Judicial conflict between Bristol-Myers Squibb Co V. Merck & Co Inc. Keytruda V. Opdivo

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1 From the SelectedWorks of haitham atiyah Spring April 10, 2016 Judicial conflict between Bristol-Myers Squibb Co V. Merck & Co Inc. Keytruda V. Opdivo haitham atiyah Available at:

2 Written by:- Haitham Atiyah WMU Cooley law school LLM OF Intellectual of property Judicial conflict between Bristol-Myers Squibb Co V. Merck & Co Inc Keytruda V. Opdivo It began the conflict between the judicial on September Bristol-Myers Squibb Co filed a lawsuit against Merck & Co Inc for allegedly infringing its immunotherapy patent. The company is seeking unspecified damages. Immunotherapy is a mechanism that uses the body's own immune system to eliminate cancer cells. In its lawsuit filed in the U.S. District Court of Delaware, Bristol-Myers said Merck was planning to exploit its invention with a later-developed treatment, pembrolizumab, violating the company's May 20 patent. FDA approved the use pembrolizumab, as a treatment for patients with advanced melanoma who are no longer responding to other therapies. See Bristol-Myers is using its patented technology to develop its own drug, nivolumab, which is being tested in different areas of cancer including melanoma. On May 20, 2014, the United States Patent & Trademark Office ( USPTO ) duly and legally issued United States Patent No. 8,728,474 (the 474 patent (Exhibit 1)) titled Immunopotentiative Composition. The inventors of the 474 patent showed for the first time that anti-pd-1 antibodies were useful in methods to treat cancer. Ono is an assignee of the 474 patent. BMS is an exclusive licensee of the 474 patent. The 474 patent claims methods for treating cancer with an antibody against PD-1. Plaintiffs have put the invention of the 474 patent into practice by developing the. breakthrough biologic drug nivolumab. Nivolumab is a monoclonal antibody that recognizes and binds to the PD-1 protein. When nivolumab binds to the PD-1 protein, that PD-1 protein cannot interact with its natural binding partners. Using nivolumab to block the interaction between PD-1 and its binding partners allows a more robust T cell response by the patient s own

3 immune system. MERCK S INFRINGEMENT Merck is planning to exploit the invention of the 474 patent with an anti-pd-1. antibody called pembrolizumab. On information and belief, Merck started developing pembrolizumab after Plaintiffs had made and started testing nivolumab, and Merck has since been engaged in efforts to meet the FDA regulatory requirements for marketing, distributing,,offering for sale, and selling pembrolizumab for the treatment of cancer. According to Merck pembrolizumab is a PD-1 antibody that works by blocking the PD-1 checkpoint to treat cancer. On information and belief, Merck has known about the 474 patent and has known that the use of pembrolizumab will infringe claims of the 474 patent since at least approximately May 20, 2014, when the 474 patent was issued by the USPTO. In its August 7, 2014, 10-Q filing with the U.S. Securities and Exchange Commission ( SEC ), Merck acknowledged that the USPTO had granted the 474 patent (Merck & Co., Inc. U.S. Securities & Exchange Commission Form 10-Q at 22 (filed August 7, 2014)). In that same SEC filing, Merck admits that the use of pembrolizumab to treat cancer is covered by the European counterpart to the 474 patent (id. ( As previously disclosed, Ono Pharmaceutical Co. ( Ono ) has a European patent (EP ) ( 878 ) that broadly claims the use of an anti-pd-1 antibody, such as the Company s immunotherapy, pembrolizumab (MK-3475), for the treatment of cancer. )). Merck has had knowledge of the family of patents that includes the 474 patent for many years and has instituted legal proceedings seeking to invalidate the corresponding patents in Europe. Merck initiated an opposition proceeding against European Patent EP ( EP 878 patent ), a European counterpart of the 474 patent, in the European Patent Office on June20,2011. Merck made numerous submissions in that opposition proceeding and an oral hearing Was held on June 4, On information and belief, Merck s outside counsel referred to the 474 patent during the oral hearing. That same day, the panel hearing oral argument rejected Merck s opposition and held the EP 878 patent valid. On May 22, 2014, Merck filed a revocation action in the United Kingdom seeking to revoke the U.K. patent corresponding to the EP 878 patent. BMS has filed a counterclaim alleging infringement by pembrolizumab in that action. On information and belief, Merck received approval from the FDA on September 4, 2014 to market pembrolizumab as a treatment for certain patients with melanoma. Merck s

4 pembrolizumab is especially made for use in infringing the 474 patent and has no substantial non-infringing uses. By virtue of obtaining approval to market and sell pembrolizumab as a treatment for certain patients with melanoma, Merck has the specific intent to cause infringement of the 474 patent or, at a minimum, Merck has been willfully blind to the infringement of the 474 patent that will inevitably result. 23. On information and belief, Merck either has begun efforts to produce substantial supplies of pembrolizumab in anticipation of an imminent launch in the United States, and/or will soon begin manufacturing, distributing, using, offering for sale, selling, and/or importing in the United States the pembrolizumab antibody product to be prescribed and used for the treatment of cancer. COUNT FOR DECLARATORY JUDGMENT OF PATENT INFRINGEMENT Plaintiffs incorporate by reference paragraphs 1-23 as if fully set forth herein. 25. As set forth above, a real, immediate, substantial, and justiciable controversy has arisen and now exists between the parties under the Declaratory Judgment Act, 28 U.S.C Defendant Merck is actively preparing to and will imminently infringe the 474 patent. As set forth above, on information and belief, by making meaningful preparations to market, make, use, sell, offer for sale, and/or import pembrolizumab in the United States for the treatment of cancer, Merck will imminently infringe the 474 patent, including by actively inducing infringement under 35 U.S.C. 271(b) and as a contributory infringer under 35 U.S.C. 271(c). On information and belief, Merck has been aware of the 474 patent since at least approximately May 20, 2014, when the USPTO issued the 474 patent and Merck s imminent infringement is deliberate, willful, and in reckless disregard of valid patent claims of the 474 patent. Plaintiffs will be injured by and will suffer substantial damages as a result of Merck s imminent infringement. BMS Sues Merck As Soon As USPTO Grants Cancer Patent The continuing conflict between the two companies Bristol-Myers Squibb Co. went after Merck and Co. in Delaware federal court for allegedly infringing on its immunotherapy cancer treatment, filing the suit on the same day that the U.S. Patent and Trademark Office granted Bristol-Myers a patent for the process. Bristol-Myers accused Merck of piggybacking on its revolutionary cancer treatment that uses a patient s own immune system to eliminate cancer cells by using antibodies that bind to a protein called PD-1, according to the complaint. The company said Merck is exploiting its invention by using a similar process involving the same protein and antibodies. The plaintiffs put this scientific breakthrough into practice by developing an anti-pd-1 antibody called nivolumab, the first anti-pd-1 antibody approved anywhere in the world for

5 cancer treatment, Bristol-Myers said in the complaint. Merck is threatening to exploit, and is exploiting, that invention with a later developed anti-pd-1 antibody." Bristol-Myers outlined the breakthrough treatment in its complaint, detailing how its process protected under United States Patent No. 9,073,994 uses a protein found on the body s T cells called PD-1, which acts as an immune checkpoint that regulates immune response. The company s immunotherapy treatment helps to make sure that cancer cells aren t able to exploit the PD-1 protein by shutting down the body s regular immune system response to cancerous cells, as is often the case with many types of cancer. Bristol-Myers said in the complaint that it was granted the 944 patent on July 7, the same day as the suit was filed, claiming it showed for the first time that anti-pd-1 antibodies were useful in methods to treat cancer." The company had previously used nivolumab in Japan, where it was approved in July 2014, and in the United States, where the U.S. Food and Drug Administration approved it for treatment of advanced melanoma in December, according to the complaint. Though Merck received approval to sell its competing product pembrolizumab in the U.S. in September, Bristol-Myers said Merck started developing it after Bristol-Myers started testing nivolumab, the company said. Additionally, Merck was aware of Bristol-Myers work on the product through related patent litigation around the world, the company said. Now that Bristol-Myers has its patent, it said, Merck will be infringing on its rights starting on July 7. Meanwhile, Bristol-Myers said it is pursuing approval for use in treating numerous types of cancer, including nonsmall cell lung cancer, renal cell carcinoma, head and neck cancer, glioblastoma, and non-hodgkin's lymphoma, it said. Judicial conflict continuous On MAR, 2016 Defendant Merck filed a motion to dismiss BMS s claims under U.S. Patent No. 9,069,999 due to lack of patentable subject matter under Section 101, arguing that the patent claims the natural operation of the body s immune system via the PD-1 pathway and does not contain an inventive concept sufficient to render that natural phenomenon patenteligible. Merck contended that the patent-in-suit was similar to the patent found to be ineligible in Mayo because it contained only a natural phenomenon and an administering step. Bristol-Myers Squibb Co., et al. v. Merck & Co., Inc., et al., C.A. No GMS, Or. at 2 n.1 (D. Del. Mar. 17, 2016). BMS responded that the challenged claim was a method of treatment claim and that every method of therapeutic treatment at its basic level relies on the biological activity of the patient s immune system. Id.

6 Judge Sleet first rejected BMS s contention that the patent-in-suit did not touch upon a natural phenomenon: The inventors relied on the fact that inhibiting signals of PD-1, PD-L 1 or PD-L2 inhibit cancer proliferation through the mechanism of the recovery and activation of immune function. This interaction is a natural phenomenon. Id. at 3 n.1 But Judge Sleet went on to find that there were factual disputes regarding whether the claims add enough to the natural phenomenon that could not be resolved on a motion to dismiss: Whether the claims amount to an implementation step is a complicated factual determination that the court could better resolve after discovery. Additionally, the 999 patent is entitled to a presumption of validity under 35 U.S.C Rarely can a patent infringement suit be dismissed at the pleading stage for lack of patentable subject matter. Id. Accordingly, Judge Sleet denied the motion to dismiss. This conflict will remain inevitable, it is finished or not a patent violator but I do not think we will find an answer to this question soon.