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June 16, 2015 Articles

Facing Section 101 Challenges in the Biological and Chemical Arts

Recent USPTO guidance and court decisions provide strategies for current and future litigants

By Leslie T. Grab and Cynthia B. Rothschild

The patent landscape with respect to patentable subject matter for the biological and chemical arts is in a state of flux. After the Supreme Court's decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012), holding that claims directed to natural phenomena, coupled with known techniques, do not claim patent-eligible subject matter, and Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad I), 133 S. Ct. 2107 (2013), holding that claims directed to isolated DNA that is naturally occurring do not claim patent-eligible subject matter but that claims directed to cDNA may be patentable, many lawyers began to question whether patents directed to diagnostic applications and genetic discoveries are directed to non-patent-eligible subject matter. This article briefly summarizes the current state of the law under 35 U.S.C. section 101 and provides tips and strategies for patent owners to successfully defend against challenges under section 101.

The Subject Matter Landscape Post-Mayo and Myriad I

Following Mayo and Myriad I, the U.S. Patent and Trademark Office (USPTO) issued its March 2014 guidelines for subject-matter eligibility for claims reciting or involving laws of nature, natural phenomena, and/or natural products. Using the three-step analysis promulgated by these guidelines, patent examiners began rejecting increasing numbers of pending applications as not being directed to patent-eligible subject matter. Then, in June 2014, the Supreme Court referenced the analysis set forth in Mayo with approval in Alice Corp. Pty. Ltd. v. CLS Bank, International, 134 S. Ct. 2347 (2014). There, the Supreme Court rearticulated the two-step analysis for determining whether a claim is directed to patent-eligible subject matter: First, determine whether the claims at issue are directed to a patent ineligible concept; if so, then ask "what else is there in the claims before us?" Thereafter, the USPTO promptly issued additional guidelines (June 2014 guidelines) a few days after the decision. These were largely seen as applying to abstract ideas in the computer arts.

The Federal Circuit specifically addressed the issue of patent-eligible subject matter in the biological arts in two decisions in 2014. In In re Roslin Institute, 750 F.3d 1333 (Fed. Cir. 2014), the court considered whether claims directed to a cloned animal (Dolly the sheep) were patentable subject matter. After analyzing the claims under the rationale set forth in Myriad I, the court found that Dolly was "an exact genetic replica of another sheep and does not possess 'markedly different characteristics from any [farm animals] found in nature.'" Roslin, 750 F.3d at 1337. The court further found that Roslin "did not create or alter any of the genetic information of its claimed clones, nor did [Roslin] create or alter the genetic structure of the DNA used to make its clones." Roslin, 750 F.3d at 1337 (internal alterations and quotation marks omitted). Therefore, the court held that Roslin's claims did not satisfy the requirements of patent eligibility under section 101.

The Federal Circuit again addressed claims related to breast cancer testing in In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation (Myriad II), 774 F.3d 755 (Fed. Cir. 2014). In this litigation, the plaintiffs contended that the claims now before the court were fundamentally different than those previously considered by the U.S. Supreme Court. The plaintiffs argued that the method claims included significant, nonroutine technical steps such as amplification and/or sequencing, and therefore these methods amounted to more than a patent on a natural principal. The plaintiffs further argued that claims to short sequences of BRCA1/BRCA2 DNA that were used as primers were not naturally occurring sequences as they did not exist in nature in their single-stranded form. The court applied the analysis set forth in Mayo and Myriad I and held that the newly asserted claims also did not constitute patentable subject matter. In doing so, the court held that the additional steps of amplification and sequencing were well known and routine in the art and that the primer sequences necessarily must have the same sequence, or its complement, to the DNA it was designed to amplify.

Just one day before the Federal Circuit published its decision in Myriad II, the USPTO issued its December 2014 Interim Guidance on Patent Subject Matter Eligibility (2014 Interim Guidance). With this guidance, the USPTO provided certain Nature-Based Product Examples. The guidance and accompanying examples superseded the March 2014 guidance and MPEP sections 2106.01 and 2105 (in part). The guidance and examples provide a more streamlined analysis for patent eligibility. In webinars and other statements, representatives from the USPTO have characterized the new guidelines as more user-friendly and designed to decrease the number of applications that are rejected under 35 U.S.C. section 101. Further, the USPTO has implemented a program to train examiners on the application of the new guidelines and recent section 101 jurisprudence. Practitioners are already seeing increased allowance rates and reversals of previous rejections of nature-based products as a result of the new guidelines and training procedures.

Effects on Current Patent Litigation

Defendants often file summary judgment motions challenging claims under section 101. Additionally, some district courts have allowed defendants to file motions under Federal Rule of Civil Procedure 12(b)(6) to address issues relating to section 101 at the pleading stage. The U.S. District Court for the District of Delaware entertained such a motion in the Genetic Technologies Ltd. v. Laboratory Corporation of America Holdings, No. 12-1736-LPS-CJB, 2014 WL 4379587 (D. Del. Sept. 3, 2014), and held that motions addressing section 101 are not premature at the 12(b)(6) stage, and that claim construction may not be required to decide such motions. Genetic Technologies filed a notice of dismissal shortly after the court's ruling, thus ending the litigation. This tactic was also encouraged by Judge Mayer of the Federal Circuit in I/P Engine, Inc. v. AOL Inc., 576 F. App'x 982, 996 (Fed. Cir. 2014), where he stated:

From a practical perspective, there are clear advantages to addressing section 101's requirements at the outset of litigation. Patent eligibility issues can often be resolved without lengthy claim construction, and an early determination that the subject matter of asserted claims is patent ineligible can spare both litigants and courts years of needless litigation.

Strategies to Defend Against Section 101 Challenges
Although recent decisions may give patent owners pause, there is hope for patent owners who wish to enforce their patents against infringers. There are several strategies for patent owners who are currently in litigation, contemplating litigation, or still prosecuting high-value patents to guard against section 101 challenges.

Current litigants. Patent owners currently in litigation who may face a challenge under section 101 should consider the following arguments that may be raised to oppose a motion to dismiss or for summary judgment.

Patent owners may argue that the asserted claims at issue are not in fact directed to one of the judicial exceptions as they have a different function than a natural product. The USPTO's December 2014 guidance is clear that section 101 does not apply to claims that merely involve a judicial exception, but rather that the claim must be directed to the judicial exception itself to trigger invalidity under section 101. Patent owners should emphasize that the claim does not seek to tie up the subject matter nor preempt others from using it. See 2014 Interim Guidance, supra, at 11. The Supreme Court has held that courts should tread carefully in scrutinizing such claims because at some level, all inventions embody, use, reflect, rest upon, or apply a law of nature, natural phenomenon, or abstract idea. Alice, 134 S. Ct. at 2354 (quoting Mayo, 132 S. Ct. at 1293–94). Alice further held that an invention is not patent-ineligible simply because it involves an abstract concept and that applications of such concepts to "a new and useful end" can remain patent-eligible. Alice, 134 S. Ct. at 2354. Examples of claims that may fit that description include primers or probes that are fluorescently labeled, unique mixtures of known compounds, a genetically modified bacterium, or a humanized antibody.

Another argument that patent owners may raise in response to a section 101 challenge is that the asserted claims have a technological component that solves a problem by going beyond the routine and conventional. As such, these claims do not preempt the general application of a natural process and thereby do not render the claims patent-ineligible. The 2014 Interim Guidance indicates that claims that include a specific limitation that is not well-understood, routine, and conventional in the field, or claims that include an unconventional step that confines a claim to a particular useful application may be valid. Examples of inventions that may benefit from such arguments include the production of a novel crystalline form of an antibiotic, or manmade cells in a biocompatible scaffold.

If claims directed to, for example, methods for the treatment of specific diseases or conditions using a natural product are challenged, then arguments that the claims apply the product or process in a novel or limited way may be successful in overcoming the challenge. The USPTO has interpreted these types of claims as focusing primarily on the process of applying the product to a particular disease or condition rather than being directed to the natural product itself. See Nature-Based Product Examples, supra, ex. 3 at 3–5. In support of this rationale, the Federal Circuit in Myriad II suggested that claims that are limited in scope, such as claims that recite a specific group of predisposing mutations, may be directed to patent-eligible subject matter. Myriad II, 774 F.3d at 755.

Also, patent owners facing a section 101 challenge in the early stages of litigation, and particularly before claim construction, may benefit from raising arguments that issues of fact exist with respect to certain elements of the claims. In granting early motions to dismiss or summary judgment motions, courts have relied on the fact that there are no known issues of material fact that are anticipated to arise after claim interpretation. See, e.g., Genetic Technologies, 2014 WL 4379587. Therefore, patent owners who highlight such issues that may arise from claim construction may succeed in identifying a material issue of fact and thereby defeat a motion brought under Rule 12 or Rule 56.

Future litigants. Patent owners contemplating asserting patents against infringers have more options than those currently engaged in litigation. When considering what claims to assert, patent owners should give thought to potential section 101 challenges and consider the following strategies to either head off or minimize the risk of such challenges.

To the extent possible, patent owners should draft claims that conform to specific examples or track guidance from the USPTO. Examples include claims that include practical application of a natural phenomenon, claims directed to a specific mix of components not routinely found together in nature, claims for nonnatural molecules (e.g., monoclonal antibodies, genetically modified cells, or chemically modified DNA), or claims that use a natural product for a practical application (e.g., treatment of cancer). When drafting and prosecuting such applications, patent owners should, to the extent possible, emphasize the novel application of the invention and draw parallels to the examples set forth by the USPTO.

Potential litigants should also consider a strategy of layering asserted claims to discourage defendants from attempting to obtain a complete dismissal of all claims on an early section 101 motion. Asserting a mix of claims that have broad coverage and perhaps more narrow coverage but recite a specific technical feature, such as including dependent claims in the suit that recite nonroutine steps, unique combinations of compounds, or modified DNA, will complicate any section 101 challenge and make it more difficult for a defendant to obtain an early dismissal.

Finally, patent owners may consider "cleaning up" claims prior to asserting them against an infringer. Patent owners may take advantage of USPTO procedures such as ex parte reexamination or reissue to either add new claims or amend existing claims to more closely conform to current section 101 jurisprudence before asserting them.


In summary, the key to success for patent owners defending or guarding against section 101 challenges is to create issues of fact with respect to the asserted claims and/or align such claims to currently accepted standards for patent-eligible subject matter.

Keywords: litigation, intellectual property, patentability, biological and chemical arts, laws of nature, natural phenomena, natural products

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