Posts Tagged: "US Supreme Court"

All the Judges rely on the same Supreme Court precedents in Gottschalk v Benson, Parker v. Flook, Diamond v. Diehr, Bilski v. Kappos, and Mayo v. Prometheus. All the Judges recognize the same judicial exception to statutory subject matter under §101 for laws of nature, natural phenomena, and abstract ideas. All the Judges recognize that a claim must include “meaningful limitations” that go beyond an abstract idea. Hollow field-of-use limitations and insignificant pre or post-solution activity don’t count. However, this is where their similarities end.

While the Supreme Court has done away with the “useful, concrete and tangible result” test from State Street Bank v. Signature Financial, in Bilski v. Kappos, 8 out of 9 Justices (i.e., everyone except Justice Scalia) signed onto an opinion that recognized that the patent claims in State Street displayed patent eligible subject matter. Indeed, the dissenters in Bilski specifically acknowledged that the claims at issue in State Street did not deal with processes, but dealt with machines. See Footnote 40 of the Steven’s dissent. The import of this is that machines are specifically patent eligible subject matter, so if the claims of State Street are to machines then claims that are similarly configured would also be directed to machines and therefore patent eligible.

Since my last article here on IPWatchdog.com, the pharmaceutical industry has been simply overflowing with interesting developments, including the US Supreme Court hearing arguments concerning three significant cases. The first case argued at the Supreme Court will determine whether generic drugmakers can be sued for alleged flaws in the design of their medications. Another argument before the Supreme Court was about pay-to-delay deals in which a brand-name drugmaker agrees to pay a settlement to a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. The Court also heard arguments about a case that raises crucial questions about whether human genes can be patented. And the outcome may well reset the boundaries and direction of medical research in the US, which of course has tremendous implications for investments made by the biopharmaceutical industry and the battle against many diseases, notably cancer.

If cDNA is patent eligible subject matter, as it seems likely based on the tone of the oral argument, that should be very good news for Myriad. As Justice Breyer recognized during questioning of Mr. Hansen (representing AMP), the Myriad claim says they want “the isolated DNA of claim 1 wherein said DNA has the nucleotide sequence set forth in SEQ ID No. 1.” If you look at SEQ ID No. 1 clearly states that the molecule type is cDNA, thus cDNA seems to be a part of the claim, not to mention that the cDNA used by Myriad was a consensus sequence made from hundreds of different patients. Thus, if cDNA is patent eligible then the Supreme Court must find that at least some genes are patent eligible and must also find the Myriad claims patent eligible. Whether the Supreme Court Justices really captured that nuance remains in doubt. It seemed at times that Justices Sotomayor and Kagan were openly arguing the AMP/ACLU case. Sadly, at times it was apparent that the Supreme Court doesn’t understand even the most basic and fundamental patent law concepts.

Social policy concerns have influenced the AMP v Myriad debate. The Supreme Court, to the extent it must make a ruling for our times, informed by societal context, should dispassionately consider all the available empirical evidence, from the academic work cited here, to the claim scope limits resulting from massive sequence publication projects and recent court cases, and the thriving innovation ecosystem in personalized medicine at and among for profit and not for profits, and render a clear forward compatible decision for us all.

Rader: “I come from the commercial law area where to tell the CEO that “well I’m going to have to balance several factors and ask three courts over a period three years whether or not you can have this product enter the market” is simply an inadequate response. In the commercial area we have to have a predictable, yes or I will use the B word — a Bright line rule. Now, that’s lead to kind of this culture clash where the Supreme Court says there needs to be more balancing and flexibility. The formalism of the Federal Circuit is uncomfortable to [the Supreme Court]. But that’s a function of our legal culture. I think perhaps the answer is the Federal Circuit needs to gain a little bit more flexibility from its experience with the Supreme Court, but I hope the Supreme Court also recognizes that the Federal Circuit is reaching its decisions for well considered reasons.”

The Supreme Court tried to simplify the issue by concentrating on whether the state-law claim raised a substantial and disputed federal issue, which a federal forum would be able to entertain without disturbing the approved balance between federal and state jurisdictional responsibilities. The Supreme Court went on to note that “federal jurisdiction over a state law claim will lie if a federal issue is: (1) necessarily raised, (2) actually disputed, (3) substantial and (4) capable of resolution in federal court without disrupting the federal-state balance approved by Congress. Where all four of these requirement are met, we held, jurisdiction is proper because there is a ‘serious federal interest in claiming the advantages thought to be inherent in a federal forum.”

The Honorable Alex Kozinski immediately posed the question—by way of an analogy to scientists who stare at the stars—of why should someone be able to get a gene patent just because there was a significant amount of effort put in to discover that gene. Throughout the event, Judge Kozinski took on the role of the generalist judge, who would need to be convinced that the invention in the lab is anything other than a product of nature. Professor David Winickoff of UC Berkeley followed that question up by discussing James Watson’s amicus brief and the idea that genes are both symbolic in our culture and shared by all humans, thus making them a unique item in our world.

While one can never know for certain how the Supreme Court will rule, even a casual observer has to conclude that the Supreme Court seems poised rule in favor of Monsanto. Seconds after Bowman’s attorney started Chief Justice Roberts interrupted asking why anyone would ever patent anything if Bowman were to prevail. Shortly thereafter Justice Breyer openly concluded that Bowman infringed in a matter of fact way. It later may have seemed Breyer was probing for a response he didn’t get more so than announcing his view of the case. Nevertheless, if Bowman loses Breyer he has no chance.

In its amicus brief, CLI responds by arguing that the term “makes,” as used in Section 271(a), has its plain and ordinary meaning, which embraces the concepts of “bringing about” or “causing.” CLI contends that Bowman, through his acts of planting and cultivating, brought about and caused the formation of a next-generation of herbicide-resistant soybeans. Alternatively, CLI argues that, even if the concept of a “making” only literally reaches the acts of the herbicide-resistant soybean plants Bowman cultivated, Bowman would still be liable for those acts under principles of agency-instrumentality law. Based on his acts of planting and cultivating, CLI asserts that Bowman exercised sufficient control over the herbicide-resistant soybean plants he raised that they should be treated as mere instrumentalities of his, the conduct of which can and should be attributed to him.

The parties and amici have filed over 25 briefs in this case, almost none of which address or even consider whether the actual right granted under Section 109(a)—to “sell or otherwise dispose of” copies—applies outside the United States; instead, they have focused almost exclusively on Section 109(a)’s “lawfully made under this title” preamble, resulting in unsatisfactory readings of the Copyright Act as a whole. As the American Intellectual Property Law Association has urged the Supreme Court in its amicus filing, applying long-standing extra-territoriality principles to the actual right created by Section 109(a) handily harmonizes both Sections 109(a) and 602(a)(1). It also avoids damage to the rest of the Act caused by undue emphasis on the prefatory “lawfully made under this title” language.

Bowman v Monsanto involves a farmer who figured out how to get Monsanto’s patented seeds cheaper from a grain elevator than from the company. I won’t attempt to delve into the intricacies of the litigation or the doctrine of patent exhaustion, but do want to consider a larger point. What happens if our innovators lose confidence in the patent system? Some apparently believe this is a desirable outcome

The Court went to the actual terms of the Covenant to determine if Nike had met this very tough burden burden. In this case, though, Nike did. The terms of the Covenant were unconditional and irrevocable. They prohibited Nike from making any claim or demand, and even went so far as to shield YUMS’ distributors and customers. This coupled with the fact that YUMS did not provide a shred of evidence that it had plans to market a shoe that the Covenant wouldn’t cover was enough to convince the Court that the possibility of future harm was just too remote here.

The concurring opinion of Justice Kennedy is even more unfortunate. Like Chief Justice Roberts, while agreeing with Justice Thomas’ holding that the traditional “four-factor” test applied to the grant of injunctive relief in patent cases, Justice Kennedy’s concurring opinion went even further to suggest that “trial courts should bear in mind that in many instances the nature of the patent being enforced and the economic function of the patent holder present considerations quite unlike earlier patent cases.” As Justice Kennedy saw it, “an injunction, and the potentially serious sanctions arising from its violation, can be employed as a bargaining tool to charge exorbitant fees to companies that seek to buy licenses to practice the patent.” What is particularly distressing about Justice Kennedy’s concurring opinion is the further comments he makes about injunctive relief in the context of patents on “business methods.”

Patent exhaustion is one of the most fundamental restrictions on patent rights. Under this doctrine, an authorized sale of a patented article moves it outside the scope of the U.S. patent monopoly. With respect to the vended article, the patent right is extinguished and the patentee can no longer sue for infringement. One question that remains unsettled, however, is the role of territoriality. That is, where must the authorized sale take place? For well over a century courts have struggled to answer whether extraterritorial sales qualify for purposes of patent exhaustion.