In what some perceive as a major shift from decades of precedent, the United States Supreme Court held last week that laches – unreasonable delay – is no longer a valid defense against a claim for patent infringement so long as the patent owner brings suit  within the 6-year look-back limitation period prescribed in 35 U.S.C. § 286.

In SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC, SCA, held a patent concerning the manufacture and sale of certain adult incontinence products.  In October 2003, SCA sent a letter to First Quality asserting that First Quality was infringing SCA’s patent rights.  In response, First Quality maintained that the patent at issue was invalid and could not support an infringement claim.  SCA took no further action until July 2004 when, without notifying First Quality, asked the Patent and Trademark Office (PTO) to initiate a reexamination proceeding to determine whether the relevant patent was valid in light of certain pre-existing patents.  Three years later, in March 2007, the PTO issued a certificate confirming the validity of the relevant patent.

Over three years later, in August 2010, SCA filed a lawsuit for patent infringement against First Quality.  First Quality moved for summary judgment based on laches and equitable estoppel, and the District Court granted the motion on both grounds.  SCA appealed to the Federal Circuit, which affirmed the District Court’s holding that laches can be asserted to defeat a claim for damages incurred within the 6-year period set out in the patent statute.

On appeal, the Supreme Court reversed, in part, basing its decision on the plain language of the statute, which it found evinced a judgment by Congress that a patentee may recover damages for any infringement committed within six years of the filing of the claim.  The Court went on to find that it “would be exceedingly unusual, if not unprecedented, if Congress chose to include in the Patent Act both a statute of limitations for damages and a laches provision applicable to a damages claim.”  Thus, the Court held, that the doctrine of laches cannot bar an otherwise timely claim for damages under the patent statute.  The Supreme Court did note, however, that the doctrine of equitable estoppel can still provide protection against some of the problems that may arise when patentees induce potential targets of infringement suits to invest in the production of arguable infringing products.

In view of this decision, parties accused of patent infringement should be cognizant that they are potentially liable for six (6) years from the time of alleged infringement, regardless of how diligent the patent owner is in pursuing its claim.

Under United States law, the holder of a patent on a brand-name, FDA-approved drug can bring suit for patent infringement against a generic drug manufacturer even before the generic manufacturer brings the drug to market.  That right to sue is triggered by the generic manufacturer’s filing of the short-cut application to the FDA to sell the drug known as an Abbreviated New Drug Application, or “ANDA.”  On March 18, 2016, the Federal Circuit Court of Appeals held that a generic drug manufacturer’s intent to manufacture and market drugs in a particular state – even before they start selling there – is enough to sue the generic manufacturer in the federal court in that state.  The decision will go a long way in cementing “home field advantage” for branded drug companies that traditionally bring suit in their home state before the generic drug is ever actually manufactured or marketed there.

The decision came in the context of two separate actions brought in Delaware against generic drug manufacturer Mylan Pharmaceuticals Inc.  In both cases, the plaintiffs sought to halt Mylan’s efforts to manufacture and market allegedly infringing generic drugs described in Mylan’s ANDA’s filed with the FDA.  Mylan moved to dismiss both cases on the basis that Delaware could not exercise jurisdiction over Mylan because Mylan lacked sufficient “minimum contacts” with Delaware as required under the United States Constitution.  The Federal Circuit held that Mylan’s efforts to obtain FDA approval to manufacture and/or sell its generic drugs in Delaware, along with Mylan’s established distribution channels, satisfied the minimum-contacts standard.  Although fairness and undue burden should always be considered, generally speaking, the courts need not wait for a product to be manufactured or sold within a particular state before hearing a case in which the propriety of such future, potentially infringing conduct is considered.

It has become commonplace for branded drug companies to bring ANDA-related lawsuits in their home states, most commonly New Jersey and Delaware, with the generic manufacturer vigorously fighting to dismiss and/or remove the case to another state (such as the generic company’s state of incorporation) based on jurisdictional arguments.  Barring an appeal to the United States Supreme Court, the Federal Circuit’s decision should greatly reduce the number of such disputes, with the majority of cases remaining in New Jersey and Delaware, where the sheer volume of ANDA cases has resulted in a familiarity and expertise among the judiciary that remains largely unmatched throughout the country.


A case decided this month by the Federal Circuit Court of Appeals involving technology for preparing multi-cryopreserved liver cells reminds how critical experts can be in deciding patent disputes, including in the context of preliminary proceedings.

The patent involved in Celsis In Vitro, Inc. v. Cellzdirect, Inc. concerns mechanisms for the preservation of liver cells through multiple freezing processes, which enables researchers to have increased access to cell samples over time, and a larger population of donors. Celsis brought suit alleging infringement and, following limited discovery and an evidentiary hearing, obtained a preliminary injunction barring the sale of the accused products.

The principal issues on appeal were the correctness of the trial court’s conclusions as to infringement and validity (that the patented method was not obvious in view of the prior art), as well as the determination of irreparable harm. Applying the abuse of discretion standard of review applicable to rulings on preliminary injunctions, the Federal Circuit relied heavily on the district court’s assessment of expert testimony (or lack thereof) in affirming the injunction.

On the infringement issue, the district court heard testimony from the parties’ competing experts and found the patent owner’s expert was “helpful in carefully explaining how [the defendant’s] accused process [met] all the limitations of the asserted claims” whereas the defense’s experts “didn’t offer anything in the way of opinions to address the proper interpretation of the patent’s claims.” Finding the plaintiff’s expert more persuasive, the district court had ruled that the patent owner was likely to succeed on its claim, weighing in favor of the issuance of an injunction. On appeal, the Federal Circuit held that the district court did not abuse its discretion in finding a likelihood of success as to infringement.

Similarly, the Federal Circuit deferred to the district court’s determination that the testimony of the defense’s experts on issues of obviousness were not credible, opining that the district court “has wide discretion to weigh expert credibility” and the Federal Circuit will defer to those determinations.

On the issue of irreparable harm, the district court found that Celsis would suffer irreparable harm in the form of price erosion, loss of goodwill, damage to reputation and loss of business opportunities based on the unrebutted expert testimony of Celsis’ expert. The Federal Circuit held that there was “no error in the district court’s reliance on Celsis’ unrebutted expert testimony” and based on such testimony, found no reason to revise the district court’s fact determinations. Relatedly, on the district court’s conclusions regarding the balance of harms weighing in Celsis’ favor, the Federal Circuit opined: “This preliminary injunction factor is also affected by [the defense’s] decision not to present expert testimony to rebut Celsis’ expert testimony.”

The Celsis case highlights the significance of both the credibility of dueling experts on issues before the court, as well as the determination of whether to present rebuttal expert testimony.

The United States Supreme Court affirmed the application of the clear and convincing standard for proving a patent invalid, holding that the standard of proof applies regardless of whether the US Patent and Trademark Office considered the relevant evidence during prosecution of the patent.  The decision in Microsoft Corp. v. i4i Limited Partnership has a broad reach in patent litigation, where prior art validity challenges are virtually always made. 

Section 282 of the Patent Act states that a “patent shall be presumed valid” and the “burden of establishing invalidity of a patent . . . shall rest on the party asserting such invalidity.” The Federal Circuit has long read the Patent Act to require a party seeking to overcome a patent’s presumption of validity to prove its case by clear and convincing evidence.

Microsoft’s challenge sought to lower Section 282’s standard to a preponderance of the evidence.  Microsoft argued that the statutory presumption of validity should not apply when an issued patent’s validity is challenged, especially when the challenge is based on prior art that was not disclosed to the PTO during the examination period. The underlying theory for this argument is that the presumption of validity – premised on the notion that a government agency is presumed to perform its function – is faulty where the PTO did not actually consider the allegedly invalidating material in deciding to allow an invention to issue as a patent.

The Supreme Court was unconvinced.  The Court explained that in asserting an invalidity defense, the accused infringer “must contend with the first paragraph of Section 282, which provides that ‘[a] patent shall be presumed valid’ and ‘[t]he burden of establishing invalidity . . . rest[s] on the party asserting such invalidity.’” Congress, in choosing Section 282’s phrase “presumed valid,” used a term with a settled meaning.  According to that meaning, a defendant raising an invalidity defense bears a heavy burden of persuasion, requiring proof of the defense by clear and convincing evidence.  The Court also noted that courts have interpreted Section 282 the same way for decades and that “during this period, Congress has often amended the patent law, but apparently never considered any proposal to lower the standard of proof.” 

Although the Court recognized that courts of appeals have “observed that the presumption of validity is ‘weakened’ or ‘dissipated’ in the circumstance that the evidence in an infringement action was never considered by the PTO,” it rejected the notion that such cases indicated a lowered standard of proof.  Instead the Court interpreted such statements as indicating how newly considered evidence may carry more weight.  Thus, while it may be easier for a patent challenger to meet its burden of proof with newly considered evidence, the height of its burden remains the same.

Had the Court sided with Microsoft, the lower standard of proof could have created uncertainty as to the stability of patent rights and caused a significant shift in patent-infringement litigation.  In the end, the Court preserved the status quo.

The Federal Circuit took another step toward restricting the scope of patentable business methods in its August opinion in Cybersource v. Retail Decisions, 2011 WL 3584472, finding Cybersource’s patent claims invalid as unpatentable “mental processes.”  Of particular interest was the Court’s solidifying “mental processes” as a subcategory of unpatentable “abstract ideas,” and its holding that the addition of concrete structure in a claim, such as a computer hard drive, will not be sufficient to render an otherwise unpatentable abstract idea patentable.

The Court described the Cybersource claims as “broad” and encompassing “any method or system for detecting credit card fraud which utilizes information relating credit card transactions to particular ‘Internet address[es].’”  The method claim involved obtaining information about previous transactions that were conducted through a particular Internet address which was the same address as a current credit card transaction, mapping credit card numbers associated with the previous transactions and using the map to determine if the current transaction is valid.  According to the Court, the computer media claim recited the same method, but in the form of computer instructions on a computer readable medium (e.g., hard drive or DVD). 

Affirming the District Court’s judgment of invalidity, the Federal Circuit held Cybersource’s patent failed to meet the subject matter requirements for patentability under 35 U.S.C. § 101.   

The Court first analyzed the method claim under the “machine or transformation test,” where the claimed subject matter must either be “tied to a particular machine or apparatus” or “transform a particular article into a different state or thing.”  Cybersource’s method claim failed this test, but the Court ultimately premised its decision on the ground that the patent claims comprised only “mental processes,” a subcategory of one of the three case law defined exceptions to patentable subject matter — abstract ideas. 

Quoting from prior decisions, the Federal Circuit explained: “‘[T]he patent statute does not allow patents on particular systems that depend for their operation on human intelligence alone, a field of endeavor that both the framers and Congress intended to be beyond the reach of patentable subject matter…. [I]t is established that the application of human intelligence to the solution of practical problems is not in and of itself patentable.’”  The Court was not persuaded by arguments that the claims were rendered patentable because they required physical data gathering steps (obtaining information about prior Internet transactions), instead finding the method could be performed “in the human mind or by a human using a pen and paper.”  The Court held, “[m]ethods which can be performed entirely in the human mind are unpatentable not because there is anything wrong with claiming mental method steps as part of a process containing non-mental steps, but rather because computational methods which can be performed entirely in the human mind are the types of methods that embody the ‘basic tools of scientific and technological work’ that are free to all men and reserved exclusively to none.”

In addition, the Federal Circuit held that claiming the invention in the form of computer media did not render the claim patentable.  The Court explained that regardless of the statutory category of the claim (e.g., process or article of manufacture), it is the underlying invention which must be assessed for patent eligibility purposes.  The Federal Circuit viewed the underlying invention of Cybersource’s computer media claim as identical to its method claim (a method for detecting fraud), and thus reached the same conclusion that the computer media claim was unpatentable.  The reasoning of the Court was consistent with its prior decisions finding unpatentable methods were not saved by the addition of the use of a computer in an “insignificant” manner.  The fact that the computer media claim recited a physical structure or involved the use of a computer to perform the method steps was insufficient to render the claim patentable because those elements of the claim were merely incidental.  In other words, the claim was merely a “software implementation” of a mental process where the addition of computer elements did not impose “meaningful limits on the claim’s scope” or “play a significant part in permitting the claimed method to be performed.” 

With the Cybersource decision, the Federal Circuit has tightened the chokehold on business method patents, more firmly entrenching the “mental processes” exception to patentability and expanding the scope of what will be considered insignificant computer or machine elements in a claim to include “computer readable media.”  Notwithstanding the Supreme Court’s latest pronouncement in Bilski v. Kappos that business method patents are not, as a class, unpatentable, it remains to be seen exactly what types of business methods could past muster given the Federal Circuit’s current treatment of such methods.