For the half-year to 30 June 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Alberto Bellan, Darren Meale and Nadia Zegze.

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Wednesday, 24 October 2012

Time for GSK to give up drugs and take to booze

Inspired by the EU's
proposal for a common
logo for online pharma
 traders,
the UK may be
creating a 'no-risk' logo
for pharma companies
that switch to making
and selling vodka
(see below)
"Proposals to cut risks for pharmaceutical sector" is the title of today's media release from the Department of Business, Innovation and Skills, which opens with the positive message: ""A new consultation launched today, sets out proposals to make the UK a more favourable place for pharmaceutical companies to carry out research and development of new drugs". Could it be good news for the pharma sector, at last? The media release explains:
"The Intellectual Property Office (IPO) is proposing to make changes to the Patents Act to make the system fairer by allowing clinical and field trials for new drugs to be carried out without risking being sued for patent infringement [Merpel, who has recently been contemplating level playing fields, wonders whether a more diminished risk of being sued for patent infringement in the UK than elsewhere in the European Union might just tempt a surge of inward investment. 'Tests and trials' is, funnily enough, one area of proposed unitary patent reform on which all competing texts are in agreement: see Enhanced Cooperation in the Area of the Creation of Unitary Patent Protection, Article 8(c) of the Working document for Coreper (Part 1) of 2 December 2011].

Marketing a drug in the UK, needs regulatory approval which requires conducting human clinical trials or animal field trials [note for non-native English speakers: 'trial' is a handy word that applies to clinical tests and to the process of litigating patent disputes in front of a judge] to show the product is safe and effective. Under current UK patent law, limited research and tests can be conducted using patented products required for the regulatory approval of generic drug products without infringing the rights of the patent owners. However, clinical and field trials for new drugs are not exempt from patent infringement.

Risk-free support
There are many instances where a company may legitimately [one might have thought that, since 'legitimate' essentially means 'in accordance with the law;, it is the law that defiines legitimacy and not vice versa ...] need to use a patented drug in a clinical trial, for example to compare their new drug to a patented product, or to develop therapies which combine the use of their new drug and a patented product. Currently, if a pharmaceutical company uses a patented product as part of their trial they risk being sued by the patent holder. Today’s proposals would remove this risk and create a more supportive environment for pharmaceutical research and development in the UK.

Minister for Intellectual Property, Lord Marland said:
“The UK needs an intellectual property system which supports our world class UK pharmaceutical industry that invests over £12 million in Research and Development every day. Our proposals look to remove the uncertainty around patent infringement in clinical and field trials, so that our life sciences sector continues to create jobs and growth in the UK economy [Recalling the UK government's preoccupation with evidence-based policy-making, Merpel wonders how the diminution of uncertainty has been correlated to job growth, given that there are two ways of diminishing it: decreasing the level of protection to its bare bones or ramping it up to much higher levels]".
The Intellectual Property Office’s Chief Executive, Sean Dennehey said:
“Previous discussions with the pharmaceutical industry revealed a widespread appetite for change in the way UK patent law treats clinical or field trials. This consultation now offers a formal opportunity to shape the patent infringement provisions so that they can better support growth in this key industry sector [The second sentence is a revealing one in light of the first, says the IPKat: it suggests that, while pharma companies want change, they clearly don't all want the same change: that's why this consultation is so important].

“I look forward to receiving a wide response providing views and evidence enabling us to move in the direction which industry needs to succeed".
The consultation will run for eight weeks from 24 October [that's today!] to 19 December 2012".
Meanwhile this Kat, having thought for as long and as hard as only a Kat can, strongly advises the pharmaceutical drug sector to give up making pharma products and produce vodka instead.  The reasons are obvious:

Quality control standards in the vodka
industry are quite different to those in
the pharmaceutical sector -- and far
more enjoyable 
  • Vodka is a long-established product for which consumer demand is stimulated by repeated use. In comparison, many medicines turn consumers into non-consumers by curing them (if they are efficacious) or killing them (if they're not);
  • In the case of medicines, their curative properties have to be carefully measured against their side-effects and  regulatory approval may be withheld if the latter are too severe.  The consumption of vodka, in contrast, produces nothing but side-effects and there is no need to gain regulatory approval.
  • You can make your vodka however you like, and can confidently reverse-engineer its ingredients by analysing your competitors' products in your laboratories. You will have no messy problems with other people's patents (or your own), unlike medicines.  Since vodka is essentially a generic product industry, the risks associated with any new product are minimised while the risk-free profitability of the generic sector is exploited.
  • You can call your vodka whatever you want, so long as you check first with Mr Justice Arnold as to whether it really is vodka, and you can sell it even if it isn't, so long as you don't give it a confusingly similar name.
  • Vodka is reassuringly easy to administer: there are no mandatory instructions for dosage or storage. It can be stored for ages with no sell-by or drink-by date.
  • Retail sale of vodka is far less regulated than that of most medicines.  Consumers can purchase vodka for instant consumption in hotels, bars and restaurants, or can buy it for home consumption from the Out-Patients Department of Tesco.
  • A person who acquires medicine does so for his personal use, whereas vodka is frequently purchased even by non-consumers as a gift for others.

This Kat suspects that readers may by now have conceived of a few further benefits of their own which, he hopes, they will be willing to share with him.

5 comments:

Anonymous said...

Many other EU members provide greater freedom to conduct trials without risk of an infringement suit so the changes are required to prevent further outward investment as opposed to promoting inward investment. The government erred in their narrow application of the EU 'Bolar' directive.

Anonymous said...

Is it true or merely salacious gossip/slander that Reckit Benckiser have applied to the FDA to withdraw Vodka from the market in order to gain a monopoly with its replacement, Cilit Bang, instead?

Anonymous said...

The statement that medicines which are not efficacious kill patients is drivel. It not even helpful in a humorous context.

Jeremy said...

@Anonymous 1:00pm

I'm sad you feel that way. I wasn't trying to be humorous, but rather to point to the handicaps that proprietary pharma companies face as compared with other, far less important, industries. I think I made my point.

Suleman said...

I think this is excellent. The UK is waking up to the fact that globalisation means we are competing with other developed countries in offering R & D services. We cannot compete on price, but we can on quality and depth of expertise in clinical research.

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