Wednesday, 30 May 2018

FDA Attempts to Shame Pharmacuetical and Biotechnology Companies

The U.S. Federal Drug Administration (FDA) recently decided to try to “shame” some pharmaceutical and biotechnology companies for failing to provide samples to companies who wish to produce generic versions of their pharmaceuticals.  The FDA states:

In passing the 1984 Hatch-Waxman Amendments to the Federal Food, Drug & Cosmetic Act, Congress created a system that balances encouraging and rewarding medical innovation with facilitating robust and timely market competition. One of the primary ways that FDA facilitates a competitive marketplace is through the efficient approval of generic drugs, which are often lower-cost than brand drugs.

Unfortunately, the process established by Congress may not always function as intended. At times, certain “gaming” tactics have been used to delay generic competition. One example of such gaming is when potential generic applicants are prevented from obtaining samples of certain brand products necessary to support approval of a generic drug. The inability of generic companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process – leading to delays in bringing affordable generic alternatives to patients in need.

As described in further detail below, these kinds of problems with generic access to necessary samples may occur when brand products are subject to limited distribution – whether the company has voluntarily adopted limitations on distribution, or the limitations have been imposed in connection with a Risk Evaluation and Mitigation Strategy (or REMS), a program that FDA implements for certain drugs to help ensure that their benefits outweigh their risks. In some cases, brand drug sponsors may use these limited distribution arrangements, whether or not they are REMS-related, as a basis for blocking potential generic applicants from accessing the samples they need.

As part of the FDA’s Drug Competition Action Plan (DCAP), FDA is committed – among other things – to addressing and improving transparency about this and other gaming tactics that delay the generic competition Congress intended.

There are around 50 drugs listed, including about 40 different pharmaceutical and biotechnology companies.  Do you think this tactic will work?  Interestingly, a New York Times article describes Celgene’s response, here. 

Tuesday, 22 May 2018

Gender Diversity in IP and Technology Policy: A New Resource and Way to get Noticed

The most recent WIPO Magazine is devoted to women and IP.  There are a number of fascinating articles concerning women involved in creating in various technology and artistic spaces.  One interesting story involves Sybilla Masters.  She “developed a way to process Indian corn in 1715 and her achievements were recorded in the patent document, the associated right was issued to her husband.  At that time, the prevailing laws stated that women could not own property.”  WIPO also discusses the gender gap in patent filings—only about 4% to 20% of patent applications include a female inventor depending on the country.  The United States is at 10%.  Interestingly, WIPO points to several causes of the gap: 1) fewer women in STEM fields; 2) “Female scientists and engineers are less likely than their male counterparts to think about commercializing their inventions, and are less comfortable marketing themselves and their work to potential business partners.;” and 3) Female scientists and engineers “are less likely to be invited to sit on prestigious scientific boards or advisory panels where they could meet potential innovation partners.” 

The Brookings Institute recently announced the creation of Sourcelist.  Sourcelist is a database of women who are experts in technology policy, and coming soon—a database of other diverse groups who are also experts in technology policy.  Sourcelist states that it was created because:

Recognizing that women and underrepresented genders in technology policy—a field at the intersection of Silicon Valley and the Washington Beltway—face a particular set of institutional barriers, we dedicated the first Sourcelist database to Women+. Issues associated with underrepresentation have not gone unnoticed, and countless organizations have made important progress in raising awareness of the problem and educating stakeholders on the importance of greater gender diversity. Sourcelist seeks to help in the last mile of those efforts; it is a resource for those looking to put good intention into practice.

This looks like a great idea!  If you are female, sign up to get on the list! 

Monday, 21 May 2018

Solutions in Search of a Problem: The Trademark Register Clogged?

Commentators have debated the question of whether there are too many trademarks.  Are we going to end up in a situation where there just are not enough good trademarks left, particularly wordmarks?  Some would argue that there is an inexhaustible supply of potential trademarks, particularly when considered with words and designs in combination.  A recent Wall Street Journal article asserts that U.S. intellectual property officials are concerned about a large number of applications filed in the United States by Chinese companies and citizens.  Apparently, part of the concern is with fraudulent applications. 

One of the curbs on excessive use of trademarks in the United States is the use requirement.  For most filings in the United States, there must be a use--or eventually a use with an intent to use based application.  Interestingly, CompuMark has released a survey which states that China will become the leader in trademark filings domestically and in the world by 2020.  According to CompuMark, China has filed "nearly 120,000 foreign trademark applications in 2017."  And, the number of trademark applications in the U.S. by Chinese companies or individuals has increased by 800% since 2014.  The Chinese trademark registry now has "over 5 million new trademark applications in 2017" and sixty percent of the trademark registrations in the world are in China.  In the U.S., trademark registrations stay in effect for a basic ten year term after the first five years.  

Let's assume there is a problem.  The problem is there aren't enough good trademarks for legitimate businesses and there's a potential for hold-up of legitimate businesses by "weak" marks.  I suppose another related problem is the increase in search costs due to avoiding a massive number of marks.  Some of our solutions could include increasing filing fees and maintenance fees.  Another solution is shortening the time periods for requiring fees.  The U.S. has very long terms.  We could shorten them to two to three years.  We could increase penalties for the filing of fraudulent marks, including increased penalties for the US attorney who files the marks.  We could lower the costs for challenging existing marks.  We could also create a way to dismiss spurious suits for trademark infringement early and penalize over-enforcement through cease and desist letters.  Many of these solutions have been proposed.  Is there a problem?  

Saturday, 5 May 2018

Trump Administration Releases Annual IP Report to Congress

The White House U.S. Intellectual Property Enforcement Coordinator has released its Annual Intellectual Property Report (Report) to Congress (around 170 pages!).  The Report outlines the Trump Administration’s approach to intellectual property policy and provides information concerning the activity of the various agencies in the U.S. government with duties related to intellectual property.  The bulk of the Report includes appendices which are descriptions of the work of each agency concerning intellectual property over the last year or so. 

The general thrust of the Trump Administration’s approach to intellectual property is stated by a President Trump quote:

“We will safeguard the copyrights, patents, trademarks, trade secrets, and other intellectual property that is so vital to our security and to our prosperity. We will uphold our values, we will defend our workers, and we will protect the innovations, creations, and inventions that power our magnificent country.” 

The Report outlines the Administration’s four-part strategic approach, which includes: 

• engagement with our trading partners; • effective use of all our legal authorities, including our trade tools; • expanded law enforcement action and cooperation, and • engagement and partnership with the private sector and other stakeholders.

Under the first strategic approach, the Report outlines various initiatives and activities across different agencies to engage and educate trading partners, including the USPTO’s Global Intellectual Property Academy.  Under the second strategic approach, the Report notes that the Trump Administration will strengthen the Committee on Foreign Investment in the United States as well as utilize the WTO Dispute Settlement process.  On the third strategic approach, the Report notes:

 At the end of FY 2017, the FBI had 228 pending IPR investigations. The largest number of investigations deal with the theft of trade secrets (79), copyright infringement (79),31 and trademark infringement (64).32 During FY 2017, the FBI initiated 44 new investigations, made 31 arrests, got 23 convictions, and had seizures totaling $750,205, forfeitures totaling $86,949, restitution totaling $53,396,003, and FIRE (Frozen, Indicted, Restrained, Encumbered) totaling $750,000. 

In FY 2017, the number of CBP and HSI IPR seizures increased more than eight percent, to 34,143 (from 31,560 in FY 2016). The total estimated Manufacturer’s Suggested Retail Price (MSRP) of the seized goods, had they been genuine, was $1,206,382,219.

In FY 2017, ICE-HSI initiated 713 intellectual property investigations and had 457 arrests, 288 indictments, and 240 convictions.

In FY 2017, the IPR Center vetted 27,856 investigative leads; of these 16,030 were referred to law enforcement partners. Additionally, the IPR center de-conflicted 4,750 investigative targets for partner agencies and industry. While performing these de-conflictions, the IPR Center identified 321 situations where two or more entities were investigating the same target. Finally, the IPR Center referred 959 leads to private industry for follow-up.  . . .

U.S. law enforcement and Federal agencies participated in Operation Pangea X, which was conducted from August 19, 2017 to September 19, 2017, with the participation of 123 countries, and culminated with a week of action, where participating countries and agencies conducted and/or reported the results of their respective operations. U.S. and Mexican authorities typically participate in Pangea independent of each other. However, in FY 2017, ICE-HSI, CBP, and Mexico collaborated during the U.S. operational phase of this operation. On September 25, 2017, INTERPOL issued a press release highlighting the results of Operation Pangea X, which resulted in 3,584 websites taken off-line, 400 arrests worldwide, and the seizure of 470,000 packages with an estimated value of $51 million in potentially dangerous medicine.

The IPR Center’s Operation Apothecary addresses, analyzes, and attacks potential vulnerabilities in the entry process that might allow for the Internet-facilitated smuggling of commercial quantities of counterfeit, unapproved, and/or adulterated drugs through international mail facilities, express courier hubs, and land borders. During FY 2017, Operation Apothecary resulted in 59 new cases, 38 arrests, 37 indictments, and 41 convictions, as well as 567 seizure incidents of counterfeit items.

On standard setting, the Report notes:

Standards Setting: Many of America’s economic competitors engage strategically in standards setting organizations (SSOs), often to the detriment of American innovators. As the Administration and American industry engage with SSOs, it will be important to ensure that SSOs are being used fairly to promote the adoption of new technologies, rather than impeding the ability for American innovators to continue creating and inventing.  And as SSOs promote the adoption of new technologies, such technologies should be available to industry under fair, reasonable and non-discriminatory terms.