Posts Tagged: "patents"

For almost ten years, U.S. patent law has experienced extraordinary confusion and uncertainty about what types of inventions and discoveries are patent eligible. The U.S. system changed from offering strong protection for novel and nonobvious inventions to questioning whether groundbreaking technologies are even the type the Founders thought would promote the progress of the “Useful Arts.” But recent developments, including the USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (Section 101 Guidance), suggest that winds of change may clear the fog and bring back some clarity to U.S. patent law.

Yesterday a unanimous Supreme Court ruled that the America Invents Act’s (AIA’s) language barring patent protection for inventions that were “in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention” under 35 U.S.C. § 102(a)(1) extends to private sales to third parties. The decision upholds pre-AIA Federal Circuit precedent establishing that a “secret sale” could invalidate a patent. The question patent owners have been asking since 2011 was whether the AIA’s addition of the phrase “or otherwise available to the public” overruled the Federal Circuit’s judicial construction of the on-sale bar. “No,” said the High Court. As always, IPWatchdog reached out to experts across industries for their views on the decision. From “well-reasoned and correct” to “a disappointment” and “dismissive,” they had wide-ranging perspectives on the ruling’s broader implications.

Since its inception, the Patent Trial and Appeal Board (PTAB) has been a frequent venue for patent challenges in the pharmaceutical and biotechnology industries. By the end of the U.S. Patent and Trademark Office’s (USPTO’s) 2018 fiscal year, patents in those fields were targeted in nearly 10% of all petitions for inter partes review (IPR), totaling approximately 900 individual petitions. Of these 900 petitions, roughly 5% challenged patents listed in the FDA’s Orange Book for approved drug products. The remaining petitions challenged biologic drugs (1.3%) and other biologic-, biotechnology-, or pharmaceutical-related patents (3.5%). Many of these petitions have ultimately resulted in the cancellation of all challenged claims, including those of a significant number of Orange Book patents. Based on the PTAB’s initial high rate of claim cancellation in pharma and other areas, critics of the PTAB were quick to deem it a patent “death squad.” Does the PTAB still deserve the “death squad” label when it comes to Orange Book patents? In this article, we examine the rates of challenge, institution, and final written decision outcomes for patents listed in the Orange Book, from the PTAB’s inception through the end of its 2018 fiscal year.

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.

n a relatively short, unanimous decision authored by Justice Thomas, the Court begins by explaining that twenty-years ago in Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 67 (1998) the Court determined that an invention was on sale within the meaning of pre-AIA § 102 if it was subject to a commercial offer for sale and it was ready for patenting. Moreover, Thomas recognized that prior to passage of the AIA the Federal Circuit had clearly established that a secret sale could invalidate a patent. Therefore, given the settled precedent, Justice Thomas explained that there was a presumption “that when Congress reenacted the same language in the AIA, it adopted the earlier judicial construction of that phrase.” The Court also found the catch all phrase “or otherwise available to the public” was “simply not enough of a change… to conclude that Congress intended to alter the meaning of the reenacted term ‘on sale.’”

In AC Techs., S.A. v. Amazon.com, Inc. the Federal Circuit found the PTAB did not exceed its statutory authority by addressing a non-instituted ground on reconsideration; in fact, it would have violated the statutory scheme for the PTAB not to consider the previously non-instituted ground… The claims at issue related to data access and management, namely, storing copies of data across a network to improve data integrity and reduce network lag. Amazon and Blizzard challenged the ’680 patent based on a single prior art reference. They presented three grounds in their petition, all centered on the construction of the term “computer unit.”

The ‘650 patent covers a compound called fesoterodine, which is an antimuscarinic drug marketed as Toviaz® and used to treat urinary incontinence. Mylan Pharmaceuticals petitioned for IPR of the ‘650 patent alleging certain claims were obvious. After institution of the IPR, Amerigen and two other companies joined as parties to the proceeding. After the PTAB’s finding that the challenged claims were not unpatentable, Amerigen—but not Mylan—appealed the decision.

On appeal, UCB asserted Amerigen lacked standing. Specifically, UCB argued that, based on the Paragraph III certification accompanying Amerigen’s abbreviated new drug application (ANDA), the FDA will not approve Amerigen’s ANDA until the expiration of the ‘650 patent, previously upheld in a separate suit in the District of Delaware, in 2022. Consequently, UCB contends Amerigen is foreclosed from infringing the ‘650 patent, and without a possibility of infringement there can be no justiciable dispute.

The Federal Circuit rejected UCB’s argument for several reasons. First, this case did not arise under the Hatch-Waxman Act. Second, Amerigen did not rely a risk of infringement liability as a basis for injury. Rather, Amerigen pointed to a concrete commercial injury that it incurred from the listing of the ’650 patent in the Orange Book, which was only possible so long as the ’650 patent was not found invalid. Specifically, the listing of the ‘650 patent blocked the launch of Amerigen’s tentatively approved ANDA, and invalidation of the patent would advance its drug’s launch.

Hopefully, you’ve been fortunate enough—at least once in your life—to work for someone you really admired. That happened to me as a Senate Judiciary Committee staffer for Senator Birch Bayh (D-IN), who gave me the opportunity that changed my life. He turns 91 today… Bayh-Dole not only cut through the bureaucratic red tape strangling the development of federally-funded R&D; it marked a turning point in how patents were viewed in Congress. When I first joined the Committee, patents were considered tools for big business to stifle competition. Intellectual property fell under the jurisdiction of the Subcommittee on Antitrust and Monopolies. The Senate Small Business Committee was a hot bed of anti-patent sentiment.

Several weeks ago, the Court of Appeals for the Federal Circuit issued a nonprecedential decision in Glasswall Solutions Limited v. Clearswift Ltd., affirming a district court’s findings that claims from two patents that were asserted in an infringement case filed by Glasswall were directed to unpatentable subject matter under 35 U.S.C. § 101… The Federal Circuit found that testimony offered by an expert witness for Glasswall didn’t preclude a dismissal on the pleadings as the alleged factual assertions in that testimony weren’t actually factual in nature but, rather, were conclusory legal arguments the district court wasn’t bound to accept as true.

On January 11, GKN Automotive LTD. filed a brief in opposition to a petition for writ of certiorari filed by JTEKT Corporation. The question JTEKT seeks to have the Supreme Court consider is whether any inter partes review (IPR) petitioner, even a petitioner without standing, may appeal a final written decision of the Patent Trial and Appeal Board (PTAB) to the Court of Appeals for the Federal Circuit. The standing requirement for litigants in order to gain entry to a federal court is well-established, black-letter law taught to every law student across the country. It is hardly shocking that the Federal Circuit would apply well-established Constitutional safeguards and procedural law to prevent those without appropriate grievances from entry into the federal appellate system. In this case, JTEKT simply did not have any injury, real or imagined.

The Supreme Court has brazenly admitted it is not following Congress’ statutory instructions on patent eligibility in several cases. And it has carried out virtually none of the required statutory construction. It is judicial activism in the extreme… [I]t is hard to imagine a more unconstitutional statement than that discoveries cannot be patented when the statute the Court is applying states that any invention or discovery can be patented.

Occasionally, we hear people say, “brokered patents are all junk.” This begs the question, “are operating companies and non-practicing entities (NPEs) spending hundreds of millions of dollars buying junk patents?” Luckily, the short answer is no. We know clients have successfully bought and used brokered patents to substantially alter their licensing and litigation posture at a lower cost than the alternatives. We also know that patents on the brokered market rank higher than average patents. So why this disconnect? We are victims of our own cognitive biases and the behavioral economic traps that make it harder for buyers to find and buy patents… When only a small fraction of what we are looking at is ultimately interesting to us, our brains can trick us. Using a structured decision-making process together with some tools can overcome those biases and allow us to identify and buy the patents that fit our business needs.

That feeling that you are a fraud and that, one day, people will find out you have no idea what you are doing has a name—Impostor Syndrome. It is common among young attorneys and inexperienced patent professionals and can strike when you get that first job, during law school, or during conversations with supervisors. One particular situation where imposter syndrome can be especially prevalent for patent prosecutors is interviews with patent examiners. Imposter syndrome can make you feel like you are not qualified to represent your client or that you don’t deserve your accomplishments. It is estimated that at least 70% of successful people have experienced Impostor Syndrome.