The Federal Circuit in Shire v. Amneal, a Hatch-Waxman case, reaffirmed that the burden rests with the defendants to prove motivation for a person of ordinary skill in the art to arrive at a claimed chemical compound. The ANDA filer asserted that 18 claims of four Shire patents (U.S. Pat. Nos. 7,105,486; 7,655,630; 7,659,253; and 7,662,787) covering L-lysine-d-amphetamine (LDX) dimesylate (marketed as Vyvanse® to treat ADHD) were invalid due to obviousness. The court also considered whether an API supplier should be held liable for induced infringement for supplying the ANDA filers with the patented API.
Continue Reading Shire v. Amneal – Compound Claim Not Obvious and API Supplier Not Liable Under FDA Safe Harbor

The Patent Trial and Appeals Board (“PTAB”) recently ruled in IPR2015-00822 (“the ‘822 IPR”) that contractual estoppel, wherein the petitioner has signed a settlement agreement including a “no challenge” clause, cannot be asserted to preclude the institution of an inter partes review where the potential prejudice to the patent owner does not outweigh the prejudice to the petitioner of losing an opportunity to challenge the claims of a patent before the office.
Continue Reading Patent Licensors Beware – No Challenge Clause Does Not Bar Challenge Before the PTAB

Split infringement is an important consideration for personalized medicine patents because often one entity performs the diagnostic step, and a second entity performs the treatment step. Avoiding split infringement issues are difficult as diagnostic method claims alone must contend with subject matter eligibility problems, as discussed in our previous post. Adding a treatment step may make the claim patent eligible, so long as it passes muster under the Supreme Court’s Mayo decision.
Continue Reading Glimmer of Hope for Personalized Medicine Patents-Akamai

From biotech and pharmaceutical startups to Big Pharma, companies would likely not engage in drug development without the potential to recoup their significant investment through patent protection.1 These industries rely heavily on patent licensing to achieve returns on investment and to spread the risk of drug development. Thus, Kimble v. Marvel Entertainment, LLC,2 where the Supreme Court reaffirmed their precedent, Brulotte,3 will significantly impact pharmaceutical companies as they design their licensing arrangements. While post-expiration royalties remain unlawful per se, the Court emphasized that there remains a multitude of ways “to accomplish payment deferral and risk-spreading” through both licensing and other business arrangements.4
Continue Reading BioPharma Strategies – Kimble

In a previous blog post, we discussed the Federal Circuit’s reluctance to relinquish control of claim construction after the Supreme Court’s Teva1 ruling as exemplified in the Enzo2 decision. The trend continues with the Federal Circuit’s decision in Teva on remand from the Supreme Court just last month. A divided panel still found the asserted claims, specifically the term “molecular weight,”3 indefinite and therefore invalid, reversing the district court.4 The Supreme Court in Teva agreed with Teva that the Federal Circuit precedent5 of reviewing all aspects of claim construction de novo is inconsistent with Fed. R. Civ. P. 52(a)(6), which provides that factual findings of the district court may only be set aside if “clearly erroneous.”6 The Court explained that claim construction is ultimately a question of law, but subsidiary factual findings must be given deference and reviewed under the “clear error” standard of review.7 Also, while Teva was pending, the Supreme Court issued the Nautilus II8 decision, which modified the Federal Circuit’s “insolubly ambiguous” standard for indefiniteness under 35 U.S.C. § 112, ¶2 to a more stringent “reasonable certainty” standard.9
Continue Reading The Federal Circuit’s Continued Reluctance to Give Deference to the District Court Despite Expert Testimony

In a case involving Google’s “very cool”1 Street View technology, Google convinced the district court that its technology did not infringe four Verderi’s patents.2 But Google’s victory was short lived. The Federal Circuit disagreed with the district court on claim construction, and remanded the case to the district court to determine infringement based on the Federal Circuit’s own claim construction. Google applied for, and was recently denied, Supreme Court review.3
Continue Reading During Claim Construction, Claim Amendments Need Not Be Strictly Construed Against Applicant

Last month, the United States Court of Appeals for the Third Circuit overturned a district court’s dismissal of an antitrust suit challenging a Hatch-Waxman Act settlement that GlaxoSmithKline PLC (Glaxo) signed with Teva Pharmaceutical Industries Ltd. (Teva), over the epilepsy drug Lamictal.1

Continue Reading Pay-For-Delay Holding Extends to “Other Unusual, Unexplained Transfer of Value”

In previous posts “Will Formal Opinions Act as a Shield Against Charges of Induced Infringement?” and “What’s the Intent? Comparing Induced Infringement and Willfulness”, we discussed the impact of the Federal Circuit’s decision in Commil v. Cisco Systems on opinions of counsel. The Supreme Court recently overturned the Federal Circuit’s ruling in Commil, holding that a defendant’s belief regarding patent liability is not a defense to an induced infringement claim. In the opinion, the Court reaffirmed Global-Tech, which held that liability for induced infringement can only attach if the defendant knew of the patent and knew that the induced acts constitute patent infringement. The Court clarified that a person or entity who, for example, reads the patent’s claims differently than the patent holder, and the reading was reasonable, would not be liable for induced infringement. In other words, inducement “requires proof the defendant knew the acts were infringing.”2 The Court’s holding thus affirms that a reasonable opinion of counsel regarding non-infringement can be used to defend against a charge of induced infringement.
Continue Reading Written Opinions Remain Important Following the Supreme Court’s Decision in Commil

The United States government enjoys immunity from suit under the doctrine of sovereign immunity, the legal privilege by which American federal, state, and tribal governments cannot be sued. There are, however, statutes that grant limited waivers of the U.S. government’s sovereign immunity, e.g. with respect to: claims of monetary damages arising out of contracts with the government or for bad faith actions of government employees against a plaintiff.
Continue Reading Does the scope of immunity from assertions of patent infringement against U.S. government contractors under 28 U.S.C. § 1498 extend to acts of indirect infringement?

On May 7, 2015, the California Supreme Court revived a class-action lawsuit against pharmaceutical giant, Bayer AG, in which it was accused of violating the state’s antitrust law.1 A settlement agreement between Bayer and generic pharmaceutical, Barr Laboratories, is central to the dispute. In a 1997 agreement, Bayer paid Barr almost $400 million in cash, and Barr in turn withdrew its challenge on the validity of Bayer’s ciprofloxacin patent (i.e., U.S. Patent No. 4,670,444) and agreed to postpone marketing a generic version of Cipro until the patent expired. Ciprofloxacin was Bayer’s bestselling antibiotic, generating $6 billion in gross sales between 1997 and 2003. The 1997 settlement between Bayer and Barr produced a wave of state and federal antitrust suits. This appeal arose from nine such coordinated class action suits brought by indirect purchasers of Cipro in California against Bayer and Barr.2
Continue Reading Reverse Settlement Payments in Patent Disputes Come Under Scrutiny Under Both Federal Law and State Antitrust Law