, swelling, bouyancy, entrapment efficiency, drug release profiles and kinetic modelling. The microbeads were spherical to ovoid in shape with sizes ranginf from 1093 to 1209 micrometer. The swelling index was 5 to 184 % and it increased with increase in gum concentration. The total floating time was highest (175.5 h) for formulations having 20 %w/w gum and least (5.5 h) for those with 80 %w/w gum. The entrapment efficiency generally increased with increase in gum concentration up to 40 % and then reduced. The microbeads showed controlled release patterns of metronidazole with least t80 greaer than 5.8h. The drug release kinetics fitted Korsmeyer-Peppas model with non-Fickian anomalous diffusion mechanism. Terminalia mantaly gum can be further developed for use as co-polymer in the formulation of floating metronidazole microbeads.

Extraction and Evaluation of Lepidium Sativum and Flax Seeds Mucilage as a Pharmaceutical Granulation Binder

The powders holdtogether by a binder to form granule. Some excipients of natural origins arecurrently available as an alternative over the synthetic ones in pharmaceuticalformulation. The aim of this study was to isolate the mucilage from differentplant seeds and compare them to evaluate the binding effects. In present studyan effort was made to investigate the efficacy of mucilage obtained from Lepidiumsativum and flax seeds as granules excipient. The mucilage   was extracted from selected seeds byconventional method by precipitation of soaked and blended seeds in acetone.The dried mucilages were subjected to several phytochemical and physicochemicalproperties. Granules were formulated by wet granulation method by usingextracted mucilage as a binding agent and comparison was made against thegranules prepared with standard binder as PVP. The granules evaluated byvarious physical properties such as (bulk and tapped densities, Hausner’sratio, Carr’s index, angle of repose and friability). The results showed thatthe granules prepared from extracted mucilage as a binder had good flow andmechanical properties, all evaluated parameters were within the permissiblelimits. Thus, mucilage could be used as an alternative binding agent in pharmaceuticalgranules.