Posts Tagged: "innovation"

The Federal Circuit last week upheld a PTAB final written decision invalidating Mayne Pharma’s U.S. Patent 6,881,745 over its objection that the petition for inter partes review (IPR) filed by Merck Sharpe & Dohme (MSD) was fatally defective for having omitted parent corporation Merck & Co., Inc. as a real-party-in-interest. Mayne Pharma Int’l v. Merck Sharp & Dohme, Case No. 2018-1593 (Fed. Cir. June 21, 2019). Because Merck would have had to add its parent as an RPI in the proceeding after the one-year time bar had lapsed, Mayne argued the error was not correctable. The Federal Circuit rejected this view, holding that the Board has authority to make corrections to a petition that are “in the interest of justice.” This decision suggests that form will not be elevated over substance in addressing the one-year IPR time bar of Section 315(b).

The United States is on the brink of making changes to the U.S. patent law that would be modeled on India’s Patent Law. At a Senate Judiciary Committee markup scheduled for tomorrow, June 27, Senator Lindsey Graham (R-SC) plans to offer language as an amendment in the form of the No Combination Drug Patents Act. The language of the bill would prohibit the patenting of new forms, new uses and new methods of administration of new medicines unless the patent applicant can show “a statistically significant increase in efficacy”. This language is oddly similar to India’s Section 3(d), something the Trump Administration’s U.S. Trade Representative has complained “restricts patent eligible subject matter in a way that poses a major obstacle to innovators” (see here, page 49). Other Senators have also weighed in against “a generally deteriorating environment for intellectual property” in India (see here), including Judiciary Committee ranking member Dianne Feinstein (D-CA) and Judiciary Committee members Mike Crapo (R-ID), Amy Klobuchar(D-MN)and Chris Coons (D-CT).

Seventy-two companies and organizations, ranging from Tivo to Bristol-Myers Squibb and from the American Conservative Union to the Alliance of U.S. Startups & Inventors for Jobs (USIJ)— as well as retired Federal Circuit Chief Judge Paul Michel—have sent a letter to Senators Thom Tillis and Chris Coons and Representatives Hank Johnson, Doug Collins, and Steve Stivers in support of the current draft language to reform Section 101 of the U.S. Patent Act. The letter comes as the patent community eagerly awaits a new version of the bill, following three hearings and 45 witnesses in which most voiced their general support for the approach taken in the draft, but several sticking points were identified. The next iteration is expected soon after Congress’ July 4 recess.

The Lanham Act’s ban on federal registration of “immoral or scandalous” trademarks is unconstitutional under the First Amendment.  So held the United States Supreme Court on Monday, resoundingly, if a bit uneasily, in Iancu v. Brunetti.  It’s a good result, and one that the trademark bar and the free speech community had broadly urged, including Debevoise’s client, the International Trademark Association (INTA), in an amicus brief that we had the privilege of writing. 

This week on Capitol Hill and vicinity, the Supreme Court issues its decision in Iancu v. Brunetti and issues orders in several other IP cases. Meanwhile, various House committees will explore the Federal Communications Commission’s broadband Internet coverage maps, state and local government cybersecurity issues, voting technologies, fintech, federal agency IT acquisition and artificial intelligence. Senate committee hearings this week will look at emerging technologies in surface transportation, the persuasive effects of machine learning in Internet platforms as well as a pair of drug patent bills. Elsewhere, the Information Technology and Innovation Foundation hosts an event looking at the effect of global trade tensions on technology supply chains and the Brookings Institution considers the potential of privacy legislation to address concerns with digital information-sharing systems.

Panelists in this past Thursday’s IPWatchdog webinar, “Dissecting Alice,” gave credit to the U.S. Patent and Trademark Office (USPTO) for the steps it has taken to minimize the damage caused by the courts’ lack of action on patent eligibility, but expressed concern that it simply isn’t enough. USPTO Commissioner for Patents Drew Hirshfeld joined the webinar to report on the progress made since the decision came out and said that, while Alice undoubtedly caused some confusion and disarray for practitioners, “we’re in a better place today than we were two or five years ago.” Hirshfeld explained that the Office’s initial approach to providing guidance for examiners on Alice was to use a “case law matching process,” which eventually became untenable after years of case law had built up. He said that the January 2019 Guidance—which Hirshfeld noted is also binding on the Patent Trial and Appeal Board—was developed over an intensive eight-month period by a small team of people that included Director Andrei Iancu himself and involved at least one full Sunday. He added that the examiner training effort for the 101 Guidance has also been more thorough than any he’s seen in his 25 years at the USPTO. The Office is currently in the process of developing additional concrete case examples for examiners and practitioners to work with in order to further enhance the guidance.

When it was announced that I would be testifying to the Senate Judiciary Subcommittee on IP about Section 101, I was surprised. Not only did they grant a critic of the 101 roundtables a chance to speak, but not one inventor who used patents to fund a startup has testified in any patent-related hearing in decades. This gave me faith that Senators Tillis and Coons are serious about fixing 101 right by considering what inventors need. When the hearing was announced, several inventors contacted me. They wanted to personally tell their stories to Congress. They trusted the government to protect them, but instead lost their careers, their secrets, and their investments of hard work and money. A few even lost their families, their home, or their health. The inventors were happy about eliminating all 101 exceptions, but the draft language of 100(k) and 112(f) transfer the damage to those sections.

The landmark judgment of the Supreme Court of India in Novartis AG & Ors. .v. Union of India & Ors. AIR 2013 SC 1311, a case that dealt with the patenting of a polymorphic form of the anti-cancer drug Imatinib mesylate, created a furor at the international level, particularly within the pharmaceutical and drug discovery communities. This fear and confusion have only been exacerbated by subsequent decisions by Indian courts rejecting patents for a series of pharmaceutical substances. Most of these decisions centered on section 3(d) of the Indian Patent Act, which was introduced in 2005. In the midst of these controversies, it has gone unnoticed that patented drugs are becoming more common at the commercial level in India. The country is slowly moving to an exclusive patent regime for new drug substances similar to that of major markets like the United States and Europe. Recognition of this trend has been obfuscated by the controversy over section 3(d).

This week in Other Barks & Bites: Senators Tillis and Coons ask federal agencies to step up enforcement against IP theft; Senator Stabenow and Congressman Cummings ask GAO to review government’s drug patent authority; USPTO Director Iancu says that Congress will have to fix patent eligibility problems; China releases a new national IP strategy after the U.S. halts IP theft proceedings at the WTO; Adidas loses European trademark for three-stripe logo; VidAngel ordered to pay more than $60 million over copyright infringement; music lyric site Genius accuses Google of ripping content for its own platform; and Apple asks the United States Trade Representative to rescind tariffs that would affect consumer tech goods.

During the week of June 10, the Patent Trial and Appeal Board (PTAB) issued institution decisions for 21 petitions seeking inter partes review (IPR) proceedings to challenge the validity of patents. In all, the PTAB instituted seven IPRs, denied eight, and terminated another six after granting motions for joinder. That latter group of IPRs were petitioned by Priceline.com and Booking.com, both of whom were successful in joining Shopify IPRs challenging the validity of three patents owned by DDR Holdings. The most IPR denials last week were issued to Comcast, but those petitions were denied in large part because they all challenged a patent which already had a pending IPR proceeding instituted against it. Other successful petitions at the PTAB included three IPRs instituted for 3Shape A/S, two IPRS instituted for ASM IP Holding, and one instituted for Cook Incorporated.

The growing debate over the effects of patents on the rising price of pharmaceuticals continues to encourage the introduction of drug pricing-focused bills in Congress over the past few months. Most recently, a pair of proposed bills have been introduced which seek to limit the ability to patent follow-on innovations involving medicines which have already received patent protection in one level of dosage or method of administration. On June 12, a press release announced the introduction of the Terminating the Extension of Rights Misappropriated (TERM) Act into the U.S. House of Representatives. The bill is sponsored by a bipartisan coalition including Representatives Hakeem Jeffries (D-NY), Doug Collins (R-GA), Debbie Mucarsel-Powell (D-FL) and Ben Cline (R-VA). According to the release, this proposed law looks to change the burden of proving patentability of a drug-related invention under existing patent statute from generic drugmakers challenging drug patents to the pharmaceutical research and development firms filing patent applications.

Since the Supreme Court issued its decision in Alice v. CLS Bank five years ago today, patent eligibility jurisprudence and practice have become increasingly chaotic—at least in the opinion of many IP stakeholders and the members of Congress who are spearheading the effort to rectify the situation. Today, to commemorate Alice’s five-year anniversary/ birthday, IPWatchdog posed the following—admittedly somewhat leading—statement to a cross-section of the IP community, and gave them a chance to agree or disagree with it. Many did not respond—including the Electronic Frontier Foundation and Google—perhaps because of the sensitive moment in the history of patent eligibility law in which we find ourselves right now. However, the responses below do reflect a range of views on the impact of the case so far.

Today is Alice’s fifth birthday; some may not be celebrating, but as a birthday gift, John Vandenberg argues the decision was not new law and should not be abrogated. – On the third day of the U.S. Senate Judiciary Committee – IP Subcommittee’s hearings this month on whether to radically revise the standards for patent eligibility, I testified on behalf of our patent system’s under-appreciated second engine of innovation. Below are some of the key arguments I made in my oral and written testimony and my thoughts on why the Alice Corp. v. CLS Bank decision was good law that should not be abrogated. Much of the anti-Alice commentary touts our patent system’s first engine of innovation, which uses the lure of monopoly profits or royalties to incentivize innovation and the public disclosure of those innovations. Today’s Sec. 101 jurisprudence is said to harm that first engine of innovation, particularly in life sciences where it is easier to get a patent in Europe and China than in the U.S., causing investment in personalized therapy and medicine R&D in the U.S. to suffer. While some question those factual premises, the “101 status quo” camp primarily responds that Alice (along with IPRs) has curtailed abusive patent troll litigation, cutting patent litigation costs by 40% or more. But, another important point has received little attention: expanding what can be patented, and how claimed, risks harming our patent system’s second engine of innovation.

Here’s the hypothetical: A patent application has been filed for a new medical device. The device reads various physiological signals from a patient and presents, with previously unheard-of accuracy and reliability, the condition of the patient’s immune system.

Your client, who made a heavy investment in research and development of this device, wants U.S. patent protection, and is willing to pursue remedies in court if necessary.

A patent application has been filed. The subject matter has been claimed as a device and as a method. The claimed method recites actions performed with the physical components of the device.
To your client’s disappointment, a hypothetical examiner has rejected the claims as patent ineligible under section 101. The examiner relied principally upon the case of Electric Power Group, LLC v. Alstom, 830 F.3d 1350 (Fed. Cir. 2018), concluding that the method claims and the device claims “are directed to a patent-ineligible concept, namely, collecting information, analyzing it, and displaying certain results of the collection and analysis.”  If the “directed to” inquiry means that patent eligibility depends upon what the device does, then the examiner has a legitimate point invoking the Electric Power case. Your client’s device does indeed collect information, analyze that information, and display the results of the analysis. Even though the examiner had a legitimate point, that does not mean the examiner is correct; but it does mean that there is a good chance that the examiner will not reverse the stated position on ineligibility. You have, therefore, advised your client of the foreseeability that your quest for patent protection will have to go to the Patent Trial and Appeal Board (PTAB), and may well end up in court. Your client is ready to go the distance. Your immediate job is to respond to the pending rejection. You must argue in favor of patent eligibility under section 101. You must preserve the arguments you expect to make in the foreseeable appeals, even if you have confidence that the examiner’s ruling on patent eligibility will not be reversed by the examiner. You do not want to be in the position where an appellate tribunal points out that you are making arguments for the first time on appeal.

Late last week, the Federal Circuit issued Power Integrations, Inc. v. Semiconductor Components Indus., LLC and Regents of the Univ. of Minnesota v. LSI Corp. These two precedential decisions bring further clarity to who is subject to the time bar for filing petitions for inter partes review (IPR) and whether sovereign immunity protects patents from being subject to IPR challenges. The key takeaways are: (1) Consider the impact of mergers and acquisitions on IPR petitions, including those that have already been filed; and (2) Patents owned by states (including, state universities and research institutions) can be challenged in an IPR.