Last week it was announced that Abbvie entered into a settlement agreement with Samsung Bioepis that would delay the U.S. launch of Samsung Bioepis’ biosimilar version of Humira® (adalimumab) until June 30, 2023. This is the second such settlement agreement that Abbvie has entered into related to the its blockbuster rheumatoid arthritis drug. In September 2017, Abbvie also entered into an agreement with Amgen that would delay the U.S. launch of Amgen’s biosimilar product until January 31, 2023, several months earlier than the Samsung Bioepis’ biosimilar.
While a 2023 biosimilar launch perhaps cuts Humira’s patent market exclusivity by more than a decade -- some of Humira’s patents have a patent term extending to 2034 – both settlement agreements provide for undisclosed royalties on Amgen’s and Samsung Bioepis’ biosimilar once those biosimilars launch. Even more impressively, both settlements allow Abbvie to continue marketing Humira without competition more than four years beyond the expiration of a key patent protecting Humira in 2018 (U.S. Patent No. 8,889,135 (‘135 patent)), and more than five years beyond the invalidation of that same patent by the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) proceeding in the Summer 2017.
As I previously wrote about, the ‘135 patent is important because it covers the dosing and treatment regimen of the drug, which is necessary for any biosimilar drug looking for gain FDA approval. Specifically, claim 1 is directed to “A method for treating rheumatoid arthritis in a human subject, comprising administering subcutaneously to a human subject having rheumatoid arthritis a total body dose of 40 mg of a human anti-TNFα antibody once every 13-15 days for a time period sufficient to treat the rheumatoid arthritis….”
This begs the question, how has Abbvie managed to extend Humira’s monopoly even when one of its key patents has been invalidated? The simple answer is found in Abbvie’s aggressive patent strategy. While it is unreasonable to believe that all companies will follow the patent strategy that Abbvie took with Humira, there are some lessons to learn from Humira’s IP portfolio that could be beneficial to others seeking to protect their IP assets, especially in today’s anti-patent climate.
Our marketplace understands the importance of patents; their value to business in the US cannot be overstated. Patents provide several offensive and defensive marketplace benefits to their owners or licensees. They can do everything from preventing competitors from making, using, selling, and importing the owner’s claimed product, protecting and expanding one’s presence in the marketplace, to attracting investment from venture capitalists, potential partners, and other investors.
Despite their importance, it should be no surprise to patent owners and licensees that the U.S. is currently operating in an anti-patent climate. Patents are being challenged through various strengthened post-grant procedures enacted by the America Invents Act of 2011 (AIA) or through a more traditional litigation pathway provided by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and patent holders are finding more and more that their patents are becoming susceptible to attack from competitors prior to the expiration of the patents.
The IPR process, for instance, allows a third party to challenge the patentability of an issued patent based on prior art under 35 U.S.C. §§ 102 and 103. The IPR process differs from a traditional district court litigation because it is heard in front of the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB), a final decision can be typically expected within 12-18 months, and the costs are a fraction of a traditional patent infringement litigation. As I’ve written previously, when a company challenges a patent by requesting an IPR, their odds of invalidating the challenged claim(s) are high.
No company is completely immune from an IPR challenge, although these proceedings are more popular in certain fields like electronics and computers. While IPRs are less popular in the biopharma space, they are still used consistently and with tremendous impact. Humira, for instance, has been a favorite target of IPRs from different challenges. In the summer of 2017, the PTAB struck down the ‘135 patent two times in two months finding it obvious over prior art. Other patents covering Humira were also subject to IPR challenges, including U.S. Patent Numbers 9,017,680; 9,073,987; 9,085,619; 8,802,100; and 9,512,216. Abbvie is certainly not the only company facing IPR challenges. Other biologics that are currently facing or have faced IPR challenges include Avastin®, Enbrel®, Lantus®, Neulasta®, Rituxan®, and Herceptin®.
To mitigate the threat from an IPR, companies need to develop a patent portfolio that is robust enough to withstand not only IPR challenges and traditional litigations, but also possible invalidations. Abbvie’s Humira patent portfolio is a perfect example of this strategy, often termed the “patent thicket” strategy. Despite the challenges and invalidations of Humira’s ‘135 patent over the summer of 2017, no competitor can yet market a biosimilar of Humira in the U.S. without fear of triggering a patent infringement lawsuit. Amgen and Samsung Bioepis are the first in line after signing their settlement agreements, but they will not even be able to enter the market until 2023.
Humira’s dominance in light of the unfavorable environment is in part due to its robust patent portfolio. Humira is protected by about 110 patents, some of which extend the life of the patent portfolio all the way into 2034. We can learn a few things from Humira’s patent portfolio.
First, the Humira patent portfolio is big. As I mentioned previously, there are more than 100 patents protecting various aspects of the drug. Such a large portfolio is designed to contain so many different types of claims, sets of claims, and different claim scopes that at least one of the patents will continue standing even if a few patents are invalidated. Moreover, if a company wanted to challenge all of Humira’s patent, they would find themselves in a very lengthy and costly process. In contrast, many products are not protected by such large patent portfolios. More often than not, companies only pursue a handful of patents for their products, making the portfolio, and thus the product, less valuable and more susceptible to attack.
Second, the Humira patent portfolio is very diverse. In a presentation in October 2015 entitled “Broad U.S. Humira Patent Estate”, Abbvie outlined its strategy: to cover every aspect of the drug. Abbvie listed 22 patents directed to various diseases or methods of treatment, 14 patents directed to the drug’s formulation, 24 patents encompassing the manufacturing practices surrounding production of the drug, and 15 “other” patents. Often companies focus narrowly on specific formulations, indications, or manufacturing processes instead of incorporating modifications, alternatives, or improvements, sometimes not developed until after the initial patent filing, that would expand their scope.
Third, the Humira patent portfolio is temporally staggered. By not filing all the patent applications at one time and including additional inventive elements in later follow-on patent application filings, Abbvie was able to extend Humira’s patent protection to 2034, 16 years past the initial expiration of the primary patents in 2018. Within the U.S. first-to-file system, companies are sometimes too eager to file their patent applications and too focused on making their limited number of patent filings as broad as possible, thereby risking condensing their potential patent term by cutting off the ability to file future follow-on patent applications.
Of course, it should be mentioned that a portfolio like Humira’s comes at a price. Filing, prosecuting, and later maintaining a global portfolio is not cheap. As a $16 billion per year drug, Abbvie’s investment in the Humira patent portfolio most certainly pays for itself. For other products, however, companies should weigh the overall cost of prosecuting and maintaining patent applications in the US and abroad against a realistic projected value of their product in various jurisdictions of the global marketplace. That being said, patent portfolio building decisions can be made strategically to tailor the size and shape of the portfolio to fit the business strategy of the company. Competent patent counsel should guide companies through decision-making gates to determine how best to strategically design and implement the best protection strategy.
In today’s AIA and BPCIA era, companies with robust patent portfolios are better positioned to weather this attack. It is therefore important to cultivate a patent portfolio that includes claims that are not only broad enough to provide ample protection in the marketplace, but also one that is deep enough to withstand possible invalidation. Such patent portfolios should include sufficient “back-up” claims in case the first claim set falls prey to post-grant attack and should further include sturdy, well-written, and strategically planned specifications to prop up those claims and support further revisions if needed.
BioPharma Law Blog posts updates and analyses on IP topics, FDA regulatory issues, emerging legal developments, and other news in the constantly evolving world of biotech, pharma, and medical devices.