Draft legislation will create more opportunities to market new drugs in the UK but companies will need to tread carefully, says Withers & Rogers

A bill which could make it easier to secure licences for off-patent drugs will open up market opportunities but companies will need to tread carefully, according to intellectual property firm Withers & Rogers.

Pharmaceutical companies are being warned of potential patent infringement risks and firms need to carry out their own due diligence before bringing drugs to market for new uses, says Withers & Rogers. 

The Off-Patent Drugs Bill was launched by a group of MPs as a result of the need to prescribe patients potentially significant new treatments and improve efficiencies within the NHS. While an existing drug might be patented and granted a marketing authorisation for one use, the same drug could have one or more other uses to treat separate medical conditions. At present, doctors have the option to prescribe treatments for non-authorised uses on an “off-label” basis but this carries risks.

Under the bill, the Secretary of State for Health would be able to obtain a marketing authorisation for a new use of existing drugs that is not covered by a patent. In order to be granted authorisation for a new use, the off-patent drug must already be licensed to treat a specific condition. It is also required that no other organisation should be seeking a marketing authorisation for the same new use.   

Dr Nicholas Jones, a partner and pharmaceutical patent attorney at Withers & Rogers, said: “While this bill has been proposed with patient care in mind, companies interested in taking advantage of the proposed system should be aware of the potential patent infringement risks that it could pose. 

“The wording of the draft legislation could give rise to a potential problem with the definition of an ‘expired patent’. It is not uncommon for drug companies to obtain additional patents for any new uses they discover, and these patents may extend well beyond the 20-year term of the original patent. Depending on how well the Secretary of State for Health is informed, he may grant a marketing authorisation for a new use without realising that a patent covering that same new use already exists.” 

Once the Secretary of State for Health has been granted permission in relation to the new use of the off-patent drug, firms might then look to take advantage by developing the drug and bringing it to market. Companies need to be sure they won’t attract a patent infringement claim as a result.  

Dr Jones continued: “It seems that the new legislation doesn’t address this potential infringement problem and some companies may not be aware of it. Should a company commit to develop a drug for a new use, without satisfying themselves that an existing patent doesn’t already cover this use, they could end up on the wrong end of a costly patent infringement claim. It is unlikely that the Secretary of State for Health will have access to all the necessary information so manufacturers need to do their homework.”    

Under the bill, pharmaceutical companies may need to move quickly once the Secretary of State for Health obtains a licence for a new off-patent drug. It is likely that clinicians, hospitals and other charitable bodies will be swiftly notified of the new indications. 

Dr Jones added: “Although this draft legislation has the best intentions of providing patients with new treatments, it is uncertain at this stage how much impact it will have in practice. It is likely that where there was a commercially realistic opportunity to market drugs for new uses, pharmaceutical companies would have already done so.   

“Only time will tell whether any new uses implemented as a result of the bill are 'groundbreaking' in terms of clinical uses and treating life-threatening conditions. It is more likely that the new uses licensed under the bill might only be incremental advances that impact a small section of the population.”

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