Wednesday, 18 January 2017

Highlights from the RSC Law Group’s IP Case Law Seminar 2016

A couple of months ago I attended the 8th annual RSC Law Group seminar focussing on IP Case Law at Burlington House in London. The day highlighted recent and high profile intellectual property law developments with a particular angle towards Chemistry/Pharmaceutical/Biotech cases. Amongst the delegates were many IP solicitors and patent attorneys from different firms, ranging from trainee to partner level (and also a few other interested parties from non-law backgrounds - like myself!)

Eibhlin Vardy, Stephenson Harwood - Lyrica (Pregabalin) second medical use issues
A particularly interesting topic in patent law for both pharmaceutical companies and public health professionals/policy makers at the moment is second medical use patents. Eibhlin spoke about this issue in relation to Pregabalin (side note: Pregabalin was invented by Professor Silverman from North Western who I’ve seen give an excellent talk on the molecule’s history at Warwick! One of the few cases of hugely influential ($4.6 billion sales) drug discovery from University research; patent owned by the university and licenced to Pfizer).

The Pregabalin patent states “pharmaceutical composition for treating pain” /”inflammatory pain” /“neuropathic pain”. There are generic manufacturers of this drug, which is sometimes prescribed for other uses including the off-patent indications of epilepsy and generalised anxiety disorder. There has been confusion and court proceedings around the matter of labelling, as in the UK the generic manufacturers can market a drug with a ‘skinny label’ – with no use indicated on the label. Leading to some doctors/pharmacists giving generic pharmaceuticals for patented uses, and thus potentially infringing on Pfizer’s patent.

Eibhlin’s talk included potential solutions to issues like this, including national systems like that of Denmark, which have prescription labels that specify use. In summary: second medical use patents are complex issues which require communication between regulators, doctors, pharmacists, and patients.

Image: creative commons
Anthony Tridico, Finnegan - Genetic Techs. Ltd. V. Merial LLC, 2015-1202 (Fed. Cir. 2016)
Anthony spoke about a number of US cases, including this interesting case involving the detection of genetic material. Genetic Technologies Limited brought a patent infringement suit against Merial regarding this technology. The federal circuit affirmed the previous district court’s motion to dismiss due to failure to state a claim (i.e. claims were patent ineligible – laws of nature, natural phenomena, and abstract ideas not patentable). In Anthony’s experience, there is difficulty in getting diagnostic patents granted at the moment.

Jennifer Harris, Kilburn & Strode - T0308/14
This case was the second appeal of a European patent relating to a polyacrylic acid based binder composition. There was debate about the measurement method dependence of the molecular weight of polymers, with the respondent arguing the values depenend on the measurement method and thus a lack of sufficiency of disclosure.
Claim 1 of the second auxiliary request:
"1. An aqueous binder composition for coating glass fibers comprising:
a polycarboxy polymer;
a poly alcohol having at least two hydroxyl groups; and
a water-soluble extender selected from a group consisting of lignin, polysaccharides having a weight average molecular weight of not more than 10,000, proteins and sulfonated lignins, the extender being present in an amount sufficient to establish an extender-polycarboxy polymer weight ratio of at least 1:10."
In the end, the Board of Appeal dismissed the appeal as the claims on file lacked inventive step. So the MW issue was not particularly relevant to the final outcome in this case. If inventive step had been upheld though failure of the ipponent to support its observations with clarity in earlier procedings could have led to allowance of unclear/ insufficient claims.

Jo Addison, Haseltine Lake - T2306/12
Jo spoke about another case involving insufficiency due to lack of description about a particular measurement method. Claim 1 was amended during opposition proceedinds to include ‘the size of the active ingredient particles is less than 10% of the particle size of the inclusion bodies’. It was found that particle size is an issue of clarity and not sufficiency.

Monday, 16 January 2017

Conference in Australia!

In November I was lucky enough to be able to attend another conference! This time in the lovely beachside town of Lorne near Melbourne. For all the details of the conference see the report I wrote for the SCI here. I was able to see presentations by some fantastic polymer chemists, my talk - Hyperbranched polymers by thiol-yne chemistry: Control of molecular weight and branch point distribution - was well received, and conference atmosphere was superb!

Afterwards, I did some travelling around Victoria with some friends: The Great Ocean Road, Grampians national park, Melbourne (and its fantastic bars and coffee shops!), Phillip Island and Wilson's Prom!

Wednesday, 7 December 2016

CRISPR-Cas9 patent battle enters new phase

On the 6th of December, the patent dispute over the CRISPR-Cas9 gene editing tool got underway in the first hearing at the US Patent and Trademark Office (USPTO). A queue of patent attorneys, lawyers, investors , biotech industry representatives, and journalists formed in front of the court room from 5 am, indicating the wide interest in the case involving arguably one of the most important biotech inventions of the decade.

(c) Dana Verkouteren
The proceedings between Doudna of UC Berkeley and Fang of the Broad Institute have been in process since interference proceedings were requested by UC Berkeley in 2014 - an official reassessment to determine who was the first to invent the tool.

Jennifer Doudna first filed in May of 2012, before publishing their seminal article in Science, involving CRISPR-Cas9 in bacterial cells (prokaryotes). In December 2012, Feng Zhang of the Broad Institute filed his own patent, demonstrating use of the gene-editing technique in more complex eukaryotic cells, such as those found in mice and humans. The Broad Institute requested (and paid the extra fee for) expedited review for their patent application (this accelerated review process as an option for applicants is now under review by the USPTO). The USPTO awarded the Broad Institute their CRISPR-Cas9 patent in 2014, before Doudna, which is when UC Berkeley started proceedings. 

The three federal patent judges present, focused their questions on two central issues: 'obviousness' and 'reasonable expectation of success.' Berkeley insists it was obvious to extend the system from prokaryote to eukaryotes, while Broad contends that there was no reasonable expectation of success by people who had ordinary skill in the art. A piece of evidence they use to back up this claim comes from Doudna herself: a press article claiming that “she experienced ‘many frustrations’ getting CRISPR to work in human cells.”

A statement from the broad institute details: 
"Broad Institute, MIT and Harvard were first to invent and first to file patent applications with regard to CRISPR genome editing in eukaryotic cells. Given that the underlying facts have not changed, the Broad Institute is confident the USPTO will reach the same conclusion it did initially when it awarded these patents and will continue to recognize Broad, MIT and Harvard roles in developing this transformative technology." 
According to some sources CRISPR has already attracted hundreds of millions in investments and many further research projects, not to mention general excitement about its potential from the scientific community. Recently, Chinese scientists undertook the first clinical trial of CRISPR, using it to treat patients with lung cancer. Both parties have already licensed their technology to firms (Editas and CRISP Therapeutics) whom now have to place their research is on hold until this debate is cleared up. 

The hearing continues.

Sunday, 30 October 2016

Book Review: The Inevitable by Kevin Kelly

Described as one of our leading technology thinkers and writers, Kevin Kelly’s new book The Inevitable outlines his vision for the future and the role that technology will play in shaping it.

The book is organised into 12 chapters, each describing a ‘force’ that Kelly considers to be evolving at a remarkable rate. Kelly both describes these deep trends (flowing, screening, accessing, sharing, filtering, remixing, tracking, and questioning) and demonstrates how they overlap and relate to one another.

There are some slightly scary implications. Kelly suggests that future generations will look back at ours as the first that "linked them together into one very large thing". Another potentially worrying chapter involves tracking, where Kelly talks about loss of privacy and the need to create sensors - "We are on our way to manufacturing 54 billion sensors every year by 2020". (No idea where he got this number from).

Near the end of the book, he mentions some particularly hot topics at the moment - saying that “virtual reality is becoming real” and AI will become the focus for many companies, including Google, in the future.

The book has been praised for its accessible style of writing and use of examples and anecdotes rather than jargon. However, I find this means it occasionally lacks specifics or evidence. The word technology itself is possibly overused and sometimes seems hand-wavy; not really articulating the contributions of many different areas of science and engineering. It also doesn’t mention role of capitalism, or place these technological advances in wider context of human society or the environment.

Overall however, The Inevitable is an insightful and interesting read.

Kevin Kelly helped launch Wired magazine and was its executive editor for its first seven years. He has written for The New York TimesThe EconomistScienceTime, and The Wall Street Journal among many other publications. His previous books include Out of ControlNew Rules for the New EconomyCool Tools, and What Technology Wants. Currently Senior Maverick at Wired, Kelly lives in Pacifica, California.

Sunday, 18 September 2016

Samsung patents blood pressure measuring headphones

A recent patent from Samsung shows a very interesting new consumer health sensor product that could potentially hit the market in the coming years. (Spotted on my occasional searching of the @freshpatents twitter page)

The patent (United States Patent Application 20160256117 A1) published on the 8th of September relates to a pair of headphones or earphones with multiple built in light emitters and corresponding detectors. The detector-pairs read blood pulse signals at multiple points around the ear. Using this data and a stored blood pressure estimation algorithm, values for blood pressure are obtained.

A method and apparatus for measuring blood pressure are provided. According to one or more exemplary embodiments, the apparatus for measuring blood pressure obtains a blood pressure value by applying a plurality of particular points, sampled at regular intervals from a pulse wave signal detected in an ear area of an object, to a pre-stored blood pressure estimation algorithm."
Blood pressure is a key health indicator and current upper arm cuff-type inflatable measurement devices can cause users discomfort and inconvenience. The proposed headphone devices can be used for real-time, prolonged monitoring of an individual's continuous change in blood pressure, which is a great improvement.

A potential downside to this technology and a fact that could be limiting in the commercial viability of these headphones, could be that the algorithm requires blood pressure values. Therefore it would need calibrating initially with standard upper arm blood pressure measurements. The technology is also very similar to current heart rate monitors, just with the addition of the blood pressure estimation algorithm. 

Interestingly, articles surfaced online in 2014 about Apple developing similar earphone devices, but the source of this leaked Apple information later retracted his statement calling it a hoax.

Monday, 29 August 2016

Sunday, 24 July 2016

Polymer membranes for nano-sized separations

Separation techniques are increasingly important processes for chemical industry and relate to the isolation of certain components of complex mixtures. Organic solvent nanofiltration, in particular, involves the separation of solvent molecules from larger molecules, aggregates, or metal complexes based on size selective permeation. Researchers from Imperial College (led by Prof. Andrew Livingstone) have developed new polymer nanomembranes based on polyacrylate networks, and have recently published their findings in Nature Materials.

The membranes were synthesised by interfacial polymerisation of multifunctional aromatic alcohols with multifunctional acyl chlorides (on a macroporous polyimide support) leading to highly crosslinked polymer networks a few hundreds of nanometers thick.

By using non-planar aromatic alcohol monomers they were able to significantly enhance the nanoporosity of the membranes due to inefficient packing of the polymer chains. This inventive step has led to exciting new nanomembranes which are able to rapidly separate small solvent molecules very efficiently.

a) 3D representation of polyacrylate network, b) schematic diagram showing nanofilm composite membrane based separation. Image (c) NPG, used with permission.