The U.S. Supreme Court’s May 22, 2017 ruling in TC Heartland v. Kraft Foods held that personal jurisdiction alone does not convey venue for patent cases under the patent venue statute. Previously, the Court of Appeals for the Federal Circuit and the United States district courts had interpreted the patent venue statute, 28 U.S.C. §1400(b), to allow plaintiffs to bring a patent infringement case against a domestic corporation in any district court where there is personal jurisdiction over that corporate defendant. Specifically, the patent venue statute provides that “[a]ny civil action for patent infringement may be brought in either 1) the judicial district where the defendant resides” or 2) “where the defendant has committed acts of infringement and has a regular and established place of business.” But, TC Heartland, held that a domestic corporation resides only in its state of incorporation for purposes of the patent venue statute, and not just anywhere it is subject to personal jurisdiction as had previously been the case. 

However, TC Heartland did not address the second prong of § 1400(b), which makes venue proper in any judicial district where: (1) the defendant has a regular and established place of business, and (2) has committed acts of infringement. Post TC Heartland, a number of district courts and the Federal Circuit have weighed in on what constitutes a regular and established place of business under the second prong of § 1400(b). But, few courts have considered what is required to satisfy the second requirement, namely committing acts of infringement sufficient to establish venue.

Thus, it is notable that the U.S. District Court for the Eastern District of Texas, in Snyders Heart Valve LLC v. St. Jude Medical SC, Inc. et al, 4-16-cv-00812 (TXED March 7, 2018, Order), recently had to determine whether, under the second prong of § 1400(b), sufficient infringement occurred in the District to establish venue. The specific issue in the case turned on whether all sales of the accused products in the District were subject to the safe harbor provided in 35 USC § 271(e)(1). The safe harbor provided by § 271(e)(1) extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the Federal Food, Drug, and Cosmetic Act of 1938. In other words, if all of Defendants’ challenged activities in the District are covered by the safe harbor, there can be no acts of infringement in the District, and venue is thus improper.

The Plaintiff argued that the safe harbor under § 271(e)(1) is irrelevant for purposes of determining whether venue is proper, and that its allegations of infringing activity in the District—as required under §1400(b)—are sufficient. Plaintiff also argued that because the clinical trial safe harbor is all or nothing, Defendants’ commercial activity outside this District effectively revokes the safe harbor protection for activities inside the District.

The District Court first considered Plaintiff’s argument that the safe harbor defense is irrelevant to venue under § 1400(b). Plaintiff argued its mere allegation of infringing acts in the District make venue proper under § 1400(b). The Court rejected this argument, reasoning both the venue statute and the safe harbor statute speak of “acts of infringement,” not acts of “alleged” infringement. The Court continued, “if Plaintiff were right, any venue limitation could be overcome by simply making infringement accusations in the forum of the plaintiff’s choice, regardless of the defendant’s actual activities in that particular forum. This is contrary to law. Once the defendant comes forward with evidence that venue is improper, the plaintiff cannot rely on mere venue allegations in its complaint to maintain its chosen venue.” The Court then found the Plaintiff has not alleged any facts showing activities in this District other than those statutorily exempted from infringement by safe harbor under § 271(e)(1).

Next, the Plaintiff argued the safe harbor defense is “all or nothing” and to the extent Defendants make and sell accused products elsewhere in the United States for commercial purposes, such uses are not “solely for uses reasonably related” to seeking FDA approval and Defendants are not entitled to any exemption at all under § 271(e)(1). The Court also rejected this argument, reasoning the Federal Circuit has made clear that for purposes of the safe harbor, each accused activity must be analyzed separately. The Court noted a two-part test under the safe-harbor analysis: “(1) whether the activity at issue is a potentially infringing one; and (2) whether the exemption applies to that activity.” Therefore, some of the accused products could fall within the safe harbor, while some of could not, even though the accused products were all of the same group. Thus, the Court found all acts of infringement in the Eastern District of Texas are solely clinical, and therefore, the § 271(e)(1) safe harbor applies despite purported nonexempt activity in Minnesota. The Court concluded that since there are no material factual questions on challenged activities remaining, summary judgment on the safe harbor issue is proper, and this renders venue in the District deficient.

Although this case concerned a specific statutory exemption to infringement, namely the safe harbor under § 271(e)(1), its reasoning could have broader implications in the on-going evolution of venue in patent litigation cases post TC Heartland. In addition to challenging whether it has a regular and established place of business in the District, defendants may also begin challenging a plaintiff’s bare-bones allegations that the defendant has committed acts of infringement in the District. And, District Courts may begin to require plaintiffs to show actual acts of infringement in the District by Defendant in order to maintain venue.

There is some confusion about what constitutes an “on-sale bar” in patent law. The on-sale bar, set forth in 35 U.S.C §102, prohibits a patent if the invention sought to be patented was offered for sale or sold more than one year before the patent application was filed. In other words, there is a one-year grace period after an offer for sale or sale in which a patent application may be filed. The earliest date of an offer of sale or sale is the critical date, often referred to as the “statutory bar date.” The reason for the on-sale bar is that once an invention is offered for sale, it is in the public domain, and no one should be able to patent something in the public domain. 

If a patent issues and it is later found that there was an offer for sale or sale of the invention more than one year before the patent application was filed, the patent can be invalidated. The on-sale bar can be raised as a defense in patent infringement litigation to challenge the validity of the patent and it can be raised in a separate challenge to a patent’s validity.

Both the 2013 America Invents ACT (AIA) and the pre-AIA law include the on-sale bar in §102. Under pre-AIA §102(b), a patent is barred if the invention was on sale in the United States more than one year before the filing date of the patent application. The statutory bar applies regardless of whether the sale was public or secret. Under AIA §102(a)(1), the language of the statutory bar is different; a patent is barred if the invention was on-sale “or otherwise available to the public…” more than one year before the filing date of the patent application. Thus, the AIA broadened the scope of the on-sale bar to cover offers for sale and sales anywhere in the world, rather than just in the United States. However, the phrase “or otherwise available to the public…” created an ambiguity by implying that the on-sale bar only applies to public sales.

In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2017), the Federal Circuit Court of Appeals considered the on-sale bar, but did not resolve the ambiguity. Helsinn owned four patents covering a drug used to prevent nausea in patients undergoing chemotherapy. In 2001, Helsinn entered into a supply and purchase agreement with a pharmaceutical company, MGI. The parties announced the agreement in a press release and MGI filed a redacted copy of the agreement (excluding the price and the dosage terms) with the SEC. At the time the agreement was entered into, the drug was undergoing clinical trials and had not yet been approved by the FDA. In 2003, Helsinn filed a provisional patent application for the drug. In 2005 and 2006, Helsinn filed three utility applications claiming priority to the provisional, and, in 2013 filed one utility application claiming priority to the provisional. In 2011, Teva, a competitor of Helsinn, filed a new drug application in the FDA seeking approval of a generic version of Helsinn’s drug.

Helsinn sued Teva for patent infringement. Teva argued that all four patents were invalid based on the on-sale bar because Helsinn had entered into the supply and purchase agreement with MGI in 2001, over one year before the provisional application’s filing date in 2003. The trail court ruled in favor of Helsinn, holding that the on-sale bar did not apply. Teva appealed to the Federal Circuit.

The Federal Circuit explained that there is a two-part test for whether the on-sale bar applies. First, there must be a commercial offer for sale or a sale of the invention sought to be patented. Second, the invention must be “ready for patenting.” Pfaff v. Wells Electronics, Inc., 525 U.S. 55 (1998).

The court analyzed whether the Pfaff on-sale bar test was met. Three of the patents were governed by pre-AIA §102(b); one patent was governed by AIA §102(a)(1).

The court addressed whether the first part of the Pfaff test was met: whether there was a commercial offer for sale or sale more than one year before the patent application was filed. As for the three patents governed by pre-AIA §102(b), the court found that there was an offer for sale to MGI and that Helsinn had also marketed its drug to others. The court rejected Helsinn’s argument that there was no sale because FDA approval was a condition precedent to the actual sale, and there was no FDA approval at the time of the agreement with MGI. The court held that the need for regulatory approval or the existence of other conditions precedent do not mean that there is no contract for sale.

As to the one patent governed by the AIA, the court acknowledged that in enacting AIA §102(a)(1), members of Congress stated that the new §102 on-sale bar would apply only to sales in which the invention was made public, not to confidential sales as does pre-AIA §102. However, the court found that MGI’s filing of the supply and purchase agreement with the SEC was a public sale. The court held that it was irrelevant that certain specific terms of the agreement were not publicly disclosed.

The court did not address the key question of whether a confidential offer for sale or sale is an on-sale bar. Because most of the terms of Helsinn’s supply and purchase agreement were publicly disclosed, the court did not have to reach that question.

Next, the court addressed the second requirement of the Pfaff test: whether the invention was ready for patenting more than one year before the patent application was filed. This requirement is met if the invention has been reduced to practice (i.e., actually made and shown to work for its intended purpose) or if the invention has been described in writing in such detail that a person skilled in the art could make the invention.

Helsinn argued that its drug was not reduced to practice more than one year before it filed its patent application because it had not yet obtained FDA approval. The court stated the standard to obtain FDA approval is higher than the standard to show that a drug works for its intended purpose under patent law. The fact that more testing is required for an invention does not mean that the invention has not been reduced to practice. The court held that Helsinn knew that its drug worked for its intended purpose and therefore had reduced its invention to practice more than one year before it filed its patent application.

Because the Pfaff test was met for all four patents, the court held that the four patents were invalid based on the on-sale bar, reversing the district court.

After this decision, Helsinn filed a petition with the Federal Circuit seeking an en banc rehearing of the case. The Federal Circuit denied Helsinn’s petition. Helsinn has just filed a petition to the United States Supreme Court for writ of certiorari, asking the Court to answer the question of whether confidential sales fall within the on-sale bar. If the Court grants the petition, it will then have to decide whether Congressional intent was clear enough to change the approach of longstanding patent law.

In Exmark Manufacturing Company v. Briggs & Stratton Power Products, 2018 U.S. App. LEXIS 783 (Fed. Cir. 2018), the Federal Court of Appeals addressed patent infringement damages based on a reasonable royalty. Exmark Manufacturing Company owned a patent for a lawn mower with an improved flow control baffle (the part that controls the flow of air and cut grass underneath the mower). Exmark sued Briggs & Stratton Power Products for patent infringement. The jury returned a verdict of infringement against Briggs and found the infringement willful. The jury awarded Exmark $24 million in damages. The district court doubled the amount of damages for willfulness. 

Briggs appealled to the Federal Circuit on multiple grounds, including the district court’s denial of Briggs’ motion for a new trial on damages.

Damages for patent infringement can be determined in several ways. At a minimum, a successful plaintiff is entitled to a reasonable royalty for the defendant’s sale of the invention. The royalty is calculated by multiplying a royalty rate by the royalty base (the defendant’s sales of the infringing invention). However, if the patent only covers a component of the product that the defendant has sold, the plaintiff must apportion damages between the patented component and the whole product. The plaintiff is only entitled to a reasonable royalty on the patented component, not on the whole product.

On appeal, Briggs contended that Exmark’s expert should have determined damages by apportioning the royalty base, not the royalty rate. The appellate court rejected Briggs’ argument and held that damages can be apportioned by apportioning the royalty rate, apportioning the royalty base, or a combination of the two.
The court stated, at *29:

“So long as Exmark adequately and reliably apportions between the improved in conventional features of the accused mower, using the accused mower as a royalty base and apportioning through the royalty rate is an acceptable methodology….The essential requirement is that the ultimate reasonable royalty award must be based on the incremental value that the patented invention adds to the end product.”

The court explained that apportioning damages using the sales revenue from the lawn mower was proper for two reasons. First, Exmark’s patent included claims to the mower as a whole, not just the component baffle. Second, parties who negotiate licenses often use sales revenue for the whole product as the royalty base for a patented component. Id. at *29-31.

Briggs also argued on appeal that Exmark’s damage number was not admissible because its expert did not connect the royalty rate to the facts of the case. The Federal Circuit agreed with Briggs and held the district court’s denial of Briggs’ motion for a new trial on damages was an abuse of discretion. Id. at *31.

The court found that Exmark’s expert’s use of 5% as the royalty rate was not connected to the evidence in the case. Under Georgia-Pacific Corp. v. U.S. Plywood Corp., 318 F. Supp. 1116 (S.D.N.Y. 1970), several specific factors may be considered in determining damages for patent infringement based on a reasonable royalty. These factors are referred to as the “Georgia-Pacific factors.” Exmark’s expert had analyzed certain of the Georgia-Pacific factors (including the advantages of the patented baffle to customers) and had determined that, in a hypothetical licensing negotiation, the parties would have agreed to a 5% royalty rate on the sales of the lawn mower. The expert did not tie the Georgia-Pacific factors to the 5% rate. Because the court held that Exmark’s expert had not connected the 5% rate to the Georgia-Pacific factors or the facts of the case, the expert’s opinion was inadmissible. The court remanded the case for a new trial on damages.

Some commentators believe that the Exmark court’s decision may increase plaintiffs’ ability to argue that a reasonable royalty should be based on the sales revenue from the whole product, not just the patented component. The court clearly held that apportioning damages between the whole product and the patented component can be accomplished by using the sales revenue for the whole product and apportioning the royalty rate. However, because the court rejected Exmark’s 5% royalty rate as not connected to the facts of the case, the court’s decision is also a warning that if a plaintiff chooses to use the sales revenue from the whole product and apportion with the royalty rate, they must clearly tie the royalty rate to the facts of the case.

Given this decision, it is likely that in the future, plaintiffs will use the sales revenue from the whole product, as it will be a larger amount than the sales revenue from the patented component, and apportion with the royalty rate.

The Court of Appeals for the Federal Circuit just highlighted another approach plaintiffs can use to overcome early challenges to the validity of patent claims under 35 U.S.C. §101.   What is that approach?  It is a classic one:  show there is a genuine issue of fact.  That approach saved a subset of claims from summary judgment in Berkheimer v. HP. 

Berkheimer sued HP for infringement of its patent “relat[ing] to digitally processing and archiving files in a digital asset management system.”  The system parses files into objects and “tags objects to create relationships between them.”  “The objects are analyzed and compared … to archived objects” to find variations.  “The system then eliminates redundant storage of common text and graphical elements” improving efficiency and reducing storage costs.

In an Alice challenge, HP moved for summary judgment that certain claims are not patentable under 35 U.S.C. §101.  In Alice v. CLS Bank, the Supreme Court recognized that “laws of nature, natural phenomena, and abstract ideas” are not patent-eligible subject matter under §101. To determine whether claims are patent eligible the Supreme Court set forth a two-part test in Mayo v. Prometheus as further explained in Alice.  This test consists of the following steps:

Step 1:  The court determines whether the claims are directed to an abstract idea.

Step 2:  If the claims are directed to an abstract idea, then the court determines whether the claims include elements showing an inventive concept that transforms the idea into a patent-eligible invention.  Step 2 is satisfied when the claim limitations “involve more than performance of ‘well-understood, routine, [and] conventional activities previously known to the industry.’”

“[W[hether a claim recites patent eligible subject matter is a question of law which may contain underlying facts.”  Any fact, however, “that is pertinent to the invalidity conclusion must be proven by clear and convincing evidence.”

The district court granted summary judgment that a number of claims of Berkheimer’s patent were invalid under §101.  On appeal, the Federal Court found the patent is directed to an abstract idea (Step 1) and then focused on Step 2 of the two-part test.  While the patent-at-issue relates to a technique for archiving files, Berkheimer argued that “portions of the specification referring to reducing redundancy and enabling one-to-many editing contradict the district court’s finding that the claims describe well-understood, routine, and conventional activities.” Berkheimer thus argued there was a fact question to which HP had offered no evidence.  The Federal Circuit agreed the validity of some of the claims turned on whether they cover “well-understood, routine and conventional” technology.  “Whether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination.” Therefore, the Court found there was a genuine issue of fact as to whether the disclosed system archives files in an inventive manner that transforms the abstract idea into a patent-eligible invention.

Given the genuine issue of material fact, the Federal Circuit found that it was inappropriate to invalidate the claims at the summary judgment stage.  Note the Federal Circuit did not find the claims are directed to patent-eligible subject matter, but rather the district court judge should not have granted summary judgment given to the factual issue.

Therefore, a plaintiff’s patent can survive an Alice challenge in a motion to dismiss or motion for  summary judgment if the plaintiff can show a genuine issue of fact as to whether the invention is well-understood, routine, and conventional to a skilled artisan at the time of the patent.  Importantly, the Federal Circuit indicated not all cases involving Alice implicate questions of fact stating “not every §101 determination contains genuine disputes over the underlying facts…”  Thus “[p]atent eligibility has in many cases been resolved on motions to dismiss or summary judgment.”

In light of Berkheimer, it will be interesting to see whether district courts are now more hesitant to invalidate claims as patent-ineligible in early stages of litigation.

 

The fight between craft brewers and Big Beer (i.e. MillerCoors & Budweiser) has been ongoing for years. Ever since craft beer came to prominence in the late ‘90s, it has been stealing Big Beer’s share of the marketplace. In fact, craft beer has celebrated double-digit growth each year since then. In response, Big Beer has embarked on a course of action to recapture its share of the market.

In order to do so, certain members of Big Beer have acquired certain independent craft breweries, seemingly adopting the old adage, “if you can’t beat ‘em, join ‘em,” or in this case, “buy ‘em.” Now, by all means, mergers and acquisitions are part of business, and that’s fair play. But MillerCoors may have crossed the line when it decided to rebrand its Keystone brand as STONE, quickly catching the attention of craft brew powerhouse Stone Brewing, prompting Stone to file a complaint against MillerCoors in the United States District Court for the Southern District of California.

The complaint, which alleges trademark infringement, false designation of origin, trademark dilution, unfair competition, and declaratory relief, asserts that Stone Brewing has the exclusive right to utilize STONE in the brewing space. In fact, Stone has been utilizing STONE in conjunction with beer since as early as 1996, and subsequently registered the mark with the United States Patent and Trademark Office in 1998. Stone is one of the most well-known craft breweries in the industry and the ninth-largest independent craft brewer in the United States. It has even been recognized as the “All-Time Top Brewery on Planet Earth.”

MillerCoors, on the other hand, is a multinational beer conglomerate formed after a series of mergers involving Miller, Coors, and Canadian brewing conglomerate Molson. Keystone and Keystone Light is just one of many brands in MillerCoors portfolio. In general, the Keystone brand is regarded as sub-premium beer, which was formerly marketed in conjunction with the mark KEYSTONE and generally featuring imagery of the Colorado Rocky Mountains in the background. However, after Keystone’s sales dropped by approximately 25% from 2011 to 2016, and was named by USA Today as one of the “Beers Americans No Longer Drink,” MillerCoors opted to rebrand Keystone as STONE. Stone refers to the rebranding as an “aggressive second phase of the company’s pincer move against craft beer and Stone in particular.”

According to Stone, since the rebranding, which includes new cans, boxes, and logos emphasizing STONE as its primary mark, MillerCoors has launched a “viral marketing campaign that touts Keystone’s self-proclaimed new name,” and which “strategically plac[es] Keystone beer cans so that only ‘STONE’ is prominently displayed to viewers.” And if those allegations aren’t bad enough, Stone points out that MillerCoors encountered these same issues over a decade ago when it attempted to register STONES as a trademark and the USPTO refused the application because the examining attorney concluded the mark was confusingly similar to STONE. Still, MillerCoors has revived its attempt to rebrand Keystone with complete disregard of the USPTO’s prior conclusion. Although it’s almost certain that MillerCoors will have an explanation, whether believable or not, regarding the foregoing matters, this is highly favorable evidence for Stone. 

Stone has not hidden behind its attorneys regarding this lawsuit. Just the other day Stone co-founder, Greg Koch, released a video on the internet expressing Stone’s frustration with the conduct of MillerCoors and indicating that Stone intends to vindicate its rights. Stone’s counsel also indicated that unless an immediate resolution is reached between the parties, Stone intends to pursue a preliminary injunction that would preclude MillerCoors from utilizing any of its new STONE branding until the case has concluded. Frankly, for all intents and purposes, that motion could be dispositive of the case, as the Court will be forced to make a determination regarding whether the Keystone rebranding is likely to cause consumer confusion. Regardless of which direction the Court comes out on that issue, it seems unlikely that the losing party will be able to sway the Court the other direction at trial, which would likely result in the parties negotiating a resolution.

We will be keeping a close eye on this matter as it progresses and will provide periodic updates. In the meantime, check out Greg Koch’s YouTube video where Koch represents that MillerCoors can “end all of this right here and now” if it just puts “the KEY back in KEYSTONE.” In my opinion, MillerCoors should probably listen to Koch as it seems they have a heavy burden to bear.