Biosimilar Litigation Trends and Best practices we have learnt in 2019

Almost 10 years since the U.S. Biosimilars Pathway the law which comprises of the Biologics Price Competition and Innovation was introduced. In the years 2015 the first of kind biosimilar product in U.S. history was introduced and launched in 2015. This consisted of long term court cases and later as the years passed Ten new biosimilars were approved and launched in 2019. 

The Food and Drug Administration (FDA) till now has given green light to new 26 biosimilars in total, including biosimilars of nine of the world’s most important biologic medicines: Avastin, Rituxan, Enbrel, Herceptin, Humira, Neupogen, Neulasta, Remicade and Epogen. This has been possible due to the relentless efforts of the biosimilar litigations attorney. 

The Supreme Court and Federal Circuit have given provisions of the enactment. 2019 did not offer any key insights into the enacment, but a number of trends emerged and lessons were learned. 

How biosimilar litigation attorneys help you with Patent litigations between biosimilar competitors of the same biologic medicine 

• Biosimilar makers are filing for and obtaining manufacturing patent rights for their own as they do not have to use the manufacturing processes of the main manufacturers to obtain approval for their products. Then in 2019 we saw the first lawsuit between two biosimilar makers — both with biosimilars of AbbVie’s adalimumab (Humira). Then in January 2019, Coherus BioSciences, a biosimilar manufacturer, filed a complaint alleging that Amgen’s biosimilar of adalimumab (Amgevita) copied the patents for its own biosimilar version of adalimumab. From our resources we can say that Amgen launched Amgevita in Europe but officially it has manufactured Amgevita in the United States. Coherus claimed that production of Amgevita in the United States copied the main components of the patents. Now with the help of  biosimilar litigation attorneys the parties settled the suit in November 2019. 

• According the experts Amgen holds the earliest launch date in the United States of any biosimilar adalimumab and definitely soon will launch in January 2023. Following that Coherus will launch in December 2023. 

• We are going to see patent copying litigation between biosimilar competitors in the years coming ahead as biosimilar makers continue to procure and enforce patents. So will the need for biosimilar litigations attorneys. 

Expired patents may result in substantial damages imposed on the requester; the Safe Harbor does not save the companies from the pre-approved manufacturing. 

Amgen’s lawsuit with Pfizer’s Hospira involving a biosimilar of erythropoietin (EPO) has given us quite lot of illustration to very important lessons: patents that are expired at the time of biosimilar approval may still find some value to innovators at the end of the day, and the Safe Harbor provision of 35 U.S.C. 271(e)(1) does not prevent innovators from all preapproval manufacture taken care by the biosimilar legislation attorney. 

• In December 2019, the Federal Circuit passed a new jury verdict that Amgen’s expired patent was copied and cannot be considered as originator drug. Then 14 batches of Hospira’s EPO biosimilar were not being protected by the Safe Harbor provision; and then the Amgen was entitled to $70 million in damages as a fine. The Federal Circuit then made it very clear that preapproval production of a biosimilar product is not necessarily protected by the Safe Harbor provision but they can be protected only if the biosimilar batches are made solely for regulatory purposes. 

• In another case that involved Amgen’s complaint that was filed in September 2015 alleged that Hospira infringed some of its U.S. Patents and related methods of developing EPO. When the complaint was filed, Hospira’s biosimilar was not approved and launched in the United States. Hospira claimed that before the ban its 21 batches of biosimilar EPO, which were prepared during the time period of 2013 and 2015, before the expiration of the patents, are protected within the Safe Harbor provision because the products were related to the development and approval of information. 

• During the trial, Amgen concluded that their 21 batches of Hospira’s EPO had the total estimated value of over $100 million. The jury found that the claims of the patent were surely infringed and not valid, and out which 14 of the 21 batches were not protected by the Safe Harbor provision. The jury awarded Amgen the case and was given $70 million in damages.  

Settlements abound and the USPTO intervenes in biosimilar IPR appeals post-settlement 

• According to Biosimilar legislation attorney makers are taking advantage of the make use of inter partes review (IPR) proceedings to challenge against the verdict of the patents protecting biologic medicines and to finally get the approval for the drive settlements. When finally, the settlements occur after a final written verdict taken by the Patent Trial and Appeal Board (PTAB) which eventually leads to the biosimilar maker withdraws from the case, the U.S. Patent and Trademark Office (USPTO) is pulling up to protect the PTAB’s decision. 

• Another example is of AbbVie that appealed the PTAB’s Final Decision finding claims of U.S. Patent directed to the methods of using adalimumab which was not protected by the trademark. Although Coherus BioSciences and Boehringer Ingelheim settled with AbbVie and withdrew from the appeal, the USPTO had to come into the case to protect the PTAB’s decision.  

• In the same way, Biogen appealed against the PTAB’s Final Written Decision finding all claims of U.S. Patent No. 8,821,873. The case was related to the methods of treating diffuse large cell lymphoma with anti-CD20 antibodies. After the settlement between Pfizer and Biogen which was withdrawn from the court, eventually the United States government had to intervened in response to Biogen’s constitutional in order to challenge its pre-AIA patent to an IPR. Resulting in USPTO intervention to uphold the PTAB’s final verdict.

It would be interesting to see how biosimilar producers develop new scenarios for approval and launching the same in the market. But in the same way the experience required by biosimilar litigation attorneys is still very high. The biosimilar litigation attorneys would have to very minutely observe the present scenarios and the success failure rate connected to each case. 

That way the past case experiences have been handled would eventually play a major role in creating future success rates.