IP Intelligence

IP Intelligence

Insight on Intellectual Property

PTO Provides Additional Guidance on Patent Eligibility of Life-Sciences Method Claims

 

On July 14, 2016, the PTO sent a memorandum to the examining corps regarding the recent rulings in Rapid Litigation Management Ltd. v. Cellzdirect, Inc., Appeal No. 2015-1570 (Fed. Cir. July 5, 2016), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), cert. denied, No. 15-1102, 2016 WL 1117246 (June 27, 2016). After briefly describing the cases, the memorandum concludes that they “do not change the subject matter eligibility framework [of Mayo/Alice], and the USPTO’s current subject matter eligibility guidance and training examples are consistent with these cases.” The memorandum does acknowledge, however, that Rapid Litigation Management “provide[s] additional information and clarification on the inquiry for determining whether claims are directed to a judicial exception” to 35 U.S.C. § 101. Continue Reading

Federal Circuit Helps Clarify What Constitutes a Commercial Sale under Pfaff

In The Medicines Co. v. Hospira Inc., Appeal No. 2014-1469 (Fed. Cir. July 11, 2016), the Federal Circuit issued a unanimous en banc decision ruling that the on-sale bar was not triggered by a supplier’s sale of manufacturing services to an inventor largely because the title to the invention and the right to market the invention never passed from the inventor to the supplier.

BACKGROUND

The Medicines Company (MedCo) contracted with Ben Venue Laboratories (Ben Venue) to manufacture Angiomax, a drug product, which is covered by two of MedCo’s patents (U.S. Patent Nos. 7,582,727 and 7,598,343).  Slip op. at 5.  Before the critical date from which the on-sale bar of § 102(b) must be measured, MedCo paid Ben Venue a fee to manufacture three batches of product according to the patents-at-issue.  Slip op. at 6-7.  The batches were provided by Ben Venue and placed in quarantine with MedCo’s distributor, and only released and made available for sale after the critical on-sale bar date.  Slip op. at 7-8. Continue Reading

Federal Circuit Provides Additional Guidance in Reversing Holding of Patent-Ineligibility of Biotech Invention

Although it is not yet a bright line, the Federal Circuit has considerably decreased the fuzziness of the distinction between patent-eligible and patent-ineligible inventions, at least where the exception to 35 U.S.C. § 101 is a law of nature. In Rapid Litigation Management Ltd. v. Cellzdirect, Inc., Appeal No. 2015-1570 (Fed. Cir. July 5, 2016), the Federal Circuit reversed the district court’s holding of invalidity under § 101, ruling that the district court erred in applying both step 1 and step 2 of the Supreme Court’s framework for determining patent eligibility. See Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014).

The district court held that the patent in suit is directed to a law of nature—that hepatocytes, a type of liver cell, are capable of surviving multiple freeze-thaw cycles—and that the patented process lacks the requisite inventive concept. Hepatocytes have a number of uses, such as for investigating how drugs may be metabolized by the liver or measuring a drug’s effect on liver biology, but their availability is limited and their life span is short. The prior art disclosed freezing hepatocytes (“cryopreservation”), thawing them when needed, and recovering the viable cells using density gradient fractionation, but persons of ordinary skill in the art understood that that process could damage the cells and lead to poor recoveries of viable cells. Moreover, pooled samples from multiple donors, desirable to create a collection of cells approximating average liver cells, could be created only by accumulating and freezing cells from single donors and then thawing and combining them for immediate use. Those skilled in the art believed that cryopreservation could be employed only once, and cryopreservation could damage cells, which severely limited the creation of pooled cells.

The inventors’ discovery was a law of nature: that a fraction of hepatocytes can survive multiple freeze-thaw cycles. Based on that discovery, the inventors claimed a method of producing a collection of hepatocytes by subjecting previously frozen and thawed cells to fractionation to separate and recover viable cells, and refreezing the viable cells, which, after being thawed again, exhibit 70 percent viability. Thus, claim 1 recites: Continue Reading

Federal Circuit Confirms That the BPCIA Always Requires Post-Licensure Notice

The Federal Circuit answered one of the questions left open by its July 27, 2015, decision in Amgen Inc. v. Sandoz Inc. (Appeal No. 2015-1499): whether the 180-day commercial marketing notice under the Biologics Price Competition and Innovation Act (BPCIA) is mandatory even for a biosimilar applicant that has participated in the so-called patent dance. Yesterday, in a decision that may delay lower-cost competition for biologics, the Federal Circuit ruled in Amgen, Inc. v. Apotex, Inc. (Appeal No. 2016-1308) that all biosimilar applicants must provide their reference-product rivals at least 180 days’ notice before launching a biosimilar.

As was discussed in a July 27, 2015, BakerHostetler Alert, the Federal Circuit had found in the earlier Sandoz case that the 180-day notice was mandatory at least for a biosimilar applicant that had elected not to participate in the BPCIA’s patent dance – an exchange of patent information intended to streamline disputes that starts with the applicant’s providing its application and related information to the reference-product sponsor. That decision did not address the situation of an applicant that did participate in the patent dance. Yesterday’s decision holds that the requirement applies to applicants in both situations, and reiterated that the notice may be effectively given only after the FDA approves the biosimilar application. Continue Reading

CAFC Hands Down Significant § 101 Decision in Bascom Global Internet

In Bascom Global Internet v. AT&T Mobility LLC, Bascom Global sued for infringement of US Patent No. 5,987,606, titled “Method And System For Content Filtering Information Retrieved From An Internet Computer Network,” November 16, 1999 (the ’606 patent). The defendant moved to dismiss the complaint under Rule 12(b)(6), and the motion for dismissal was granted on the ground that the claims of the ’606 patent are ineligible as a matter of law under 35 U.S.C. § 101. In what could become a highly impactful decision, the Federal Circuit vacated and remanded the district court’s order dismissing the complaint.

This is only the third time that the Federal Circuit has held software claims patent eligible since the Supreme Court’s Alice decision (the first two were DDR and Enfish). Although these three cases have some common themes, they provide different paths to patent eligibility. Of the three decisions, Bascom may be the most generally applicable. Judge Chen wrote for the court, joined by Judge O’Malley. Judge Newman concurred, writing separately on her views of how to harmonize litigation on patentability and eligibility.

Background

The ’606 patent describes and claims a system for filtering Internet content. The patent describes its filtering system as a novel advance over prior art computer filters, in that no one had previously provided customized filters at a remote server. The claimed filtering system is located on a remote ISP server that associates each network account with (1) one or more filtering schemes and (2) at least one set of filtering elements from a plurality of sets of filtering elements, thereby allowing individual network accounts to customize the filtering of Internet traffic associated with the account. For example, one filtering scheme could be a word-screening type filtering scheme, and one set of filtering elements (from a plurality of sets) could be a master list of disallowed words or phrases together with an individual list of words, phrases or rules. Continue Reading

Sole Relief from the International Trade Commission

On June 23, 2016, the U.S. International Trade Commission (“ITC”) issued a decision in the closely watched Converse proceeding, invalidating one of Converse’s trademarks for its iconic Chuck Taylor shoes and issuing a broad exclusion order prohibiting the import of any shoes that infringe certain of Converse’s other trademarks. The decision highlights the benefits of bringing infringement complaints to the ITC.

The case began in the fall of 2014, when Converse launched an offensive against more than thirty companies, accusing them of trademark infringement. At the same time that it filed the complaints in federal court, Converse filed a complaint with the ITC, asserting that the companies were infringing the following trademarks in violation of Section 337 of the Tariff Act of 1930:

  • U.S. Registration No. 4,398,753 for shoe1. This registration is for the two stripes on the midsole, the design of the toe cap, and the design of the multilayered toe bumper with the diamond and line patterns (the “‘753 Registration”).
  • U.S. Registration No. 3,258,103 for shoe2. This registration is for the three-dimensional diamond tread design (the “‘103 Registration”).
  • U.S. Registration No. 1,588,960 for shoe3. This registration is also for the three-dimensional diamond tread design (the “‘960 Registration”).

Continue Reading

Supreme Court Denies Sequenom’s Petition for Certiorari

Supreme Court iStock_000008258486_LargeOn June 27, 2016, the U.S. Supreme Court, without comment, denied Sequenom’s petition for certiorari, leaving in place the Court’s previous rulings prohibiting the patenting of laws of nature and natural phenomenon.

Sequenom filed its writ of certiorari with the U.S. Supreme Court on March 21, 2016, asking the Court to provide clarification regarding the limits of 35 U.S.C. §101. Sequenom’s petition presented the following issue:

Whether a novel method is patent-eligible where

(1) a researcher is the first to discover a natural phenomenon,

(2) that unique knowledge motivates him to apply a new combination of known techniques to that discovery and

(3) he thereby achieves a previously impossible result without preempting other uses of the discovery. Continue Reading

Supreme Court Clarifies Test for Fee-Shifting in Copyright Cases

The Supreme Court on June 16 issued a unanimous ruling clarifying the test for awarding attorneys’ fees to successful copyright litigants.  The decision, in Kirtsaeng v. John Wiley & Sons, Inc., is sure to have lasting impact on how both plaintiffs and defendants weigh the risk of litigating a copyright case to completion.

BACKGROUND

The underlying facts are fairly straightforward.  Kirtsaeng was a Cornell graduate student who learned that foreign versions of certain textbooks were sold at lower prices than identical versions in the U.S.  Seeing an opportunity, Kirtsaeng bought lawful copies of the books overseas and then shipped them to the U.S., where he sold them for less than the publisher’s U.S. price, pocketing a nice profit.

John Wiley & Sons, a textbook publisher, sued Kirtsaeng for copyright infringement in the Southern District of New York.  Kirtsaeng argued that he was protected under the U.S. Copyright Act’s “First Sale” doctrine.  In general terms, that doctrine holds that once a copyright holder sells a copy of his work, that copy may be resold without restriction.  When the Kirtsaeng case was tried, the circuit courts were divided over whether the First Sale doctrine applied to copies of works first sold outside the U.S.  The Supreme Court had deadlocked 4-4 on the issue as recently as 2010.  Thus, the contrary positions advanced by Kirtsaeng and Wiley & Sons were both objectively reasonable. Continue Reading

High Court Relaxes Standards for Enhanced Damages in District Court Patent Litigation

On June 13, 2016, in a much-anticipated joint holding in Halo/Stryker, [1] the Supreme Court unanimously overturned the Federal Circuit’s rigid test for willful infringement under Seagate and conferred discretion on district courts, “narrowed” by nearly 200 years of judicial practice, to award enhanced damages to patent owners under 35 U.S.C. § 284 for “egregious cases of culpable behavior.” The High Court’s opinion was authored by Chief Justice Roberts, with Justices Breyer, Kennedy and Alito concurring.

Although the possibility of enhanced damages on a theory of willful infringement would strike fear into the heart of any accused infringer, the two-pronged test for willful infringement previously promulgated by the Federal Circuit proved challenging in practice for patent owners. The Seagate standard, as it was applied prior to the Supreme Court’s decision in Halo/Stryker, required the patent owner to prove that the accused infringer’s conduct was objectively and subjectively culpable, and it needed to do so by a heightened standard of clear and convincing evidence (compared with the preponderance of the evidence standard needed to prove patent infringement). With respect to the objective component, patent owners needed to show that the accused infringer’s defenses were objectively unreasonable – meaning that an accused infringer with effective legal counsel could avoid willful infringement by demonstrating, regardless of the defendant’s culpable pre-litigation conduct, that its defenses raised during the litigation were objectively reasonable. Continue Reading