As a partner in the law firm of Troutman Sanders LLP, Heather Morehouse Ettinger focuses her practice on intellectual property due diligence and transaction drafting, intellectual property litigation, and patent counseling and procurement in the biotechnology and pharmaceutical fields. She regularly handles domestic and international patent portfolios, and due diligence studies for clients, including major corporations and research institutes, and regularly counsels in Hatch-Waxman issues. Dr. Ettinger has a background in recombinant molecular biology, pharmaceutical formulations, genetically modified plants, enzyme and other large molecule technology and small molecule chemistry. She earned her J.D., cum laude, from Fordham University School of Law and her Ph.D. in biological and biomedical sciences from Harvard University. Dr. Ettinger is admitted to practice in New York and New Jersey, and before the U.S. District Court for the Southern District of New York. She is also a registered patent attorney with the U.S. Patent and Trademark Office (USPTO) and was recently selected as a “rising star” by New York Metro Super Lawyers. In this interview with BioTuesdays.com, Dr. Ettinger touches on a broad range of subjects dealing with life sciences IP.
How did you make the transition from science to law?
When I figured out that I didn’t want to do bench science, I got a job at Darby & Darby, one of the oldest IP law firms in the U.S., which unfortunately dissolved during the last recession. Intellectual property law was a perfect match for my skills and personality. It gave me the opportunity to use science every day, without having to do scientific experiments. I went to law school at night while I worked as a patent agent. I’ve been at Troutman for a little over three years.
Can you describe the America Invents Act?
The Leahy–Smith America Invents Act, or AIA, was signed into law in September 2011. The law represents the most significant change to the U.S. patent system in a generation. For example, the act switched the U.S. patent system to a first-to-file jurisdiction from a first-to-invent system, putting the U.S. in line with most of the rest of the world. The AIA also introduced significant new procedures that allow for third parties to challenge the validity of issued patents.
The AIA represents the most significant change to the U.S. patent system in a generation.
What’s been the biggest impact of AIA?
So far, the post-grant proceeding, inter partes review, or IPR, has probably had the biggest impact on patents post-AIA.
Can you explain Inter Partes Review?
Inter partes review was introduced by the AIA as one of several ways to challenge the validity of an issued patent. IPRs are a relatively inexpensive and fast method to invalidate a patent, compared with litigation in district court. Essentially, IPRs were put into law to help increase the integrity of our patent system by weeding out bad patents and to facilitate business certainty regarding patents that are believed to be invalid.
Who else has an interest in filing IPRs?
We’ve seen a rise in non-practicing entities, such has hedge-fund-financed entities, filing IPRs. These entities have no direct interest in the patent other than wanting to profit by shorting the stock of the patent owner. These so-called reverse trolls, attack the validity of a patent but do not practice in the area of the patent.
Any examples of high-profile IPR filers?
The well-known hedge-fund manager Kyle Bass has created several Coalitions for Affordable Drugs, which have filed several IPR petitions with the USPTO. The Coalitions’ alleged mission is to bring down the price of prescription drugs by allowing generic drug entry. Mr. Bass publicizes these patent challenges against pharmaceutical companies, while also publicly acknowledging that his funds are betting against their shares.
Where do you think this strategy is going?
We may see this strategy continue to pick up because other hedge funds are getting in on the action. But, eventually, I think the strategy will slow down for a couple of reasons. For one thing, these IPRs are not attacking all the patents that are relevant to a prescription drug. Attacking one patent, and possibly invalidating it, does not allow a generic to enter the market. To truly allow a generic to enter the market, all claims of all patents that cover the drug would have to be successfully challenged. So, I think the market may come to understand that these IPRs are not as damaging as first thought. In addition, there is pending legislation in the House that might change the ability of these non-practicing entities to file IPRs. Additionally, patent holders are launching sham litigation causes of action against some of these non-practicing entities and are also asking the USPTO to find abuse-of-process for some of these IPRs.
What has the impact been of the AIA’s first-to file change?
The Myriad decision found that naturally occurring DNA sequences should be considered products of nature and cannot be patented.
There is a tendency now to file earlier and more often than in the past. However, even though we are now a first-to-file jurisdiction, there are some nuances to get around pre-filing disclosures of the invention. Say, for example, an inventor publishes his or her work, they still have a year to file for a patent application. Or if an inventor can show that somebody else filed for a patent based on his or her invention, they have the ability to file a derivation proceeding and still get their invention patented. So we are not a strict first-to-file jurisdiction and, practically speaking, the change in the law is not as significant as first anticipated.
What court decision has most impacted your life sciences practice?
It’s the Supreme Court’s Myriad decision in 2013, which found that naturally occurring DNA sequences should be considered products of nature and cannot be patented, even when limited in their isolated form. The case involved Myriad’s patents covering the breast and ovarian cancer-associated BRCA1 and BRCA2 genes. The decision means that many of the patents that I worked on the first decade of my career are probably invalid. Also, the USPTO has taken the Myriad decision and broadened its scope to cover other naturally occurring substances, such as isolated peptides and isolated antibodies. So now, in view of Myriad, we have to think very carefully about how to capture what was previously readily patentable.
What’s the course of action?
Companies can pursue patent protection if they identify mutations of a gene that are not naturally occurring, or modifications of that gene or gene product or methods of treatment. But it’s more difficult and protection is narrower than it had been and, certainly, more work has to be done before a gene is ready to be patented.
Any other significant court rulings in life sciences IP?
In 2012, the Supreme Court ruled against Prometheus Laboratories, a diagnostics company. In that ruling, the association between a biological signal, or biomarker, and a result or conclusion, such as predisposition to a disease, response to treatment or disease diagnosis, was a discovery of a natural phenomenon and could not be patented. The consequence is that these inventions could be only validly protected if they included additional features. The Supreme Court did not specify these additional features, and the recitation of such potential features can make patent claims quite narrow. It was a significant blow to personalized medicine.
What do you see as the next hot topic in life sciences IP?
“Product hopping” or “product switching” antitrust claims. What was traditionally considered to be standard pharmaceutical life cycle management, where for example immediate release formulations of approved drugs are replaced with extended release formulations, is being attacked on antitrust grounds. I think this is going to be a big issue over the next couple of years.
Can you give us an example?
Last December, a federal judge blocked Forest Labs, which is now Actavis, from stopping sales of its older Namenda immediate release (IR) in favor of an extended release (ER) version of the Alzheimer’s drug, with a longer patent life. The decision could allow generic competition of the immediate release drug and has significant implications for pharmaceutical life cycle management strategies generally.
