Posts Tagged: "generic"

On January 10, the U.S. District of Delaware held that Actavis’ generic version of Orexo’s opioid dependency treatment infringed an Orexo patent. The patent-at-issue in this order was U.S. Patent No. 8940330, titled Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence. This non-appealable infringement judgment prevents Actavis from commercializing its generic opioid dependency treatment until Orexo’s patent rights expire in September 2032. The judgment covers all dosage levels of the Actavis generic product.

On Wednesday, August 15th, the Court of Appeals for the Federal Circuit issued a precedential decision in BSG Tech LLC v. BuySeasons, Inc. which upheld a decision by the district court to invalidate patent claims owned by BSG Tech as patent-ineligible under 35 U.S.C. § 101. The Federal Circuit panel of Circuit Judges Jimmie Reyna, Evan Wallach and Todd Hughes found that the district court correctly determined that patent claim asserted by BSG Tech were invalid as abstract ideas lacking any inventive step under the Alice/Mayo framework… The only allegedly unconventional feature of BSG Tech’s claims was the requirement that users are guided by summary comparison usage information, which was simply a restatement of the abstract idea identified under the first step of Alice/Mayo

On Wednesday, June 30th, the Court of Appeals for the Federal Circuit issued a decision in Royal Crown Company, Inc., et. al. v. The Coca-Cola Company which vacated and remanded an earlier decision by the Trademark Trial and Appeal Board (TTAB) regarding the use of “ZERO” trademarks on soft drink beverages marketed by Coca-Cola. The Federal Circuit panel, consisting of Circuit Judges Pauline Newman, Kathleen O’Malley and Richard Taranto, found that the TTAB had erred in its legal framing of the question regarding the claimed genericness of Coca-Cola’s mark and failed to determine whether the mark was at least highly descriptive if not generic.

What was the federal government thinking when Hatch-Waxman originally passed. Why would Congress incentivize generic manufacturers to challenge the patents of pharmaceutical companies? It is the same insidious thought process underlying Hatch-Waxman seen underlying the justification for post grant challenges of all patents at the USPTO. How absurd is it that those who question the need for incentive to innovate are so eager to provide incentive to challenge patents?

From a legal standpoint, a trademark that has no relation to the product or services offered will be the strongest type of mark. For example, trademarks such as “Google” for a search engine, “eBay” for online auctions and “Bose” for audio equipment make excellent and strong trademarks. Descriptive marks provide less trademark protection because if a term is descriptive it can be used by anyone else selling the same goods or providing the same services… Many sales and marketing people will gravitate toward descriptive marks for products and services hoping that potential customers will immediately identify the product or service being offered. This approach leads to a weak or sometimes even unprotectable trademarks.

On Thursday, October 12th, a pair of letters addressed to the bipartisan leadership of the Senate Judiciary Committee were delivered in an attempt to inform Senators on that committee of various issues in play regarding the recent patent deal between multinational pharmaceutical firm Allergan and the sovereign St. Regis Mohawk Tribe. The two groups sending the letters represent stakeholders in the U.S. patent system coming from very different backgrounds who realize that there are fundamental flaws in the system created by inter partes review (IPR) proceedings which are carried out at the Patent Trial and Appeal Board (PTAB).

On Thursday, September 28th, a judge in the District of Delaware entered an order stipulating dismissal in a patent infringement case brought by North Chicago-based pharmaceutical firm AbbVie (NYSE:ABBV) against Thousand Oaks, CA-based drugmaker Amgen (NASDAQ:AMGN). According to reports, the settlement follows an agreement between the two companies to delay a generic version of the anti-inflammatory drug Humira from the U.S. market until 2023… Of AbbVie’s total $6.94 billion in net revenues from U.S. and international sales during the quarter, Humira contributed $4.71 billion in revenues.

On September 12th, Judge Anthony Battaglia of the Southern District of California entered an order granting motions made by the San Diego Comic Convention in a trademark case over the use of the Comic-Con title on pop culture conventions. The order also denies motions made by a Utah-based entity which has presented a biannual Salt Lake Comic Con since 2013… The recent order entered in the Southern California case denied Dan Farr Productions’ motion to exclude testimony from an expert witness testifying for plaintiff San Diego Comic Convention while also granting a motion by San Diego to deny an expert presented by Dan Farr. Dan Farr tried to argue that San Diego’s expert witness, which included the results of a Teflon survey on the generic nature of the term “Comic-Con”, as such evidence only matters in genericide cases and not where the trademark was generic prior to the owner’s use. However, the defendant’s own pleading in the counterclaim, where it asserted a defense of generic mark, and the court found the evidence to be relevant to the case.

A memorandum signed by Judge Sleet shows that Mallinckrodt’s patents were invalidated under the Section 101 patentability standard set by the U.S. Supreme Court in 2012’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., a standard affirmed by SCOTUS’ 2014 decision in Alice Corporation v. CLS Bank International. Applying the two-step test for Section 101 patentability, the Delaware court found that the Mallinckrodt patents covered natural phenomenon which did not include an inventive step. The court found that patent claim limitations directed at echocardiography or severe adverse reactions did not satisfy the inventive concept step. “It does not matter what the severe adverse reaction is,” Judge Sleet’s memo reads. “Any reaction to treatment with iNO will be a natural phenomenon, dictated by the patient’s physiological response to the drug.”

The Ninth Circuit Court of Appeals ruled on May 16, 2017 that Google has not become a victim of its own success – that is, its Google trademark is still an enforceable brand for an online search engine and has not become generic.

On Thursday, October 6th, the U.S. Food and Drug Administration (FDA) published a 79-page notice in the Federal Register regarding new rules surrounding Abbreviated New Drug Applications (ANDAs) and 505(b)(2) new drug applications. Many provisions of the new rules affect information that must be submitted by applicants regarding patents which could affect the outcome of applications for new generic versions of drug treatments.

The vast majority of medicines found on WHO’s model list of essential medicines are off-patent according to information published by the World International Property Organization (WIPO). As of 2013, 95 percent of the 375 pharmaceutical compounds on that year’s MLEM were off-patent, indicating a high likelihood that generic equivalents of treatments are available. Going back to the early 2000s, the percentage of essential medicine on WHO’s MLEM which are off-patent has consistently been between 90 to 95 percent. Thus, it seems clear that the patent system has served its intended purpose: To incentivize the creation of important, innovative, even live saving products that society can reap the benefits from long after the exclusivity of the patent has expired.

One reason the PTAB is convenient for reaching reverse payment deals is that there is no direct antitrust oversight, since its judges are administrators with very narrow legal authority. Further, while there is a statute requiring agreements between Hatch-Waxman firms to be submitted to the Federal Trade Commission (FTC) for antitrust review, the parties may attempt to evade it. The statute requires submission of agreements that relate to the manufacture or sale of either firm’s drug. The parties might therefore feel justified (rightly or wrongly) in not submitting a consent decree stating that the patent is valid and would be infringed by the proposed generic, since this does not expressly address manufacture or sales. Alternatively, it could be that the parties submit a district court consent decree (which includes no reverse payment), but not the PTAB settlement (which could include a reverse payment). After all, a PTAB settlement simply says that the parties agree to terminate the IPR – it need not declare the patent valid – and this arguably does not relate to manufacture or sales.

Consumers suffer the scourge of high drug prices. Brand-name drug companies reap monopoly profits. But generic drugs, which promise lower prices, are often nowhere to be found. One reason is that brand firms have engaged in an array of conduct to block generics. In short: A sample is crucial. Without it, there is no generic.