Intellectual property supersedes a mere idea. It consists of those core assets that an organization needs to ensure its sustenance and long-term viability. Intellectual property has a varied range. It consists of one’s creations, logos, to even services or products. Naturally, the protection of such resources becomes paramount, given the role it plays. Protection of intellectual property prevents others from utilizing one’s ideas, generating a revenue stream by setting an organisation’s business apart and organically marketing them as different from what is already existing.
Undermining the importance of safeguarding intellectual property often causes unforeseeable damages, an example of which has been highlighted in the case of Biogen International GmbH vs. Viatris Incorporated which was caused by the lack of a detailed patent covering Biogen’s groundbreaking drug Tecfidera that is used to treat multiple sclerosis (“MS”). In 2017, Viatris- formerly Mylan Pharmaceuticals Incorporated, filed an Abbreviated New Drug Application (ANDA) seeking approval for the manufacture, use, and marketing of a generic version of Biogen’s Tecfidera which, thereafter was challenged by Biogen through a patent infringement suit against Viatris under the Drug Price Competition and Patent Restoration Act, 1984. The primary question presented in this case was determining what the definitive level of written description is, to safeguard a technology through a patent.
THE ‘514 PATENT:
In 2013, after conducting triple-phased trials aimed to determine the appropriate levels of Dimethyl Fumarate (“DMF”) to treat MS, Biogen launched its drug Tecfidera. During the last phase of Biogen’s clinical trials, it was found that administering a daily dose of 480mg to 720mg of DMF every day was efficacious in treating MS. This conclusion was drawn against the suggestions of Dr. O’Niell who had proposed the appropriate daily dosage of the drug to be 320mg. To protect this information, Biogen came forward with the ‘514 patent. This is the very patent that covers the drug Tecfidera. After its debut in the market, Tecfidera soon became one of the best-selling drugs for MS in the market, with Biogen effortlessly creating a monopoly with its product. Biogen’s official reports revealed that Tecfidera constituted $4.2 billion in revenue out of the total revenue of $12.3 billion in the year 2017.
BIOGEN VS. VIATRIS:
To be constituted a patent, The America Invents Act requires a written description of the invention to be included in the same amongst other things to allow a person of skill in the art to validate that the invention is what the patentee has claimed. During the trial, Viatris successfully established that the claims asserted in Biogen’s 514’Patent are invalid given the fact that it lacks sufficient written description regarding the drug Tecfidera. Viatris supported this statement by asserting that Dr. O’Niell; who was made in charge of developing the proposed dosage of Tecfidera by Biogen; or Dr. Lukashev; who was appointed and tasked by Biogen in finding the effect of DMF on the Nrf2 pathway during the trial phases of preparation of the drug; could not be understood as the inventors of Tecfidera through the patent. These assertions by Viatris were confirmed by both Dr. O’Niell and Dr. Lukashev.
Secondly, Biogen, through the year 2007 up to the point of the formation of the 514’ patent made various additions and cancellations to the patent that was supposed to cover the drug Tecfidera. Due to this, a considerable amount of information that was relevant to the drug was invalidated. This further caused a lack of description with regard to the claimed invention, i.e., Tecfidera as the previous patents could not be referred. However, Biogen did try to selectively combine specifications from the previous patents during the suit which was flatly rejected by the Court.
With all this information, the Court favor Viatris. It mentioned that Viatris, with transparent and convincing evidence, had sufficiently demonstrated that the claims asserted by Biogen’s 514’ patent were not valid, owing to a lack of written description. The ruling was meted out on June 18th, 2020. The session was presided over by Judge Irene M. Kelley.
Following this, Biogen put up an appeal challenging Viatris in both the years 2021 and 2022 in the Supreme Court of America, both of which were turned down. This turn of events negatively affected Biogen’s revenue and share price.
From this trial, the following analyses may be drawn:
- The first defense put up by Viatris during the course of this suit was held up by the Court due to the fact that they could prove that neither Dr. O’Neill nor Dr. Lukashev was the inventor of the drug Tecfidera. The implication here is that, if the people hired by Biogen for the development of the drug had not invented the drug or specifically asserted the effective dosage of the drug, then Biogen could not assert a monopoly in the market using the drug using the 514’ patent even if the company itself claims within the patent that the inventor of the drug was Dr. O’Niell or Dr. Lukashev.
- Secondly, the numerous additions and removal of information that Biogen did with regard to the patent covering Tecfidera would later become a hurdle for Biogen in winning the suit against Viatris. Simply speaking, removing information from a patent and holding up that very discarded information later in Court or citing a discarded patent as a defense in a suit is not viable.
Thus, Viatris successfully highlighted these loopholes in Biogen’s 514’patent covering Tecfidera during the course of the suit which contributed to its eventual win and enabled its launch of Tecfidera’s generic drug into the market at a lower price while having the same effect on the disease MS. This caused a major dip in Biogen’s revenue and shares.
From the evaluated case above, the gravity of protecting one’s intellectual property diligently can be conceived. This case poses a stellar example of careless registration of patents and how dangerously that can affect the subsistence of a company in the market. Even with all this, the inflow of generic drugs into the market has to be acknowledged. The generic drug market in itself is an indicator of a fight for a greater cause- the fight to make healthcare more accessible. The generic drug market makes medicine more available to a larger population owing to their low prices as compared to the original drug which would have otherwise been unaffordable to many. Apart from this, the generic drug market also breeds the way for innovation to thrive which in turn often leads the way to the invention of a product that would otherwise have not been in existence.
Author(s) Name: Ekoparna Datta Ray (University of Calcutta)