Speaking to the UK's Independent newspaper, AstraZeneca CEO David Brennan indicated that pharma firms must prioritise their patents in order to be best prepared for legal challenges. Brennan advised that resolving pharma patent cases in court should not be the industry's default option, and the resolution of each case should be determined by the nature of the patent in question.

Brennan spoke in the aftermath of a recent case relating to AstraZeneca's reflux treatment, Nexium. Citing infringement of the treatment, the firm had sued prominent generic producer Teva in 2008, triggering a countersuit in which Teva challenged the legitimacy of AstraZeneca's patents on the drug.

In January this year, AstraZeneca settled the case, granting Teva a licence to enter the US market with its generic version of Nexium in May 2014 – subject to regulatory approval. AstraZeneca announced that, in return, Teva had 'conceded that all patents-at-issue in Teva's US Nexium patent litigations are valid and enforceable. Teva … also conceded that six Nexium patents would be infringed by the manufacture or sale of Teva's US generic esomeprazole [the active ingredient of Nexium]'. The US District Court for the District of New Jersey entered a Consent Judgment in the case, dismissing all the relevant patent litigations.

Asked by the Independent whether this approach was sustainable, Brennan said: 'It is actually critical for us to retain our intellectual property on our products – it is mission critical. But … the thing about patents is that they are not binary. The strengths vary, so on some [in which] we have been challenged, we have settled.' Brennan added that, sometimes, the mutual-settlement route could provide a better outcome than a court decision, which is non-negotiable. However, he said: 'In other situations we have been to court. Will we continue to do it? Absolutely.'

Brennan drew attention to the competitive climate that has grown up between big pharma and generics producers, and pointed out that litigation from the latter had gradually intensified in the pursuit of economic goals. 'About 10 years ago, the generics changed their strategy and decided to challenge every patent,' he said, 'so what you're seeing is a shift from them. They are saying, "Let's get the top 20 drugs and start challenging them. We only need one patent and we've made lots of money".'

AstraZeneca spokeswoman Abigail Baron told IP Review Online that the company's core, value-creating IP strategy was to be 'a focused, integrated, innovation-driven, global biopharmaceutical company that is prescription based'.

'Firstly,' she added, 'we will deliver value from our investment in innovation, whether [from] internal R&D or in-licensed technology and projects. Our goal is to launch, on average, two new medicines per year.' In parallel, AstraZeneca will work to gain market share for its exclusive brands and drive key franchises such as Crestor – a heart disease treatment for patients who have developed their conditions from factors unrelated to cholesterol – plus Symbicort and Seroquel XR. 'We expect to successfully commercialise our recently launched products, and the next wave of products from our internal and in-licensed pipeline,' said Baron. 'We will also continue to drive our Emerging Markets business, where we believe we can achieve double-digit growth.'

Baron revealed that AstraZeneca is controlling R&D costs by working with a range of external partners spread across government, industry and even the charity sector. 'These partnerships range from basic research through to clinical testing and marketed products,' she said. 'We recently signed a deal with Cancer Research UK to conduct basic research on cancer metabolism. Other examples in the pipeline are our collaboration with Merck to investigate a novel combination anti-cancer regimen and our research and screening collaboration with Alcon, the world's leading eye-care company.

'We have also worked with major academic health centres, such as MD Anderson in Texas where we are exploring how to accelerate the clinical development processes to move new cancer treatments through development more efficiently … [and] in the past six months we have signed several major licensing agreements to access projects from outside companies.

'We rely on a strong and effective patent system that rewards innovation, research and discovery.'

John Pryor, vice president of patent portfolio optimisation at leading IP and legal services company CPA Global, gave IP Review Online his assessment of AstraZeneca's strategy. 'In an industry where one patent can literally drive billions of dollars of value,' he said, 'strengthening and protecting this IP is indeed mission critical. Otherwise there are generic firms and others waiting in the wings to take a swipe at the integrity of the patents with a view to hitting the jackpot. Sometimes this can look like a game of "patent chess", with power gained and conceded depending on the legitimacy of the next move. Therefore a comprehensive analysis of all key patents, and patents of potential use in countersuits – including their relative strength in the context of competitive threats – is part of day-to-day operations in the IP departments of pharmaceutical giants.

'Similarly,' he added, 'the pharmaceutical industry has long recognised that the best innovation might well be found outside their own R&D efforts – so collaboration and licensing arrangements are an integral part of the business strategy.'

On 22 February in the US District Court for Delaware, AstraZeneca began proceedings to defend its patent on Crestor. IP insiders will be keeping close watch on the case to see which settlement strategy AstraZeneca will adopt.