TPP Agreement would reduce data exclusivity for pharma, bio

Trade partners negotiating the Trans-Pacific Partnership trade deal have reached an agreement, although it may be months, or even more than a year, before the Obama Administration submits the deal to Congress for approval. The agreement details have not been officially released, and likely will not be for at least a month, perhaps longer.

The New York Times, POLITICO and others are reporting that, in order to reach an agreement, the United States granted a key concession relating to biologics, which are advanced medicines made from living organisms. Presently, the United States provides 12 years of data exclusivity for these types of medicines, but the TPP agreement reportedly knocks that term of protection down to 5 years.

A leaked version of the TPP from WikiLeaks, if indeed an accurate representation of the TPP, confirms that data exclusivity for 5 years was agreed to by the Obama Administration. Specifically, Article QQ.E.16.1(a), which relates to data protection for pharmaceutical test data, reads as follows:

If a Party requires, as a condition for granting marketing approval for a new pharmaceutical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product, the Party shall not permit third persons, without the consent of the person who previously submitted such information, to market the same or a similar product on the basis of:

(i) that information; or

(ii) the marketing approval granted to the person who submitted such information

for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of the Party.

(emphasis added).

Article QQ.E.20(1) on biologics reads:

With regard to protecting new biologics, a Party shall either:

(a)  with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic62,63, provide effective market protection through the implementation of Article QQ.E.16.1 and Article QQ.E.16.3 mutatis mutandis for a period of at least 8 years from the date of first marketing approval of that product in that Party; or alternatively

(b)  with respect to the first marketing approval in a Party of a new pharmaceutical product that is or contains a biologic, provide effective market protection:

Without Prejudice

(i)  through the implementation of Articles QQ.E.16.1 and QQ.E.16.3 mutatis mutandis for a period of at least 5 years from the date of first marketing approval of that product in that Party;

(ii)  through other measures; and

(iii)  recognizing that market circumstances also contribute to effective market protection

to deliver a comparable outcome in the market.

(emphasis added).

Thus, the TPP will offer different data exclusivity for pharmaceuticals (at least five years) and biologics (at least 5 years, but perhaps as long as 8 years).

While the term of data exclusivity is not one and the same with the term of market exclusivity, there is little doubt that more limited data exclusivity would likely lead to significant negative consequences for the bio-pharma industry.

According to POLITICO, some countries viewed 12 years of data protection as prohibitively expensive as they search for ways to offer such treatments to their population. The U.S. government, specifically the Obama Administration, has also long wanted a more limited term for data exclusivity.

Stay tuned as the official agreement is released and debate in Congress begins.

10.29.15 | Biotech, Pharma, posts | Gene Quinn

A patent reform conversation with Senator Coons and Congressman Massie

On Wednesday, October 7, 2015, I moderated a live Google Hangout with U.S. Senator Chris Coons (D-DE) and Congressman Thomas Massie (R-KY). The conversation took place in Senator Coons’ office in the Russell Senate Office Building in Washington, DC. Our conversation, hosted by the Innovation Alliance’s save the inventor campaign, focused on the major pending patent reform bills – the Innovation Act (H.R. 9) in the House of Representatives and the PATENT Act (S. 1137) in the Senate.

The first question I posed to Senator Coons and Congressman Massie was a broad-based, philosophical question. Unlike with virtually all other issues, patent reform is not a partisan political issue. Allegiance does not break down along party lines, but rather seems to depend philosophically on whether the individual believes patents promote innovation or whether patents hinder the progress of innovation. To start, I asked that simple question. Do patents promote or hinder innovation?

Senator Coons, who is a believer in s strong patent system, didn’t directly answer the question presented, although he did acknowledge that the question is “whether or not you think patents are essential and being able to defend those patents are essential to the vibrancy of our innovation system.” While he did not specifically say that he thinks patents are essential in this exchange, Senator Coons is on record with such views in many different forums. He is also the author and primary sponsor of the STRONG Patents Act, which presents an alternative patent reform that is widely recognized as being pro-patent and pro-innovator.

Coons, who spoke without notes and in a way that demonstrates a deep understanding of the issues, continually reiterated the need for patents to be defendable in court. He said, for instance:

Common across the advocates for a strong patent system in the House and the Senate is a profound belief that this constitutionally created and vital property right has to be defensible…that patent litigation has to remain capable of defending unique inventions, thus the Save the Inventor campaign. And those who are advancing the bills both in the House and the Senate that would change the patent litigation system are gravely concerned about what they view as so-called patent trolls and in the only hearing that we had in the Senate Judiciary Committee to discuss the bill in the current Congress, they really focused in on abusive patent litigation practices that do exist and that are a problem, but that I think can be dealt with more narrowly in a more focused and targeted way that just deals with abusive litigation practices…

On the issue of whether patents promote innovation, Congressman Massie’s response was hardly surprising to anyone familiar with the patent debate and Massie’s history. Massie is an inventor and one of only a few members of Congress to be a patent owner. He comes by his deeply rooted opinions out of experiences as an inventor and struggling entrepreneur. He said:

Well, you don’t have to believe or not believe, right? We’ve got 250 years of history in this country of innovation and we have the most innovation because we have the strongest patent system. The deal that our founding fathers gave us that was different from all the European models was what you create you own. And the charge that our Founding Fathers gave us in Congress was to promote the useful arts and sciences by granting for a limited period of time the exclusive use of an inventor’s works. So what we have to do is to decide, within that charter, how do you promote useful arts and sciences, and for what period of time? There are some people that believe that zero period of time is the correct period of time. That does not work.

Massie would then pivot to explain his own story, which is a very familiar story of an inventor starting from nothing to create a business built on the back of patented technology. Massie explained:

I’m not a lawyer, I’m an engineer. I went to MIT and I studied electrical and mechanical engineering because I love creating and right there in the laboratory and in the labs next to me people were inventing stuff all of the time and the great thing about being there in that hotbed at MIT is everybody wanted to start a company and the way you started a company was you had to go get capital and nobody was going to invest unless you had some intellectual property. So my startup that I spun out of MIT, my wife and I…we started right there in a married student housing dormitory…was licensed from MIT, from the Technology Licensing Office. Then, we went out and got venture capital and they believed in us and they knew we had a chance, but we had this limited period of time to get a return on that investment before the invention became public domain. That’s the great thing about patents. The deal you make with society is I’m going to tell you everything about how to copy this idea, and when my exclusivity lapses, everybody in the world can have it.

The entire video is available via YouTube. For a more complete transcript, please visit


10.19.15 | posts | Gene Quinn

CAFC says district court erred in refusing Apple permanent injunction against Samsung

Recently, the United States Court of Appeals for the Federal Circuit issued another in the long list of judicial decisions in the ongoing patent saga between Apple and Samsung. See Apple v. Samsung Electronics (Fed. Cir. Sept. 17, 2015).

This latest appeal arises from a suit filed by Apple against Samsung in February 2012 alleging infringement of five patents directed to smartphone and tablet interfaces. The district court held on summary judgment that Samsung infringed U.S. Patent No. 8,074,172. The case proceeded to trial, and a jury found that nine Samsung products infringed one or both of Apple’s U.S. Patent Nos. 5,946,647 and 8,046,721. The jury awarded Apple a total of $119,625,000 for Samsung’s infringement of the three patents.

Following the verdict, Apple filed a motion seeking a permanent injunction that would bar Samsung from making, using, selling, developing, advertising, or importing into the United States software or code capable of implementing the infringing features in its products. Apple did not seek to enjoin Samsung’s infringing smartphones and tablets, but only the infringing features. Moreover, Apple’s proposed injunction included a 30-day “sunset period” that would stay enforcement of the injunction until 30 days after it was entered by the district court, during which time Samsung could design around the infringing features. This “sunset period” coincided with Samsung’s representations at trial that it could remove the infringing features from its products quickly and easily.

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10.9.15 | posts | Gene Quinn

CAFC rules IPR petitioner bears burden to establish entitlement to provisional priority

Several weeks ago, the United States Court of Appeals for the Federal Circuit issued a decision in Dynamic Drinkware v. National Graphics, which asked the Court to determine who has the burden with respect to whether a provisional patent application sufficiently supports a later-issued patent so as to become effective prior art as of the provisional filing date in an inter partes review.

National Graphics owns U.S. Patent 6,635,196, which is directed to making molded plastic articles bearing a “lenticular” image. The ’196 patent issued on October 21, 2003, from an application filed on November 22, 2000. The ’196 patent claims the benefit of U.S. Provisional Application 60/211,112, filed on June 12, 2000.

Dynamic petitioned the PTO for inter partes review of the ’196 patent. In its petition, Dynamic argued that claims 1, 8, 12, and 14 of the ’196 patent were anticipated by U.S. Patent 7,153,555 (“Raymond”). The application for Raymond was filed on May 5, 2000, claiming the benefit of U.S. Provisional Application 60/182,490 (the “provisional application” or “Raymond provisional application”), filed on February 15, 2000. The PTO granted the petition in part, and instituted trial on claims 1 and 12.

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CAFC says laches still a defense to patent infringement

Recently, the United States Court of Appeals for the Federal Circuit, sitting en banc, decided SCA Hygiene Products Aktiebolag v. First Quality Baby Products, which required the Court to determine the continued applicability of the laches defense for patent infringement actions. This issue presents itself in light of the Supreme Court’s recent decision in Petrella v. Metro-Goldwyn-Mayer, Inc., 134 S. Ct. 1962 (2014), which determined that laches is not a defense to a copyright infringement action brought within the statute of limitation.

Petrella involved an assertion that Metro-Goldwyn-Mayer’s (“MGM”) 1980 film “Raging Bull” infringed a copyright in a 1963 screenplay authored by Frank Petrella. Frank Petrella’s daughter renewed the copyright in 1991, but did not contact MGM until seven years later. Over the next two years, Petrella and MGM exchanged letters concerning Petrella’s copyright claim. Petrella then went silent, and did not file suit until January 6, 2009, about nine years after her last correspondence with MGM. MGM moved for summary judgment based on laches, which the district court granted and the Ninth Circuit affirmed.

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