Intellectual property is of paramount importance in the pharmaceutical sector. While some degree of regulatory protection is available in key markets, patents (and their PTE/SPC extensions) will often provide a considerable commercial & exclusivity uplift for a given asset. With such high value at stake, pharma patents can often become the target of determined and creative litigation – so insightful and careful drafting and prosecution is particularly important in this area.

Our pharmaceutical IP specialists have extensive expertise in the field of small molecule therapeutics, including drugs, modulators and antibody-drug conjugates, complementing the expertise of our pharma life-sciences specialists who cover all classes of biologic and cell therapeutics including polypeptides, monoclonal antibodies, nucleic acid therapeutics, vaccines, stem cells and cellular immunotherapy.

Of course, pharmaceutical IP support can start well before the patent filing on a lead compound, and can extend long after global launch. In the area of patent portfolio building and life-cycle management, we can support the drafting and prosecution of novel chemical entities, novel methods of synthesis, novel salts and polymorphs, high purity forms, pharmaceutical formulations, combination therapies, dosage regimes and new medical uses.

For some clients we operate as a surrogate for an in-house IP group, dialling up and down the support according to business needs – covering everything from due diligences, in/out-licensing, patent portfolio building, freedom-to-operate support and industry-specific strategic advice.

For a number of on-market pharma products we have handled all aspects of worldwide patent prosecution on behalf of large multi-national pharma clients.

Our Extensions and Exclusivity team includes experienced IP counsel who previously specialised in the area of PTEs, SPCs and Regulatory Exclusivity while working in-house for a global pharmaceutical company. Our team regularly supports clients on strategic commercial exclusivity analysis for their products – taking account of the patent, regulatory and real-world factors in order to guide extensions strategy, before often progressing on to the SPC and PTE filings themselves.

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Pharma & Life Sciences patents

Our life sciences patent team works across all classes of biologic and cell therapeutics including polypeptides, monoclonal antibodies, nucleic acid therapeutics, vaccines, stem cells and cellular immunotherapy.

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Validation strategies for pharma

The decision on where to validate a pharmaceutical European patent is a big one. With costs often precluding an “everywhere” approach for small- to medium-sized companies, research institutions and universities, it is necessary to choose from the long list of available countries. The choice typically factors in costs, business interests, likely markets and market size, possible manufacturing and import locations and the regulatory framework in Europe.

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SPC's and other Patent Term Extensions

We have unparalelled experience with SPC’s and other Patent Term Extensions. We handled the UK’s first SPC application for leuprorelin back in 1993 and we’ve been in the top three firms for SPC filings in recent years, supporting some of the biggest multinational pharma firms worldwide.

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We work at every stage of the IP lifecycle

PROTECT

Drafting, Filing & Prosecution
Portfolio Management
Searching & Watching
Renewals & EP Validations

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DEFEND

Pre-action Advice
Oppositions & Appeals
Litigation
Alternative Dispute Resolution

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EXPLOIT

Strategic Advice
Commercial Issues
Transactions
Corporate Support

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Mewburn Ellis

FORWARD MAGAZINE

Mewburn Ellis Forward is a biannual publication that celebrates the best of innovation and exploration. Through its pages we hope to inform and entertain, but also to encourage discussion about the most compelling developments taking place in the scientific and entrepreneurial world. Along the way, we’ll engage with the IP challenges that international organisations face every day.

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