Posts Tagged: "life sciences"

As you read about the truly mind-numbing stupidity coming from decision makers, whether it is MRI machines declared to be abstract ideas or diagnostics for various forms of cancer not being patent eligible, realize that the overwhelming bulk of this stupidity relates to inventions you cannot touch or operate in any real world sense. While America’s patent remains adrift, shift innovation into the real world if you are interested in a U.S. patent. Truly groundbreaking advances in computer technologies and in the life science sector should only be undertaken if you have a global patent strategy that does not require obtaining useful patent protection in the U.S.

Founded in 1967 by Indonesia, Malaysia, the Philippines, Singapore, and Thailand, the Association of Southeast Asian Nations (ASEAN) is a regional organization that aims to “accelerate economic growth, social progress, and sociocultural evolution among its members.” The organization’s membership has subsequently expanded to ten, with the induction of Brunei, Cambodia, Laos, Myanmar, and Vietnam. Collectively, the ten economies constitute an economic powerhouse; the ASEAN Economic Community (AEC) was the third largest Asian economy and the seventh largest global economy in 2014, as per the ASEAN website. Further, the AEC is expected to grow at a feverish pace of 7% per annum and is touted to be the fourth largest economy in the world by 2030 (Ken Moriyasu; 2016).

This decision will continue to have a significant effect on the IP/IT market which has been governed by so many EU Regulations and Directives in the past (albeit not exclusively) that intricately bound the UK to the EU. The UK will in due course enter a negotiation period during which laws will be amended and enacted and international agreements will be negotiated. Due to the required notice period, the actual exit date will not be before 2018. The exact fate of the UK is also still up for debate with many options including retaining membership of the EEA only, or joining EFTA, or having a customs-only arrangement with the EU. The implications of this Brexit are currently very uncertain and will, to a large extent, be determined by the model that would be adopted and the terms of any international agreements negotiated.

The Federal Circuit, with Chief Judge Prost writing for the majority, joined by Judge Moore and Judge Stoll, vacated and remanded the case after ruling that the ‘929 patent claims are not directed to a patent-ineligible concept. “This is very heartening since the Supreme Court denied cert in Sequenom,” said Bob Stoll, former Commissioner for Patents at the United States Patent and Trademark Office and current partner at Drinker Biddle in Washington, DC. “It is great to see the CAFC apply the Supreme Court decisions more narrowly, as intended by that Court, and provide some relief to innovators that will help them to attract funding to develop their inventions.”

On its face, the new guidance seems to urge examiners to develop well-reasoned, substantive rejections rather than conclusory rejections which provide little basis for applicants to advance applications toward allowance, particularly in the complex areas of vaccines, diagnostics, methods of treatment, and screening for genetic alterations, where the new examples are focused. Furthermore, compared with prior guidance, the new examples include more claims that are considered patent eligible subject matter. Some observers believe this may be an effort by the patent office to dispel hesitation that examiners have apparently had in drawing conclusions of patent eligibility when examining claims.

On May 6, 2016, the U.S. Patent and Trademark Office released new life science examples on subject matter eligibility (Examples 28-32, consecutively numbered after the previously released USPTO examples). Examples 28 and 30 illustrate the application of the “markedly different” and “significantly more” analysis to nature-based products. Examples 29 and 31 illustrate the USPTO approach to the eligibility analysis of diagnostic claims, which has been much anticipated. Finally, Examples 32 and 33 illustrate the use of a streamlined eligibility analysis. At first glance, the new life science examples, which identify most of the presented hypothetical claims as patent-eligible, provide several teaching points for achieving patent-eligibility in commonly encountered situations in the life sciences area.

The most common form of dementia is Alzheimer’s disease, a progressive disorder of the human brain which over time reduces a person’s cognitive abilities to the point that they cannot carry out the most basic tasks. This terrible disease was thrust back into the national conscious as the result of the death of Nancy Reagan. With this in mind we thought we might take a moment to review what scientists know about Alzheimer’s disease and what treatments and cures are currently being pursued.

This is as straightforward a certiorari candidate as any patent case can be. It is manifestly important: A host of judges and amici have stressed that the result below is untenable— invalidating previously irreproachable inventions and precipitating what Judge Lourie called “a crisis of patent law and medial innovation.” And this is the vehicle this Court needs to provide that clarification: Every opinion below agrees that this case tests Mayo’s uncertain limits by invalidating an otherwise plainly meritorious invention. Here, unlike Mayo, every intuition points towards patent-eligibility. And yet the Federal Circuit felt compelled by Mayo to condemn this meritorious patent—and, a fortiori, the patents underlying an entire, vital field of American healthcare innovation.

Proteins like VRC01 are referred to as broadly neutralizing antibodies (bNAbs), a type of broad spectrum antibody which is effective in treating against infections of viruses with high mutation rates, such as HIV as well as influenza. It’s thought that VRC01 and other bNAbs useful in treating HIV-infected patients is capable of identifying the envelope spike of a single HIV viral agent to inhibit or neutralize its effects… Gene editing tools may also be part of the solution that rids HIV/AIDS from the human race for good. The discovery of clustered regularly-interspaced short palindromic repeats (CRISPR) and CRISPR-associated proteins (Cas) has given scientists hope that they’ll be able to efficiently edit genomes with a high degree of precision and flexibility.

The Supreme Court recently decided to review a pair of cases that challenge the Federal Circuit’s willful infringement test. The two cases, Halo Electronics, Inc. v. Pulse Electronics, Inc, (14-1513) and Stryker Corporation v. Zimmer, Inc. (14-1520), are drawing comparisons from commentators to the Court’s Octane Fitness, LLC v. ICON Health and Fitness, Inc. ruling last term based on the similar structure of the tests and statutory language reviewed in both cases. However, another recent SCOTUS case dealing with induced infringement, Commil USA, LLC v. Cisco Systems, Inc., may also shed some light on how the Court will think about willful infringement, since both doctrines center around the defendant’s intent.

Ex parte Khvorova is the first PTAB decision on patent eligibility in the life sciences. Until now, the PTAB has been remarkably silent on eligibility in life sciences in the midst of significant judicial activity. The invention relates to synthetically designed and produced small interfering RNA (“siRNA”) molecules, which were discovered in nature for their ability to suppress gene expression. Claim 85 recites a method of rationally designing siRNA molecules with optimal suppression efficacy.