Our society has made remarkable advances in medical science over the past few decades. A significant portion of these advances has resulted from the sizable research and development investments made into a seemingly ever-growing biotechnology industry. Unsurprisingly, biotechnology entities rely heavily on patent protection to recoup research and development costs before competitors can introduce similar products into the market. The desire for prolific patent portfolios is increasing, and without strong patent protection, biotechnology startups are likely to fail.
But, the current legal system cannot match the speed with which biotechnology is developing. More specifically, the current analytical framework for determining patent-eligible subject matter under 35 U.S.C. § 101 has become unworkable in the face of these emerging technologies. Further, the case law provides no clear prefiling guidance for biotechnology that walks the fine line between science as it is found in nature and science as it is developed by man.
Two recent Supreme Court decisions, Mayo Collaborative Services v. Prometheus Labs, Inc. and Association for Molecular Pathology v. Myriad Genetics, Inc., have addressed the threshold determination of patentable subject matter under § 101. However, no cohesive approach to patentable subject matter has been articulated following these two cases, increasing uncertainty for drafters and litigators of biotechnology patent claims. Some scholars argue that the Supreme Court continually focuses too much on textual analysis to determine patentable subject matter, neglecting to consider the promotion or progress in the useful arts as required by the constitutional mandate.
Ambiguity is intensified by the U.S. patent system’s structure, which historically has prevented challenges to the validity of a patent “until after a patent is used and then relies on the reexamination process.” An issued patent affords a strong presumption of validity that can only be defeated by clear and convincing evidence. Moreover, because the patent remains in full force during the reexamination and appeals process, this post hoc approach may encourage the patent holder to actively assert exclusivity rights and bolster his or her patent domain. Indeed, the mantra seems to be “patent first, ask questions later.”
The “lack of a forthright, principled framework for delineating the boundaries of patentable subject matter” has caused investors and inventors alike to seek expansive patent portfolios. Given the recent proliferation of validity challenges, their rights are anything but secure. Industry players may manipulate the current framework to cover as much intellectual property as possible in the event their claims are later dismantled by invalidating court decisions and declaratory judgments.
The Supreme Court insists that patent eligibility cannot “depend simply on the draftsman’s art.” But, the legal framework seems to assiduously depend on a “doctrine of magic words” whereby patentable subject matter is determined by the applicant’s recitation of key phrases and placement of terminology. Thus, if patents are to survive post hoc challenges, words that delineate the claims must be chosen and construed carefully at the prefiling stage.
As a solution to industry-wide uncertainty, I suggest a threefold approach, referred to as the Triangle Method, which can serve as a useful guide for drafters and litigators based on the Supreme Court’s recent line of § 101 cases. The three complementary sides of the triangle are: (1) inventiveness, (2) structural differences, and (3) informational or functional differences. Under this framework, a patent that satisfies all three sides of the triangle is more easily defended against future challengers seeking to invalidate the patent as ineligible subject matter. The Triangle Method thus provides predictability in the event of patent invalidation suits and, in turn, increases the dependability of our patent system as a whole.
Instead of engaging in the rich, ongoing academic debate over necessary legislative amendments or alternative intellectual property systems for adequate protection of emerging biotechnologies, I have chosen a method that works within the current patentable subject matter framework. Instead of hypothesizing over what we should do with regard to patentable subject matter and biotechnology, it is better to work with the realistic premise of what we are doing. It is more likely that the law will simply mirror its previous response to inventive industries that have outpaced legal developments by forcing the current patent law to accommodate rapidly emerging biotechnology advancements.
