Category Archives: United States Supreme Court

The Battle Over the Seeds Continues

by: Kelly A. Williams, a shareholder at Picadio Sneath Miller & Norton, P.C.

SeedsA coalition of famers, seed sellers, and agricultural organizations that challenged Monsanto’s patents on genetically-modified seeds is appealing a decision of the Federal Circuit on June 10, 2013 to the U.S. Supreme Court in Organic Seed Growers and Trade Asss’n v. Monsanto Co. (The petition for a writ of certiorari may be found here).  The plaintiffs filed a declaratory judgment action seeking a ruling of non-infringement and invalidity of Monsanto’s genetically modified seed patents. These are the same patents that Monsanto successfully enforced in Bowman v. Monsanto, which was decided by the U.S. Supreme Court on May 13, 2013. The Federal Circuit held that there was no justiciable case or controversy because Monsanto had made binding assurances that it would not take legal action against growers whose crops might inadvertently contain traces of Monsanto biotech genes, and the plaintiffs fell within this group.

Supreme Court Holds That Reverse Payments May Give Rise to Antitrust Violations

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

SupremeCourtImage_1Today, the United States Supreme Court in a 5-3 decision authored by Justice Breyer in Federal Trade Commission v. Actavis, Inc., No. 12-416, held that reverse payments by a patent holder to an accused infringer to settle a patent infringement lawsuit may implicate antitrust concerns and may be actionable. The Court declined to find that such payments are either per se actionable or immune from the antitrust laws. Instead, such payments must be analyzed under a “rule of reason” approach.

The case arose out of a “paragraph IV” patent infringement lawsuit brought by a pharmaceutical manufacture (Solvay Pharmaceuticals) against a generic manufacturer (Actavis). Solvay  filed a New Drug Application in 1999 for a brand-name drug called AndroGel that is used in testosterone replacement therapy. In 2003, Solvay obtained a patent covering the drug, which was disclosed to the FDA. Later in 2003, Actavis filed an Abbreviated New Drug Application for a generic equivalent to AndroGel, and asserted, under paragraph IV of the Hatch-Waxman Act, that it did not infringe Solvay’s patent because the patent was invalid and it did not infringe. Solvay promptly filed suit alleging infringement under 35 U.S.C. § 271(e)(2)(A).

In 2006, the parties settled the litigation. Actavis agreed to not bring its generic drug to market until 2015 (which was 65 months prior to the expiration of Solvay’s patent) and to promote AndroGel to urologists. In return, Solvay agreed to pay Actavis $19–$30 million annually for nine years. Solvay reached similar agreements with other generic manufacturers.

The Federal Trade Commission found that the settlements were designed primarily to limit competition in the marketplace. In essence, Solvay was simply paying the generic manufacturers to stay out of the marketplace, which would have the side effect of increasing prices for consumers. The FTC then brought an antitrust lawsuit against the drug manufacturers.

The District Court found that the FTC’s allegations did not state a claim under the antitrust laws and dismissed the case. The Eleventh Circuit affirmed. They held that absent an allegation of sham litigation, it was not an antitrust violation to reach these kinds of settlements when the restrictions expired prior to the expiration of the patent in question.

Justice Breyer, writing for the majority, disagreed with the Eleventh Circuit’s blanket rule based on the expiration date of the patent. Instead, the Court held that courts must use a “rule of reason” approach and consider the purpose behind the settlement before they can determine whether the settlements run afoul of the antitrust laws.

In reaching this conclusion, the Court considered that the patent may, in fact, not be valid, and there is a strong public interest in removing invalid patents that is frustrated if these kinds of settlements are allowed. The Court also considered the unusual nature of these settlements—where a patent holder pays substantial amounts to the accused infringer. This was not a case where the two parties met in the middle on a settlement figure or where the accused infringer had more valuable counterclaims. Finally, the legislative history behind the Hatch-Waxman Act suggested that Congress was not attempting to justify settlements like these.

The Court also considered the countervailing interest of encouraging settlements and allowing parties to reach mutually-agreeable resolutions. Despite that important interest, the Court was not willing to create blanket immunity for these kinds of settlements. It was concerned that these settlements have a very real potential to hinder competition.

The Court will also quick to note that it would not hold such reverse payment settlements as per se violations. It recognized that some reverse payments may be justified because they save litigation costs, allow for increased distribution of the drug, or will help develop new markets. In the end, the relevant question for antitrust purposes is why did the parties enter the agreement? “If the basic reason is a desire to maintain and to share patent-generated monopoly profits, then, in the absence of some other justification, the antitrust laws are likely to forbid the arrangement.”

The Court then remanded the case back for further proceedings. Justices Breyer wrote the opinion of the Court and was joined by Justices Kennedy, Ginsburg, Sotomayor, and Kagan. Chief Roberts dissented and was joined by Justices Scalia and Thomas. Justice Alito took no part in the decision.

Supreme Court Rules That Genes Are Not Patentable Subject Matter

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

SupremeCourtImage_1Today, the United States Supreme Court unanimously ruled in Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, that a naturally-occurring DNA segment (or gene) is not patent eligible even if it has been isolated from a genome (reversing the Federal Circuit). The Court also ruled that cDNA (complementary DNA) is patent eligible because it is not naturally occurring (affirming the Federal Circuit). Justice Thomas wrote the opinion for the unanimous Court, and Justice Scalia wrote a short concurrence. We have been following this case for some time (see herehere, and here).

The Court began by restating its position that laws of nature, natural phenomena, and abstract ideas are not patentable subject matter under 35 U.S.C. § 101. The question for the Court was whether Myriad’s patents claimed any new and useful composition of matter.

To answer this question, the Court looked at what Myriad claimed. With respect to the DNA claims, Myriad claimed the DNA segment it found in nature, and it did not change or alter any of the genetic information in that segment. Because it claimed something naturally found in nature, it was not patent eligible subject matter.

With respect to the cDNA claims, the Court reached a different result. The cDNA is not found in nature, but is created in the laboratory. This key difference meant that it was patent eligible subject matter. The Court did not address whether these claims met the other requirements of the patent statute, such as §§ 102, 103, and 112.

The Court was also very clear on what it was not deciding in this case. There were no method claims at issue, such as an innovative method for manipulating genes. Similarly, there were no  claims directed to how this new knowledge might be applied to achieve some useful result. The Court suggested (without holding) that those types of claims would be patent eligible. Finally, it noted that the claims were not directed to naturally occurring genetic code that had been altered to create some new and not natural DNA. The Court refused to suggest how it might address claims like those.

In the end, the Court stated that “[w]e merely hold that genes and the information they encode are not patent eligible under § 101 simply because they have been isolated from the surrounding genetic material.”

Supreme Court to Hear Argument on Patent Licensee’s Burden of Proof

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By: Joe Carnicella, intellectual property attorney with Picadio Sneath Miller & Norton, P.C.

On May 20, 2013, the United States Supreme Court granted cert. to hear argument on whether, in a declaratory judgment action brought by a licensee, the licensee has the burden to prove that its products do not infringe the patent, or whether the patentee must prove infringement.

Medtronic Inc. (licensee) licensed a patent from Mirowski Family Ventures LLC (patentee / licensor) relating to a device used to stop imminent heart failure.  Medtronic subsequently created new products and then filed a declaratory judgment action claiming that its new products do not infringe the patent.  The Federal Circuit Court of Appeals held that Medtronic bears the burden of proving that its products do not infringe Mirowski’s patent.

Medtronic has requested that the U.S. Supreme Court overturn the Federal Circuit’s ruling, which Medtronic has argued is inconsistent with the Supreme Court’s decision in MedImmune, Inc. v. Genetech, Inc., 549 U.S. 118 (2007).  In MedImmune, the Supreme Court ruled that a patent licensee that believes that its products do not infringe the patent is “not required . . . to break or terminate its . . . license agreement before seeking a declaratory judgment in federal court that the underlying patent is . . . not infringed.”  According to Medtronic, the Federal Circuit’s opinion undercuts the MedImmune decision because it causes a licensee to take on the significant burden and cost of a presumption that its products infringe.

In turn, Mirowski has argued that this case is distinguishable from MedImmune because the licensing agreement at issue specifically required Medtronic to file a declaratory judgment action if a dispute arose.  Mirowski believes that the Federal Circuit correctly decided that, based specifically on the contract terms between the parties, Medtronic should bear the burden of proving that it should be let out of the contract for the new products.

U.S. Supreme Court Rejects Farmer’s Patent Exhaustion Defense in Monsanto Patent Infringement Suit

by: Kelly A. Williams, a shareholder at Picadio Sneath Miller & Norton, P.C.

SupremeCourtImage_1In Bowman v. Monsanto Co., the U.S. Supreme Court held that the patent exhaustion doctrine did not permit a farmer to reproduce patented seeds them through planting and harvesting.

Monsanto invented and patented a genetic modification that enables soybean plants to survive the application of many herbicides, including Monsanto’s Roundup.  Thus, farmers using these seeds can use certain herbicides to kill weeds without damaging their crops.  The seeds are known as “Roundup Ready” seed.

Monsanto requires growers who purchase the seed to sign a special licensing agreement that permits the grower to plant the purchased seeds in one, and only one, season.  The growers are prohibited from saving any of the harvested soybeans for replanting or giving them to anyone else for that purpose.   Consequently, a grower must buy seeds from Monsanto each season.

Bowman, an Indiana farmer, purchased the patented seeds each year for his first crop of the season, and in accordance with the license agreement, he used all of that seed for planting.  He then sold his entire crop to a grain elevator.  However, Bowman also planted a second crop of each season.  Because he believed late-season planting was risky, he did not want to pay the premium price for the Roundup Ready seeds.  He therefore went to a grain elevator, and purchased “commodity soybeans” intended for human or animal consumption and planted them.  Most of these commodity soybeans were grown from the Roundup Ready seeds.  When Bowman applied a herbicide, most of the new plants survived the treatment and produced a new crop of soybeans with the Roundup Ready trait.   Bowman saved the seed from that crop to plant his second crop the following year.  Bowman did this for eight growing seasons.  Monsanto found out and sued Bowman for patent infringement.

Bowman raised patent exhaustion as a defense, arguing that Monsanto could not control his use of the soybeans because they were the subject of a prior authorized sale from the grain elevator.  The Supreme Court rejected Bowman’s argument.  The court reasoned that the patent exhaustion doctrine, which provides that the initial authorized sale of a patented item terminates all patent rights in them, does not permit a buyer to make new copies of the patented item.  A second creation of the patented item calls the patent “monopoly” in play for a second time.  Here, Bowman was reproducing Monsanto’s patented invention, and the court held that the exhaustion doctrine did not protect him.  To hold otherwise, the Supreme Court explained, would result in Monsanto having a patent with little benefit because farmers could buy the seed only once and reproduce it.

Bowman tried to argue that seeds were special in that they were naturally self-replicating and that it was the soybean, not Bowman himself, that made the replicas of Roundup Ready seeds.  The court was not convinced by this “blame-the-bean” defense because Bowman was not a passive observer of his soybeans’ multiplication, having devised a novel way to replicate seeds from the soybeans.

The Supreme Court stressed that its holding was limited to addressing the specific situation before it, rather than other self-replicating products in the market.  The court recognized “that such inventions are becoming ever more prevalent, complex, and diverse.  In another case, the article’s self-replication might occur outside the purchaser’s control.  Or it might be a necessary but incidental step in using the item for another purpose . . . .  We need not address here whether or how the doctrine of patent exhaustion would apply in such circumstances.”

Thus, the Supreme Court did not use the Monsanto case as an opportunity to give any kind of broad guidance on the patent exhaustion defense as it applies to self-replicating products.  This guidance will have to await another day.

Are Human Genes Patentable?–Association for Molecular Pathology v. Myriad Genetics

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

Supreme CourtYesterday, the United States Supreme Court heard oral argument on a key patent issue—are human genes patentable subject matter? In the Association for Molecular Pathology v. Myriad Genetics, Inc., (No. 12-398), the Supreme Court granted certiorari to decide this issue, which will have a profound impact on the medical research and pharmaceutical industries. (For a complete list of the issues presented, see here). This post follows up on our earlier post discussing the Court’s decision to grant cert.

In this case, Myriad Genetics identified and isolated a human gene that could be used to help predict a patient’s genetic predisposition to breast and ovarian cancers. Myriad then obtained a patent on, among other things, cDNA molecules associated with the relevant genes, as well as the use of the molecule to  probe a patient’s DNA and to prime the production of the patient’s DNA in the laboratory. (The parties’ briefs explaining the details of the patented claims can be found here). Myriad then created a test that could be used on patients to help assess whether they were more likely to be predisposed to certain kinds of breast and ovarian cancers.

After creating the tests and obtaining the patent, Myriad sent letters to various researchers, informing them of the patent rights and requesting that they refrain from infringing. As a result, numerous researchers ceased working in this area. A number of researchers and institutions filed a declaratory judgment action, seeking a determination, among other things, that the patents were invalid.

The Federal Circuit, in a split decision with each Judge writing separately, held that human genes are patentable subject matter. The Association filed a writ of certiorari challenging this decision, which the Supreme Court granted. Oral arguments were held on April 15, 2013, and a transcript can be found here.

While it is always difficult to predict how the Supreme Court will rule, there are some aspects that appeared to concern the Court more than others.  First, the Justices probed the parties for where and how lines should be drawn about what is a product of nature that should not be patented and what is the result of human intervention. This is the heart of the question presented and what they were struggling to define. Ultimately, the Court seemed more inclined to uphold the patent claims associated with the cDNA, as they involved more human intervention, but we will have to wait to see what they actually do.

Second, the Court  questioned whether striking these kinds of patents  would eliminate the incentives for inventors to invest the time and money in developing these kinds of tests and treatments. There was some concern that eliminating these kinds of patents could hinder innovation. On the other hand, counsel for the Association argued that allowing these kinds of patents actually creates a disincentive, as many researchers and companies will not invest any time and money for fear of being sued (which is what happened here).

The transcript of the oral argument makes for a fascinating read. What will be more interesting is reading the ruling. We expect a decision sometime later this summer.

For more analysis on the oral arguments, see here.

 

U.S. Supreme Court Interprets the “First Sale” Doctrine

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By: Joe Carnicella, intellectual property attorney with Picadio Sneath Miller & Norton, P.C.

On March 19, 2013, in Kirtsaeng v. Wiley & Sons, Inc., No. 11-697, the U.S. Supreme Court held that the “first sale” doctrine applies to copies of a copyrighted work lawfully made abroad.  Specifically, a buyer or other lawful owner of a copy (of a copyrighted work) lawfully manufactured abroad is protected under the “first sale” doctrine and such buyer may bring that copy into the United States (and sell it or give it away) without obtaining permission to do so from the copyright owner.

Section 106 of the Copyright Act grants the owner of copyright exclusive rights including the right to distribute copies of the copyrighted work to the public by sale or other transfer of ownership.  One limitation on these exclusive rights falls under Section 109(a) of the Copyright Act (commonly referred to as the “first sale” doctrine), which provides that the owner of a particular copy lawfully made under this title is entitled, without the authority of the copyright owner, to sell or otherwise dispose of the possession of that copy.  Thus, once a copy has been lawfully sold or its ownership otherwise lawfully transferred, the buyer of that copy and subsequent owners are free to dispose of the copy as they wish.  Section 602(a)(1) further provides that importation into the United States, without the authority of the owner of copyright under this title, of copies of a work that have been acquired outside the United States is an infringement of the exclusive rights to distribute copies under Section 106.

Wiley & Sons publishes academic books and assigns rights to publish, print and sell the English language textbooks abroad to its wholly owned foreign subsidiary.  Supap Kirtsaeng, while studying in the United States, asked his friends and family to purchase copies of foreign edition English-language textbooks at Thai book shops, which sold the books at low prices, and to mail the books to him in the United States, wherein he used the books, sold them, reimbursed his family and friends and kept the profit.

In 2008, Wiley initiated a lawsuit against Kirtsaeng for copyright infringement on the grounds that Kirtsaeng’s unauthorized importation of its books and his later resale of those books amounted to an infringement of Wiley’s Section 106(3) exclusive right to distribute as well as the Section 602 related import prohibition.  Kirtsaeng defended against the claim on the ground that the books he had acquired were “lawfully made” and that he had acquired them legitimately.  His position was that the “first sale” doctrine under Section 109(a) permitted him to resell or otherwise dispose of the books without the copyright owner’s further permission.  The District Court ruled that the “first sale” defense was not available to Kirtsaeng because the doctrine does not apply to “foreign-manufactured goods.”  The Second Circuit agreed with the District Court.

The Court analyzed the language within these statutes, and in particular the phrase “lawfully made under this title.”  Wiley argued that the phrase imposes a form of geographical limitation and that the “first sale” doctrine does not apply to copies of American copyrighted works manufactured abroad.  Kirtsaeng argued that the phrase imposes a non-geographical limitation, and in particular, that the intention was for the phrase to mean “made in accordance with” or “in compliance with the Copyright Act.”  In this case, Kirtsaeng asserted that the “first sale” doctrine would apply to copyrighted works as long as their manufacture met the requirements of American copyright law, e.g. copies manufactured abroad with the permission of the copyright owner.  The Court considered the language of Section 109(a), its context and the common-law history of the “first sale” doctrine and concluded that Section 109(a) favors a non-geographical interpretation.  The U.S. Supreme Court determined that, while Section 602(a)(1) makes clear that importing a copy without permission violates the owner’s exclusive distribution right, it also refers explicitly to Section 106(3), which is by its terms is subject to various limitations including the “first sale” limitation under Section 109(a).

A complete copy of the Court’s Opinion can be found on the United States Supreme Court’s website.

Supreme Court Decides Gunn v. Minton Patent Legal Malpractice Case – State Court It Is

Authored by Henry M. Sneath, Esq.  – Chair of the Intellectual Property Practice Group at Picadio Sneath Miller & Norton, P.C. , Pittsburgh, Pa.

Sneath, Henry 2012 headshotToday – The US Supreme Court in Gunn v. Minton decided that a patent legal malpractice case is properly brought in state court. The court held that even though the “case within a case” standard would require interpretation of a patent and other typically Federal Issues, that “case within a case” is a hypothetical case, that does not need to be in Federal Court.  Further the court wrote:

“Because of the backward-looking nature of a legal malpractice claim, the question is posed in a merely hypothetical sense: If Minton’s lawyers had raised a timely experimental-use argument, would the result in the patent infringement proceeding have been different? No matter how the state courts resolve that hypothetical “case with a case,” it will not change the real-world result of the prior federal patent litigation. Minton’s patent will remain invalid.

Nor will allowing state courts to resolve these cases undermine “the development of a uniform body of [patent] law. … Congress ensured such uniformity by vesting exclusive jurisdiction over actual patent cases in the federal district courts and exclusive appellate jurisdiction in the Federal Circuit. … In resolving the non-hypothetical patent questions those cases present, the federal courts are of course not bound by state court case-within-a-case patent rulings. … In any event, the state court case-within-a-case inquiry asks what would have happened in the prior federal proceeding if a particular argument had been made. In answering that question, state courts can be expected to hew closely to the pertinent federal precedents. It is those precedents, after all, that would have applied had the argument been made.”

We previously reported on this case and will follow for any interesting cases which actually try one of these malpractice cases in state court. Here is the opinion delivered by Chief Justice Roberts: http://tinyurl.com/a474okm

Supreme Court Hears Argument on Patent Legal Malpractice Case

Supreme CourtYesterday the US Supreme Court heard oral argument  in Gunn v. Minton (No. 11-1118, U.S. Sup) where the issue is the long debated question of proper jurisdiction for patent law legal malpractice cases. For more background, please see a December 3, 2012 post by my colleague Kelly Williams in this blog and to read the Amicus brief filed by the AIPLA.  Read the transcript of yesterday’s Supreme Court oral argument here: http://www.supremecourt.gov/oral_arguments/argument_transcripts/11-1118.pdf    The central question is whether legal malpractice claims against attorneys representing the inventors, for failing to raise an “experimental use” defense to the “on-sale bar” doctrine, constituted a question of exclusive state law, or one of exclusive federal jurisdiction and law – like traditionally all Patent Law issues.  The issue turns on whether such a state court claim can create or affect Federal patent rights. Our friends at Lexis-Nexis have summarized the oral argument and issues at this link: http://t.co/GaRLnbwN

We will follow this case closely: For more information, please contact Henry M. Sneath, Esq. chair of the Intellectual Property Group at Picadio Sneath Miller & Norton, P.C. in Pittsburgh, Pa. 412-288-4013 or hsneath@psmn.com  Firm Website: www.psmn.com  Blog at: www.pitiptechblog.com or follow him on Twitter @picadiosneath