Your first patent application – you try to think of all of the possible variations, all the possible diseases that could be diagnosed or treated, all the potential doses, all the potential chemical or protein variants. But will these lists provide sufficient support for the patent claims you seek in years to come?
It might depend on what data you have for support, how the application characterizes all of these possibilities, and which country ‘s patent office is the overseer.
A recent case of between Forward Pharma and Biogen illustrates some of the difficulties in crafting claims to capture the competition. It is particularly difficult when the competition doesn’t appear until years later. Forward’s original filing was a 2004 application, that matured into a PCT, and then spawned national phase applications. For the US application, Forward filed claim amendments in 2013, seeking to copy claims from a Biogen application and thereby ensnare Biogen’s multiple sclerosis (MS) drug, Tecfidera.
How is this possible? There is no prohibition on shaping your claims to cover your competitor’s product. It can be a smart strategy. But it takes some foresight to craft an application that has enough specifics and data to capture that scope. That forward view (no pun intended) is not always possible or apparent at the time the application is drafted.
Such appears to have been the case with Forward’s application. The active ingredient described in the application (and in Biogen’s patent application and product) is dimethyl fumarate (DMF). Forward’s application described how to formulate and dose DMF to address gastro-intestinal side-effects that some patients experienced when taking higher doses of DMF. The application included a large list of potential diseases that could be treated with DMF. It also described methods for slowly escalating doses over a series of weeks.
Biogen’s Tecfidera is dosed at 480 mg/day. Biogen’s patent claimed the method covering this commercial product, a method of treating MS with DMF at a dose of 480 mg/day. Forward attempted to place this claim in its 2013 amendment. Pointing to its specification, the 480mg/day was one of the doses provided in the application and MS was one of the diseases in a long list of potentially treated conditions.
However, the US patent office found that the descriptions in the application didn’t support this method claim. Why? The application lacked sufficient support that would lead one to connect the dots select the particular dose as an effective treatment for MS. In Forward’s specification, the dose was described only with specific reference to psoriasis. Moreover, the 480mg/day was one of a number of interim doses meant to acclimate a patient to a higher dosing regimen. The patent office (and the Federal Circuit when this case came to the court) explained that the application did not guide one to recognize 480 mg as the therapeutically efficacious dose (rather than an interim step) and did not provide any data or explanation that would lead one to understand this dose would be efficacious for MS.
What intrigued me in this was a comparison to another case heard by the UK Supreme Court. This case looked at what is referred to in Europe as “plausibility.” The question being how much data does a patent application need to support the claims. In the case of Warner Lambert’s pregabalin application, the claims were directed to treating neuropathic pain. However, the data in the application addressed only inflammatory pain. The court found that there was nothing within the application itself to make it plausible that the drug would also be effective for neuropathic pain. Warner-Lambert argued that the scientific literature suggested an overarching connection between the two types of pain that would make it possible that a drug could work through this shared pathway. Even so, the court held that nothing in the application or the knowledge in the field suggested that pregabalin would hit this shared mechanism rather than a target only on the inflammatory pain side of things. Possibility was not enough to get to plausibility and thus, there was a lack of “sufficiency of disclosure” (what we would call written description here in the US) for the claims at issue.
Both the pregabalin case and the Forward scenario have some overlap, namely hindsight is 20-20 It’s easy once you reach the commercial drug and the approved indication and therapeutic dose to see where the patent claims need to be. But by that time, it’s likely too late. There’s no perfect solution. Disclose too much of a general description early on and you don’t have enough specifics and enough data to support specific dosing claims and disease of interest. Wait too long and you have likely disclosed the invention in some publication or clinical trial or perhaps gotten scooped by someone else.
Where does this leave things on the practical question of how much to disclose in an application? It’s an on-going progression. Initial applications set out the key concepts. Later applications may focus on specific details of dosing and more specific disease targets. And timing is everything because earlier applications once published become prior art – so this must be planned and orchestrated to balance the need for data and sufficient description with the potential risk for creating you own prior art bomb.
 The Federal Circuit case arises from an appeal of an interference proceeding between Biogen and Forward Pharma. The interference was originally heard by the Patent Trial and Appeal Board (“Board”). The Federal Circuit affirmed the Board’s findings.
 The commercial drug is Lyrica.
The content of this blog is for informational purposes only and does not offer legal advice. Circumstances are fact-specific and you should consult an attorney for legal advice concerning your individual issues.