Source: http://www.inhousepatentcounsel.com/category/news/
Timestamp: 2019-04-19 13:32:24+00:00

Document:
On Thursday, August 13, 2015, the U.S. Court of Appeals for the Federal Circuit sitting en banc ruled that Limelight Network Inc. infringed Akamai Technologies Inc.’s patent covering methods to store and deliver video content on the Internet, reinstating a $45 million jury verdict against Limelight (Akamai Technologies Inc. et al v. Limelight Networks Inc. No. 2009-1372, -1380, -1416, -1417, 2015 U.S. App. LEXIS 14175 (Fed. Cir. Aug. 13, 2015)). The unanimous en banc court expands situations in which direct infringement under § 271(a) may be found against a party that does not actually perform all the steps of a claimed method itself. Prior to this decision, a party could only be liable for direct infringement if: (1) it performed all method steps itself; (2) it acted through a principal-agent relationship; (3) it contracted with another party to perform some of the steps of the method or (4) it formed a joint enterprise with one or more parties. In each of these situations, one entity is found to act as a “mastermind”, with sufficient control over others such that all acts can be attributable to the mastermind.
Here, the court found that there was no such mastermind where Limelight was accused of performing all of the method steps except for the final step that was performed by Limelight’s customers. However, the court stated that liability may also arise if “an alleged infringer conditions participation in an activity or the receipt of a benefit upon performance of a step or steps of the patented method, and establishes the manner or timing of that performance.” Here, the court found that Limelight’s contract with its customers conditioned use of its content delivery network on the customer’s performance of the last step in the infringed method. Further, a representative from Limelight would lead the implementation of the service on customer’s websites, including overseeing the final method step. Thus Limelight was found to have conditioned use of its services on performance of the final step by the customer and to have established the time and manner of that performance.
Because a party can now be found liable for direct infringement due to such conditioned performance, parties may now also be found liable for induced infringement under § 271(b) where one party performs some steps and another party performs the remaining steps.
On Thursday, July 30, 2015, the USPTO issued updated guidance on Patent Subject Matter Eligibility supplementary to the 2014 Interim Guidance on Subject Matter Eligibility (2014 IEG) published on December 16, 2014. This new guidance addresses comments received in response to the 2014 IEG and provides examination instructions for USPTO personnel on analyzing claims involving business methods, user interface, software, and mechanical arts. The new guidance also includes subject matter eligibility analysis, examples, relevant court decisions, a quick reference sheet, and a request for additional public feedback.
Notably absent from the new guidance are any updated instructions on subject matter eligibility analysis in the natural products and biotechnology arts. The guidance specifically notes several recent precedential decisions, such as the Federal Circuit decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. and indicates that updated examples in these areas are being developed in light of these recent developments.
On Friday, June 12, 2015, the Federal Circuit ruled another molecular diagnostic invention patent-ineligible under 35 U.S.C. §101 in Ariosa Diagnostics, Inc v. Sequenom, Inc (Fed. Cir. 2015). The patent at issue (U.S. Patent No. 6,258,540) claims the use of cell-free fetal DNA (cffDNA) from maternal blood samples for predicting the gender of the baby and for diagnosing certain genetic defects. The surprising discovery claimed in this patent allows pregnant women to avoid invasive forms of paternity tests that require taking samples from the fetus or placenta. The Court applied the two-part patent-eligibility test established by the Supreme Court (citing Mayo Collaborative Services v. Promethius Laboratories, Inc) and concluded that the Ariosa method fails to disclose patent eligible subject matter.
Michele shared her exciting career as a scientist and biotech patent attorney career path with aspiring Ph.D. students in the Neuroscience and Cognitive Science Program (NACS) at University of Maryland, College Park on Wednesday, June 3, 2015! This symposium features successful professionals from various fields who pursued “alternative career paths” after their scientific trainings in graduate school. In the session entitled “Path to Non-Academic Careers: Short Stories”, Michele spoke about the transition she made from conducting cancer research at Johns Hopkins School of Medicine, managing the complex patent portfolios at Human Genome Sciences, to opening her own IP law firm.
The Future of DNA-Based Inventions: What Have We Learned from Myriad?
The Myriad case undoubtedly raised an important debate within the biotech intellectual property community: are natural substances “patent-eligible?” Michele and Eddie co-authored a book chapter entitled “The Impact of Myriad on the Future Development and Commercialization of DNA-based Therapies and Diagnostics.” This comprehensive overview on patent protection in the biotech industry discusses the impact of the Supreme Court ruling on “patent-eligibility” related issues and the controversies of the Revised Guidance published by United States Patent and Trademark Office (USPTO). The book chapter also presents strategies on how to “claim around” in order to fully protect DNA-based inventions.
In light of U.S. Supreme Court’s decision in subject matter eligibility in Alice Corp., Myriad, and Mayo cases, USPTO issued the new guidance on Patent Subject Matter Eligibility supplementary to the June 25, 2014 Preliminary Examination Instructions. This new guidance provides examination instructions for USPTO personnel on analyzing claims involving natural products. The new guidance also includes subject matter eligibility analysis, examples, trainings, and public feedback.
Michele presented the US position on patenting of Natural Products at the 8th Berlin Conference on IP in Life Sciences at the Embassy of South Africa. This year’s conference discussed the challenges of utilizing natural substances, particularly DNA sequences, in biotechnology industry due to the complex regulations such as The Nagoya Protocol and the Convention on Biological Diversity.
On March 14, 2013, IHPC filed an Amicus Brief in support of Myriad Genetics in The Association for Molecular Pathology v. Myriad Genetics. The brief provides a comprehensive analysis on the values of patenting genes for biotech industry and argued that the validity of gene-based patents is critical for companies to secure necessary funding for research development, enhanced collaborations with academia and non-profit research organizations which all lead to disruptive innovations and solve unmet medical needs. Human Genome Sciences (acquired by GlaxoSmithKline in 2012) serves as a successful example establishing that gene patenting is important for sustainable growth for biotech companies.
Michele gave the keynote speech entitled “Human Genome Sciences- The Story of a Big Data Pioneer” in the 7th Berlin Conference on IP in Life Sciences at The Nordic Embassies. Michele explained how big data transformed and accelerated the discoveries at Human Genome Sciences and the necessity of patenting for securing the investment.
The inaugural conference on Patenting and Life Sciences was held at Cold Spring Harbor Laboratory in March 2013. The conference featured IP speakers discussing issues surrounding patenting genes and diagnostics. The topic was right in time for the heated debate over Myriad’s patentability of BRCA genes, the tumor suppressor genes often found mutated in breast and ovarian cancer patients (see Association for Molecular Pathology v. Myriad Genetics). Michele was invited to speak about the importance of patenting on promoting innovations and her experience in managing complex genomic portfolios in Human Genome Sciences.

References: v. 
 § 271
 § 271
 v. 
 §101
 v. 
 v. 
 v. 
 v.