Tuesday, September 1, 2015

Rapid Litigation Management (Celsis) v. Cellzdirect: BIO Files Amicus Brief in Another Patent Eligibility Case before the Federal Circuit

On August 28, 2015, the Biotechnology Industry Organization (BIO) filed an amicus brief in another important patent eligibility case currently before the Federal Circuit, Rapid Litigation Management (formerly Celsis In Vitro) v. Cellzdirect.  The claims at issue are directed towards a "method for freezing hepatocytes multiple times without further significant loss of cell health and viability."  The method has three steps: (1) previously frozen cells are thawed, (2) nonviable cells are separated from viable ones using a “density gradient fractionation,” and then (3) viable cells are cryopreserved for later use.  In the decision below, the District Court invalidated the claims, finding them to be directed towards patent ineligible subject matter.
In applying the first step of the Mayo two-step test for patent eligibility, the District Court found that the “patent is directed to an ineligible law of nature: the discovery that hepatocytes are capable of surviving multiple freeze-thaw cycles.”  In the second step, the court found the claimed method to lack sufficient “inventive concept,” because claimed elements such as freezing cells and the use of density gradient fractionation were found to be “well understood.”

In its brief, BIO urges the Federal Circuit to clarify the boundaries regarding the scope of the term “law of nature,” and argues that hepatocytes are not subject to repeated freezing in nature under the conditions of the claimed methods, and thus that the claim does not implicate a law of nature.  The brief also argues that the district court’s approach, which essentially “requires an undefined ‘something else,’ that cannot be satisfied by the application of known techniques and reagents to a newly recognized natural phenomenon, threatens the availability of patent protection for a host of important innovations spanning the length and breadth of biotechnology.”

BIO also argues that “[b]ecause of its well-developed record on the non-obviousness of the claimed invention, this case may present a good opportunity for this court to clarify the interplay between Section 103 and Step II of the Mayo/Alice framework."

Friday, August 28, 2015

Here Are All the Amicus Briefs That Have Been Filed Seeking En Banc Rehearing of Ariosa v. Sequenom

Yesterday I posted the amici brief I filed on behalf of BIO and PhRMA seeking en banc rehearing of Ariosa v. Sequenom.  Here are links to all twelve amicus briefs that were filed, in one place for your convenience.  Enjoy.  I have not read most of them, but I am glad to see people have taken notice and agree that there is a need for action.




Thursday, August 27, 2015

BIO and PhRMA File Amici Brief Urging En Banc Reconsideration of Ariosa v. Sequenom

The Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have jointly filed an amici brief curiae brief urging the Federal Circuit to grant en banc rehearing of Ariosa v. Sequenom.  The brief is available here.  I am the counsel of record.

BIO and PhRMA are concerned that the development and commercialization of a range of biotechnology and pharmaceutical innovations will be impeded if the Federal Circuit does not address the mounting uncertainty currently afflicting patentable subject matter jurisprudence.  The brief points out the critical importance of effective patent protection for biotechnology and pharmaceutical innovators, and the current unprecedented level of uncertainty with respect to the scope of patent eligible subject matter.  This uncertainty is affecting both the patent user community and the PTO, which has responded with an ongoing stream of revised and re-revised non-final and interim guidance documents.  With each new PTO Guidance, BIO members have observed an increasing rate of claim rejections, affecting a diverse range of biotechnology, including novel antibiotic molecules, industrial enzymes, diagnostic processes, and crop production products.

The unsettled state of the law has also created doubt as to whether issued patents will be able to withstand challenge. The brief points out that the vast majority of judicial decisions addressing patent eligibility under the recently articulated standards have resulted in a determination of ineligibility.  For example, Appendix 3 of the recent PTO “July 2015 Update: Subject Matter Eligibility,” identifies 24 post-Mayo  subject matter eligibility cases decided by the Federal Circuit, of which 22 held all of the challenged claims to be patent ineligible.

The brief urges the court to clarify the contours of both Step I and Step II of the Mayo two-step test for patent eligibility.  It posits that the Supreme Court would not have articulated a two-step test if it did not intend the first step to serve some meaningful gatekeeping function, but that under the standard applied by the panel it is difficult to see how any analytical or detection method would ever not satisfy Step I, so long as that method is designed to detect something that occurs naturally.  With regard to Step II, the brief asks for clarification with regard to the proper application of the “inventive concept” and “preemption” standards of patent eligibility.  As an example, the brief discusses the practical challenges facing the inventor of a new diagnostic test under the new patent eligibility jurisprudence.

In its recent decisions the Supreme Court apparently assumed the existence of limiting principles that would maintain patent eligibility for truly meritorious inventions (this was Judge Linn’s characterization of Sequenom’s claimed invention in his concurring opinion), even if that invention can be deconstructed into a combination of natural phenomena and conventional technology. The brief argues that en banc reconsideration would allow the Federal Circuit to address the nature of these limiting principles suggested in Mayo.  Alternatively, if the court finds that Supreme Court precedent does not provide for limiting principles that provide a meaningful opportunity for patenting important biotechnology innovations, that would suggest a need for the Supreme Court to readdress the contours of patent eligibility in the context of biotechnology. Ariosa v. Sequenom would be an appropriate vehicle for alerting the Supreme Court to the urgent need for this clarification.

Law Professors File Amicus Brief Supporting En Banc Rehearing of Ariosa v. Sequenom

A group of 23 law professors, myself included, have filed an amicus brief in support of en banc rehearing of Ariosa v. Sequenom.

The brief is available here.

Adam Mossoff, a professor at George Mason University School of Law and a Director at the Center for the Protection of Intellectual Property (CPIP), and Kevin Noonan, a partner at MBHB, took the lead in drafting the brief.

Eli Lilly v. Teva: District Court Applies the Federal Circuit's Recent Akamai Decision to Drug Method-of-Treatment Claim

In 2014 I published an article entitled “Caught between a Rock and a Hard Place: How Limelight Compounds the Challenges Facing Biotechnology Innovators after Mayo and Myriad” (available here), which explained how Supreme Court’s decision in Limelight Networks v. Akamai Technologies limiting the ability of patentees to establish liability in cases of divided infringement had undermined the value of method claims, particularly with respect to diagnostics and drugs.  In that article, I noted that in Limelight the Court had explicitly pointed out that its decision did not necessarily preclude the Federal Circuit from revisiting that court's decision in Muniauction, and to reinterpret 271(a) in a manner that would allow a patent owner to hold at least certain parties liable for active participation in a concerted act of divided infringement.  I also predicted that that the Federal Circuit would likely revisit the issue and expand 271(a) in a manner that would hold at least some divided infringer’s liable.

On Aug. 13, 2015, the Federal Circuit did just that when it issued an en banc opinion unanimously setting forth the law of divided infringement under 35 U.S.C. § 271(a) and vacating the earlier panel decision. Akamai Technologies, Inc. v. Limelight Networks, Inc., 2015 WL 4760450 (Fed. Cir.).  Akamai explicitly overruled prior case law regarding divided infringement, “[t]o the extent [those] prior cases formed the predicate for the vacated panel decision,” and no longer limited § 271(a) to principal-agent relationships, contractual arrangements, and joint enterprises.

Under 35 U.S.C. § 271(a), direct patent infringement occurs where all steps of a claimed method are performed by or attributable to a single entity. In Akamai, the court held that “[w]here more than one actor is involved in practicing the steps, a court must determine whether the acts of one are attributable to the other such that a single entity is responsible for the infringement.” On a claim for direct infringement of a method patent, the court will hold an entity responsible for anothers’ performance of method steps under two circumstances: (1) where that entity directs or controls others’ performance, and (2) where the actors form a joint enterprise. With respect to the former requirement, Akamai concluded that “liability under § 271(a) can also be found when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.” In those instances, the third party’s actions are attributed to the alleged infringer “such that the alleged infringer becomes the single actor chargeable with direct infringement.”
In Limelight, Eli Lilly filed an amicus brief with the Supreme Court explaining the critical role of method-of-treatment claims in pharmaceutical innovation, and noting that such claims ‘‘routinely and sometimes necessarily present divided infringement issues.’’ According to Lilly, ‘‘[i]t has been increasingly common for patent challengers to argue that the relationship between these various actors does not meet the current standard articulated by the Federal Circuit necessary to find liability for direct infringement under 35 USC 271(a).’’

On August 25, 2015, Eli Lilly’s concerns were presumably at least partially abated by the district court's decision  in Eli Lilly v. Teva (available here).  The  Eli Lilly court applied the new Akamai standard and held that doctors directly infringed an Eli Lilly method-of-treatment claim, even though the claim explicitly recites the step of administering folic acid to a patient prior to administration of the drug, and it is the patient that takes the folic acid, i.e., the doctor does not administer the folic acid to the patient.  As a consequence, a generic company would be liable for inducing the doctor’s infringement based on drug labeling that instructs doctors to have their patients take folic acid prior to the doctor administering the drug to the patient.  It is significant that the generic drug company is required by law to use essentially the same label as the branded drug, and is thus required to “induce” doctors to instruct patients to take their folic acid.

In particular, the district court found that “the instant case involves the administration of a medical treatment, the factual circumstances are sufficiently analogous to those in Akamai to support a finding of direct infringement by physicians under § 271(a), and thus inducement of infringement by Defendants under § 271(b), under the legal standard recently set forth by the Federal Circuit.”  The generic company defendants argued unsuccessfully that the "actions of the patient in taking folic acid prior to [administration of the drug] cannot be attributed to the physician because the physician does not physically place the folic acid into the patients’ mouth, and because patients are instructed to obtain folic acid, either by prescription or over the counter, and take it on their own.”  But the district court found this argument to be premised on “now overruled case law on divided infringement,” and found the following language of the label to be unambiguous on this point:
The prescribing information requires physicians to “[i]nstruct patients to initiate folic acid 400 mcg to 1000 mcg orally once daily beginning 7 days before the first dose of ALITMA®.” Additionally, the patient information states “[i]t is very important to take folic acid . . . during your treatment with ALITMA to lower your chances of harmful side effects. You must start taking 400-1000 micrograms of folic acid every day for at least 5 days out of the 7 days before your first dose of ALITMA.” TX. 3017 at 2 (emphasis in original). It is clear from the patent, the prescribing information, and the patient information that taking folic acid in the manner specified is a condition of the patient’s participation in pemetrexed treatment as described by the patent, and is necessary in order to receive the benefit of such treatment. If the patient fails to carry out this step, he or she would not receive the benefit of the patented method, i.e. a reduction of potentially life-threatening toxicities caused by pemetrexed. The physician, based upon the patented method, directs the manner and timing of the patient’s ingestion of folic acid—400 to 1000 μg of folic acid for at least five days out of the seven days prior to and during pemetrexed administration—and the patient is required to do so to receive the full benefit of the treatment.

Wednesday, August 26, 2015

WARF Files Amicus Brief in Support of En Banc Rehearing of Ariosa v. Sequenom

The Federal Circuit’s discouraging opinion in Ariosa v. Sequenom has been discussed in previous posts.  Sequenom has petitioned for en banc rehearing, its brief is available here, Amicus briefs are due tomorrow, Aug 27, but WARF got its in a bit early, and it is available here.

Here is a summary of WARF’s argument, i.e., their argument as set forth in the Table of Contents:

  • The goal of the two-step Mayo/Alice framework is to ensure that patentees cannot effectively monopolize natural phenomena, laws of nature, and abstract ideas—no more and no less
  •  Where an inventor claims only an application that makes practical use of a natural phenomenon, the claims do not monopolize the natural phenomenon itself and are patent-eligible under Section 101
  • The panel’s analysis of Mayo/Alice Step Two was mistaken because isolation, amplification, and analysis of cffDNA in maternal fluids were not conventional

      More briefs will be posted shortly, including one I am helping to prepare for Biotechnology Industry Organization

Tuesday, July 21, 2015

Former Grad Student Fails in Bid for “Constructive Trust” in Professor’s Patent

On July 16, 2015, in Genspera v. Mahka, the Federal Circuit affirmed without discussion (i.e., under Rule 36) a district court decision denying a former doctoral student’s claim to a constructive trust in a patent issued to her former thesis advisor, a professor at Johns Hopkins University. The affirmed district court decision also denied her conversion claim against the professor.

The professor, along with another professor at Johns Hopkins, are named inventors on patents claiming a cancer prodrug. The graduate student, Mahka, claims that she came up with the idea for the only specific chemical compound claimed in the patents, a compound that is currently undergoing clinical testing. Genspera is a company started by the professors to develop and commercialize the prodrug.

Mahka initially sought to be added as an inventor to the patents, but the district court granted Genspera summary judgment because “a finding that Mhaka added an invention to the Application after the disclosure was filed would invalidate the Patents, and a district court cannot apply § 256 to require the Patent Office to add an inventor to an issued patent when doing so would invalidate the patent.”  The problem was that the prodrug allegedly invented by Mahka was not created until after the filing date of the patents.

Mahka then turned to state law causes of action. She claimed conversion of her invention by the professors, but the district court rejected this claim. The court found that under Maryland law the tort of conversion does not extend to completely intangible rights, and that Mahka’s asserted rights in the “invention” claimed in the patents was completely intangible.

Mahka also sought a constructive trust, a form of equitable relief which would have required the professors to share some of the benefits they derived from the patents, specifically stock in Genspera.  A constructive trust remedy is applied when “property has been acquired by fraud, misrepresentation, or other improper method, or where the circumstances render it inequitable for the party holding the title to retain it.” Its purpose is “to prevent the unjust enrichment of the holder of the property.”

The district court denied this claim, finding that it was barred by laches, i.e., Mahka waited too long to file her lawsuit.  The district court held that she needed to file her claim within three years of learning of the alleged failure to name her on the patent, and that she had waited more than four years.  After leaving Johns Hopkins, Mahka worked at a venture capital firm doing intellectual property research, which is where she allegedly learned of the patents.  She learned about them, and her omission as an inventor, in 2008, and contacted John Hopkins at that time, who advised her to hire her own lawyer. She waited until 2012 to file a lawsuit, at which point her cause of action was time-barred.