FDA Lawyers Blog

Last week, the U.S. Patent and Trademark Office ("USPTO") instituted its first inter partes review of a design patent, U.S. Patent No. D617,465 ("the '465 Patent") assigned to Luv N' Care, Ltd. Petitioners, Munchkin, Inc. and Toys "R" Us, Inc., successfully persuaded the Patent Trial and Appeal Board that "there is a reasonable likelihood that Petitioners would prevail with respect to the sole claim of the '465 Patent."

The claim of the '465 Patent recites "the ornamental design for a drinking cup, as shown and described." The '465 Patent includes five figures of a drinking cup having a vessel, collar, and spout. The Petitioners alleged that the claim of the '465 Patent was obvious over U.S. Published Patent Application No. 2007/0221604 published September 27, 2007 ("Hakim '604") and, separately, obvious over U.S. Patent No. 6,994,225 issued February 7, 2006 ("Hakim '225"). The Petitioners also presented numerous combinations of references to assert that the claim of the '465 Patent was obvious. These additional obviousness arguments were grouped into nine categories according to the primary reference being asserted.

Written by Shelly Fujikawa. Ph.D

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As an initial matter, the Board addressed the effective filing date of the claim of the '465 Patent since several asserted references were intervening prior art, in particular Hakim '604 and Hakim '225. The '465 Patent issued from U.S. Application Serial No. 29/292,909, which was filed on October 31, 2007, as a continuation of U.S. Application Serial No. 10/536,106 ("the '106 Application"), which is the national stage of PCT Patent Application PCT/US03/24400 filed August 5, 2003. The Board concluded that the claims were not entitled to the benefit of the filing date of the '106 Application, because the '106 Application did not have sufficient disclosure to demonstrate that the inventor possessed the claimed subject matter at the time of filing the '106 Application. In particular, the drawings of the '106 Application do not show the same design as the drawing of the '465 Patent.

On April 15, the U.S. Supreme Court heard oral arguments in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. et al., the famous case concerning the patent-eligibility of human gene patents. At issue is the validity of Myriad's patents on the human genes, BRCA1 and BRCA2, but ruling would surely cover the patent eligibility of all animal and plant genes and impact various biotechnology industries. Additional details may be found in previous blogs, for instance here and here.

The Justices appeared skeptical of Myriad's argument that isolated DNA is patent-eligible subject matter. Isolated DNA is DNA that is cut from a chromosome, resulting in an "isolated" piece of DNA that has the same nucleotide sequence as the naturally-occurring genomic DNA.

Written by Dan Constantinescu, Ph.D.

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The Justices compared Myriad's isolated DNA to the discovery of plants with medicinal properties. Justice Breyer commented that it was long-standing patent law that while particular applications of such a plant can be patented, the plant cannot be. If someone discovers a medicinal plant "he gets a patent on the process, on the use of the thing, but not the thing itself." Justice Sotomayor expressed her understanding that to obtain a patent "you had to take something and add to what nature does" and wondered, "how do you add to nature when all you are doing is copying its sequence?"

Over the past months, there has been a lot of speculation (see recent blogs here , here, and here) whether the White House's proposed budget would cause a sequester situation for FDA, resulting in potential layoffs or program cuts, in an era of new user fees for generic drugs and biosimilar biological products. While initial reports and temporary budget fixes (called continuing resolutions) appeared to keep FDA's user fees intact and available for use, FDA's Commissioner, Margaret A. Hamburg, M.D., recently reported to members of a biotechnology trade association, the Massachusetts Biotechnology Council ("MassBio"), that it was not clear what would happen with user fees in the new federal budget.

Released on April 10, the White House's proposed fiscal year 2014 budget is a mixed bag that has been called a "political document rather than a serious piece of legislation" with a "series of bargaining positions" that "would bleed pharma." On the one hand, the plan would appear to confirm that FDA's user fees would not be sequestered, given that it supported the $4.7 billion in total program budget requested by FDA, which included user fees that would help fund over 90 percent of the requested increases. On the other hand, the budget includes a myriad of proposals that would change the way the government pays for medical care and products. For example, Medicare (senior citizens' drug coverage) Part D manufacturer discounts for branded drugs would be increased from 50% to 75% in 2015 (rather than 2020) and low-income individuals would be pushed more to generic drugs by increasing certain copayments for branded drugs and lowering certain copayments for generic drugs.

Written by Brian J. Malkin

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Many of the more controversial proposals were nestled in a document called "Reducing the Deficit in a Smart and Balanced Way". Here, the White House proposes, among other things, several items to purportedly lower drug costs, including: 1) authorizing the Federal Trade Commission to stop companies from entering into certain "pay-for-delay" agreements (see below) and 2) beginning in 2014, to reduce biologic product exclusivity from 12 years to 7 years and prohibit additional periods of exclusivity for minor changes to product formulations. These two items could open up some unanticipated debate regarding the White House's budget.

On March 27, FLH attorneys Brian Malkin and Christopher Gosselin attended the International Trade Commission ("ITC") Trial Lawyer's Association ("ITCTLA") luncheon with administrative law judge ("ALJ") Thomas B. Pender. Judge Pender joined the ITC in October, 2011, and is one of six ALJs at the Commission.

Judge Pender arrived at the luncheon with a number of themes that he wanted to discuss. Chief among them is a concern shared by many other ALJs and district court judges about the scope of electronic discovery in today's litigation. He urged the practitioners in the room not to lose control of the paper, and to reign in the costs and scope of electronic discovery. In Pender's experience, less than 1% of all discovery becomes an exhibit, and less than 5% of those exhibits are ever argued. In addition to paring back discovery, Pender would like to see fewer patents and patent claims being asserted by complainants. Ultimately, Pender would like to see more efforts taken to reduce the cost of litigation at the ITC, and hopes that more streamlined cases will allow him to finish an Initial Determination in a year or less.

Written by Christopher Gosselin

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Judge Pender also suggested, on a related note, that big firms make an effort to send their associates "to the podium," both to give the associates valuable experience, and to reduce the cost of a trial. In his experience, well-prepared associates perform as well or better than partners who had less time to prepare. Pender cautioned parties to think twice before betting an entire case on one witness, and suggested that secondary witnesses could and should be handled by associates.

On February 11, the American Medical Association ("AMA") voiced its opinions regarding the U.S. Supreme Court's upcoming review of pharmaceutical patent litigation settlements that include payments to patent challengers, commonly referred to as "pay for delay" settlements.

As explained here, pay-for-delay settlements occur in the context of pharmaceutical litigation under the Hatch-Waxman Act. In a nutshell, they involve payments from a patent holder to a generic manufacturer (who has filed an abbreviated new drug application ("ANDA") relying on the patent holder's brand-name drug product and been sued) in return for an agreement to refrain from selling the generic product for a period of time. These settlement deals have become targets of the antitrust enforcement agencies and, as widely predicted, the High Court has agreed to resolve a circuit split over their presumptive legality.

Written by Rachael P. McClure

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The question presented, from the 11th Circuit case FTC v. Actavis (Docket No. 12-416), is "whether reverse-payment agreements are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud (as the court below held), or instead are presumptively anticompetitive and unlawful (as the Third Circuit has held)." The Eleventh Circuit determined that the U.S. Federal Trade Commission's ("FTC's") assertion that a patent holder was "not likely to prevail" in the underlying infringement action against generic manufacturers did not assert a valid antitrust claim because focus is "on the potential exclusionary effect of the patent, not the likely exclusionary effect," and a settlement that imposes restraints lesser than that full potential effect do not exceed the "scope of the patent." The Third Circuit, conversely, applied a "quick look rule of reason," finding that "any payment from a patent holder to a generic patent challenger who agrees to delay entry into the market [is] prima facie evidence of an unreasonable restraint of trade," rebuttable by a "showing that the payment (1) was for a purpose other than delayed entry or (2) offers some pro-competitive benefit."

This Thursday, FLH Partner Brian J. Malkin will host Legal Office Hours at The Venture Café in Cambridge, Massachusetts. Mr. Malkin's Legal Office Hours description reads:

Learn how you can protect your start-up with patent and trademark protection from intellectual property Partner Brian J. Malkin, Frommer Lawrence & Haug LLP. Mr. Malkin is an expert on FDA-regulated products, in particular pharmaceutical/biotechnology products and biosimilars, and can discuss pathways for FDA approval, as well as life cycle management and due diligence investigations. Mr. Malkin recently published a chapter on biosimilars, has a primer on the drug and biologics approval process, frequently speaks on a variety of IP- and FDA-oriented topics, and is the editor of FDA Lawyers Blog, a blog that focuses on legal and scientific developments for FDA-regulated products.

The Venture Café was created to provide a resource for the Boston entrepreneurial and innovation communities. Our mission is to enable fresh and useful conversations.

Cambridge is a fountain of innovative spirit, spirit that needs a framework to reach its full potential. The Venture Café serves as a nexus for helping innovators and entrepreneurs find one another and collaborate to bring their dreams to reality.

Even in this digital world, it's important to have a physical space. Shared physical spaces provide common meeting ground and a forum for semi-serendipitous encounters that often foster brainstorming and drive creativity. Meeting in person establishes the trust that's so crucial to working together, particularly on risky, underfunded projects. The Venture Café can provide the framework upon which numerous experimental "applications" can be nurtured and launched.

On January 24 to a packed house, the Food, Drug and Cosmetic Law Section of the New York State Bar held its annual meeting. This year, the agenda featured presentations on medical devices, a Supreme Court update, an in-house/outside counsel panel to discuss effective relations for FDA/regulatory advice, a discussion of the Federal Sunshine Act, and "A View from the Inside" retrospective of some hot issues at FDA from a recent high-level official at FDA, including the new food and pharmacy initiatives under development.

In the Supreme Court update called "Pivotal Court Cases for FDA Practitioners 2012-2013 Updates", FLH Partner Brian J. Malkin, spoke on two cases to watch in the first quarter of 2013, Mutual Pharm. Co., Inc. v. Bartlett , No. 12-142 (U.S., cert. granted Nov. 30, 2012, argument scheduled Mar. 19, 2013) and Bowman v. Monsanto Co., No. 11-796 (U.S., cert. granted Oct. 5, 2012, argument scheduled Feb. 19, 2013). The question presented in Mutual v. Bartlett is:

Whether the First Circuit erred when it created a circuit split and held--in clear conflict with this Court's decisions in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)--that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products.

Written by Brian J. Malkin

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Bowman v. Monsanto is a case that my firm, Frommer Lawrence & Haug LLP, is arguing on behalf of petitioner Bowman, where the question presented is:

Patent exhaustion delimits rights of patent holders by eliminating the right to control or prohibit use of the invention after an authorized sale. In this case, the Federal Circuit refused to find exhaustion where a farmer used seeds purchased in an authorized sale for their natural and foreseeable purpose--namely, for planting. The question presented is: Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?

Mr. Malkin's summaries of these two cases may be found here. His presentation for these two cases, including topics for consideration by the Food, Drug, and Cosmetic Section may be found here.

Earlier this week, the U.S. Supreme Court denied GlaxoSmithKline's certiorari petition in a case that would have helped clarify the scope of 35 U.S.C. § 271(e)'s safe-harbor provision. The issue facing the Court was whether section 271(e)(1) applies to postmarketing activity as well as premarketing activity.

Section 271(e), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention "solely for uses reasonably related to the development and submission of information under [federal drug laws]," does not include a time limitation. The question about timing was highlighted in two recent Federal Circuit cases. In Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit explained that "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Last year, however, a different panel of judges in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) held that post-approval studies performed for the FDA fall within § 271(e)(1)'s safe harbor and explained that Classen held that 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."

Written by Scot B. Pittman

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As previously blogged on here, the Solicitor General had urged the Supreme Court to deny GSK's petition in the Classen case. Despite a belief that the Federal Circuit erred in Classen, United States Solicitor General Donald Verrilli offered the following reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit's Momenta decision sufficiently clarified and narrowed the Classen holding; (2) it was unclear whether the safe harbor applied to the types of patents at issue in the Classen case; and (3) the petitioners were not entitled to the safe harbor protection regardless of the Supreme Court's interpretation of the provision.

The Solicitor General has urged the U.S. Supreme Court to deny GlaxoSmithKline's ("GSK's") pending certiorari petition in GlaxoSmithKline v. Classen Immunotherapies, Inc., case number 11-1078 The issue facing the Supreme Court should it grant GSK's petition is whether the Federal Circuit correctly interpreted 35 U.S.C. § 271(e)(1)'s safe harbor as applying to only pre-market approval of generic counterparts. In its amicus brief submitted late last week, the Solicitor General explained that there is no need to clarify the safe harbor provision and voiced concerns that the Classen case would not be the proper vehicle to do so should the Supreme Court feel the need.

The dispute between GSK and Classen involves three patents, U.S. Patent Nos. 6,638,739, 6,420,139, and 5,723,283, which relate to methods of optimizing vaccine immunization schedules to decrease the risk of developing chronic immune-mediated disorders. Classen sued a number of defendants, including GSK, alleging infringement of its patents through various vaccination research projects. GSK's allegedly infringing activities related to its participation in a government study that evaluated a suggested association between the timing of childhood vaccinations and the risk of developing type 1 diabetes. GSK argued, and the district court agreed, that such activity was within section 271(e)(1)'s safe harbor because the information was ultimately submitted to FDA. On appeal, the Federal Circuit reversed, holding that section 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained." Classen Immunotherapies, Inc. v. Biogen Idec at 1070. The Federal Circuit further explained, "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Id. at 1071.

Written by Scot B. Pittman

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In the amicus brief, United States Solicitor General Donald Verrilli expressed his belief that the Federal Circuit's interpretation of § 271(e)(1) in Classen was incorrect. 35 U.S.C. 271(e)(1) reads:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

This Tuesday, the European Parliament approved European Union ("EU") regulations creating a European patent with unitary effect ("unitary patent") and setting forth related language translation requirements. The unitary patent, granted by the European Patent Office ("EPO"), will be offered in addition to already-existing national patents. It will be effective across the EU (except Spain and Italy) and enforceable with a single court ruling.

If ratified by at least thirteen states including France, Germany, and the United Kingdom, a Unified Patent Court ("UPC") will exercise exclusive jurisdiction over unitary patents. The UPC Agreement will come to vote in February of next year. (Notably, the Court of Justice of the EU ruled last March that a proposed unified patents court would not be compatible with EU treaties.) The unitary patent is set to take effect beginning in 2014 or when the UPC is ratified, whichever is earlier.

Written by Rachael P. McClure

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European Commissioner Michel Barnier declared the "long-awaited agreement" a "decisive contribution to the implementation of the economic and growth agenda." Barnier let the numbers speak for themselves: "In the United States, in 2011, 224 000 patents were granted, in China 172 000 while here in Europe only 62 000 European patents were delivered. One of the reasons for this difference is without a doubt the prohibitive cost and the complexity of obtaining patent protection throughout the single market."

On December 7, 2012, the U.S. Supreme Court granted the Federal Trade Commission's ("FTC's") certiorari petition and will address the question of whether settlements of Hatch-Waxman pharmaceutical patent litigation that include so-called "reverse-payments" are per se lawful unless the underlying patent litigation was a sham or the patent was obtained by fraud or, instead, are presumptively anticompetitive and unlawful.

As previously reported here, the FTC has repeatedly attacked reverse payment agreements between branded and generic pharmaceutical companies, alleging that such settlements--which the FTC also refers to as "pay-for-delay"--are a violation of antitrust laws. There is currently a split in the circuits regarding the legality of these agreements. In the decision now being reviewed by the Supreme Court, FTC v. Watson Pharmaceuticals, Inc. (involving the brand-name drug AndroGel), the Eleventh Circuit held that such settlements are legal so long as they fall within the "scope of the patent" and there is not evidence of sham litigation or fraud in obtaining the patent. Other courts have arrived at similar conclusions, including the Second Circuit (In re Tamoxifen Citrate Antitrust Litigation) and the Federal Circuit (In re Ciprofloxacin Hydrochloride Antitrust Litigation). In contrast, the Third Circuit's recent In re K-Dur Antitrust Litigation decision held that these agreements create a rebuttable presumption that the settlement is anticompetitive. Both Merck and Upsher-Smith filed petitions to the Supreme Court to review the Third Circuit's K-Dur decision; however, the Court has not yet announced whether it will grant those requests.

Written by Richard F. Kurz

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In AndroGel, the FTC asks the Supreme Court to adopt the Third Circuit's approach. The FTC argues that the "scope-of-the-patent approach in general, and the decision of the [Eleventh Circuit] in particular, reflect a misapplication of federal competition law." Thus, the FTC advocates for the Third Circuit's "approach, [in which] the restraints embodied in reverse-payment agreements are presumed to be anticompetitive, and the antitrust defendants--who, after all, have settled litigation against each other by agreeing not to compete--bear the burden of advancing some countervailing procompetitive virtue." (Internal quotation omitted).

On November 30, 2012, the U.S. Supreme Court decided to consider the question of whether human genes are patentable subject matter. The American Civil Liberties Union ("ACLU"), representing petitioner Association for Molecular Pathology, challenged Myriad Genetics' patents claiming "isolated" DNA molecules. The ACLU's position is that such patents improperly claim laws of nature and, thus, are not patentable. The Federal Circuit Court of Appeals disagreed, however, determining that Myriad's claims to isolated DNA molecules are patent-eligible. Now, the Supreme Court may have the final word.

At issue is the patentability of human genes, i.e., DNA. Natural DNA exists in the human body as one of forty-six large, contiguous DNA molecules. In contrast, isolated DNA is a free-standing portion of a larger, natural DNA molecule. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. The Federal Circuit reasoned that isolated DNA has a "markedly different chemical structure compared to native DNA." This is because isolated DNA results from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, which imparts a distinctive chemical identity on that isolated DNA. Thus, the Federal Circuit decided that the "claimed isolated DNA molecules are distinct from their natural existence as portions of their larger entities" and are patent-eligible subject matter.

Written by Richard F. Kurz

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In its Supreme Court petition, the ACLU argued that patents on isolated DNA improperly claim products and laws of nature because isolated DNA is defined according to a naturally-occurring functional characteristic, namely coding for a naturally-occurring polypeptide. The ACLU alleges that isolated DNA does not have markedly different characteristics from DNA found in nature because both are DNA, their structures are not markedly different, the protein coded by each is the same, and their use in storing and transmitting information about a person's heredity is identical. Based on this, the ACLU believes that isolated DNA is not patentable subject matter.

American Conference Institute's 2nd Comprehensive Guide to Patent Reform once again unites experienced in-house counsel from top innovators, private practice experts, and senior officials from the USPTO to answer patent professionals' most pressing questions, including:

• What does "first to file" actually mean under the AIA requirements? Which system can you or should you file under - the current first to invent or the new first to file (or both)? And how do you avoid first-to-file bubble filings before 3/15/2013?

• When can on-sale and public use activity be considered prior art? Has secret §102(f) prior art been eliminated?

• Do you need to include best mode in the application or not and what happens if you don't? Is best mode completely toothless now? How will examiners be able to address the best mode issue?

• What will be required in the PGR process? What type of discovery? Expert witnesses? How do the estoppel provisions alter your analysis of whether to engage in the PGR system?

• What estoppel provisions are associated with IPRs and how are these different from the inter partes reexamination provisions? When do you file a 3rd party parallel IPR?


For more information, please visit our website: www.americanconference.com/patentreform

FDA Lawyers Blog subscribers are entitled to a discount when referencing the code: FDA 200.

On November 7, 2012, FLH Partner Brian J. Malkin and Associate Christopher Gosselin were in attendance at this year's International Trade Commission Trial Lawyers Association Annual Meeting at the International Trade Commission ("ITC") in Washington, D.C. The theme of this year's meeting was the enforcement of ITC exclusion orders at the border, and the relationship between customs and the ITC.

ITC Chairman Irving A. Williamson opened the meeting, stressing his commitment to reducing the overall length of Section 337 Investigations from 16 months to 13.5 months. He also promised to continue efforts to reign in the cost of discovery during Section 337 Investigations.

Written by Christopher Gosselin

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During the refreshment break, guests were invited to view the new courtroom on the second floor, and heard brief remarks from Chief Administrative Law Judge ("ALJ") Charles E. Bullock. The new courtroom is spacious and well equipped with modern technology ranging from video projection screens to LCD monitors at every table. The courtroom should see plenty of use once it opens for business, as even with the new courtroom, the ITC still has more ALJs than available space. Although the ITC saw a 30% decrease in newly instituted investigations in 2012 after a record setting number in 2011, the ALJs continue to manage a near record level of active investigations.

K-V Pharmaceutical Company ("K-V") has taken the fight over its preterm-birth prevention drug, Makena® (17-hydroxypreogesterone caproate solution) ("HPC"), to the International Trade Commission ("ITC"). In its complaint, K-V asks the ITC to: (1) issue a temporary general exclusion order prohibiting any unauthorized importation of HPC and (2) issue a temporary cease and desist order stopping owners, importers, and consignees from importing, selling, offering for sale, distributing, or soliciting any HPC unless authorized by K-V.

K-V states that its merits argument will focus on the importation of HPC for the purpose of making compounded versions of Makena®. K-V argues that importation of HPC for use in compounding copies of Makena® is a violation of Section 337 of the Tariff Act of 1930. According to Section 337, "[u]nfair methods of competition and unfair acts in the importation of articles . . . in the United States, or in the sale of such articles by the owner, importer, or consignee, the threat or effect of which is . . . to destroy or substantially injure an industry in the United States," are "unlawful." 19 U.S.C. § 1337(a)(1)(A). K-V argues that, because all HPC in the United States comes from abroad, and the only use for HPC is in the manufacture of Makena® or allegedly unlawful copies of Makena®, the importation of HPC undermines federal law and K-V's statutory orphan drug exclusivity and "is clearly an unfair act and an unfair method of competition."

Written by Scot B. Pittman

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According to the Complaint, all the requisites for temporary relief are present. First, there will be immediate and irreparable harm to K-V because the pharmacies compounding copies of Makena® have diverted so much potential revenue from K-V that the drug company has had to file for Chapter 11 bankruptcy. Second, as mentioned above, there is a likelihood of success on the merits. K-V argues that the importation of HPC for the use in compounding violates the prohibition against mass-scale compounding and undermines K-V's statutory orphan drug exclusivity. These unfair acts and unfair methods of competition are threatening to destroy K-V, i.e., the domestic industry. Third, K-V argues that the following public interest factors favors granting the desired relief: (1) prevention of preterm births; (2) ensuring safe and effective drugs; (3) preservation of a domestic industry; and (4) effectuating Congress's intent to promote development of treatments for rare conditions. Finally, K-V states that it faces the balance of hardships. K-V argues that the compounding pharmacies have few, if any, protectable rights, whereas K-V has a "Congressionally-granted seven-year exclusive right to market Makena." Additionally, K-V notes that its business's survival depends on the success of Makena®, whereas the proposed respondents compound many other products and will survive if they are unable to compound Makena® during the exclusivity period.