Chemical & Life Sciences Patent: Year In Review
This year brought us very significant changes in patent jurisprudence from the Supreme Court and Federal Circuit affecting Chemical & Life Sciences patent practice.
The Supreme Court decided five patent cases in 2017, upending decades of Federal Circuit precedent. The Court expanded patent exhaustion doctrine, limited venue for patent litigation, and eliminated the defense of laches. The Court also limited infringement under 271(f), excluding from infringement those situations where only one component of a multicomponent system is exported from the United States. The Court also resolved key issues in implementing the Biologics Price Competition and Innovation Act (“BPCIA”). Notably, each of these decisions reversed the Federal Circuit in nearly unanimous decisions.
The Federal Circuit in 2017 decided Aqua Products en banc, reversing the Patent Trial & Appeal Board (“Board”) for placing the burden on patent owners with respect to a motion to amend in IPR. Although this may sound like a groundbreaking victory for patent owners, the effect of this decision may not be as widespread. In addition, several other cases were argued in 2017 dealing with other aspects of IPR, including the constitutionality of the procedure itself.
The Federal Circuit continued the trend of invalidating diagnostic patent claims under 35 U.S.C. § 101, often at the motion to dismiss stage of litigation. In Cleveland Clinic, the Federal Circuit found the patent owner’s claims to detecting myeloperoxidase (MPO) in a patient’s blood and correlating the results to cardiovascular risk is directed to ineligible subject matter. With respect to on-sale bar, the Federal Circuit in Helsinn invalidated patents over an on-sale bar due to a contract for sale more than one year before the filing of its patents. The court held the invention was ready for patenting at the time of the contract, and the America Invents Act (“AIA”) did not change the meaning of “on sale” in the circumstances presented.
The Federal Circuit issued several decisions upholding claims over obviousness challenges. These cases show some emerging trends in the area of obviousness. First, it is difficult to rely on inherency in order to establish that a claim is obvious. Second, the Federal Circuit places more emphasis on “reasonable expectation of success” than in the past. Third, disagreement among the judges has arisen as to how to weigh the Graham factors.
The written description case law relating to antibodies took a significant turn in 2017 with the Federal Circuit’s decision in Amgen v. Sanofi. There, the court rejected the “newly characterized antigen” test which, according to the Court, “flouts the basic legal principles of the written description requirement.” The court also condoned the use of post-filing date examples to show the specification does not disclose sufficient species to provide written description support for the full breadth of the claims.
The Federal Circuit’s approach on indefiniteness and joint-infringement appears favorable for patent owners. The court showed that it is willing to look hard at claim scope before throwing in the towel and finding invalidity for indefiniteness. The court upheld joint infringement for pharmaceutical co-administration claims, showing the viability of joint infringement in the pharmaceutical field under the framework of Akamai.
On doctrine of equivalents (DOE) in the chemical arts and inequitable conduct, the court issued decisions unfavorable for patent owners. The court suggested that the function-way-result (FWR) test does not apply in chemical arts, but instead that the “insubstantial differences” test “might seemingly be more appropriate.” This will often make proving DOE more difficult in the chemical arts. As to inequitable conduct, the Federal Circuit took the unprecedented approach of relying on litigation misconduct to make an adverse inference of deceptive intent for inequitable conduct in prosecuting the patents before the Patent Office.
Click here to find a detailed analysis on Chemical & Life Sciences cases that were pivotal in 2017.