Posts Tagged: "pharmaceuticals"

During a hearing of the Senate Committee on the Judiciary on Tuesday titled, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition,” senators heard from five witnesses about proposals to lower drug prices for Americans and what role the patent system plays in the high cost of prescription drugs. The witnesses included two professors, a patient advocate, the Director of South Carolina’s Department of Health and Human Services, and the Executive Vice President and General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA). The hearing is one of several so far this term on the topic. Judiciary Committee Chair, Lindsey Graham (R-SC), opened the hearing by summing up the problem they faced in a question: essentially, how do we make sure that America continues to be the most innovative place on the planet and avoid killing the “goose that laid the golden egg,” without having a system that drives up cost for the consumer? Graham said he expects the committee will move on legislation related to patents and prescription drug pricing this year, and there seemed to be broad agreement on at least one bill currently under consideration—the CREATES Act of 2019, which has been floating around Congress since 2016.

High prescription drug prices and their impact on costs borne by the government in Medicaid, Medicare Part D and other federal programs, is a front burner topic in Washington. The President has committed to reducing the price of prescription drugs, and pressured drug companies to hold the line. The Department of Health and Human Services (HHS) has proposed two regulatory initiatives—price disclosure in drug advertising and foreclosing rebates from manufacturers to pharmacy benefits managers (PBMs)—aimed at pushing prices down. Some Democrats have urged more sweeping actions, such as having the government negotiate Medicare drug pricing as a single buyer or regulating drug prices by reference to an international index based on government-negotiated drug prices abroad. These proposals cannot solve the drug pricing problem. The Administration’s proposals merely tweak the status quo and put no effective restraint on new drug prices. Jawboning by the Executive has had a minimal impact. Disclosure of manufacturers’ list prices, unless accompanied by numerous and inherently confusing caveats highlighting the difference between those prices and the co-pay an insured consumer must bear at retail, is potentially misleading and, in any event, has no direct impact on prices. Eliminating rebates, as HHS’s rulemaking acknowledged, will inevitably raise health insurance costs now partly paid for by rebates while manufacturers’ pricing power remains unabated. The Democrats’ call for government power buying or price regulation would impact drug prices but also require politically sensitive government determinations about the “worth” of prescription drugs to patients—a significant step on the road to government-allocated health care. 

The year 2017 proved to be a difficult one for the territory of Puerto Rico. Even before Hurricane Maria hit in September of that year, the island was in trouble. By the end of year, the economy was predicted to shrink back to levels not seen since 2000, the average household income was a mere $19,350, one-half that of Mississippi, the poorest state in the nation. Meanwhile, the cost of living in San Juan, Puerto Rico’s capital, was 11.6% higher than in an average U.S. metropolitan area. The government was already dealing with $74 billion in bond debt and another $49 billion in unfunded pension obligations, with U.S. banks taking at least $1 billion to manage its bond sales. In the fall of 2017, after Maria hit head on as a Category 4 hurricane that caused catastrophic damage, the second blow to Puerto Rico was brewing—this time in Washington. The Republicans, being in control of the House, Senate, and the White House, drafted a tax reform bill that proposed the biggest change to the tax code in 30 years. Within that tax bill was a provision that was predicted to decimate what is left of Puerto Rico’s remaining economy. The tax bill proposed, and ultimately the President signed into law, a provision that levies a 12.5% tax on profits derived from foreign-owned intellectual property. This hits Puerto Rico in two ways. First, Puerto Rico has a complicated taxation relationship with the United States. Its citizens do not pay federal income taxes, although they do pay into Social Security. However, when it comes to taxation, the IRS considers Puerto Rico to be a foreign country. Thus, any profits derived from intellectual property in Puerto Rico would be considered foreign profits subject to the excise tax. The second problem is that Puerto Rico derives a great deal of its revenue from the manufacturing of prescription drugs, representing the very profits from intellectual property contemplated in the law. According to the U.S. Bureau of Labor Statistics, pharmaceuticals account for 72% of Puerto Rico’s 2017 exports, which was valued at $11.5 billion.

The Senate has a busy schedule related to tech and innovation topics for the week of April 8, including hearings on prescription drug pricing, broadband Internet coverage maps developed by the U.S. government, free speech on social media and tech platforms, and clean energy innovations to address climate change. The Senate Environment Committee also has a business meeting this week to discuss a piece of legislation that would support innovation in direct air carbon capture. This week’s tech and innovation lineup at the House of Representatives is a bit lighter, although there are hearings looking at a proposed bill to restore net neutrality, as well as a review of the 2020 budget request for the National Institute of Standards and Technology. Elsewhere, the Brookings Institution hosts events on EU-U.S. digital data collaboration and the impact of automation on the future of work, and the Information Technology and Innovation Foundation explores funding issues for the National Institutes of Health and their impact on American biomedical innovation.

Just as the drug pricing debate on Capitol Hill is heating up, an important new study, “The Bayh-Dole Act’s Vital Importance to the U.S. Life-Sciences Innovation System,” published by the Information Technology & Innovation Foundation (ITIF), underscores the law’s contribution to the United States’ lead in the life sciences. The report warns that attempts to misuse the march-in rights provision of the law to control drug prices would have serious consequences to our competitiveness and our health. Predictably, the critics condemned the report as “A lot of myth and propaganda.” Despite being repeatedly rebuffed, they continue to argue the law authorizes the government to license competitors if a resulting product isn’t “reasonably priced.” That debate spilled over to the Capitol Hill unveiling of the study, in which I participated. What happened there sheds a lot of light on the nature of the argument.

This week on Capitol Hill, both houses of Congress are abuzz with a full schedule of hearings related to science, technology and innovation topics. In the House of Representatives, various committees explore a proposed net neutrality bill, innovation in the aviation industry, and ways to improve competition in the pharmaceutical industry—a hot topic of debate in recent weeks. Both the House and the Senate will hold hearings on the future of America’s space program. The Senate will also consider consumer data privacy regulations, rural broadband investments, and military applications of artificial intelligence. On Tuesday, a pair of events at the Brookings Institution will look at the impact of technological advances on public policy, as well as the artificial intelligence race between the U.S. and China.

This week on Capitol Hill and in the Washington D.C. area, the Supreme Court grants cert in Iancu v. NantKwest; the U.S. House of Representatives will hold several hearings on important topics in technology, including electronic health records modernization for veterans, cybersecurity measures for voting systems and research on the nexus between energy and water. House committees will also explore ways to improve broadband access for small businesses and promote generic competition to reduce branded pharmaceutical prices. Drug pricing, which often involves a focus on patents, is the subject of a two-part hearing series in the U.S. Senate. Other Senate hearings this week will look at data breaches in the private sector and IP issues related to Chinese trade. The week is book-ended by a pair of events hosted by the Information Technology & Innovation Foundation, including a Thursday event that looks at the impact of the Bayh-Dole Act of 1980 and controversial calls to enforce certain provisions of the law to reduce drug prices.

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure prophylactic (PrEP) treatment to reduce the risk of contracting human immunodeficiency virus (HIV) in sexually active individuals. Recently, this HIV PrEP treatment and its patent have been thrust into the spotlight thanks to a commercial for Truvada that Gilead ran during the January 27 broadcast of Rent: Live on the Fox television network. While many were encouraged by the fact that a national TV network was raising awareness about PrEP treatment, the commercial sparked a return to a debate over the high price of Truvada. As of June 2018, news reports indicated that once-daily Truvada treatment cost about $1,500 per month, or around $18,000 per year. Although the cost of Truvada is often covered by health insurance, the treatment hasn’t been adopted as widely as was expected when the drug was approved. Between January 2012 and March 2014, a review of half of U.S. pharmacies by Gilead showed that only 3,253 had begun a PrEP regimen during that time, far less than the estimated 500,000 people who would make good candidates for Truvada. That number has expanded rapidly to 77,120 U.S. PrEP users in 2016 and an estimated 136,000 users by the end of 2017’s first quarter, but that’s still far short of the estimated 1.2 million American adults at high risk of HIV infection who could benefit from PrEP. “Based on feedback from partners and our work in the field, we believe that one of the greatest barriers to Truvada for PrEP access today is limited awareness of Truvada for PrEP’s role in HIV prevention,” Gilead told IPWatchdog. “Data from our patient support programs do not suggest that cost is a primary obstacle to treatment. The majority of people receiving Truvada for PrEP today who utilize our co-pay coupons pay less than $5 per bottle.”

Earlier this month, the Federal Circuit dismissed an appeal from the Patent Trial and Appeal Board (Board) where the Board upheld the patentability of a biologics patent. After Momenta Pharmaceuticals petitioned the Board for an inter partes review (IPR) of the patentability of Orencia® (abatacept), the Board sustained patentability and Momenta appealed. During the course of the appeal, Momenta ceased development of an abatacept biosimilar. The Federal Circuit held that the cessation of potential infringement mooted the injury and removed Momenta’s standing to maintain the appeal. Momenta Pharm., Inc. v. Bristol-Myers Squibb Co., No. 2017-1694, 2019 U.S. App. LEXIS 3786 (Fed. Cir. Feb. 7, 2019) (Before Newman, Dyk, and Chen, Circuit Judges) (Opinion for the Court, Newman, Circuit Judge).

Promoting public health has always been a bipartisan priority in Washington, D.C. Under the previous administration, lawmakers passed the 21st Century Cures Act and launched the cancer moonshot, two initiatives that aimed to transform health outcomes through greater investment in the next generation of medical treatments. In his State of the Union address last month, President Trump announced an ambitious plan to end HIV/AIDS by 2030 and increase funding for often-neglected childhood cancers. For each of these initiatives to be successful, lawmakers must recognize that investing in the cures of tomorrow requires continued bipartisan cooperation. This rings true for passing the U.S.-Mexico-Canada Agreement (USMCA), as well. The next generation of medical innovation depends on significant private sector investments. The intellectual property (IP) provisions of USMCA help to lay the foundation for continued investment into the research and development (R&D) of innovative cures across North America. In particular, the 10-year term of regulatory data protection for biologics will help ensure that North America continues to lead the world in developing life-saving technologies.

Last month, business news outlets were reporting that stock prices for pharmaceutical firms Pfizer and Merck took a tumble after financial analysts downgraded the performance of both firms over concerns about impending patent cliffs or exclusivity issues – although more recent reports paint a mostly promising picture for the companies, thanks to upcoming acquisitions. A pharmaceutical analyst for UBS downgraded Pfizer from buy to neutral, citing the loss of patent protection in the 2025 to 2029 timeframe for several drugs which contributed 30 percent of Pfizer’s total revenue in 2015. For Merck, although patent expiry wasn’t cited in a note from a pharmaceutical analyst from BMO, that analyst dropped Merck’s rating from outperform to market perform based on the expectation that the company’s blockbuster cancer drug Keytruda would face increased competition in the immuno-oncology field during 2019. As of January 30, stock prices for both firms were down by at least a dollar per share from their closing price on January 23. The downgrades for both firms are further proof of the importance of maintaining exclusivity through patent protection to pharmaceutical firms.

The success of a life science product, and thereby the company, rests heavily upon a combination of patent protection, regulatory exclusivity and product life cycle management. A company’s ability to formulate and articulate an integrated strategy is critical to obtaining investments, strategic partnerships and market success. In this two-part series, we will discuss recent judicial developments that affect life science companies’ IP strategies and also outline the four basic principles of an integrated IP strategy on which a company’s intellectual property audit and preparation for third-party diligence should focus. These are: (1) patent prosecution and strategy, (2) rights and ownership, (3) interplay of patent and regulatory exclusivity, and (4) freedom to operate and competitors. Part one will focus on patent prosecution and strategy, as well as rights and ownership.

Last week, the U.S. Court of Appeals for the Federal Circuit reversed a ruling of the U.S. District Court for the Eastern District of Virginia, which had affirmed a patent term adjustment (PTA) calculation of the United States Patent and Trademark Office (USPTO). See Supernus Pharmaceuticals, Inc. v. Iancu, No. 2017-1357 (January 23, 2019). The Federal Circuit held that the USPTO cannot count as applicant delay any period of time during which there was no possible action that the applicant could take to reasonably conclude prosecution. A sensible ruling, and one the panel explained was entirely consistent with both the PTA statute and Gilead Sciences, Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015). “A period of time including no identifiable efforts that could have been undertaken cannot be ‘equal to’ the period of failure to undertake reasonable efforts under the terms of the statute,” wrote Judge Reyna.

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.

The United States Court of Appeals for the Federal Circuit recently affirmed a district court decision finding the ‘229 patent valid, unexpired, enforceable, and infringed, and granting an injunction until February 2019. Specifically, the Federal Circuit held that the ‘229 patent’s five-year term extension pursuant to 35 U.S.C. § 156 was valid, even though it effectively extended the term of a related patent. The Court also held that the ‘229 patent was not invalid based on obviousness-type double patenting because obviousness-type double patenting cannot invalidate a patent which has received a valid term extension. Novartis AG v. Ezra Ventures LLC, No. 2017-2284, (Fed. Cir. Dec. 7, 2018) (Before Moore, Chen, and Hughes, Circuit Judges) (Opinion for the court by Chen, Circuit Judge).