Tag Archives: pittsburgh patent litigation

Federal Circuit Sanctions Non-Practicing Entity for Baseless Lawsuit — Eon-Net LP v. Flagstar Bancorp

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

Non-practicing entities (NPEs) are often criticized for bringing meritless lawsuits against companies with the sole intention of forcing settlements by offering amounts far less than the cost of litigation. Even though the claims may be baseless or tenuous at best, the cost of fighting often far outweighs the settlement demands. Faced with paying a relatively small amount to assure the case goes away versus paying substantially more to defeat the claim through litigation, companies will often acquiesce to the settlement demands even if they feel that they have not infringed a valid patent.

On Friday, the Federal Circuit issued a decision in Eon-Net LP v. Flagstar Bancorp, (No. 09-1308) reminding defendants that there are other options for defendants facing frivolous lawsuits. The Court in a unanimous decision affirmed a district court’s decision to award over $600,000 in attorney fees and sanctions under 35 U.S.C. § 285 and Rule 11 against an NPE for filing a frivolous patent infringement lawsuit. The Federal Circuit panel consisted of Judges Lourie, Mayer, and O’Malley.

Eon-Net LP—Non-Practicing Entity

Eon-Net LP (and its related companies) are NPEs that have filed over a hundred lawsuits against a variety of different defendants. They typically offer to settle cases for $25,000–$75,000, based on the amount of the defendant’s sales, which are amounts far lower than the potential damages or the litigation costs. This is the typical non-practicing entity

35 U.S.C. § 285 and Attorney Fees in Exceptional Cases

A district court has the discretion under § 285 to award attorney fees to the prevailing party in a patent infringement lawsuit if it determines the case is “exceptional.” The Federal Circuit, while indicating that it will review these determinations, also indicated that it will not lightly disturb a court’s finding because of the court’s lengthy and personal experience with the case, the parties, and the attorneys.

The Federal Circuit mentioned a variety of actions by a losing party that can make a case exceptional—(1) litigation misconduct, (2) unprofessional behavior, (3) misconduct in getting the patent at issue, and (4) bringing an objectively baseless litigation in bad faith. The Court found that Eon-Net’s litigation misconduct and filing of a baseless infringement action in bad faith made the case exceptional.

The Eon-Net case is pretty much a checklist for what not to do in filing a lawsuit. First, Eon-Net intentionally destroyed potentially relevant documents prior to filing suit. Next, it failed to participate in the litigation process in good faith by not offering constructions for any of the disputed claim terms, lodging incomplete and misleading evidence with the court, and submitting contradictory declarations. In short, “[t]he district court also found that [Eon-Net’s principal] displayed a ‘lack of regard for the judicial system’ and that Eon-Net and [its principal] had a ‘cavalier attitude’ towards the ‘patent litigation process as a whole.’” Taken together, the Federal Circuit found this behavior unprofessional.

The Federal Circuit also affirmed the finding that Eon-Net filed a baseless lawsuit in bad faith. The written description in the patent clearly refuted Eon-Net’s need construction to find infringement, which it should have known before filing suit.

In finding that Eon-Net filed suit for an improper purpose, the Federal Circuit looked beyond the litigation before it and to Eon-Net’s history of filing what it considered to be “extortionate” lawsuits with settlement demands far lower that the litigation costs. “The record supports the district court’s finding that Eon-Net acted in bad faith by exploiting the high cost to defend complex litigation to extract a nuisance value settlement from Flagstar.” On its face, the Court’s analysis brings into question the entire business model for many NPEs.

In addition, the Court was troubled by the disproportionate and asymmetric discovery costs often present in cases like these. NPEs will often have little, if any, relevant documents or personnel to depose. In contrast, defendants may have enormous amounts of potentially relevant documents and witnesses. Because discovery costs are generally borne by the producing party, an NPE can force a defendant to expend hundreds of thousands or millions of dollars during discovery—costs that it will never have to bear because of the dearth of information it has.

Finally, the Court was troubled by the fact that NPEs are rarely put at risk in these kinds of lawsuits. They do not typically sell any products, so there is no chance of a patent infringement, unfair competition, or antitrust counterclaim. The only risk is the loss of the patent itself, which is typically only one of a number of licensing revenue sources. There is no chance that they will face increased competition from a competitor if they lose.

Taken together, the Federal Circuit had no problem with the finding that Eon-Net filed a baseless lawsuit in bad faith for an improper purpose sufficient to warrant a finding that this was an exceptional case.

Rule 11 Sanctions

In addition to awarding attorney fees, the Federal Circuit also affirmed the district court’s imposition of Rule 11 sanctions because Eon-Net and its attorneys failed to perform a reasonable pre-suit investigation. While Eon-Net’s counsel did examine Flagstar’s website before filing suit, they did not perform an objective evaluation of the claim terms when assessing infringement.

What Can We Learn From This Decision?

This decision is really a slap in the face to NPEs and indicates that the Federal Circuit does not take kindly to litigants filing baseless claims to extort settlements from defendants. While this decision serves as a warning to NPEs and their attorneys, it also serves as a cautionary tale for other litigants.

First, the decision emphasizes the need to conduct a proper pre-filing investigation, which should include a claim-by-claim analysis of infringement and the potential construction of any key claim terms. Depending on the nature of the allegedly infringing product, this analysis may be difficult. For example, if claim limitations are not observable from inspecting the product (such as limitations contained in source code), the attorneys will need to make educated assumptions about how the allegedly infringing product works and be ready to defend the legitimacy of those assumptions, if necessary.

Second, plaintiffs need to be aware that the obligation to preserve potentially relevant evidence begins before they file the lawsuit. Intentionally destroying documents before filing a lawsuit can have serious consequences, and if a company had a standard document destruction policy, it must determine if that policy needs to be suspended before (not after) filing suit.

Third, litigants need to take the litigation seriously and respect the process, even if it feels cumbersome or annoying at times. Flippant comments, like those made by Eon-Net’s principal, can come back to haunt a losing party. Ignoring the process or filing half-hearted papers can cause serious problems.

Finally, this case is a real indictment of the standard NPE business model of making extremely low settlement offers to entice defendants to not fight the lawsuit. Many NPEs use this business model with lawsuits of questionable merit knowing that defendants will be reluctant to fight the lawsuit given the prospective costs. This decision may serve as a wake-up call for NPEs and their attorneys to be more careful in what suits they file.  Given that Eon-Net only makes between $25,000–$75,000 per settlement, a $600,000 fee award against it likely is a substantial hit to its business. In addition, this decision will haunt Eon-Net in all future proceedings and likely lead to more awards against it if it continues to bring these kinds of meritless lawsuits.

This decision shows that fighting the fight can sometimes be worth the battle and help to deter other NPEs from coming after a company. Unfortunately, it is still likely a losing proposition for the defendants. Even in this best-case scenario, they are generally only compensated for their litigation costs, not all of the other costs of being a defendant (such as lost employee time, opportunity losses, and the damage to their image by being involved in a lawsuit). There is no windfall for defendants in these circumstances.

Federal Circuit Holds That Isolated Genes Are Patent Eligible — Association for Molecular Pathology v. Myriad Genetics

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

The patentability of genes and genetic testing remains a controversial topic, enough so that the Supreme Court granted cert in Mayo Collaborative Services v. Prometheus Laboratories to address some of these issues. (See our prior post). On Friday, the Federal Circuit issued a lengthy and fractured 105-page decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (No. 10-1406) that held that claims to an isolated DNA molecules were patentable subject matter under 35 U.S.C. § 101. Judge Lourie delivered the decision of the Court, Judge Moore concurred in part, and Judge Bryson concurred and dissented in part.


The patents at issue are directed a test to screen for mutations in BRCA genes that correlate with an increased risk of breast and ovarian cancer. The inventors identified markers in DNA sequences from individuals with inherited breast and ovarian cancers. This knowledge allowed Myriad to create diagnostic testing services for women.

Myriad began sending cease-and-desist letters to doctors who performed testing that it believed infringed its patents. A number of doctors and researchers then filed a declaratory judgment action against Myriad Genetics, Inc., claiming that certain claims in seven of Myriad’s patents were invalid because they contain patent-ineligible subject matter under 35 U.S.C. § 101. The district court agreed with the plaintiffs and invalidated all fifteen challenged claims. The Federal Circuit reversed as to three of the claims (in a 2–1 decision) and unanimously affirmed the district court’s decision as to the remainder.

The Claims at Issue

Myriad’s claims fell into three broad categories: (1) three composition claims, (2) a screening method claim, and (3) eleven comparing/analyzing method claims. The Federal Circuit found that the first two types were patent-eligible under § 101, but the third type was not.

The composition claims were for two “isolated” human genes (BRCA1 and BRCA2) that are free-standing portions of a larger, native DNA molecule and synthetic complementary DNA molecule (cDNA). In essence, these isolated genes are sections of DNA that has been cleaved from a naturally-occurring DNA molecule. Myriad isolated the portions of the naturally-occurring DNA molecule that correlated with the cancer and patented it.

The screening method claim recites the steps of growing host cells transformed with an altered BCRA gene in the presence of a potential cancer therapeutic, determining the growth rate of these cells, and comparing the growth rate of the host cells. The comparing/analyzing method claims, on the other hand, simply call for comparing samples from a tumor of the isolated genes from a patient with a non-tumor sample.

The Court Finds the Composition Claims Are Patentable Subject Matter

Before making its determination, the Court traced the state of the law regarding § 101 by looking at the Supreme Court’s decisions in Diamond v. Chakrabarty, 447 U.S. 303 (1980) and Funk Borthers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948). These decisions involved whether man-made, living microorganisms are patentable under § 101.

Ultimately, the Federal Circuit concluded that § 101 requires that a composition’s identity must be “markedly different” in comparison with what exists in nature for the composition to be patent-eligible:

The distinction, therefore, between a product of nature and a human-made invention for purposes of § 101 turns on a change in the claimed composition’s identity compared with what exists in nature. Specifically, the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given “markedly different,” or “distinctive,” characteristics.

Judge Lourie found that Myriad’s composition claim satisfied this test because the isolated genes, while they could be found inside a naturally-occurring DNA molecule, had distinct chemical identities and natures different from the DNA molecule once they were removed. The isolated genes are not the same molecules as exist in the body, and the creation of these isolated genes requires human intervention. He rejected the argument that the isolated genes are merely purified forms of a natural material.

Judge Moore, in her concurrence, reached the same result. She found that a fragment of a DNA sequence has different properties and different physical characteristics than the parent DNA from which it is obtained. In addition, the cDNA gene is entirely different than the naturally-occurring DNA molecule because introns are removed and it contains the opposite (complementary) sequence of RNA. The exact cDNA gene is not found in nature, so it is easily patent-eligible.

In his dissent, Judge Bryson sharply disagreed with respect to the non-cDNA composition claims. He would have held that any gene that is found in nature, even if found within a larger DNA molecule, is unpatentable. Judge Bryson analogized these genes to minerals discovered in the earth. Simply extracted a naturally-found mineral is not patentable, so simply extracting a naturally-found gene from DNA should not be patentable.

The Method Claims

The decisions with respect to the method claims were much easier for the Court, and the Judges unanimously agreed. The comparing/analyzing claims were not patent eligible because they amounted to nothing more than the mental steps of comparing two genes. There was no transformation involved, so they were not patent eligible. The screening method claim, on the other hand, had a number of transformations central to the purposes of the claimed process. Thus, it was patent eligible.

Standing to Bring the Action

A significant part of the decision also addressed whether any of the plaintiffs had standing to bring the claim under the Declaratory Judgment Act. All three Judges agreed that at least one of the doctors did have standing. For those interested in standing issues and what is sufficient under the Declaratory Judgment Act, this decision is an interesting read.

The Takeaways

The Federal Circuit seems to have a different test for genetic materials than other compositions. All three Judges agreed that extracting a naturally-found mineral or element from a rock would not be eligible for patent protection. Under the majorities’ holding, however, extracting genetic material from a naturally-occurring DNA molecule is eligible for patent protection (assuming the other requirements of the Patent Act can be met). The decision maintains a long history of allowing patents in the field of genetics.

It will be interesting to see if this case is addressed en banc or whether the Supreme Court will weigh in on these issues in its upcoming case in Mayo Collaborative Services. Given the sharp dissent in this case, and the importance of these types of patents, it is unlikely that we have seen the last of these decisions.

Federal Circuit Hears Oral Arguments on Constitutionality of Patent False Marking Statute

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

Yesterday, the Federal Circuit heard oral arguments in FLFMC, LLC v. Wham-O, Inc. (No. 2011-1067) to decide whether the patent false marking statute (35 U.S.C. § 292) is constitutional under the “Appointments” and “Take Care” clauses of the United States Constitution (Article II, Sections 2 and 3). The panel is comprised of Judges Linn, Dyk, and Prost, and attorneys representing FLFMC, Wham-O, the US government, and the Chamber of Commerce of the United States of America argued before the Court. An audio recording of the argument can be heard here.

The district court below (from the Western District of Pennsylvania) dismissed FLFMC’s lawsuit, finding that it lacked standing to bring the action, and FLFMC appealed to the Federal Circuit.

It is difficult to predict how the Court will rule from the argument yesterday, but we can get an idea of some of the key issues that the Court is wrestling with. The argument chiefly focused on two key issues—(1) is there a sufficient government notice requirement in the statute and (2) does the government have sufficient control over the litigation to satisfy its constitutional obligations?

Does § 292 Require Notice to the Government?

As to the first issue, counsel for FLFMC noted that there is a provision for giving the USPTO notice of any lawsuit involving a patent (35 U.S.C. § 290) and many plaintiffs are giving the government notice as a matter of routine practice. Counsel for Wham-O countered that many plaintiffs are not giving notice under § 290 or otherwise and that § 290 only requires notice within 30 days of filing suit, by which time many cases have been settled and dismissed. In either case, the government is not getting adequate notice to fulfill its constitutional obligations. The government conceded that the notice under § 290 does not specifically indicate that the lawsuit involves allegations of false marking, so the government would have to specifically investigate every patent case filed to determine whether it involved false marking, as opposed to infringement, for example.

The Court clearly was concerned about the apparent lack of notice, and the panel questioned whether it could create a notice requirement to preserve the constitutionality.

Does the Government Have Sufficient Control of the Litigation?

The other key issue was the government’s ability to intervene and control the litigation. On its face, the statute is silent about government control and intervention. Counsel for FLFMC argued that the Federal Rules of Civil Procedure give the government the right to intervene because it has a stake in the outcome of the lawsuit, and that the Court can look to these Rules in determining the constitutionality. The Court seemed to accept this argument. Counsel for Wham-O countered that while the government may be able to intervene, it has no ability to control the litigation. It cannot force a dismissal of the lawsuit or reject a settlement. It can only ask the Court for assistance, which puts the government in no better a position that any other amicus or intervenor. There was also some dispute over whether civil litigants should be precluded from bringing suit if the government has already filed a criminal action.

What’s Next?

Given the tenor of the argument, it seems safe to say that the Court has some concerns about the constitutionality of the false marking statute. Whether those concerns rise to the level of invalidating the statute is another question. What will be interesting is how the decision in this case will affect the legislation pending in Congress that rewrites the false marking statute (HR 1249, § 16 and S 23, § 2(k)). Should the Court hold that the current false marking statute is unconstitutional, it may require Congress to revisit the amendments to that statute.

Additional Materials

  • The parties’ Federal Circuit briefs can be found here.
  • The District Court order finding no standing can be found here.

Will Patent False Marking Litigation Flame Out?

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

With the House and Senate passing versions of the America Invents Act that will reform the patent laws as we know them, I thought it would be interesting to look back at how patent false marking litigation burst onto the scene in 2010 and how it appears to be flaming out now in 2011. In the last two years, the patent world has been abuzz with claims of false marking brought by individuals against some of the largest companies in America. There were fears that this litigation would result in monstrous penalties where there was little “wrongful” action. As typically happens, these fears appear to have been overblown. While certainly a headache for those companies that were sued and for those companies that have gone to great lengths to verify compliance with the statute, the result seems to be more of a short-term inconvenience.

History of False Marking Law

False patent marking has been around for a long time, first appearing in the Patent Act of 1842, which prohibited the false marking of products with the intent to deceive the public with a fine of not less than $100. Later, in 1952, Congress changed the statute to impose a penalty of not more than $500 per offense:

(a) Whoever, without the consent of the patentee, marks upon, or affixes to, or uses in advertising in connection with anything made, used, offered for sale, or sold by such person within the United States, or imported by the person into the United States, the name or any imitation of the name of the patentee, the patent number, or the words “patent,” “patentee,” or the like, with the intent of counterfeiting or imitating the mark of the patentee, or of deceiving the public and inducing them to believe that the thing was made, offered for sale, sold, or imported into the United States by or with the consent of the patentee; or Whoever marks upon, or affixes to, or uses in advertising in connection with any unpatented article, the word “patent” or any word or number importing that the same is patented for the purpose of deceiving the public; or Whoever marks upon, or affixes to, or uses in advertising in connection with any article, the words “patent applied for,” “patent pending,” or any word importing that an application for patent has been made, when no application for patent has been made, or if made, is not pending, for the purpose of deceiving the public– Shall be fined not more than $500 for every such offense.

35 U.S.C. § 292(a). Prior to 2009, courts interpreting these statutes held that the penalty should not be imposed for each article falsely marked, but rather should be imposed for the decision to falsely mark a product line. See, e.g., London v. Everett H. Dunbar Corp., 179 F. 506 (1st Cir. 1910). As a result, there was little incentive for a litigant to bring a false marking claim and few cases were filed.

Pequignot v. Solo Cup and Forest Group v. Bon Tool

In 2007, things began to change. Matthew Pequignot, a patent attorney, filed suit against Solo Cup for falsely marking its plastic cup lids with expired patent numbers. Pequignot argued that the prior holdings were incorrect and that penalties should be imposed per article. Because there were potentially over 21 billion cups that were falsely marked, Solo Cup theoretically faced more than $10 trillion in potential penalties under Pequignot’s interpretation.

As the case was winding its way through the courts, the Federal Circuit heard an appeal in an unrelated case Forest Group, Inc. v. Bon Tool Co., 590 F.3d 1295 (Fed. Cir. 2009) that would ultimately spark a huge new cottage industry. Forest Group had a patent covering stilts commonly used in construction and sued Bon Tool for infringement of its patent. Bon Tool counterclaimed, alleging that Forest Group falsely marked its stilts. The court found that (1) Bon Tool did not infringe; (2) Forest Group had falsely marked some of its stilts and fined it $500 for a single offense of false marking; and (3) the case was not exceptional, so the court did not award attorney fees. Bon Tool appealed the last two findings, and the Federal Circuit determined that the fine under the false marking statute applies to each article falsely marked, not the decision to mark as the district court had held. (The Federal Circuit affirmed the decision not to award attorney fees). On remand, the district court imposed a fine of $180 for each of the 38 stilts that were falsely marked. Thus, the case that lit the false marking industry on fire and resulted in thousands of subsequent lawsuits was ultimately over a $6,840 fine.

Forest Group Launches a Thousand Suits

From 2007 to 2009, only 47 false marking cases had been filed in federal courts, but after the December 28, 2009 decision in Forest Group, patent attorneys and litigants stormed court houses across the country, filing almost 1,500 cases in the next year and a half. Given the potential $500 per article fine, companies that mass produced products were understandably concerned about facing potentially huge liability for wrongly marking their products.

Because false marking is a qui tam action and the statute appeared to authorize anyone to file suit, there was no need for patent attorneys to find clients who had been actually injured by the alleged false marking. Instead, patent attorneys were filing suit on their own or creating their own corporations to file suit against alleged false markers. The lawsuits tended to focus on products that had expired patent numbers, rather than products that were marked with inappropriate, but still valid, patent numbers. The reason was obvious—there was no need to go through the costly exercise of proving that the patent did not cover the product when the patent had expired. One could immediately jump to the question of whether the product was falsely marked with the intent to deceive the public.

Two later decisions by the Federal Circuit only intensified the flames sparked by the Forest Group decision. In Pequignot v. Solo Cup Co., 608 F.3d 1356 (Fed. Cir. 2010), the Court confirmed that marking a product with an expired patent number fell within the scope of the false marking statute (although it affirmed the judgment against Pequignot because he could not prove that Solo Cup acted with an intent to deceive). And, in Stauffer v. Brooks Brothers, Inc., 619 F.3d 1321 (Fed. Cir. 2010), the Court confirmed that anyone had standing to bring suit under the false marking statute, even if they did not suffer any direct personal injury.

The Federal Circuit appeared to be showing no inclination to beat back this fire. All indications were that a new form of patent “trolling” litigation was here to stay.

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Federal Circuit Affirms District Court Limiting the Number of Claims a Patentee Can Assert–Stamps.com Inc v. Endicia, Inc.

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

In an interesting nonprecedential opinion issued this week in Stamps.com Inc. v. Endicia, Inc. (No. 10-1328), the Federal Circuit affirmed (among other things) the District Court’s decision to limit the number of claims a patentee could bring against an accused infringer. The Court held that the District Court did not abuse its discretion in arbitrarily limiting Stamps.com to asserting 15 claims against Endicia, as long as the District Court gave the patentee an opportunity to assert additional claims for good cause shown. While not a ground-breaking decision, the case is instructive for parties involved in litigating large numbers of patent claims.

The Case Below

Stamps.com sued Endicia for allegedly infringing 629 claims in 11 patents. Endicia moved the court to limit the number of claims, and the court agreed, limiting Stamps.com to 15 claims. The court did state, however, that it would remain flexible and revisit the limitation if Stamps.com could show good cause for needing to assert additional claims. The court then construed 10 claim terms in 15 claims from 7 patents. After briefing on summary judgment, the court invalidated the 7 claims.

Stamps.com then moved the court to pursue additional claims, which the court denied when it granted judgment for Endicia. Stamps.com appealed to the Federal Circuit, which affirmed and rejected Stamps.com’s challenge to the court’s 15-claim limitation, because of the “good cause” outlet the District Court provided.

Take Aways From This Case

This case confirms that trial courts have great discretion to manage their dockets, including limiting the number of claims that can be adjudicated, as long as the court provides some mechanism for a patentee to show good cause for adding additional claims. Thus, a defendant faced with allegations that it infringes hundreds or thousands of claims should consider moving the court to limit the number to a more manageable amount. At the same time, a patentee that finds itself limited to a subset of claims should take care to both choose the best claims to assert and be ready to show good cause for why additional claims may be necessary. Unfortunately, the Court did not identify what “good cause” would be sufficient to expand the number of claims asserted. Nonetheless, a patentee should begin to develop facts and arguments to be ready to use, if necessary.

Supreme Court to Consider Patentability of Natural Phenomena—Grants Cert in Mayo Collaborative Services v. Prometheus Laboratories

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

Yesterday, the Supreme Court granted cert in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (No. 10-1150) to address whether a patentee can monopolize basic, natural biological relationships. This case could have far-reaching effects for those patenting medical procedures and biological processes. In particular, the Court appears to be confronting the issue of what are the bounds of patentable subject matter with natural phenomena and processes. The specific question presented is:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

The Court previously began to consider this issue in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006), but dismissed the case for technical reasons. Three dissenting Justices (Breyer, Stevens, and Souter) and would have decided the case and held that such claims are not patentable subject matter because they cover a law of nature and a basic scientific relationship. The full Court will now consider this issue.

The Patent at Issue

At issue in Mayo Collaborative is Prometheus’s patent claim involving the treatment of autoimmune disorders by administering a drug and determining whether the dosage was appropriate based on an observed metabolite level in the patient. Once administered, the body automatically converts the drug into a metabolite, the amount of which determines whether the dosage was appropriate. Specifically, the claim reads:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Case Below

Defendant (Mayo) argued that this claim was invalid because it was not patentable subject matter–all it amounts to is administering a drug and observing a reaction. Prometheus did not try to patent the reaction, which is a naturally-occurring one. Mayo also argued that the claim was unpatentable as a matter of public policy because of its broad scope and the effect it would have on public health and research. In particular, Mayo argued that any doctor that administered a drug and saw the results may infringe the patent, even if the doctor never took any action based on the results.

The patent was held invalid in the District Court, but the Federal Circuit reversed, finding that the claims satisfied the “machine-or-transformation” test under 35 U.S.C. § 101. On its first appeal, the Supreme Court remanded so that the Federal Circuit could consider the then-recent decision in Bilski v. Kappos, 130 S. Ct. 343 (2010). On remand, the Federal Circuit again reversed the District Court, finding that the patent claims were not invalid. Mayo again petitioned the Supreme Court for cert, which was granted yesterday.

What This Case Means

This case should clarify the scope of patents, especially as they relate to biological and natural processes. In Bilski, the Court rejected the Federal Circuit’s prior “machine-or-transformation” test as being too rigid. It will be interesting to see if and how they revise or clarify that standard. In addition, the Court will likely have to address whether an idea that is not abstract can nonetheless be so broad as to be unpatentable on that basis (as opposed to being anticipated or obvious).

If the LabCorp decision is any guide, the Court (or at least Justice Breyer) will be particularly hostile to claims that appear to cover laws of nature, natural phenomena, and abstract ideas. In that case, which also involved a patent claim for correlating test results with a physical condition, Justice Breyer found the claim invalid because it simply patented a natural phenomenon, albeit in the cloak of the abstract patent language of a process. In addition, Justice Breyer was concerned about the chilling effect of patents like these on doctors and their patients.

Regardless of what the Court determines, this case should be particularly important for those in the biological and pharmaceutical markets and could have a large impact on what kinds of inventions and processes can be patented.

In re Klein–Federal Circuit Reverses Obviousness Rejection Because Non-Analogous Art Used

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

Last week, the Federal Circuit issued a rather interesting opinion in In re Klein, No. 2010-1411, reversing the Patent Office’s rejection of a hummingbird nectar mixer based on non-analogous art. The Court found that the five references were inappropriately used by the Patent Office because they were not analogous art and therefore not prior art under § 103.

What makes this case interesting is the fact that the invention in question, basically a cup with a moveable divider in it, is such a simple device. Under KSR, one would expect that such a simple mechanical device would be particularly vulnerable to obviousness challenges. In addition, the patentee included a purpose clause in his preamble, which many practitioners now avoid. By doing so though, it turned out to narrow the scope of his claim and protect him from the art cited against him by the Patent Office.

The Application

Mr. Klein applied for a patent on a device for mixing nectar for hummingbirds, orioles, and butterflies. The device (shown below) is basically a cup with a moveable divider. One side is filled with water, and the other with sugar. By moving the divider, the ratio of water to sugar changes creating nectars better suited for different animals.

The only independent claim recited:

21. A convenience nectar mixing device for use in preparation of sugar-water nectar for feeding hummingbirds, orioles or butterflies, said device comprising:

a container that is adapted to receive water,

receiving means fixed to said container, and

a divider movably held by said receiving means for forming a compartment within said container, wherein said compartment has a volume that is proportionately less than a volume of said container, by a ratio established for the formulation of sugar-water nectar for humming-birds, orioles or butterflies, wherein said compartment is adapted to receive sugar, and wherein removal of said divider from said receiving means allows mixing of said sugar and water to occur to provide said sugar-water nectar.

The particular nectar ratios used were admittedly well-known and not novel.

Only Analogous Art Can Be Used Under § 103 for Obviousness Determinations

The Court noted that “[a] reference qualifies as prior art for an obviousness determination under § 103 only when it is analogous to the claimed invention.” There are two separate tests for determining what defines the scope of analogous art:

  1. “whether the art is from the same field of endeavor, regardless of the problem addressed” and,
  2. “if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.”

The issue in this case was the second test—what is reasonably pertinent to the particular problem—because the cited references were clearly not in the same field of endeavor.

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W.D. Pennsylvania District Court Selected to Participate in Patent Pilot Program

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

wd-pa-courthouseOn June 8, 2011, Chief Judge Gary L. Lancaster announced that the Administrative Office of the U.S. Courts selected the U.S. District Court for the Western District of Pennsylvania to be one of 14 Districts Courts to participate in a 10-year Patent Pilot Program. As part of this program, the Courts will funnel the majority of patent cases to designated patent judges in each district with the intention of providing litigants with Judges that have special training and interest in hearing these cases. As the U.S. Court press release stated:

“In the pilot program, patent cases filed in participating district courts are initially randomly assigned to all district judges, regardless of whether they have been designated to hear such cases.  A judge who is randomly assigned a patent case and is not among the designated judges may decline to accept the case. That case is then randomly assigned to one of the district judges designated to hear patent cases.”

The Administrative Office selected Courts with an established history and interest in patent litigation and those with local patent rules already in place (the Western District of Pennsylvania implemented its local patent rules back on April 1, 2005). The fourteen District Courts selected by the Director of the Administrative Office of the United States Courts were:

  • Eastern District of New York
  • Southern District of New York
  • Western District of Pennsylvania
  • District of New Jersey
  • District of Maryland
  • Northern District of Illinois
  • Southern District of Florida
  • District of Nevada
  • Eastern District of Texas
  • Northern District of Texas
  • Western District of Tennessee
  • Central District of California
  • Northern District of California
  • Southern District of California

The Western District of Pennsylvania’s participation in this pilot program, along with its local patent rules already in place, reinforces that Pittsburgh is an attractive venue for litigants wishing to resolve patent disputes.

Supreme Court Affirms Clear and Convincing Standard for Proving Invalidity in Microsoft v. i4i Decision

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

Today, the Supreme Court confirmed that parties challenging the validity of a patent have the burden to prove invalidity by clear and convincing evidence. Justice Sotomayor delivered the unanimous opinion for the Court in its decision in Microsoft Corp. v. i4i Limited Partnership (No. 10-290), which affirmed the Federal Circuit. Justice Breyer filed a concurring opinion, and Justice Thomas filed an opinion concurring in judgment. Chief Justice Roberts took no part in the decision.

Circumstances Below

By statute (35 U.S.C. § 282), patents are presumed valid, based, in part, on the deference shown to the Patent Office in examining patents. In the underlying case, Microsoft challenged the validity of the patent using a reference never considered by the Patent Office when examining the patent. Microsoft argued that the presumption of validity did not mean that it needed to prove invalidity by clear and convincing evidence, especially in these circumstances. Both the district court and the Federal Circuit disagreed, finding under long-established precedent that those challenging the validity of a patent must prove invalidity by clear and convincing evidence in all circumstances.

Microsoft’s Arguments For a Preponderance of the Evidence standard

At the Supreme Court, Microsoft argued that the Court should adopt one of two standards, either (1) accused infringers need only prove invalidity by a preponderance of evidence or (2) a hybrid approach where accused infringers need to prove invalidity by clear and convincing evidence for those references considered by the Patent Office but only by a preponderance of the evidence for anything else. The Supreme Court strongly rejected both approaches and affirmed the clear and convincing standard in all circumstances.

The Supreme Court’s Analysis

Tracing the history of patent law in the United States, the Court noted that it had previously considered the standard of proof in its decision in Radio Corp. of America v. Radio Engineering Laboratories, Inc., 293 U.S. 1 (1934). In that decision, Justice Cardozo stated that “there is a presumption of validity, a presumption not to be overthrown except by clear and cogent evidence.” This common-law understanding was well-rooted by the time that Congress enacted § 282, which declared that patents are presumed valid.

The Court also found persuasive how Congress reacted to the courts on this point. In 1984, the Federal Circuit recognized the clear and convincing standard of proof in its decision in American Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350 (Fed. Cir. 1984), and, in the nearly thirty years since that decision, consistently reaffirmed this standard of proof. Despite amending the patent act numerous times since the American Hoist decision, Congress never expressed disapproval with the Federal Circuit’s decisions, which indicated to the Court that Congress agreed with this standard.

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Supreme Court Clarifies Rights Under Bayh-Dole Act in Stanford v. Roche Decision

by: Robert Wagner, intellectual property attorney at Picadio Sneath Miller & Norton, P.C.

Today, the Supreme Court announced its decision in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems, Inc. (No. 09-1159) involving the rights of parties to inventions under the Bayh-Dole Act (also known as the University and Small Business Patent Procedures Act of 1980, 35 U.S.C. § 200 et seq.). Chief Justice Roberts wrote the decision for a 7-2 court, in which the Court confirmed that invention rights are held by individuals and held that the Bayh-Dole Act does not by itself automatically void ab initio an inventor’s rights in government-funded inventions. Justice Sotomayor concurred and Justices Breyer and Ginsburg dissented.

The Court first traced the history of the Bayh-Dole Act. “The Bayh-Dole Act applies to subject inventions ‘conceived or first actually reduced to practice in the performance of work’ ‘funded in whole or in part by the Federal Government.’”  The Court stated that “The Bayh-Dole Act does not confer title to federally funded inventions on contractors or authorize contractors to unilaterally take title to those inventions; it simply assures contractors that they may keep title to whatever it is they already have.” Contractors in this context means the university or agency receiving federal funding, not the employees of such entities. “Only when an invention belongs to the contractor does the Bayh-Dole Act come into play. The Act’s disposition of rights—like much of the rest of the Bayh-Dole Act—serves to clarify the order of priority of rights between the Federal Government and a federal contractor in a federally funded invention that already belongs to the contractor. Nothing more.” The Court clarified that a university would not obtain title to an employee’s invention simply because some amount of federal funding was used during conception or reduction to practice. Rather, the contractor must first obtain the rights to the invention from its employee, which should be standard practice.

The Court affirmed the Federal Circuits decision finding that Stanford University lacked standing to sue Roche for patent infringement because the researcher in question (Dr. Mark Holodniy) had assigned his rights to Cetus, which Roche later acquired, and the Bayh-Dole Act did not give Stanford University the right to trump that assignment. By only obtaining an agreement from Dr. Holodniy to assign his rights, rather than an actual assignment, Stanford could not use the Bayh-Dole Act to trump that assignment.

One of the key insights to glean from this decision may involve an issue that the Court expressly declined to consider. As stated above, when Dr. Holodniy began working with Stanford University, he agreed to assign his rights in any inventions made using Stanford’s funding to the University. He did not actually assign the rights to the University, however. Instead, he assigned them later to Cetus. The Federal Circuit, based on its precedent in FilmTec Corp. v. Allied-Signal, Inc., 939 F.2d 1568 (Fed. Cir. 1991), determined that the language in his agreement with Stanford (“agree to assign,” rather than “do hereby assign”) was only a promise to assign rights in the future and did not act as an actual assignment of these rights. This particular issue was not appealed by Stanford, so it was not addressed in the briefs or explicitly considered by the Court. In his dissent, however, Justice Breyer strongly indicated that this rule is questionable, at best, and suggested that the Court remand for the Federal Circuit to consider this rule more carefully. Justice Breyer’s dissent suggests that the Court will be taking this question up in the future. For now, though, practitioners should carefully consider employee or contractor assignment provisions to make sure that they are drafted so as to assign the rights immediately, and not act simply as a promise to assign them later.