In a development that has disrupted the traditional innovator-v-generic litigation format, biologic and biosimilar makers are more often considering other innovator and generics companies as litigation targets, which will increase blue-on-blue court actions.
Patent lawyers from Zentiva, Insud Pharma and an innovator drug business explain that biosimilar makers are steadily growing their biologic patent portfolios, and are increasingly looking to assert those rights against other biosimilar makers because of the dynamics of the large-molecule market.
Kristin Cooklin, head of patents at Zentiva, explains that blue-on-blue litigation has always been a possibility in the small molecules market because most life sciences companies have patent portfolios. A generics company might have a patent on a formulation or different polymorph to design around the patentee, for example, and could choose to assert that patent against other generics companies.
Such challenges are uncommon in the small molecules arena, she adds, because in a situation where a blockbuster drug is about to lose exclusivity, a generics firm knows that 15 other companies will likely to come onto market at the same time as them. It would be too costly for that business to try and knock out all of them and a waste of time to try and take out just one or two.
“You are pretty much committed to your molecule at that point, and it becomes much more cost effective to start an action against the patentee than to spend money on R&D designing around it – particularly when the patentee could just amend the specification to cover your changes”
That is not the case for the biosimilars market, however, which is larger and has fewer players than small molecules. In that market, it often makes financial sense to knock out one or two players when the reward of a significantly increased market share and being one of the first players on the scene will massively outweigh the cost of litigation.
Cooklin adds that there are more sophisticated patents that can be developed in respect to biosimilar products, which also makes the chances of a court case win more likely than perhaps with a small molecule patent. “There may be more blue-on-blue action as we see more portfolio growth among biosimilar makers,” adds Tomos Shillingford, associate general counsel at Insud Pharma. “You rarely see generic producers suing each other over small molecules, but the biosimilar market has very different financial drivers.”
Biologic civil war
From the innovator side, biologics makers will likely look to take on other originators because of the time frames involved in producing a new large-molecule invention. A senior IP lawyer at a US-based biotech company says that if one or several other originators went to make an antibody, for example, for the same target at the same time, especially when there were no patents registered on that technology, it would be difficult or incredibly costly to design around it.
He explains that biologics take a long time to produce, and by the time a patent has come out on a particular product, the company has likely already spent significant resources on its potentially infringing product.
“You are pretty much committed to your molecule at that point, and it becomes much more cost effective to start an action against the patentee than to spend money on R&D designing around it – particularly when the patentee could just amend the specification to cover your changes.”
He says that a biosimilar maker formulation or process patents are less of a concern because there are usually ways around those. Biologic patents, however, are often very broad and hard to design around. Considering the lucrative nature of biologic products, he adds, litigation can be a good way of knocking competitors out of the market and gaining a huge advantage by being the first player on the scene.
FTO expansion
For biosimilar makers looking to clear the path and ensure freedom to operate (FTO) for their large-molecule innovations, of course, the willingness of other generics to enforce their biologic patents is a new and important consideration – especially when attaining certainty for a biosimilar launch is so important.
Sources point out that it is frustrating, but not the end if the world from a financial perspective, if a small molecule launch is delayed by a previously unknown patent. But that is not the case for biosimilar inventions, which are more difficult and costly to produce.
One industry source points out that biosimilar makers already have to content with huge patent thickets on biologic products to secure FTO. The blockbuster arthritis-treating drug Humira, for example, which was copied and launched as a biosimilar in the EU in October 2018, was surrounded by more than 70 patents. And there is no point spending a lot of time and money cutting down those patents years before a planned biosimilar launch, just to be blocked at the last minute by another generic’s patent.
The head of IP at a global pharmaceutical firm adds that the FTO incentive might not necessarily cause more blue-on-blue litigation because it will depend on each set of circumstances whether the biosimilar maker chooses to work around the patent, invalidate the registration at the patent office, or start national litigation.
“Biosimilar firms should be looking at these choices a long time before you go to market. If you are talking about a patent that covers a particular formulation or a method of manufacturing, you can work around it.”
He adds that the last thing these companies want is to make changes to a formulation or manufacturing process during clinical studies “You want the process and formulation baked-in earlier in development because if you start making changes after you have started clinical studies, you will need to do more to show the changes you made to the manufacturing step does not have an effect on the way your product behaves.”
It is important to conduct FTO searches six or seven years before the product comes to market to give the business time to oppose new patents at the IP office, he says – particularly at the EPO, which gives businesses nine months to file and opposition.
He says that that filing an action in the national courts would be done much later in the process, because national litigation is more expensive, and the business should first ensure that it has a viable product for the market.
The biologics landscape has flipped the pharma litigation landscape on its head. Innovators and generics are facing actions from, and filing actions against, their own kind – and it is important that they come to terms with that change quickly if they want to make the most out of the budding large molecule market.
