Patent Baristas

We don’t usually plug movies around here but not too many movies have patent infringement as the major plot line.  Universal Pictures’ upcoming film titled Flash of Genius, starring Greg Kinnear, Lauren Graham, Dermot Mulroney and Alan Alda, tells the story of the landmark patent case of inventor Robert Kearns.

Billed as educational while also inspiring and entertaining, the early reviews have been positive.  The story is based on the true story of college professor and part-time inventor Robert Kearns’s (Greg Kinnear) long battle with the U.S. automobile industry and his fight to receive recognition for his invention.  Kearns took on a battle that nobody thought he could win.

Kearns invented and patented the intermittent windshield wiper mechanism for use in light rain or mist and tried to license it to the big automakers. They all rejected his idea and then some went ahead and put intermittent wipers in their cars beginning in 1969. In 1967, he received the first of more than 30 patents for his wipers.   He sued Ford in 1978 and Chrysler in 1982 for patent infringement.

Ford argued that Kearns’ patents were overly broad and therefore invalid.  In 1990, a jury decided that Ford infringed on Kearns’ patent, though it concluded the infringement was not deliberate. Ford had contended the patent was invalid because the windshield system contained no new concepts. But Kearns argued a new combination of parts made his invention unique.

That jury failed to reach agreement on how much he should be awarded, and another jury later ordered Ford to pay Kearns $6.3 million, trimmed by a judge to $5.2 million. To settle the case, Ford agreed to pay $10.2 million and to drop all appeals.  Chrysler ended up paying Kearns $18.7 million plus interest.

It is noteworthy that Kearns did not want to just collect license fees (what some might call a patent troll today) but instead wanted to be a manufacturer of the devices and supply that system to the automotive industry.  When Chrysler appealed to the Supreme Court, it ruled that Kearns was entitled to the money but rejected his argument that Chrysler should be prohibited from using his design

Interestingly, intermittent wipers came about after Kearns was hit in his left eye by a champagne cork on his wedding night in 1953. Later, Kearns was driving his Ford Galaxie through a light rain, and the constant movement of the wiper blades irritated his already troubled vision. He modeled his mechanism on the human eye, which automatically blinks every few seconds.

Some of the patents at issue:

• United States Patent 3,351,836, Windshield Wiper System with Intermittent Operation.
• United States Patent 3,602,790, Intermittent Windshield Wiper System.
• United States Patent 4,544,870, Intermittent windshield wiper control system with improved motor speed.

See the Flash of Genius trailer here. See more “flash of genius” here.

It appears that no matter who wins the presidential election this November, both Barack Obama and John McCain back expanded use of generic drugs as a way to lower drug costs,  According to their advisers, both campaigns have pledged their support to help create a market for generic biotech drugs or biosimilars.

As a part of their respective strategies to contain healthcare costs, both candidates want shorter exclusivity periods for branded biologics.  When generic biologic treatments (biogenerics) find a pathway in the U.S., the introduction of a biogenerics will put a serious damper on biopharmaceutical revenues.  I say when and not if since the government is the largest consumer of medical care via medicare and medicaid and given the fact that sales of biotech drugs were $40.3 billion last year.

The sticking point is (in general) that the brand name drugmakers and generics are unable to agree over just how long a biotech drug should be on the market before a generic drugmaker can market a generic. The Biotech Industry Organization has called for 14 years of market exclusivity, while  generic makers want the period limited to no more than five years of protection.

Not to be confused with patents, data exclusivity is the period after the FDA approves a product during which an imitator can’t rely on the innovator’s clinical data for safety and effectiveness. It can run during and longer than the period of patent protection.

The generic and biotech drug industries have spent a lot of cash lobbying Congress over how generic biotech drugs should be approved although McCain has not been the the sector’s favorite in terms of donations.  This is probably because McCain has also argued for re-importation to save money and he voted against the expansion of Medicare to include a drug benefit because it didn’t allow direct price negotiations by the government and because the program covers too many people.  You can see a complete side-by-side comparison of healthcare policy positions here.

The Center for Responsive Politics reports that McCain has received $39,797 in donations from pharmaceutical manufacturers. That puts him behind Obama ($154,710), Clinton ($140,544), Mitt Romney ($103,825), Rudy Giuliani ($91,550) and even Chris Dodd ($68,200)

Unlike traditional chemical drugs, biotech companies currently face no generic competition in the U.S. because the Food and Drug Administration lacks authority to approve copies of biotech medicines. Generally, biotech drugs are more complicated than regular drugs because they are made from living cells or bacteria.

For a generic drug manufacturer to win approval of a generic version of a traditional prescription drug, the product must have the same active ingredient, strength, dosage form and route of administration as the original drug. This means that generic drugs are the exact same chemically as their brand name counterparts and they act the same way in the body.

Such a process is not possible with biologics. Biologics manufacturers must ensure that the manufacturing process remains the same over time by controlling the source and nature of starting materials and controlling the manufacturing process. When a follow-on biologic is created, it requires a new manufacturing process with new starting materials. As a result, it will produce a product that is different from and not therapeutically equivalent with that of the brand name biologic.

In an earlier proposed update in the regulatory pathway for FDA approval of follow-on biologics, the Senate’s Senate Health, Education, Labor and Pensions HELP Committee gave the thumbs up to the Biologics Price Competition and Innovation Act of 2007 (S. 1695), which would address the scientific, regulatory and legal issues involved in bringing generic biologics to the marketplace.  See also H.R. 5629: Pathway for Biosimilars Act.

The legislation includes standards for the FDA to approve follow-on biologics as well as a period of exclusivity for the brand name drug company. The Act amends section 351 of the Public Health Service Act to provide for an approval pathway for safe biosimilar and interchangeable biological products (relying in part on the previous approval of a brand product):

• A biosimilar applicant is required to demonstrate that there are no clinically meaningful differences in safety, purity and potency between its product and the brand product. A demonstration of biosimilarity includes analytical data, animal testing and one or more clinical studies, unless such a requirement is determined by the FDA to be unnecessary.
• The Act provides incentives for the development of both new life-saving biological products and interchangeable biosimilar products: 12 years of data exclusivity for the brand company during which a biosimilar product may not be approved, and 1 year of exclusivity for the first interchangeable biological product.
• The biosimilar applicant must provide its application and information about its manufacturing process to the brand company. A series of informational exchanges then occur in which the biosimilar applicant and the brand company identify patents in question and explain their views as to their validity or infringement.

Earlier, BIO released a set of principles to guide the development of a pathway for the approval of follow-on biologics. BIO also developed a detailed rationale supporting the need for substantial data exclusivity. Meanwhile, generic manufacturers expressed concern that a 12 year exclusivity for the brand company is too long.

This issue will continue to be hotly debated.

See Primer for Follow-On Biologics.

Jon Dudas, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office has (proudly?) highlighted the fact that the allowance rate for patents is currently 42%.  This is in contrast to allowance rates in excess of 70% just eight years ago.  So, did patent applications really get that much worse in just a few years?

Also, the percentage of Board of Patent Appeals decisions in which the examiner is affirmed or affirmed in part has increased from 51% to 69%. Finally, since the pre-appeal brief program was established in midyear 2005, the percentage of applications reviewed under the program in which the examiners action is deemed correct has increased from 45% to 56%.

The drop in the approval rate of patent applications has increased the need for filing appeals, making patent protection more complicated, expensive and difficult to obtain.  In response to the changing winds, Prof. Kayton’s Patent Resources Group is introducing a new comprehensive course designed to train professionals to effectively manage appeals to the USPTO.

The course, entitled “When, Why and How to Effectively Appeal to the USPTO Board of Appeals and Interferences,” will teach attendees when to file an appeal to the USPTO, considering the nature of the examiner’s rejection(s) and the legal and technological issues involved.

The course rolls out on October 18 during Patent Resources Group’s upcoming Advanced Courses program in Santa Ana Pueblo, N.M.  The course will be taught by William F. Smith, who was an Administrative Patent Judge on the Board for 19 years.

The course comes at an opportune time, with the BPAI’s new rules going into effect in just a few months.  This course could help patent law practitioners save their companies millions of dollars in appeals prosecution.

In Janssen Pharma v. Apotex (08-1062), Apotex tried to get the federal circuit to grant a do-over of the dismissal of its declaratory judgment action for noninfringement against Janssen.

Janssen holds an approved NDA for its drug Risperdal® Oral Solution for which the Orange Book listed U.S. Patent Nos. 4,804,663, 5,453,425 and 5,616,587.  The ’663 patent has been the subject of prior litigation where it was found to be infringed, valid, and enforceable.  While Apotex was not a party to that trial, Apotex stipulated to infringement, validity, and enforceability of the ’663 patent based on the Federal Circuit opinion.

Prior to September 2002, Teva Pharma filed an ANDA to make a generic version of risperidone oral solution.  In filing its ANDA, Teva respected the validity of the ’663 patent by filing a Paragraph III Certification on that patent.  Teva was the first ANDA applicant to file a Paragraph IV Certification on the ’425 and ’587 patents.  As such, Teva is entitled to 180 days of generic market exclusivity.

Since Teva filed a Paragraph III Certification with respect to the ’663 patent, the FDA will not approve Teva’s generic product before the expiration of the ’663 patent.  Because Janssen did not sue Teva for infringing the ’425 and ’587 patents, the FDA will be able to approve Teva’s generic version of risperidone oral solution upon the expiration of the ’663 patent.

Teva will be able to commercially market its generic product immediately upon receiving FDA approval.   Then, Apotex submitted an ANDA application to the FDA seeking approval to market its generic version of risperidone oral solution, in which Apotex also filed Paragraph IV Certifications on the ’425 and ’587 patents.  Later, Apotex amended its ANDA and provided Janssen with an additional Paragraph IV Certification directed to the ’663 patent.

Janssen sued Apotex for infringing the ’663 patent but not on the ’425 and ’587 patents (collectively, the unasserted patents).  Apotex then asked for declaratory judgment of noninfringement of the two unasserted patents.

Janssen provided Apotex with a covenant-not-to-sue with respect to the ’425 and ’587 patents and the district court granted Janssen’s motion to dismiss Apotex’s counterclaims for lack of subject matter jurisdiction.  The district court found “no case or controversy” regarding the ’425 and ’527 patents.

Congress directed federal courts to exercise jurisdiction over ANDA Paragraph IV declaratory judgment actions “to the extent consistent with the Constitution.”  The relevant text of the Declaratory Judgment Act reads:

In a case of actual controversy within its jurisdiction . . . any court of the United States, upon the filing of an appropriate pleading, may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought.

In MedImmune, the Supreme Court emphasized that the dispute must be:

“definite and concrete, touching the legal relations of parties having adverse legal interests;” and that it be “real and substantial” and “admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a  hypothetical state of facts.”

Apotex argues that it is suffering three actual and continuing injuries which create a substantial controversy of sufficient immediacy to warrant the issuance of a declaratory judgment.  Specifically, Apotex argues that (1) it is unable to promptly launch its generic risperidone product and compete in the market immediately upon the expiration of the ’663 patent; (2) its approval of its noninfringing generic risperidone product is being indefinitely delayed; and (3) its affiliates, suppliers, and downstream customers face patent uncertainty because Janssen’s covenant-not-to-sue does not cover them.

Apotex argued that its inability to immediately launch their product on expiration of the ‘663 patent created a substantial controversy of sufficient immediacy to warrant the issuance of a declaratory judgment.  Without a declaratory judgment, Teva’s 180-day exclusivity period will commence when it commercially launches its generic risperidone product after the expiration of the ’663 patent.  Therefore, the earliest Apotex will be able to enter the market is 181 days after the expiration of the ’663 patent.

Note, if Apotex was successful on its declaratory judgment action, Teva’s 180-day exclusivity period would be triggered at a time that Teva will be unable to launch its generic product.  In spy-vs-spy fashion, one generic (Apotex) was trying to trip up the another generic’s (Teva’s) 180-day exclusivity period by having it exhausted prior to the expiration of the ’663 patent.  Therefore, Apotex would be able to enter the market immediately upon the expiration of the ’663 patent.

Apotex tried to rely on Caraco v. Forest Labs, in which the federal circuit held that despite the existence of a covenant-not-to-sue, a declaratory judgment claim brought under the Hatch-Waxman Act presents a justiciable Article III controversy.

The CAFC said Nay:

The key difference between Caraco and this case is that the harm that gave rise to the jurisdiction over the declaratory judgment claim in Caraco ceased to exist once Apotex stipulated to the validity, infringement, and enforceability of the ’663 patent.  Therefore, unlike Caraco, Apotex cannot claim that at the time of the district court’s dismissal it was being excluded from selling a noninfringing product by an invalid patent—it stipulated to the validity of the ’663 patent.  Even if Apotex successfully invalidates the ‘425 and ‘527 patents, it cannot obtain FDA approval until the expiration of the ‘663 patent because of its stipulations with respect to that patent.  Instead, the harm to Apotex that has continuously existed is its exclusion from selling its alleged noninfringing product during Teva’s statutorily entitled 180-day exclusivity period.  Apotex is being excluded from the market by Teva’s 180-day exclusivity period—a period which Teva is entitled to under the Hatch-Waxman Act.  This is a different injury than that alleged in Caraco.

Affirmed

The Food and Drug Administration (FDA) issued two Warning Letters to Ranbaxy Laboratories and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency’s concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India.

Because of the extent and nature of the violations, the FDA issued an Import Alert blocking any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The problems at these two Ranbaxy plants relate to deficiencies in the company’s drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products.

The announcement does not impact products from Ranbaxy’s other plants which are not affected by today’s actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The 30 drugs affected are posted on the FDA site (Drug List).

One Warning Letter addressed problems at Ranbaxy’s Dewas facility found during an inspection conducted by FDA in early 2008. Specific areas of concern included the following aspects of the firm’s quality control program:

• The facility’s beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
• Inadequate batch production and control records;
• Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
• Inadequate aseptic (sterile) processing operations.

The second Warning Letter addressed the Paonta Sahib facility.This inspection documented various cGMP deficiencies, including the following:

• The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP;
• Inaccurate written records of the cleaning and use of major equipment;
• Incomplete batch production and control records; and,
• Inadequate procedures for the review and approval of production and control records for drug products.

See the Notice here:  FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India

The USPTO is developing a Continuing Education for Practitioners (“CEP”) system for on-line delivery of educational materials for patent practitioners.  The goal of this whole business — according to the USPTO — is to increase efficiency, reduce pendency, and improve quality in the patent process.

For now, the USPTO trying out the system in a limited pilot program so we signed up to see what the scoop is.  Basically, the CEP program presents brief educational materials concerning recent USPTO rule changes, revised patent examination guidelines, or the like. The practitioner (that’s us) will have to respond to “verification questions” after reviewing the educational materials.

The verification questions are drawn from the training material and the practitioner has access to the educational material while responding to the questions. In other words, the verification questions are designed to verify you have actually viewed the materials instead of playing on-line poker (not that we’d do that, of course); they are not a test of knowledge or skills.

According to the literature, the total time spent reviewing the educational materials and responding to verification questions should be approximately one hour. Practitioners would be required to complete one CEP program per year. No fee will be charged to access the training materials (yippee!) and a fee would accrue only for failing to timely complete the training.

In going through the on-line materials, the Program offers a slick video presentation with synchronized slide presentation and written notes.  The first session provides an overview of the Supreme Court decision in KSR v. Teleflex, which incidentally will make it harder to get new patents and to defend existing ones. You could say the materials are “a flash to a genius.”

While the training materials gloss over the fact that KSR introduced yet more undefined terms like “real innovation” while continuing to lack definition for “obvious,” the introduction points out that the program covers only guidelines for Examiners to help determine obviousness [see Examination Guidelines published 10/10/07].  The guidelines are NOT substantive rulemaking.  So, the failure of an Examiner to follow the guidelines is neither appealable nor petitionable.

I have to admit, the last thing we like to hear is “Hey, how about spending more time not billing?”  However, given that the CEP will only require one hour per year (and at no cost), we think the program could provide a lot of benefit with minimal cost.

We’ll report back on our progress.

Senate Finance Committee Chairman Max Baucus (D-MT) and Sen. Orrin Hatch (R-Utah) introduced the International Intellectual Property Protection and Enforcement Act of 2008, legislation meant to crack down on the theft of U.S. intellectual property around the world.

The bill would compel the U.S. Trade Representative to develop action plans for countries on the piracy “Priority Watch List,” and empower the president with enforcement tools if corrective actions are not taken.  It would also ensure the placement of officials at foreign embassies tasked with enforcing American IP rights.

While the bill seems directed towards protecting big content provides, press release specifically mentions “the piracy of American films, the counterfeiting of American-designed products and other violations,” the bill would cover U.S. copyrights, trademarks, patents, and even unpatented product designs.

The International Intellectual Property Protection and Enforcement Act of 2008 requires the United States Trade Representative to spur countries that violate U.S. intellectual property rights to take specific steps to stop IP violations, provides funds to increase USTR’s capability to work with developing countries to improve IP protection and enforcement, and gives the president powerful enforcement tools to deal with countries that refuse to fight widespread theft of U.S. intellectual property.

Provisions of the Act include:

Action Plans. The bill requires the United States Trade Representative (USTR) to develop an action plan for each foreign country that has remained on USTR’s “Priority Watch List” of intellectual property deficient countries for at least one year. The action plan must list the legislative, enforcement, or other actions that the foreign country must take in order to achieve adequate and effective protection of intellectual property rights, and fair and equitable market access for U.S. companies that rely on intellectual property protection.

Enforcement Actions. If a foreign country has not complied with its action plan within one year, the bill authorizes the President to take various enforcement actions against the country. These actions include (1) prohibiting federal government procurement from the foreign country; (2) prohibiting new financing by the Overseas Private Investment Corporation and the Export-Import Bank of the United States with respect to projects in, or exports to, the foreign country; and (3) withdrawing any preferential treatment for which the foreign country qualifies under the Generalized System of Preferences or other U.S. preference programs.

Developing Country Assistance. The bill authorizes appropriations to USTR to assist developing countries in complying with their action plans. Such assistance may include capacity building, activities designed to increase awareness of intellectual property rights, and training for officials responsible for enforcing intellectual property rights in the developing country.

Congressional Report. The bill requires USTR to include, in its annual “Special 301” report, a description of the action plan developed for each country and the actions taken by each country pursuant to that plan.

Intellectual Property Officials. The bill requires the President to ensure that intellectual property officials are placed in the U.S. embassy of each foreign country that has a commercially significant relationship with the United States. The official will (1) serve as a liaison between the United States and the foreign country on matters relating to intellectual property protection and enforcement; and (2) gather and provide information requested by USTR for purposes of developing or determining compliance with the intellectual property action plans.

Expect this to go through harsh revisions.

In Prasco v. Medicis Pharmaceutical (07-1524), Prasco tried to get a declaratory judgment that one of its products did not infringe various patents owned by Medicis Pharmaceutical Corp. and Imaginative Research Associates. The district court dismissed the action for lack of jurisdiction, concluding that Prasco’s complaint failed to establish a case or controversy under Article III of the Constitution.

Medicis markets a benzoyl peroxide cleansing product TRIAZ®, which is marked as being covered by U.S. Patent Nos. 5,648,389; 5,254,334; 5,409,706; and 5,632,996.  Prasco, which makes a generic benzoyl peroxide cleansing product OSCIONâ„¢, wanted a declaratory judgment that OSCIONâ„¢ did not infringe the patents

This problem can also be viewed through one of the prongs of the ripeness doctrine, whether the complained-of-conduct has an “immediate and substantial impact” on the plaintiff such that withholding court consideration would cause hardship to the plaintiff. Article III courts cannot issue advisory opinions.

Prasco sent a sample of OSCIONâ„¢ and an ingredient list to Medicis and Imaginative Research Associates and requested a covenant not to sue under the four patents.  Medicis and Imaginative Research Associates returned the favor by pressing for a motion to dismiss.

The Supreme Court, in MedImmune v. Genentech, reaffirmed that the proper test for subject matter jurisdiction in declaratory judgment actions is “whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between the parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

The district court applied the Federal Circuit’s reasonable apprehension of suit test and found that Prasco had not alleged a case or controversy noting that even if MedImmune had overruled the reasonable apprehension of suit test, it would still conclude that there was no case or controversy because there was “no definite and concrete dispute that touches the legal relations of these parties.”

The Declaratory Judgment Act provides:

In a case of actual controversy within its jurisdiction . . .  any court of the United States, upon the filing of an appropriate pleading, may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought.

The Declaratory Judgment Act provides a remedy available only if the court has jurisdiction from some other source, limited by Article III of the Constitution, which restricts federal judicial power to the adjudication of “Cases” or “Controversies.”

Per MedImmune, for there to be a case or controversy under Article III, the dispute must be “definite and concrete, touching the legal relations of parties having adverse legal interests,” “real and substantial,” and “admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts.”

The standard is whether “the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

Prior to MedImmune, the federal circuit had generally required that a declaratory judgment plaintiff in a patent dispute demonstrate (1) conduct by the patentee that created a “reasonable apprehension” of suit on the part of the declaratory judgment plaintiff and (2) present activity by the declaratory judgment plaintiff that could constitute infringement or “meaningful preparation” to conduct potentially infringing activity.

However, in MedImmune, the Supreme Court found that requiring a reasonable apprehension of suit conflicted with the Court’s precedent. While the Supreme Court rejected the reasonable apprehension of suit test as the sole test for jurisdiction, it did not completely do away with the relevance of a reasonable apprehension of suit.  Rather, following MedImmune, proving a reasonable apprehension of suit is one of multiple ways that a declaratory judgment plaintiff can satisfy the more general all-the-circumstances test to establish that an action presents a justiciable Article III controversy.

Here, the Federal Circuit did not think that the facts created the necessary elements of a justiciable Article III controversy:

Considering the totality of the circumstances, Prasco has not alleged a controversy of sufficient “immediacy and reality” to create a justiciable controversy.  This “immediacy and reality” inquiry can be viewed through the lens of standing.  To satisfy standing, the plaintiff must allege (1) an injury-in-fact, i.e., a harm that is “‘concrete’ and actual or imminent, not ‘conjectural’ or ‘hypothetical,’” (2) that is “fairly traceable” to the defendant’s conduct, and (3) redressable by a favorable decision.

As Prasco acknowledges, MedImmune does not change our long-standing rule that the existence of a patent is not sufficient to establish declaratory judgment jurisdiction.  See Capo, Inc. v. Dioptics Med. Prods. Inc., 387 F.3d 1352, 1355 (Fed. Cir. 2004) (“More is needed than knowledge of . . . an adversely held patent.”).  The mere existence of a potentially adverse patent does not cause an injury nor create an imminent risk of an injury; absent action by the patentee, “a potential competitor . . . is legally free to market its product in the face of an adversely-held patent.”

Prasco argued that a case and controversy was created because Medicis caused Prasco to suffer an actual harm — namely, “paralyzing uncertainty” from fear that Medicis will bring an infringement suit against it.

The Federal Circuit thought differently:

To the contrary, notwithstanding this lawsuit, Prasco has launched its OSCIONâ„¢ product.  More importantly, the Supreme Court has emphasized that a fear of future harm that is only subjective is not an injury or threat of injury caused by the defendant that can be the basis of an Article III case or controversy.

Rather than a purely subjective fear or the mere existence of a potentially adverse patent alone, the alleged injury at the root of most justiciable declaratory judgment controversies in the patent context is a “restraint on the free exploitation of non-infringing goods,” or an imminent threat of such restraint.

Thus, for a patentee to cause an injury they would need to, for example, create a reasonable apprehension of an infringement suit, e.g., demanding the right to royalty payments or creating a barrier to the regulatory approval of a product that is necessary for marketing.

Here, Medicis’ silence was golden.

See also:

A Hint At The Effects of MedImmune
Practical Implications of MedImmune
Supreme Court High-Fives MedImmune