AIPPI Congress Report 7: Medical devices and patents

Come near the AmeriKat with a medical device and
this is the look you will encounter

Warwick Rothnie was back in AIPPI's Pharma Day sessions to report on the proceedings for the IPKat's readers.  Next up was what can be a complex matrix of medical device regulation.  Warwick reports:  

"Hector Chagoya Becerill (moderator) noted that there is a trend developing, particularly over the last two years, for patent applications for medical devices, especially for devices introducing active ingredients into the human body. 

Michelle Pratt agreed that there were increasing number of filings in medical technology, particularly for apparatuses and apparatuses plus drugs. This meant pharma companies are facing challenges about drafting claims and portfolio planning issues including issues for second and subsequent medical uses. Patents are also being sought in relation to 3D printing such as for organs and other body parts. 

Derek Minihane said the combined global devices market had gone from $60 billion to over $130 billion in a very few timeframe. Cochlear is testing embedding steroids in the electrodes of its devices and other companies are exploring other enhancements including using electrical stimulation to promote growth of the ganglia to connect directly with the electrode. 

John Todaro identified issues with indefiniteness (US) or clarity. Until 2014, this was a fairly low threshold under US law. In 2014, however, a US Supreme Court decision radically changed this standard. Thus, in one recent case, the term “molecular weight” was ruled ambiguous and so the patent was invalid. As a result, Merck now included a specific check list item when drafting medical device patents to confirm that terms were clearly defined.

Also, the standard of obviousness appears to be different and higher for medical device patents than the standard applicable for new drug compounds. 

The busy Dominic Adair returned to explore issues relating to wearable devices; not just Fitbits and the like, but hearing aids and pain adjustment technology. With such devices, the device provider may be storing the patient’s private data. One issue is the need to share the data with medical staff treating the patient. Another issue is the risk of hackers gaining unauthorised access to the data. In Europe, there will be stringent new privacy regulations coming into force next year. These will impose obligations for training, reporting breaches and security protections will need to be built into the device. The penalties for breach will be significantly increased, up to 4% of turnover. These rules will affect anyone with customers in the EU. 

Michelle Pratt noted that European law precluded patents for methods of using a device given the exclusion on surgical or therapeutic methods. However, the EPO is developing limited rules to enabling some patents for the use of devices containing active ingredients.

Derek Minihane noted one of the challenges is the broad range of technology Cochlear is dealing with. This could include algorithms, biology and many other technical fields. Cochlear had identified seven key tech streams which were its key points of focus across the spectrum. This meant that the attorneys Cochlear works with also need to have, or have available, multi-disciplinary skills. 

Dominic Adair reported that the EU has adopted two new Regulations to replace three previous directives: the Medical Device Regulation and the In-vitro Diagnostic Medical Devices Regulation. They are already in effect, but become applicable in, first, May 2020 and the second in May 2022. The Medical Device Regulation will apply to apparatus and drug combinations where the apparatus is the main element. If the drug is the main element, the product will be classified as a medical product. 

The scope of these Regulations is much broader than the previous directives. For example a range of cosmetic products would be covered for the first time. He described many other detailed changes which will require careful consideration and action. This will mean that companies will need much stronger internal management and external advice. 

Derek Minihane outlined US administrative practices. One point is that regulatory submissions to the FDA need to be carefully utilised to ensure that patent applications are consistent with the regulatory application. In particular, the pre-RFD process should be used to identify how the device will be characterised. 

Dominic Adair noted that a medicinal product would have an eight year data exclusivity period, followed by two years of marketing exclusivity with the possibility of an additional one year. There is no regulatory data exclusivity for a medical device. Under the new Regulation, however, it will be necessary to get the original developer’s consent to access and use the relevant data. In this respect, therefore, originators will be better protected. They will have to do much more work before they get regulatory approval however. 

John Todaro said that compounds could get up to five years’ data exclusivity in the USA. What exclusivity may be available for devices would depend on the classification. Class 1 devices do not get data exclusivity. Class 2 products, for “substantially equivalent products”, get a much quicker review time - 90 days, but must identify the nearest competitive product. This can expose the party to greater risks of early infringement action. Class 3 products involve a longer review time - 180 days. Derek Minihane noted it was good practice to get pre-filing approval before testing. In Europe, even class 3 type products typically obtained only 2 - 4 months review. 

Michelle Pratt discussed patent term extensions (SPC) and medical devices. Extension of term is available only for products where the pharmacologically active agent(s) are the principal feature. It appears that whether an SPC is available for a medical device will vary from country to country. The Netherlands and Germany seem likely to allow; so far the UK has not granted such an extension. It is understood a German court has made a preliminary reference on the question to the CJEU. John Todaro considered it would be likely that device for administering a drug, a method of use, could potentially be listed in the Orange Book. Careful thought should be given whether or not to do this. He considered it would probably not be possible to list devices alone which did not recite a specific therapeutic agent."