Much of the excitement is linked to the imminent advent of Europe’s first real European patent. After decades of failed attempts, by the beginning of 2014 the European Union will finally have a ‘unitary patent’ — a system offering a single patent valid across all the member states (or nearly all — two member states have been more excited about the prospect of sabotaging it). For its many supporters, the unitary patent offers real advantages. Probably faster, certainly cheaper, and very much easier to manage than the patents available under the current patchwork of patents granted by national authorities or patents granted by the European Patent Office and requiring subsequent national validation.

The attractions are evident of securing a patent across most of Europe for just €4,725
(UDS$6, 180) instead of the €36,000 (UDS$47,100) it typically costs today, and being able to obtain it with a single application, and just in English, French or German (instead of multiple applications or validations subject to local language rules). In addition, it will be backed by a new international court specialized in patents, empowered to give rulings rapidly, and across every country where a patent is disputed — instead of parallel litigation in national courts leading to inconsistent rulings.

The “sabotage” attempts came from Italy and Spain, the two member states that have consistently held out against a Europe-wide system, largely because they feared negative effects on national innovation from the exclusion of their languages from the new system. They mounted a challenge at the EU’s own court against the creation of a mechanism they object to. But the court threw out that claim in April, ruling that the 25 countries could lawfully go ahead with their plan — particularly since Spain and Italy are free to join it if they so choose.

Even so, there are concerns about how the new system will work in practice. For all the simplicity of the underlying concept, its implementation is necessarily complex. As lawyers and accountants working for the innovative drug industry probe the detail, there is still a lack of clarity about precisely what it can and cannot do, and precisely how much it will cost.

There are concerns among generic manufacturers too. They do not want to see easier patent protection resulting in increased limits on competition.  That, they argue, could have a perverse effect on the EU’s sacred principle of a single market — or internal market, as the jargon terms it. “It is imperative that there is a balance in the rules between the ability of patentees to enforce their rights and the principles of the internal market: freedom of movement and competition”, insists the European Generic Medicines Association in an assessment of the plans for implementing the new system. It is anxious to secure fair competition, and to ensure that generic companies have a voice in decisions on disputes with originators, “without compromising legitimate enforcement of patent rights.” So there should be no easy route for originators to delaying tactics on generic entry, unless a court has duly assessed the validity of the patent.

So between now and the start of next year, a fever of expectation will be matched by a feverish search by all sides to get the best out of the new system. Meanwhile, alongside the moves on the unitary patent, further excitement is sweeping through the world of intellectual property over broader questions of just who should be making decisions on what a patent can and cannot do. Mirroring in some ways the issues raised by generic drug firms, this is emerging as an institutional battle between competition authorities and patent authorities, and it is taking place simultaneously in Europe and in the USA. It goes much wider than the drug industry, as demonstrated by recent decisions by the EU competition authorities questioning the scope of mobile phone patents. But the consequence is that, by a fine irony, just as getting a patent is about to get easier in Europe, hanging on to it may be getting harder.

Plenty of excitement still to come!

Peter Houston

You know this: digital marketing means you have the potential to get your message in front of more people than ever before; search and social media offer reach on an unparalleled scale. According to global internet analytics firm Comscore, there are 13.7 billion searches conducted on Google every month. With 60% of US consumers saying they looked for health information online in the last year, that’s a lot of potential patients.
The problem is, that reach is available to everyone else from top-10 pharma to your local Deli: We’re all publishers now.

Actually we’re not all publishers, we’re all authors. Publishers — certainly in the traditional sense of the word — would never allow most of the content on the Internet out of the slush pile. And it’s the public accessibility of that slush pile that might just provide Pharma with its best opportunity to be heard above the noise.

Content marketing — the art of creating and distributing relevant and valuable content to attract, acquire, and engage a clearly defined and understood target audience — is being hailed as the brightest hope for marketers desperate to cut through the Internet’s clutter. So far so good – Pharma has been producing quality, expert-led, evidence-based content for ever.

If you read some of the content marketing blogs you would think these geniuses had just invented the concept. But content marketing has been around almost as long as marketing.

• John Deere, America’s favourite tractor manufacturer, released the first customer magazine in 1895
• Guess what brand of flour my mother-in-law has on her kitchen shelf. Here’s a clue – she swears by her BeRo Flour cookbook first published in 1923 and now in its 40th edition.
• Have you ever wondered why the world’s leading restaurant guide is named after a tyre manufacturer? Back at the turn of the last century Michelin published its first restaurant recommendations to give drivers a good reason to burn more rubber.

What is new is the importance marketers are placing on real value delivered through content. Possibly the biggest reason for this new focus on quality is that Google, the daddy of web search, got tired of people gaming its search algorithms with sub-standard content

To combat SEO tactics that had more to do with keyword stuffing than content quality, Google changed the rules of the game with its Penguin algorithm, introduced this time last year and already headed for its third update. I won’t even begin to pretend to understand how Google’s algorithms work, but I do know they are focusing more and more on the quality and ‘shareability’ of content to improve the search experience and this puts content marketing firmly in the frame.

There’s also the added benefit that, rather than interrupt people with unwanted sales pitches, content marketing offers a non-interruptive approach to customer communication. The ideal is to create a regular stream of valued, trusted content that customers will actively seek out and share.

Pharma’s content-marketing opportunity is to make sure that when a doctor or a patient goes searching for health information — which they are doing more and more — the right content is there waiting for them. When they get exactly what they want, when they want it they’re also happy to pass it on to friends and family. The problem is pharma doesn’t like sharing.

Content marketing principles — valuable content that engages a clearly defined audience – might have been at the heart of pharma’s efforts to help HCPs and patients understand and adopt new treatments for years. Pharma should have a head start in the content marketing race, but it’s firms like Marriot, Old Spice and American Express that are getting noticed for their content marketing efforts, because they love people to share their content

“As a well-oiled content machine that knows how to build relationships, pharma should thrive in this new era,” writes Dr Candice O’Sullivan of Australia’s Wellmark agency on PharmaForum. “Here is an industry well used to the rigours of consistently producing high-quality content — the number one challenge for most content marketers — but finds it virtually impossible to ‘share’.”

O’Sullivan closes by describing Pharma as an industry “too preoccupied by the risks involved to be able to make the most of this opportunity”. Sound familiar?

Peter Houston is former Group Content Director for Advanstar Pharma Science. He is now an independent media consultant and founder of Flipping Pages.

The localized outbreak of measles in the UK is alarming in more ways than one. There can only be sympathy for the victims of this sudden return of a disease that had almost slipped from the perception of an entire generation. In addition to the discomfort — and on occasions serious complications — of the disease itself, there is now a sense of something approaching panic in the region where the incidence is highest. Anguish over the risks is evident in the faces of the parents and young children jostling with adolescents in long queues outside special vaccination centres that have been set up.

But there is a more general reason for concern. The background to this sudden recrudescence is well known. Urban myths about the risks of the MMR vaccine were given prominence more than a decade ago in a campaign by a local newspaper in the area where the most cases have been registered. The result was wide refusal of the MMR vaccination across the region. The subsequent clear rebuttal of the myth never received equivalent publicity — such is often the nature of the media. “Titanic sinks!” is a story. “Titanic doesn’t sink” isn’t.

Consequently, the ill-founded conclusions from the pseudo-research that lay behind the perception of risk remained as the accepted wisdom among a large swathe of the population over many years. Bolstered by the apparent absence of measles, there was even a small sense of triumph: “We were right to avoid the risks of vaccination — because the vaccination is anyway unnecessary. There is no measles,” ran the logic…

…until recently.

Emergency clinics and modern treatment techniques will probably manage to bring the outbreak under control over the coming weeks and months. But it is a wake-up call, not just to parents hesitant about the merits of immunization programmes, but to everyone involved in healthcare planning and healthcare provision. Because the circumstances in which urban myths can flourish have gone through a revolution since that local paper spread ignorant pseudo-science in the valleys of South Wales.

The entire communication game is changing. It has always been changing — but most of the time slowly. More recently, it’s been changing faster. And now it’s changing very fast, out of all recognition. That’s an earthquake for everyone involved in every aspect of healthcare communication.

There was a time, thousands of years ago, when most information came from the person with the loudest voice. But gradually technology took over. And in the last couple of centuries these technologies tended to concentrate the power of communication into very few hands – consolidating a system in which a few people at the top told everyone at the bottom what the people at the top wanted them to know.

Over the same period, the healthcare business moved on, leaving behind the vestiges of witchdoctors and barbers. The new healthcare establishment tended to dominate communication too — leading to a culture in which the doctor told the patient what the doctor chose to tell the patient, and prescribed the treatment he or she chose — perhaps influenced by the drug industry, and perhaps even by research … but most patients never saw much of that.

More recently, after years of patient docility, another trend started to emerge, principally among patients, who wondered if they were getting the best deal from being at the bottom of this top-down approach. The effect was a small rise over the last 50 years in activism — and even skepticism and distrust.

Then technology took another step forward — a giant leap for mankind. The internet. Communication — all types of communication — moved into a different dimension. The monopoly of authority over communication started to crumble.

Now, no single powerful voice can dictate unchallenged to everyone else. Everyone else can, if they wish, communicate among themselves, changing the balance, dethroning the former authorities.

From the perspective of democracy, this is unquestionably a good thing. From the perspective of healthcare communication, it raises as many questions as it answers. Of course researchers, regulators, drug firms and doctors can make use of the new technology in their own work — and are doing so in many cases with transformational consequences. But their voices are only some of the voices among so many others. There is much to be said for patients, consumers, customers, even the public, acquiring a new status in healthcare information and discussion. Patients, consumers, customers, the public, can no longer be taken for granted.  The paternalistic top-down approach has been more or less neutralised by the rise in technology and the rise of — for want of a better expression — people power.

It would be foolish to suggest that everyone who has traditionally been at the top until now — doctors, researchers, drug firms — is necessarily wrong. Importantly, it would be equally foolish to suggest that everyone else is always right. It is flying in the face of common sense to contend that all healthcare issues are best solved by a form of popular democracy. This can go right, or it can go wrong. In some instances, a majority can come up with an answer that looks right, but isn’t. Vox populi is not necessarily vox dei — as the UK measles outbreak demonstrates. If patients or the public have the right to question the traditional sources of information, they also have a duty to maintain a similar degree of healthy skepticism about all sources of information — including from other patients or consumers or customers or the public. The web 2.0 and the smart phone are not the weapons of a coup d’état. They are merely the tools to permit a better debate.

You’d be forgiven for missing it with the vast array of new agencies and the policy documents, guidance, consultations and ‘engagement’ activity they’re doing on in the ‘new’ NHS in England, but on the 4th April NHS England (formerly the NHS Commissioning Board) set out 15 commissioning policies in 250 pages.  They’re important, as they set out the approach NHS England will take when they’re spending some £20 billion plus worth of services.  Not only that, the new Clinical Commissioning Groups (CCGs) who are responsible for the rest of the over £100billion budget of the NHS in England, are likely to take a leaf out of NHS England’s book when they look at investment and dis-investment themselves. 

Medicines in focus
The policies arguably focus on medicines (although other technologies would also be covered, such as devices); ranging from Individual Funding Requests (IFR), funding of NICE guidance, and funding medicines for those patients taking part in and/or following the closure of clinical trials.  Only 6 of the 15 documents are more general, and even then medicines feature as part of the overall package of services and treatments that NHS England will be considering.

Setting the tone
The documents set the tone for how NHS England will approach decisions to invest or even cut services.  Key themes include:

• Value for money dominates. The documents mention whether something is affordable, affordability, value for money, and cost effective/ness no less than 98 times.  The first line of their overarching guidance notes their ‘fixed budget’. NHS England will also take a ‘take it or leave it’ approach to guidance because it’s just too expensive to implement all NICE guidance, let alone guidance from others like the Royal Colleges. NHS England will follow guidance for technologies positively appraised by NICE, because that is a legal requirement.  And price negotiation is listed as an ‘option’ when “useful treatments which are not cost effective or not affordable although they are clinically-effective.” NHS England do say other criterion will apply, but reading the policies it’s hard to see how much they could sway decisions.

• Tough scrutiny when considering investing in new services and treatments. NHS England only want to invest in those services and treatments that are ‘of proven cost effectiveness’.  If that’s missing, then funding will be linked with research to fill that gap.  Business cases and the evidence they draw on need to be viewed with ‘confidence’ by NHS England, suggesting little tolerance of uncertainty.  Those who can’t deliver that to NHS England are unlikely to get the funding that they want.

• Strict rules. NHS England will be strict about requests for funding that may come in via the IFR route for example; clinicians must get the Trust management to sign off on the application and NHS England won’t consider it unless all the i’s have been dotted, and the t’s crossed.  The ‘rule of rescue’ is simply ruled out too.  And if there are more than 5 patients who are alike with treatment costing more than £100,000 (or perhaps £150,000 as both figures are mentioned), no IFR funding will flow; instead it will be considered as part of the usual approach to funding new services.  NHS England is also clear that it will not necessarily be the one to pick up funding of medicines after clinical trials or pay for unproven or experimental treatments.  That’s for those who initiated the trial to do, or at least make it clear to patients what will happen once the trial ends.

• Constrained support for R&D. NHS England say that commissioner support for R&D is ‘highly desirable’ but should be seen in the context of ‘constraints’.  Not exactly a sign that NHS England will be committing much to R&D in the future.

‘Interim’ policies
The NHS England commissioning policies just published are not the last word though.  All of them are marked ‘interim’ and will be subject to further discussion. What that means though isn’t clear (who will they be talking to, and will they listen?), and what could happen is that these simply become the de facto commissioning approaches at the centre of the new NHS in England.

Leela Barham is an independent health economist. You can contact her on: leels@btinternet.com

By Leela Barham.

England’s Cancer Drugs Fund (CDF) could be in its final financial year, after running in full since April 2011.  The fund covers the cost of cancer treatments either when NICE has said ‘no’, or hasn’t yet come to a view.  Companies can’t circumvent NICE though; if a company was invited to submit to NICE and refused, it’ll be refused CDF funding for its product too.  The CDF is supposed to be a ‘bridge’ to Value-Based Pricing (VBP), due to be implemented in January 2014.

Why was a fund needed?
The Fund was driven by a heady mix of a desire by the Conservatives to grab votes in the last General Election in 2010, strong political lobbying and perceived weaknesses in how England makes it’s decisions on which products to recommend for use.  The latter really means that many expensive but potentially beneficial products were simply not being recommended by NICE.

Stats illustrate this with NICE saying no in more than a third of recommendations in 87 technology appraisals of cancer medicines since the year 2000.  But that also hides the distinction between ‘recommended’ and ‘optimized’; where optimized means restricted to use in specified circumstances, so not all of the remaining two thirds are recommended to all patients.  Such stats are important; so too are the processes that lead to recommendations being made.  The concerns are many, but for cancer centre on:

• Whether tools like the EQ 5D actually pick up on what matters for those with cancer
• How people in real life trade quality and length of life versus how economic models assume they do
• Whose values count, patients, or the public or even some combination

What did the fund buy?
Up to December 2011 the fund made around 10,000 treatments available to patients, covering 34 products.  Commentators now suggest that it’s now over 28,000 patients who have benefitted.

Too much £?
The Fund is small though, starting with £50 million and now £200million a year.  It amounts to very little when compared with the £5.1 billion spend on cancer by the NHS in 2010/11. Worryingly though, there are reports that not all the money was actually spent last year. It’s not clear if that’s because there isn’t unmet need or if everyone was just overly cautious and didn’t want to bust the budget.

Move to a national approach
Change is abound in the English NHS as a result of the Health and Social Act (2012) and the CDF has not escaped reform either.  The fund is now the responsibility of NHS England, the new national agency tasked with spending some £20billion and overseeing the Clinical Commissioning Groups who will spend the rest of the over £100billion NHS budget. There’s a single approach to making decisions, and there’s a single list of products that will be funded.  That’s quite a change from the regional approach taken up to now, with 10 funds previously in operation across England.  That may be good for some; it’s less likely that there will be a different view depending on where a patient lives.  That may also be bad for others; if a companies drug doesn’t get on the national list, it has no hope to get on a list anywhere else.

And the list is more restrictive now; 28 products versus the 34 reported available under the regional approach.  There is some scope for variation from the list though, with clinicians able to ask for funding for treatments for individuals with rare cancers. Decisions on whether or not to fund these will rest with 4 panels spread across England, but they’ll have to use the same process.

Will VBP fix the problems that led to the fund in the first place?
The answer at the moment is that no-one really knows.  The details of VBP are not yet known, and maybe not even worked out.  The uncertainty that this creates is leading to widespread concerns, and headlines and concerning stats like:

Cancer Drugs Fund: Patients to Lose Out….6,427 patients every year could be denied access to the medicines

Drugs fund axe ‘will hit 16,000 cancer patients’ as experts claim access to medication will be worst in Europe

One thing is for certain though; the success or otherwise of VBP will be measured in access to cancer medicines.

Leela Barham is an economic consultant. She can be contacted via her site or at leels@btinternet.com

By Morten Hjelmsoe.

Since the early days of the internet, we’ve been busy creating websites and other digital channels. It’s not an exaggeration to say that most pharmaceutical companies already have hundreds of websites and still more are coming. And now everybody is building apps.

There’s a lot of activity and in many ways that is a good thing; these digital channels have the potential to reach a lot of people. That’s why they are assumed to be the future of pharmaceutical marketing; the expectation being that we’ll move our customers to these more efficient channels of communication.

Yet there is a problem: how are we planning to get the medical professionals to connect to them? It’s pretty obvious that most of these initiatives don’t attract the numbers of people that we were hoping for; and they are nowhere near to being the cheaper alternative channel of communication we anticipated.

Morten Hjelmsoe

Asking people to make an effort — whether it’s going to work, seeing a movie, or visiting a website — will only happen if you believe that the benefit outweighs the effort required. In other words, if the content that you’re asking your customers to invest energy in looking up isn’t both highly valuable and accessible with a minimum of effort, then they just aren’t going to go.

The only one who knows what’s valuable for you – is you!

The fact is that what’s valuable for one person may be totally irrelevant for another. That’s why the huge industry effort of pouring digital content into web “libraries” often ends up being, for the audience, both irrelevant and a poor investment of their time. Content has to be both relevant and easily accessible for the individual. And that doesn’t just mean putting it “out there” in a nicely designed website. That fact that there are lots of examples of precisely this, I believe, demonstrates that companies often update their technology without updating their thinking. They are still trying to do an old-fashioned “push” rather than a “pull” that technology now makes possible.

New channels might feel like pull communication because healthcare professionals can go and pull out the information, but it’s deceptive. Really it’s still a push, though a passive one. So if push is saying, “Here’s is what we want you to know,” then most channels are saying, “Over here is some information I want you to know.” True pull communication, by contrast, is about saying; “What do you need to know and how would you like it delivered?”

The rep as pull-channel tailor
The good news is that we already have the best pull agent we can imagine. And that’s our sales force. Empowered with pull marketing technology, our reps can not only personally connect healthcare professionals with new channels but also make them relevant to each individual. That means that each customer can now have his or her own tailor-made channel.

So rather than saying, “There’s a library over there with everything a healthcare professional needs to know on this topic,” we can now say, “Here’s the precise knowledge you’re seeking – presented in a way that’s just for you.”

Which would you choose?

Morten Hjelmsoe is founder of Agnitio. You can read his first post here.

Any complacency that the world of healthcare might be feeling about advances in the ability to treat patients suffered a head-on assault in Dublin, Ireland, last week, at a conference organized under the auspices of the Irish Presidency of the European Union and featuring a galaxy of Irish and European stars from the worlds of politics, regulation, research, industry and patients. “Crazy,” “broken,” “failing” and “haphazard” were among the less extreme accusations made.

“Healthcare systems in Europe are failing patients,” charged one highly articulate cancer patient. Failing #1, he claimed, is inadequate data collection. “We are not in a position to analyse what we don’t have — and we are told this is an information age!” Failing #2 is incompetence. “Delayed and incorrect diagnosis is still far too common — the causes are cultural, structural, and about competence in primary healthcare.” Follow-up is “haphazard,” “often poorly defined, not really understood, and its value is under-researched.” The list went on and on.

“The pharma development model is cracked,” he said. “Because it is profit driven, commercial opportunism results. We get competing agents, me-too drugs and protectionist strategies, which hinder medical practice to the dis-benefit of patients.” Meanwhile, “costs have risen at every stage in the process, which itself has got longer. There is increased regulation. Pricing has become an art form.” And the new emphasis on the search for value is an attempt at something that is “very difficult to define.”

Health technology assessment was dismissed as “fractured,” because its processes are biased against rare diseases and their treatments at the very time when genetic research is fragmenting the old histological definitions of cancer and providing many more new ones, the aggrieved patient went on. “Every cancer is now rare, every treatment is orphan,” he insisted, and “a meaningful randomized clinical trial is sometimes impossible.”

The context for drug development was also pilloried. “To compound the problems, academic peer review and journal publishing is also broken,” ran the accusations. “The academic process kills patients. They die because evidence does not get published at all, they die while journals decide whether to publish evidence, they die because academic and healthcare regulators prioritise peer reviewed publication and thus preserve a system which builds in delay.”

The patient at the forefront of these attacks was Roger Wilson, who founded Sarcoma UK, and who has good reason to know both the merits and the demerits of current treatment regimes. Since he was diagnosed with a soft tissue sarcoma 14 years ago — after initial misdiagnosis — he has experienced multiple operations, chemotherapy, and amputations, and has benefited from successive remissions, but is about to start another round of treatment after Easter.

His recommendations ranged across the full area of interventions. In diagnosis, he argued, “genetics changes everything, and we have never had a better chance of improving things.” Primary treatment could be “an evolving success story for personalised medicine — built on 200 years of skill development, innovation, new technology and some admirable pragmatism.” Follow-up, through risk modelling, nurse-led clinics, and in primary care, could deliver more benefits if they were taken more seriously. HTA bodies should “use judgement, not rigid processes, and be sensitive to social factors, not dominated by economic factors.” He said there was a need for “new systems, which are appropriate for assessing biological treatments, supported with proper use of new technologies.”

The right approach, in his view, would be to recognize that “when curative treatments with toxicity and nasty side effects are futile, healthcare systems must provide the symptom control patients need, simple therapies such as morphine.” And healthcare systems “must offer good counseling and practical support which helps families address their own needs as well as those of their loved one,” he said. “If we fail to take up this last challenge we will create expectations which result in massive dissatisfaction, despair and unhappiness.”

His approach to his audience was as direct as his message was harsh: “Let me also remind you that every one of you will die one day, and rather too many of you from cancer; so I suggest you sit up and pay attention.”

There’s a thought for Easter — one more related to entombment than resurrection.

Alderley Park, home to 2,900 jobs and 40 years of history in drug discovery, is known for its status as AZ’s central R&D hub, but not any longer, with more than 1,000 of the facility’s jobs shifted to a new, purpose-built facility in Cambridge. The closure is a blow to the parliamentary constituency represented by finance minister George Osborne, an area hit hard by the loss of the UK base in manufacturing.

AstraZeneca's Alderley Park facility

The company is also moving 300 of its R&D employees in the US from facilities in Wilmington, Delaware to a more updated Gaithesburg, Maryland location, where AZ can build on the biologics footprint of its 2007 acquisition of MedImmune.  In the process, the company will axe another 650 positions. In total, the net worldwide job cuts amount to ten percent of its 51,700 workforce, with 2,300 of the cuts in sales and admin positions, most of which are within the EU.

The cuts align with CEO Soriot’s push for more deal-making in an effort to replenish the company’s depleted drug portfolio. Analysts estimate AZ stands to lose six billion dollars in the next five years due to loss of patent protection for many of its branded drugs. Soriot also notes the company will spend less money on research for anti-infectives and neuroscience in favor of cancer, cardiovascular and metabolism disorders, respiratory and inflammatory diseases. To ensure that research remains close to the business AZ will also keep its business development function embedded in the R&D operation—a position at odds with the org charts in the other big pharma firms.

The recent shifts in R&D taking place across the industry show its growing desire to build a more symbiotic relationship with academic research institutions. Return on R&D investment has become less about simply producing new medicines but creating products that can me documented as addressing the standard of care. Companies are finding they have to spend more on early stage discovery to stay relevant. Dr. Ken Kaitin, Director of The Tufts University Center for the Study of Drug Development points out, “It’s tough to justify because this type of research occurs very upstream, and it’s a long time before companies see the fruits of that effort.” He continued, “By partnering or collaborating with academic institutions, teaching hospitals, and government agencies where this is already going on, big pharma companies can divest their efforts in that area and take advantage of some of the (hopefully) exciting and innovative research going on in the academic centers.” These coalitions ultimately benefit both the companies and institutions that partner with them, but as in AstraZeneca’s case and others, such shifts take a toll on workforce morale—a red flag in an industry that depends almost entirely on productive human capital.

Soriot discussed his strategic plan for the company during AZ’s Capital Markets Day on March 21 in NYC.

What’s your opinion? Will the cooperative relations forming between pharma and academia ultimately reap rewards?

So, you’ve done it. You have left big business or forsaken the dusty halls of academia to launch that start-up of your own. At last, you can turn your ideas into something constructive and tangible. Goodbye to the pettifogging bureaucracy!

But, who is this gray specter at the feast, the dull humourless pedant? It’s the patent attorney, detailing a complex and arcane world, with blood-curdling tales of theconsequences of a failure to pay close attention. Best to just do what he says and pay those eye watering bills … or close your eyes and ignore everything associated with IP.

Despite the complexities of IP, however, the strategic considerations are actually very simple. They boil down to these simple points:

1. You need exclusivity and freedom to operate (FTO).
a) Exclusivity —nobody else can make, use or sell your product. Make sure you get it.
b) FTO — you will suffer if someone else’s patents cover what you do.

2. Patents cost money.
a) There is little value to a patent that doesn’t give you exclusivity.
b) Check you have coverage in the right countries.
c) Invest time and money early on, rather than trying to remedy problems later.

Let’s apply this to the characteristics of a typical start-up or spin-out life sciences company.

Choosing your advisers
Which patent attorney to work with day to day is your decision. Technical competence should be a given. Patents are diverse, driven by the technology skills of the attorney concerned. Don’t hire someone with an electrical engineering degree for your new antibody  program. Look for a team and make sure work is done by the person most cost effective to do it. The senior partner may offer great advice when an issue comes up in patent prosecution, but he should not be the person filling in routine patent filing forms. A personal prejudice is for attorneys with industry experience. They are used to drafting patents that are there to be upheld and survive litigation. Their patents tend to be narrowly drafted, robust and focussed on providing exclusivity.

Find an attorney you trust, who you can talk to and feel comfortable with. Communication style is important; some lawyers can give you 12 reasons for and against any course of action, others will deliver a blunt recommendation on a postcard — cheaper, and effective. Business focused, pragmatic attorneys have much to offer. Furthermore, firms with linked skills can also be a great help, for example, offering both non-disclosure agreement and advice on litigation.
Capturing inventions

The skill is in filing for the right patents. Your venture capitalist may be happy to see an increasing list of patents; it gives the sense that you are making progress. But patents are highly expensive, so focus on a few high value pieces rather than throw money at every patentable opportunity.

As a starter, build a relationship with your attorney; bring them close to your discovery  program. They will find it easier to spot your inventions and to time your filings, and advise you on FTO and publication strategy. It is easy to destroy value with an ill-timed publication or disclosure at a conference.

What patent claims?
Not all patents are equal. In life sciences, greatest value comes from a claim to the entity, such as the compound or antibody.

Expense comes when multiple filings are made around a genus. The inventor finds he has a broad genus patent that covers but doesn’t exemplify the entity of interest. Further filings are made to fill this gap. Then some salt forms because they weren’t listed in the original patent. Then, a list of polymorphs is identified. These multiple filings lead to massive expense, but they provide little value over one good compound filing with data, decent boilerplate language and the compound exemplified.

Method of treatment or second medical use style claims can be almost as effective, provided every possible approvable indication is covered. Once one use is not covered, or the patent covering a use expires, off label prescribing will destroy your market.

Process claims give little exclusivity but can be key in terms of generating FTO. Here a publication strategy could be more effective.

Which countries?
The wider the breadth of your patent filing, the greater your patent costs. The absence of cover in key countries can kill the value of your product; IP in others can be of tenuous value. Most important is the USA. Without it, there is unlikely to be a product. Europe and Japan are key regions. Thereafter, Canada, Mexico, Australia, Russia & New Zealand are important territories with south-east Asia, China and India emerging as markets for the future. There is no definitive answer as to which countries to chose, but think hard about your aims and the return from each individual country.

For Europe, there are validation costs as patents must be translated in each country to be enforceable. As this is expensive it is best to validate only in key territories such as UK, France, Germany, Spain, Italy and possibly Netherlands and Sweden. It remains to see how the Unitary patent will affect this.

Due diligence when you acquire assets
On most deals, the seller discloses information, the buyer does its own due diligence, and the agreement between them, and the price, reflect the outcome.

It is crucial to make sure that you are buying what you think you are buying. Checking this will largely be done by the legal team which negotiates the deal on your behalf. The best assistance you can give is to provide the fullest information you can about what it is you are buying.

Ask them to provide you with a checklist of what they need, and give them all the information you can. Ask the team to focus on key points, rather than doing a full report. Which are your important markets? What are your minimum intellectual property requirements? Do you want a particular entity that you think can be taken straight into development or are you looking to take a series of potential leads for a research  program to find a suitable candidate for development? Tell them if you are aware of any disputes, and if you are buying knowhow. By narrowing the work the team does to the areas you are interested in, you will save both time and cost.

Preparing to sell on
Now you are on the other side. Know what will be needed for your data room, prepare it yourself as far as you can, then keep the room clear and clean. The buyer wants to know what exclusivity the product has, how long for, and where. An attorney docket management system can produce this as a report in moments. Get the paperwork in order. Are all your assignments complete for a start?

Focus will be on whether the key patents will be granted and upheld. The other side will likely have read through the prosecution history which is available on line. You will need to talk about the challenges of getting the key patents granted. Explain your global prosecution strategy to deal with the repeated objections you are likely to incur. Be ready to answer questions.

Do your own FTO search ahead of time, know what the problems are and explain your strategy to deal with them. This allows the attorney assessing the value of your estate to make a more informed judgement about the strength of your patent portfolio, and hopefully to recommend payment of a high price.

The more you engage with that arcane world of IP, the higher your returns are likely to be.

About the Author
Jason Rutt is Head of Patents at the specialist IP law firm Rouse. Jason joined Rouse in January 2012 from Pfizer where he was Head of their UK patent department.

PE: How is the disease community inspired by NORD industry working thus far? What have you accomplished?

NORD: Our collective partnership approach has been very successful and we look forward to more progress in the future. Among the achievements that we can cite to date: Connecting patients & patient organizations: We created a platform for online disease-specific communities. NORD and our European partner, EURORDIS, host these with disease-specific patient organizations in the U.S. and Europe. Posts can be translated into any of 5 languages. There are currently 36 communities interacting with each other. The platform is viewable at www.RareConnect.org.

Promoting global awareness and education through Rare Disease Day: EURORDIS launched Rare Disease Day in 2008 and sponsors this initiative globally. NORD is the national sponsor in the U.S. and we co-promote the day’s activities and related events with EURORDIS.

Position papers/white papers: We have co-authored position papers such as a recent one issued jointly by NORD, EURORDIS and CORD (the Canadian Organization for Rare Disorders) on basic requirements for patient registries, which are being used more extensively to help policy-makers track outcomes.

We have encouraged a more seamless working relationship between FDA and EMA in the area of rare diseases, which has a solid carryover effect in improving the medicines approval process to speed access to our patients.

Finally, we have invited companies that are members of NORD’s Corporate Council to join the EURORDIS Round Table of Companies and EURORDIS has encouraged its Round Table members to join NORD’s Corporate Council. This gives our advocacy with a private sector an integrated global approach.

PE: What challenges have NORD and EURORDIS found in their relations with biotech and pharmaceutical companies? What can be improved upon?

NORD: We face many of the same issues, and I believe that we can achieve more by collaborating and talking. We are always conscious that patient organizations need to maintain a position of independence in their advocacy positions. But companies and patient organizations on both sides of the Atlantic want to work together in appropriate ways. It’s just a matter of defining the terms of the relationships and maintaining appropriate transparency. We have to keep working on that.

PE: What do governments need to do in order to be more in sync with the collaboration going on between EURORDIS and NORD as well as other partnerships with international rare disease organizations?

NORD: Government agencies are focusing more attention on rare diseases and orphan products than ever before. This is because we are transitioning to an era of more personalized medicine, and toward a better understanding of the underlying basis of disease. We hear repeatedly from government agencies that we all have the same goal — to improve the lives and health of people with rare diseases – and we can accomplish more by working together. We want to build on these relationships and forge common understanding and goals.

PE: What sort of policy initiatives could help advance these partnerships? Does this come in the form of regulatory harmonization to ensure broader market access? Does it come in the form of giving patient groups more access to research initiatives taking place?

NORD: Certainly we encourage government agencies to talk with each other and share data and perspectives. The patient voice is very important. We have worked to help fashion at the US Food and Drug Administration (FDA) a program to create systems to strengthen the patient voice as a required interlocutor in the drug development and approval process, and we have made enormous strides. The US Congress last year endorsed that goal. We believe that the patient voice in the regulatory process is getting stronger and that it will continue well into the future.

PE: What can your two organizations do to speed up market access? For example, conducting international scale clinical trials?

NORD: We support any efforts to speed market approvals for new products and to assure patient access to them. Our contribution from the patient perspective is to identify and codify patient information that will lead to a better understanding of diseases and their natural histories, and to bring patients together more quickly so that clinical trial recruitment can be sped up. Most clinical trials these days are international in scope and of course we support more expansive trials when possible. Diseases do not have geographic boundaries.

PE: How has social media transformed the landscape of rare disease? What do you hope to accomplish in effectively wielding this new medium?

NORD: Social media is a tool that is just now being tapped. Both of our organizations encourage patients to use social media to communicate with each other and to share experiences and information. RareConnect is just one example of social media efforts. We hope to encourage more.

PE: Is there a concerted effort to expand this partnership beyond into a worldwide partnership/community? Or is that taking its time?

NORD: NORD just signed an agreement with the Japanese patient community to collaborate more formally. We will look for further opportunities to bring the international patient community together. Rare Disease Day, always the last day in February, at which time we celebrate the progress made by the rare disease community, has become an international event.

PE: As work on rare diseases moves forward, does NORD see the definition of rare diseases changing or shifting to accommodate currently excluded patient constituencies?

NORD: We are not aware of anyone in the rare disease community who believes their disease is being excluding from our work. We do wish to make the definition of rare disease as inclusive and wide-ranging as possible. All of our activities strive for that objective.

To learn more about NORD and its initiatives, visit their website: http://www.rarediseases.org/