The year 2019 noted a remarkable year for biosimilar in the United States as in the year 2020 the FDA approved its 30th bio similar product and with its launch marked its 30th product in the list. As of now we are looking forward.
Later in 2021 we this progress was combined by the new amendments made by FDA, which is new proposed and enacted legislation, and many such new enhancements in court proceedings.
This article will focus on the updated legal developments made by the biosimilar litigations attorneys and its related sector — specifically, litigation under the Price Competition and Innovation Act (BPCIA), Bio similar litigation attorneys alleged anti compliance behavior on the part of reference product sponsors, and biologic-related post-grant challenges has caused some issues on part of the legislation.
Bio similar attorney & BPCIA litigants courts handled new issues in 2019. The Federal govt. is busy, with numerous issues pending and few new decisions imposed last year. We will try to briefly summarize overall percentage regarding BPCIA district court litigation and the ongoing BPCIA district court cases. Subsequent enhancement in this legislation will be discussed later in the BPCIA district court cases that settled in 2019 newly decided BPCIA appeals.
Since the BPCIA’s legistaiton in 2010, more than 40 BPCIA cases have been registered in district courts. Amgen which consists of 15 cases and Genentech which has 13 cases has most of the active complaints and together account for the plaintiff side in more than half of all BPCIA litigation to date.
Amgen is also the most common BPCIA defendant which has eight cases, while Celltrion acting as defendant in seven cases and Sandoz acting as defendant in six cases are not lagging behind.
Later in 2019 we saw decrease in new BPCIA court filings in comparison to the last three years. Later in 2019 there were several cases that were follow-on cases for adding new patents, as opposed to new disputes involving new parties assisted by bio similar attorney’s for biosimilars.
From the five new BPCIA court cases registered in 2019, these are the ones which are still ongoing. Genentech v. Immunex and Immunex v. Samsung Bioepis are still in court; the other cases have been dismissed. The newly filed BPCIA cases are summarized above and are discussed individually in the section addressing ongoing litigation below and in the review of litigation resolved in 2019.
Ongoing BPCIA District Court Litigation managed by Biosimilar attorney’s
As mentioned above, the BPCIA cases filed in 2019 that are currently ongoing include:
- Genentech v. Immunex (19-cv-00602 D. Del.)
This case consists of Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab), and also relates to two prior cases between the parties consolidated into Case №17–1407 (D. Del.).
2. Immunex v. Samsung Bioepis (19-cv-11755 D.N.J.)
This case has the reference of biosimilar product Enbrel (etanercept) and Samsung Bioepis’ biosimilar, Eticovo. On April 30, 2019 — after approving Eticovo — Immunex loged five patents against Samsung Bioepis, three of which were of them were owned by Immunex and two that of Immunex had exclusively licensed from Roche (Dkt. 1 at 3). Samsung Bioepis answered this complaint filed by Immunex on August 5, 2019 (Dkt. 70).
3. Genentech v. Amgen (17-cv-01407, 17-cv-01471 D. Del)
This litigation involves Amgen’s biosimilar version of Genentech’s reference product Avastin (bevacizumab). This case saw significant activity in 2019 as the parties engaged in fact discovery.
On July 10, 2019, Genentech filed a case for a TRO to protect Amgen from launching Kanjinti until the court passed a decision on the following a full trial (Dkt. 308). The court denied the case, finding that Genentech had to wait too long to file: (Dkt. 315 at 5). The court decided that Genentech’s delay was sufficient to deny its case and that Genentech would not suffer any harm due to its previous license of certain asserted patents. The result Genentech appealed on July 19, 2019 and launched Kanjinti in July 2019.
4. Amgen v. Hospira (18-cv-01064 D. Del.)
This case is still under expert consideration. This includes Nivestym, Hospira and Pfizer’s biosimilar of Amgen’s Neupogen (filgrastim). On July 18, 2018, Amgen asserted one patent in its initial complaint: U.S. Patent №9,643,997, directed to protein purification (Dkt. 1 at 3).
As the biologics market domain continues to expand day by day, patent litigation is also increasing. Here we examine what we’re likely to see in the coming years in the biosimilar industry. Also how biosimilar litigation attorneys can prepare for the increase of innovation in biosimilars and next generation therapies.
We are comparing our own findings of the industry with those of companies at the top of the shelf of these biosimilar developments. We focus on what bio similar litigation attorney currently are doing when they are with patent claims in cases involving biosimilars and biologics. Also what new findings they expect to see in future patent disputes.
Through experience and observation, a biosimilar litigation attorney will assess the current market situation and future predictions that can provide a valuable insight into the following:
- Biologics vs biosimilars — new trends in biosimilar litigation
- Key challenges that requesters may face in patent litigation for biologics and biosimilars
- Different patent litigation and alternative business strategies
- The current patents system and the possible enhancement in biologics legislation
- The key jurisdictions leading the way in biosimilars patent litigation
- The launch of the Unified Patent Court in Europe and its possible effect on future cases
The drug manufacturers are now increasingly putting pressure on both sides of the courtroom. This protects the manufacturers their high-price products from biosimilars — biopharmaceutical drugs with the treatment properties of medicines they seek to mimic — while simultaneously challenging rivals’ patent claims.
Biologics, manufactured in living cells, then extracted and purified, are more complicated than traditional medicines and cannot be copied with precision, and so their other versions are called biosimilars instead of generics.
Lastly, its under the Supreme Court jurisdiction whether they consider biosimilar applicant may give the notice. But still the outcome of these application will rely on the outcome whether these manufacturers can begin marketing at the time that its application is approved instead of having to wait for six months after approval.