Dr. Classen (yes, an M.D.) has patented methods for modifying vaccination schedules to reduce the risk that chronic immune-system responses and diseases such as diabetes, asthma, hay fever, cancer, multiple sclerosis, and schizophrenia would appear after a vaccination.
So what did Classen do when Kaiser Permanente, Merck, Biogen, and other companies in the vaccine business tried to make vaccines safer for patients and reduce serious, but rare, side effects? Well, naturally, he sued them.
The problem is that he 1) did not actually conduct vaccine safety research, or 2) determine the relationship between any vaccine and the risk that certain immune diseases would appear afterwards, or 3) describe any risk-reduction schedules for particular vaccines. Are his broad methods patentable? The court was really divided on this issue, but finally decided that two of his patents will live to fight another day, for now.
Classen Immunotherapies, Inc. v. Biogen IDEC, Nos. 2006-1634, -1649 (Fed. Cir. Aug. 31, 2011) (Chief Judge Rader, Judges Newman and Moore)
Did you ever wonder what would happen if someone figured out whether certain vaccines actually cause/contribute to certain diseases? We have had a healthy national debate about vaccine side effects for decades. As a result of a lot of research and many agency hearings, some vaccines have been officially linked to certain diseases. In fact we have a national vaccine injury table, which lists all immune diseases and other side effects with a scientifically proven relationship to vaccinations. Good to know.
But I digress from the point of this blog post. This is the story of one doctor who decided to patent any method of reducing the risk that vaccinated patients would contract diseases like diabetes. Meet Classen.
The Classen Patent Saga
Classen has had a wild ride in the courts with his patent litigations.
First, he obtained several patents that claim methods of studying the risk of contracting immune disorders or other side effects that are related to vaccinations or drugs taken by patients.
Then, he sued a slew of biotech and healthcare companies in Maryland for infringement of his patent portfolio. In one of those cases against Elan and King Pharmaceuticals, he accused the companies of infringing a related patent that covers modification of a drug-administration schedule to reduce side effects. I represented Elan in that case at trial.
This is the second lawsuit against numerous biotech companies and healthcare providers involved with vaccine manufacturing, sales, or dispensing to patients according to approved immunization schedules. This suit has been up to the Supreme Court and was returned to the Federal Circuit so that the lower court could consider whether the claimed technology was patent-eligible.
Classen argued that two of his patents are infringed when a health care provider reads the relevant literature and selects and uses an immunization schedule that lowers the risk of developing chronic immune-mediated disorders. He also asserted the patents are infringed by the act of reviewing published vaccination studies, regardless of whether the review leads to any change in the immunization schedule.
Finally, Classen alleged that the last patent is simply infringed when a person reviews relevant information regarding an immunization schedule (as a manufacturer, health care provider, or parent of a child to be vaccinated). In his view, the infringing act for this patent is assessing risk, not conducting clinical trials or modifying the immunization schedules based on that assessment.
The court issued fractured opinions on almost every appealed issue.
So You Can’t Patent the Process of Reading Scientific Articles?
For the second time, the Federal Circuit considered the question of whether Classen’s vaccine method claims are eligible for protection under 35 U.S.C. § 101, or whether they are directed to the non-patentable abstract idea that there is a relationship between the infant immunization schedule and chronic immune diseases that tend to show up later in life.
Judges Newman and Rader concluded that two of the three claimed methods are eligible for protection under § 101 given the Supreme Court’s recent guidance on the scope of patent law protection of certain business methods in the Bilski case. While the court expressed doubt regarding the patentability of the claims, it decided to return two of the patents to the district court for further consideration.
Judge Newman explained that the last patent, however, does not contain a step of immunizing based on a schedule affected by the incidence or severity of chronic diseases; it claims an abstract idea. Since it essentially claims methods of collecting and comparing data without applying the data to adjust an immunization program, the lack of concrete physical implementation steps proved fatal for this patent.
Chief Judge Rader wrote separately in support of this decision and noted that while § 101 patent-eligibility has been a hot issue lately, it is not the appropriate vehicle to be making important substantive decisions about whether something is patentable or not. He would leave the heavy lifting to the novelty, nonobviousness, and § 112 requirements. He does not see the patent-eligibility section as one that has a major gatekeeping role in patent law.
Classen’s Patent Claims Are Like Comparing Two Cups of Coffee to See Which One Is Stronger
Judge Moore, in a thoughtful dissent, concluded that the claims of all three patents cover fundamental scientific principles that are basic and abstract in nature. She compared the claims to the patent claims at issue in the Prometheus case, which was recently taken up by the Supreme Court for consideration of the patent-eligibility issue (just a short time after it decided the Bilski case). In her view, Classen’s claims lack the reasonable scope limitations found in the Prometheus claims, such as the compounds specifically covered in them.
Noting that it is hard to imagine broader claims than Classen’s, Judge Moore decided that his claims are “directed to a thought apart from any concrete realities, specific objects or actual instances. This is very much like patenting E=mc2.” (This appears on page 7 of the dissent.)
Concluding that Classen seeks to monopolize the process of discovery itself in the immunology field, Judge Moore also described the last patent as the reverse of the methods claimed in the first two that the majority called patentable.
Entering the Patent Infringement Safe Harbor
Another issue the court considered is the scope of the safe harbor protection for research and development activities relating to regulatory approval and monitoring of drug products.
Congress created a patent infringement exception for companies that conduct research or undertake other development activities for the purpose of gaining Food and Drug Administration (FDA) approval to market a generic counterpart to a patented pharmaceutical product. (This exception is found in 35 U.S.C. § 271(e)(1).)
The court determined that it does not protect activities that occur after the FDA has approved a drug product for marketing in the U.S. Thus, the majority disagreed with the district court’s decision that Biogen and GlaxoSmithKline’s (GSK) activities that occurred after it received FDA approval are protected by the safe harbor, and returned the infringement issue to the district court.
Again, Judge Moore disagreed. She noted that the statute broadly states that the safe harbor from infringement claims covers activities “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” § 271(e)(1).
Since the plain language of the statute does not limit the safe harbor to pre-approval uses and activities, and the Supreme Court Integra decision considered the narrow context of pre-FDA approval activities only, she concluded it also covers certain post-FDA approval activities required by the agency.
Under Judge Moore’s reading, some of Biogen and GSK’s activities relating to reporting of adverse events would be protected under the safe harbor provision. Since they are not required by law to perform post-FDA approval vaccinations in order to generate data, Judge Moore would not exempt all of the accused activities of these companies relating to vaccines.
Merck’s Hepatitis Vaccine Predated the Classen Patents?
Well, maybe. Merck asked the Federal Circuit to determine, as an alternative to the patent-ineligibility decision, that it does not infringe Classen’s patents because its own hepatitis vaccine predates and invalidates them.
Judges Newman and Rader decided not to reach this issue because Merck’s request for an invalidity ruling relating to its own vaccine program was denied by the district court (it struck down all three patents on other grounds). Judge Moore noted that the issue was fully briefed, and that Merck was missing a few aspects of the claims, but could likely cure that issue when two of the patents were returned to the district court.
Believe it or not, this is a very short summary of three different opinions written in the Classen case. If you want to read the original opinions, you can find them here.